ULTRASOUND PROBE EXAMINATION - WordPress.com · James T. Lee, MD, PhD University of Minnesota Minneapolis, MN William A. Rutala, PhD, MPH University of North Carolina Health Care

ULTRASOUND PROBE EXAMINATION

National & international guidelines for high level disinfection of probes used in semi-critical and critical conditions

ULTRASOUND PROBE EXAMINATION:

NATIONAL & INTERNATIONAL GUIDELINES

FOR HIGH LEVEL DISINFECTION OF PROBES

USED IN SEMI-CRITICAL AND CRITICAL CONDITIONS

As the risk of infection with ultrasound probes (endovaginal,

endorectal and external probes when used for biopsy) is

significantly high (see Risk Studies Book), National and

International Healthcare Authorities are expediting the release

of guidelines to contain the sanitary risk.

It is estimated that in a country like France where 4 million

endocavitary ultrasound probe examinations are performed every

year without systematic high-level disinfection between each

patient, 30 000 new infections occur each year.

Thus, many countries and international/national healthcare

societies have joined the position of the United States and

Canada that require high-level disinfection between each patient

for many years.

Guidelines for High Level Disinfection between each patient

1. USA / 2008 : extract of Center for Desease Control guidelines

2. Australia: jointly published by The Australian Society for Ultrasound in Medicine (ASUM) and by The Australasian

College for Infection Prevention and Control (ACIPC)/2017

3. Walles / 2014 : extract of guidelines 4. Scotland / 2016 : extract of guidelines 5. Ireland / 2017 : extract of guidelines 6. ECMUS (European Committee for Medical Ultrasound Safety)/

2017

7. WFUMB (World Federation of Ultrasound in Medecine and Biology)/ 2017

8. European Society of Radiology Ultrasound / Nov 2017 9. Society and College of Radiographers and British Medical

Ultrasound Society (BMUS) / Dec 2017 : extract of guidelines

1.USA / 2008 : extract of Center

for Desease Control guidelines

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008


William A. Rutala, Ph.D., M.P.H.1,2, David J. Weber, M.D., M.P.H.1,2, and the Healthcare

Infection Control Practices Advisory Committee (HICPAC)3

1Hospital Epidemiology University of North Carolina Health Care System Chapel Hill, NC 27514 2Division of Infectious Diseases University of North Carolina School of Medicine Chapel Hill, NC 27599-7030

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3HICPAC Members

Robert A. Weinstein, MD (Chair)

Cook County Hospital

Chicago, IL

Jane D. Siegel, MD (Co-Chair)

University of Texas Southwestern Medical Center

Dallas, TX

Michele L. Pearson, MD

(Executive Secretary)

Centers for Disease Control and Prevention

Atlanta, GA

Raymond Y.W. Chinn, MD

Sharp Memorial Hospital

San Diego, CA

Alfred DeMaria, Jr, MD

Massachusetts Department of Public Health

Jamaica Plain, MA

James T. Lee, MD, PhD

University of Minnesota

Minneapolis, MN

William A. Rutala, PhD, MPH

University of North Carolina Health Care System

Chapel Hill, NC

William E. Scheckler, MD

University of Wisconsin

Madison, WI

Beth H. Stover, RN

Kosair Children’s Hospital

Louisville, KY

Marjorie A. Underwood, RN, BSN CIC

Mt. Diablo Medical Center

Concord, CA

This guideline discusses use of products by healthcare personnel in healthcare settings such as

hospitals, ambulatory care and home care; the recommendations are not intended for consumer use of

the products discussed.

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As with laparoscopes and other equipment that enter sterile body sites, arthroscopes ideally

should be sterilized before used. Older studies demonstrated that these instruments were commonly

(57%) only high-level disinfected in the United States 28, 86

. A later survey (with a response rate of only

5%) reported that high-level disinfection was used by 31% and a sterilization process in the remainder of

the health-care facilities30

High-level disinfection rather than sterilization presumably has been used

because the incidence of infection is low and the few infections identified probably are unrelated to the

use of high-level disinfection rather than sterilization. A retrospective study of 12,505 arthroscopic

procedures found an infection rate of 0.04% (five infections) when arthroscopes were soaked in 2%

glutaraldehyde for 15–20 minutes. Four infections were caused by S. aureus; the fifth was an anaerobic

streptococcal infection 88

. Because these organisms are very susceptible to high-level disinfectants, such

as 2% glutaraldehyde, the infections most likely originated from the patient’s skin. Two cases of

Clostridium perfringens arthritis have been reported when the arthroscope was disinfected with

glutaraldehyde for an exposure time that is not effective against spores 182, 183

.

Although only limited data are available, the evidence does not demonstrate that high-level

disinfection of arthroscopes and laparoscopes poses an infection risk to the patient. For example, a

prospective study that compared the reprocessing of arthroscopes and laparoscopes (per 1,000

procedures) with EtO sterilization to high-level disinfection with glutaraldehyde found no statistically

significant difference in infection risk between the two methods (i.e., EtO, 7.5/1,000 procedures;

glutaraldehyde, 2.5/1,000 procedures)89

. Although the debate for high-level disinfection versus

sterilization of laparoscopes and arthroscopes will go unsettled until well-designed, randomized clinical

trials are published, this guideline should be followed 1, 17

. That is, laparoscopes, arthroscopes, and other

scopes that enter normally sterile tissue should be sterilized before each use; if this is not feasible, they

should receive at least high-level disinfection.

Tonometers, Cervical Diaphragm Fitting Rings, Cryosurgical Instruments, and Endocavitary

Probes

Disinfection strategies vary widely for other semicritical items (e.g., applanation tonometers,

rectal/vaginal probes, cryosurgical instruments, and diaphragm fitting rings). FDA requests that device

manufacturers include at least one validated cleaning and disinfection/sterilization protocol in the labeling

for their devices. As with all medications and devices, users should be familiar with the label instructions.

One study revealed that no uniform technique was in use for disinfection of applanation tonometers, with

disinfectant contact times varying from <15 sec to 20 minutes 28

. In view of the potential for transmission

of viruses (e.g., herpes simplex virus [HSV], adenovirus 8, or HIV) 184

by tonometer tips, CDC

recommended that the tonometer tips be wiped clean and disinfected for 5-10 minutes with either 3%

hydrogen peroxide, 5000 ppm chlorine, 70% ethyl alcohol, or 70% isopropyl alcohol 95

. However, more

recent data suggest that 3% hydrogen peroxide and 70% isopropyl alcohol are not effective against

adenovirus capable of causing epidemic keratoconjunctivitis and similar viruses and should not be used

for disinfecting applanation tonometers 49, 185, 186

. Structural damage to Schiotz tonometers has been

observed with a 1:10 sodium hypochlorite (5,000 ppm chlorine) and 3% hydrogen peroxide187

. After

disinfection, the tonometer should be thoroughly rinsed in tapwater and air dried before use. Although

these disinfectants and exposure times should kill pathogens that can infect the eyes, no studies directly

support this 188, 189

. The guidelines of the American Academy of Ophthalmology for preventing infections

in ophthalmology focus on only one potential pathogen: HIV. 190

Because a short and simple

decontamination procedure is desirable in the clinical setting, swabbing the tonometer tip with a 70%

isopropyl alcohol wipe sometimes is practiced. 189

Preliminary reports suggest that wiping the tonometer

tip with an alcohol swab and then allowing the alcohol to evaporate might be effective in eliminating HSV,

HIV, and adenovirus189, 191, 192

. However, because these studies involved only a few replicates and were

conducted in a controlled laboratory setting, further studies are needed before this technique can be

recommended. In addition, two reports have found that disinfection of pneumotonometer tips between

uses with a 70% isopropyl alcohol wipe contributed to outbreaks of epidemic keratoconjunctivitis caused

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by adenovirus type 8193, 194

.

Limited studies have evaluated disinfection techniques for other items that contact mucous

membranes, such as diaphragm fitting rings, cryosurgical probes, transesophageal echocardiography

probes 195

, flexible cystoscopes 196

or vaginal/rectal probes used in sonographic scanning. Lettau, Bond,

and McDougal of CDC supported the recommendation of a diaphragm fitting ring manufacturer that

involved using a soap-and-water wash followed by a 15-minute immersion in 70% alcohol96

. This

disinfection method should be adequate to inactivate HIV, HBV, and HSV even though alcohols are not

classified as high-level disinfectants because their activity against picornaviruses is somewhat limited72

.

No data are available regarding inactivation of human papillomavirus (HPV) by alcohol or other

disinfectants because in vitro replication of complete virions has not been achieved. Thus, even though

alcohol for 15 minutes should kill pathogens of relevance in gynecology, no clinical studies directly

support this practice.

Vaginal probes are used in sonographic scanning. A vaginal probe and all endocavitary probes

without a probe cover are semicritical devices because they have direct contact with mucous membranes

(e.g., vagina, rectum, pharynx). While use of the probe cover could be considered as changing the

category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and

because condoms/probe covers can fail 195, 197-199

, the probe also should be high-level disinfected. The

relevance of this recommendation is reinforced with the findings that sterile transvaginal ultrasound probe

covers have a very high rate of perforations even before use (0%, 25%, and 65% perforations from three

suppliers). 199

One study found, after oocyte retrieval use, a very high rate of perforations in used

endovaginal probe covers from two suppliers (75% and 81%) 199

, other studies demonstrated a lower rate

of perforations after use of condoms (2.0% and 0.9%) 197

200

. Condoms have been found superior to

commercially available probe covers for covering the ultrasound probe (1.7% for condoms versus 8.3%

leakage for probe covers)201

. These studies underscore the need for routine probe disinfection between

examinations. Although most ultrasound manufacturers recommend use of 2% glutaraldehyde for high-

level disinfection of contaminated transvaginal transducers, the this agent has been questioned 202

because it might shorten the life of the transducer and might have toxic effects on the gametes and

embryos 203

. An alternative procedure for disinfecting the vaginal transducer involves the mechanical

removal of the gel from the transducer, cleaning the transducer in soap and water, wiping the transducer

with 70% alcohol or soaking it for 2 minutes in 500 ppm chlorine, and rinsing with tap water and air

drying204

. The effectiveness of this and other methods 200

has not been validated in either rigorous

laboratory experiments or in clinical use. High-level disinfection with a product (e.g., hydrogen peroxide)

that is not toxic to staff, patients, probes, and retrieved cells should be used until the effectiveness of

alternative procedures against microbes of importance at the cavitary site is demonstrated by well-

designed experimental scientific studies. Other probes such as rectal, cryosurgical, and transesophageal

probes or devices also should be high-level disinfected between patients.

Ultrasound probes used during surgical procedures also can contact sterile body sites. These

probes can be covered with a sterile sheath to reduce the level of contamination on the probe and reduce

the risk for infection. However, because the sheath does not completely protect the probe, the probes

should be sterilized between each patient use as with other critical items. If this is not possible, at a

minimum the probe should be high-level disinfected and covered with a sterile probe cover.

Some cryosurgical probes are not fully immersible. During reprocessing, the tip of the probe

should be immersed in a high-level disinfectant for the appropriate time; any other portion of the probe

that could have mucous membrane contact can be disinfected by immersion or by wrapping with a cloth

soaked in a high-level disinfectant to allow the recommended contact time. After disinfection, the probe

should be rinsed with tap water and dried before use. Health-care facilities that use nonimmersible

probes should replace them as soon as possible with fully immersible probes.

As with other high-level disinfection procedures, proper cleaning of probes is necessary to ensure

the success of the subsequent disinfection 205

. One study demonstrated that vegetative bacteria

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category, this guideline proposes use of a new 195, 197-199

category, this guideline proposes use of a new condom/probe cover for the probe for each patient, and 195, 197-199


category, this guideline proposes use of a new

because condoms/probe covers can fail

condom/probe cover for the probe for each patient, and


condom/probe cover for the probe for each patient, and

, the probe also should be high-level disinfected. The , the probe also should be high-level disinfected. The

relevance of this recommendation is reinforced with the findings that sterile transvaginal ultrasound probe

, the probe also should be high-level disinfected. The because condoms/probe covers can fail , the probe also should be high-level disinfected. The

the findings that sterile transvaginal ultrasound probe

covers have a very high rate of perforations even before use (0%, 25%, and 65% perforations from three covers have a very high rate of perforations even before use (0%, 25%, and 65% perforations from three 199

One study found, after oocyte retrieval use,

covers have a very high rate of perforations even before use (0%, 25%, and 65% perforations from three

suppliers).

commercially available probe covers for covering the ultrasound probe (1.7% for condoms versus 8.3%

. These studies underscore the need for routine probe disinfection between leakage for probe covers)

examinations. Although most ultrasound manufacture


inoculated on vaginal ultrasound probes decreased when the probes were cleaned with a towel 206

. No

information is available about either the level of contamination of such probes by potential viral pathogens

such as HBV and HPV or their removal by cleaning (such as with a towel). Because these pathogens

might be present in vaginal and rectal secretions and contaminate probes during use, high-level

disinfection of the probes after such use is recommended.

Dental Instruments

Scientific articles and increased publicity about the potential for transmitting infectious agents in

dentistry have focused attention on dental instruments as possible agents for pathogen transmission207,

208. The American Dental Association recommends that surgical and other instruments that normally

penetrate soft tissue or bone (e.g., extraction forceps, scalpel blades, bone chisels, periodontal scalers,

and surgical burs) be classified as critical devices that should be sterilized after each use or discarded.

Instruments not intended to penetrate oral soft tissues or bone (e.g., amalgam condensers, and air/water

syringes) but that could contact oral tissues are classified as semicritical, but sterilization after each use is

recommended if the instruments are heat-tolerant 43, 209

. If a semicritical item is heat–sensitive, it should,

at a minimum, be processed with high-level disinfection 43, 210

. Handpieces can be contaminated

internally with patient material and should be heat sterilized after each patient. Handpieces that cannot

be heat sterilized should not be used. 211

Methods of sterilization that can be used for critical or

semicritical dental instruments and materials that are heat-stable include steam under pressure

(autoclave), chemical (formaldehyde) vapor, and dry heat (e.g., 320ºF for 2 hours). Dental professionals

most commonly use the steam sterilizer 212

. All three sterilization procedures can damage some dental

instruments, including steam-sterilized hand pieces 213

. Heat-tolerant alternatives are available for most

clinical dental applications and are preferred43

.

CDC has divided noncritical surfaces in dental offices into clinical contact and housekeeping

surfaces43

. Clinical contact surfaces are surfaces that might be touched frequently with gloved hands

during patient care or that might become contaminated with blood or other potentially infectious material

and subsequently contact instruments, hands, gloves, or devices (e.g., light handles, switches, dental X-

ray equipment, chair-side computers). Barrier protective coverings (e.g., clear plastic wraps) can be used

for these surfaces, particularly those that are difficult to clean (e.g., light handles, chair switches). The

coverings should be changed when visibly soiled or damaged and routinely (e.g., between patients).

Protected surfaces should be disinfected at the end of each day or if contamination is evident. If not

barrier-protected, these surfaces should be disinfected between patients with an intermediate-disinfectant

(i.e., EPA-registered hospital disinfectant with tuberculocidal claim) or low-level disinfectant (i.e., EPA-

registered hospital disinfectant with an HBV and HIV label claim) 43, 214, 215

.

Most housekeeping surfaces need to be cleaned only with a detergent and water or an EPA-

registered hospital disinfectant, depending of the nature of the surface and the type and degree of

contamination. When housekeeping surfaces are visibly contaminated by blood or body substances,

however, prompt removal and surface disinfection is a sound infection control practice and required by

the Occupational Safety and Health Administration (OSHA) 43, 214

.

Several studies have demonstrated variability among dental practices while trying to meet these

recommendations216, 217

. For example, 68% of respondents believed they were sterilizing their

instruments but did not use appropriate chemical sterilants or exposure times and 49% of respondents

did not challenge autoclaves with biological indicators216

. Other investigators using biologic indicators

have found a high proportion (15%–65%) of positive spore tests after assessing the efficacy of sterilizers

used in dental offices. In one study of Minnesota dental offices, operator error, rather than mechanical

malfunction218

, caused 87% of sterilization failures. Common factors in the improper use of sterilizers

include chamber overload, low temperature setting, inadequate exposure time, failure to preheat the

sterilizer, and interruption of the cycle.

Mail-return sterilization monitoring services use spore strips to test sterilizers in dental clinics, but

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2. Australia: jointly published by

The Australian Society for

Ultrasound in Medicine (ASUM) and

by The Australasian College for

Infection Prevention and Control

(ACIPC)/2017

Guidelines for ReprocessingUltrasound Transducers

The Australasian Society for Ultrasound in Medicine (ASUM)is the leading multidisciplinary medical ultrasound societyadvancing the clinical practice of diagnostic medicalultrasound for the highest standards of patient care in Aus-tralia and New Zealand. The Australasian College for Infec-tion Prevention and Control (ACIPC) is the peak body forInfection Prevention and Control professionals in the Aus-tralasian region focused on promoting education and evi-dence based practice outcomes for a healthy community.This document was developed collaboratively by ASUM andACIPC to establish nationally accepted guidelines for repro-cessing ultrasound transducers. The requirements in theseguidelines have been based on the standards of AS/NZS4187:2014 and AS/NZS4185:2006.1 These guidelines mustbe used as the minimum standard of practice for reprocessingultrasound transducers and considered to be best practice atthe time which they were issued.

1. IntroductionIn Australia, ultrasound is increasingly utilised as an imagingmodality in a diversity of care environments. Each ultrasoundprocedure involves contact between an ultrasound transducerand the patient’s skin, mucous membranes, or sterile tissues.Failure to adhere to minimum infection control standards,including the proper cleaning and reprocessing of the equip-ment and transducers, increases the risk of pathogen transmis-sion and subsequent infection. Lack of compliance withscientifically based guidelines for infection control has led tonumerous outbreaks arising from ultrasound examinations,2–10

including cases of infection resulting from ultrasound-guidedprocedures,4,11–13 and ultrasound transducers that have notundergone appropriate disinfection (Medical Device Alert Ref:MDA/2012/037)14,15 or have been damaged.16

1.1 Scope and target audienceThe Guidelines for Reprocessing Ultrasound Transducersprovides recommendations for the cleaning and disinfectionof all medical ultrasound transducers and any additionalequipment that may be utilised during the procedure, suchas the keyboard and ultrasound gel. These guidelines arerecommended for all individuals directly or indirectlyinvolved with medical ultrasound.

Abbreviations

ACIPC Australasian College for InfectionPrevention and Control

ARTG Australian Register of Therapeutic GoodsAS/NZS 4815:2006 Australian/New Zealand StandardTM

Office-based health care facilities –Reprocessing of reusable medical andsurgical instruments and equipment, andmaintenance of the associatedenvironment

AS/NZS4187:2014 Australian/New Zealand StandardTM

Reprocessing of reusable medical devicesin health service organizations

ASUM Australasian Society for Ultrasound inMedicine

FDA Food and Drug AuthorityHAI Healthcare-Associated InfectionHLD High Level DisinfectionIFU Instructions for UseLLD Low Level DisinfectionMRC Minimum Recommended ConcentrationNHMRC National Health and Medical Research

CouncilSDS Safety Data Sheet: a form supplied with the

product detailing the properties of theproduct

TGO54 Therapeutic Goods Order No.54TGA Therapeutic Goods Administration

Correspondence to:ASUM Dr Jocelyne [email protected] Assoc Prof Thea F van de [email protected]: 10.1002/ajum.12042

30 AJUM February 2017 20 (1) © 2017 Australasian Society for Ultrasound in Medicine and the Australasian College for Infection Prevention and Control

Guidelines

2. Definition of terms (adapted from AS/NZS4187:2014)

2.1 CleaningThe removal of contamination from an item to the extentnecessary for further processing or for intended use.17

2.2 DisinfectionThe destruction of many microorganisms (including humanpathogens) using thermal or chemical means. Unlike sterilisa-tion, disinfection is not effective against high numbers of bacte-rial endospores. Disinfectants are classified by grade as follows:• Low-level instrument grade: disinfectant that kills vegetativebacteria, some fungi and some viruses.

• Intermediate-level instrument grade: disinfectant that killsvegetative bacteria, Mycobacteria, viruses and most fungi butnot bacterial endospores.

• High-level instrument grade: disinfectant that kills allmicroorganisms with the exception of high numbers of bacte-rial endospores.

2.3 SterilisationSterilisation destroys microorganisms on an object rendering itfree from viable microorganisms.

3. Medical device classificationThe Spaulding classification system states that medical devicesare classified as non-critical, semi-critical or critical accordingto the risk of transmission of microorganisms associated withtheir use.

3.1 Non-critical medical devicesUltrasound transducers that come into contact with intact skin areconsidered non-critical medical devices and as such are repro-cessed by cleaning and may be followed by low-level disinfection(LLD) method as described in Section 7.1 ‘Low-level disinfection’.

3.2 Semi-critical medical devicesUltrasound transducers that come into contact with non-intactskin and / or mucous membranes and transducers that havehad likely contact with blood / body fluids are considered assemi-critical medical devices due to the high risk of potentialcontamination. These transducers are reprocessed by cleaningfollowed by a high-level disinfection (HLD) method asdescribed in Section 7.2 ‘High-level disinfection’.

3.3 Critical devicesTransducers are extremely delicate and heat sensitive and assuch are reprocessed as a semi-critical medical device by clean-ing followed by a HLD method as described in Section ‘High-level disinfection’. An appropriate sterile sheath or transducercover is applied, allowing it to be used on the critical asepticfield (AS/NZS4187:2014 Clause 5.1.3 (e)).

4. Sterilisation and disinfection methodsWhile there are multiple methods of sterilisation in practice, ster-ilisation of ultrasound transducer is impractical, due to the heatsensitivity of transducers. High-level disinfection of ultrasoundtransducers must kill all forms of bacteria (including mycobacte-ria), viruses, fungi and protozoa and achieve disinfection.

5. Mechanisms of infection

5.1 Endogenous infectionEndogenous infection occurs as a result of breakdown of a normalbarrier, thereby allowing the patient’s own flora to access a nor-mally sterile site. This can occur during ultrasound-assisted biopsyand other procedures where normally sterile sites are accessed.This mode of infection is an intrinsic risk in the collection of abiopsy from an ordinarily sterile site and is not related to thecleaning, disinfecting or sterilising of ultrasound equipment.

5.2 Exogenous infectionExogenous infection results from an organism extrinsic to thepatient’s own microbiota. Disinfection and cleaning proceduresare intended to prevent this type of infection. There are twokinds of exogenous infection: patient to patient and hospitalenvironment to patient. The risk of exogenous infection isincreased if ultrasound equipment / accessories: (i) have notbeen properly cleaned and disinfected (ii) have been damaged(iii) are poorly designed, and / or (iv) are contaminated by theultrasound gel. Poor compliance with infection control guideli-nes increases the risk of infection.Ultrasound procedures are used to collect biopsy samples for

microbiological examination. Improper collection procedurescan lead to the contamination of these samples and the erro-neous diagnosis of infection.

6. Agents potentially transmitted by ultrasound proceduresUltrasound procedures contaminated with pathogenic bacte-ria can cause disease and may lead to further spread ofthese organisms.7,9,10,14–16,18–21 Of particular concern are thefollowing:• Staphylococcus aureus (including Methicillin-Resistant S. au-reus (MRSA))

• Vancomycin-Resistant Enterococci (VRE)• Multi-resistant gram-negative organisms (MRGN)• Carbapenem-resistant enterobacteraciae (CRE)• Mycobacterium tuberculosis complex (MBTC)• Non-tuberculous ‘atypical’ mycobacteria

○ Mycobacteria are relatively resistant to most chemical dis-infectants, including aldehydes. Transmission of mycobacte-ria has been associated with ultrasound procedures.2

• Clostridium difficile○ Spores of C. difficile are less resistant to some disinfectantsthan the spores of other bacterial species. High-level

© 2017 Australasian Society for Ultrasound in Medicine and the Australasian College for Infection Prevention and Control AJUM February 2017 20 (1) 31

Guidelines for Reprocessing Ultrasound Transducers

disinfection procedures have been shown to inactivate C. dif-ficile spores.

• Neisseria gonorrhoeae, Chlamydia trachomatis, Treponemapallidum (syphilis), Mycoplasma genitallium○ Transmission of these organisms is a specific risk whentransoesophageal, transrectal or transvaginal ultrasounds areperformed. These organisms may not be removed by low-level disinfection wipes.22

Blood-borne viruses (BBVs) such as the human immunodefi-ciency virus (HIV), Hepatitis B virus (HBV) and Hepatitis Cvirus (HCV) can be spread through contact with the blood orbody fluid of infected persons. Many chemical disinfectantsinactivate blood-borne viruses; however, ineffective cleaningprior to disinfection limits the effectiveness of chemical disin-fection and leads to the persistence of active virus after a disin-fection procedure. Improperly cleaned and disinfectedultrasound equipment maybe capable of transmitting BBVs;18

however, ancillary equipment, particularly related to biopsyand the administration of intravenous medication, presents thehighest risk of transmission.12 It is a vital and best surgical andanaesthetic practice that is adhered to in addition to appropri-ate ultrasound equipment cleaning and reprocessing to min-imise the risk of transmission.Human herpes virus 1 (HHV1) and human herpes virus 2

(HHV2) are common viruses that are relatively resistant todecontamination. Transducers are known to become contami-nated with these viruses, even when a transducer cover isused.23 Transmission of herpes viruses during vaginal ultra-sound in pregnancy may have consequences for a subsequentdelivery and create a risk of neonatal herpes.Human papilloma viruses (HPVs) are of particular concern

when performing transvaginal ultrasound. Certain ‘high-risk’types (in particular 16 and 18) are agents of cervical cancer.This virus is known to be persistent in the environment andretain a high proportion of its infectivity after dehydration for7 days. Several studies have examined the likelihood of trans-mission of this organism through transvaginal ultrasound usingcurrent infection control practices and found that transducercovers do not adequately prevent the contamination of trans-ducers with HPVs24 and that low-level disinfection may notremove HPV from ultrasound transducers.22,24

Many other potentially infectious agents may be transmittedvia improperly maintained, cleaned and disinfected ultrasoundequipment, accessories and transducers, including protozoalpathogens such as Trichomonas vaginalis, intestinal parasitessuch as Entamoeba histolytica or fungal pathogens includingdermatophytes and hyphomycetes.

7. Recommended cleaning and disinfection proceduresCleaning is an essential prerequisite for all LLD and HLD pro-cesses. Organic residue may prevent the disinfectant from con-tacting all surfaces of the medical device being processed andmay also bind and inactivate chemical disinfectants.25 If the

transducer has grooves or crevices, then it must be cleaned witha soft brush prior to any LLD or HLD reprocessing.Cleaning agents and instrument-grade HLD methods must

be intended for use on medical devices and entered the Aus-tralian Register of Therapeutic Goods (ARTG). All transducersmust be cleaned according to the manufacturer’s instructions.Ultrasound transducers are heat-sensitive items and as

such will need to be disinfected using low-temperaturechemical sterilising / disinfecting agents or other approvedautomated systems. Any products used for cleaning or disin-fection must be compatible with the ultrasound equipmentas determined by the ultrasound equipment manufacturer.The instructions for use for any ultrasound equipment mustbe consulted to ensure compatibility prior to using any typeof disinfectant on their transducers. Care should be taken tofollow each disinfectant manufacturer’s labelled conditionsfor the use of their specific products. Directions for use arenot interchangeable between formulations from either thesame or different manufacturers.Some disinfectants may have associated toxicity issues, and

personal protective equipment (PPE) need to be used, alongwith fume cabinets and / or any other safety instructions out-lined on the Safety Data Sheet (SDS).

7.1 Low-level disinfectionManually remove all ultrasound gel prior to cleaning.(a) Clean transducer using a TGA-approved disposable clean-

ing wipe or system intended for use on medical devices.or

(b) Clean transducer using freshly made up solution of clean-ing agent at the correct concentration. Rinse thoroughlyunder running water to remove cleaning agent residues.Dry using a single-use low linting cloth.

7.2 High-level disinfectionHigh-level disinfection, with an approved disinfectant method,is necessary for further statistical reduction in the number ofmicroorganisms. The definitions given in TGO54 indicate thatwhen used as recommended by the manufacturer, high-leveldisinfection methods inactivate all microbial pathogens, exceptlarge numbers of bacterial endospores.Following step 7.1, transducers must undergo high-level

disinfection (HLD) using a TGA-approved instrument gradedisinfection method following the manufacturer’s instructionsfor use (IFU). Methods of high-level disinfection include, butmay not be limited to, the following:(a) Liquid high-level instrument grade chemical disinfectantsor

(b) Automated high-level disinfection systems, for examplechemical or light-based

or(c) High-level instrument grade disinfectant wipes.



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7.2.1 Rinsing / neutralisation and dryingRinsing / neutralisation is an important step to remove any dis-infectant residue or by-product post high-level disinfection. Alltransducers must be rinsed with clean water post-HLD tomaintain the microbiological quality of the reprocessed trans-ducer (AS/NZS4187:2014). Transducers should be dried using asingle-use low linting cloth.Transducers used on critical aseptic fields require filtered or

sterile water to be used for rinsing to comply with AS/NZS4187:2014 requirements. Immediately following HLD andrinsing, transducers should be dried using a sterile single-uselow linting cloth prior to insertion into the sterile sheath /sleeve or transducer cover.

7.3 StorageAfter cleaning, all transducers must be stored in an appropriateenvironment to protect from environmental contamination(AS/NZS4187:2014, Table 5.1). It is recommended that a speci-fic cabinet is used, but if this is not available the minimum stan-dard recommended is a clean disposable cover applied to thetransducer to mitigate risks from environmental contaminants.

8. TraceabilityRecords of HLD must be kept in accordance with the require-ments specified in AS/NZS4187:2014 (Clause 2.4.3.2 (a)) toensure a system of traceability is in place to enable recall proce-dures to be followed in case of decontamination failure.AS/NZS4187:2014 requires documentation of the following:

• Date of reprocessing;• Type of transducer and unique identification number, forexample the serial number;

• Person responsible for the cleaning and disinfection andrelease of the transducer for use;

• Batch numbers and expiry dates of the disinfectant and anychemical indicator test strips used to check minimum recom-mended concentration (MRC);

• For manual HLD processes:Record of the immersion time in and out of the HLD, andwhere applicable the temperature of the solution; results ofchemical indicator test strips used to check MRC and com-pletion of the final rinse to remove HLD residues;

• For automated HLD processes:Record of the process cycle for automated cleaning and / ordisinfection;

• For HLD wipes:Record of the batch number and expiry dates of the productsused for cleaning, HLD and neutralisation.

9. Equipment cleaningAny equipment that has been in contact with the patient oroperator should be cleaned with a detergent / disinfectant wipeor solution between use, for example the leads to the transducer,the keyboard or the bed. This reduces the risk of potential cross-

contamination between the patients and the operator.22,26–29

Ensure that all cleaning agents used for the general environmenthave been approved by the equipment manufacturer.

10. WorkflowWorkflows should promote best practice to reduce risk of con-tamination of clean areas with contaminated equipment. Work-flows in the reprocessing area will be unidirectional to avoid therisks of cross-contamination of clean and / or high-level disin-fected transducers. Reprocessing can be performed at the pointof care (POC) or in a separate room. If conducted at POC, theproducts used must be safe to use in that setting. If reprocessingis performed in another room, a system for transducer trans-port must be implemented to ensure that dirty and clean trans-ducers are not mixed. Separate transport containers for dirtyand clean transducers are required.

11. Operator requirements and standard precautionsEvery patient must be regarded as a potential source of harmfulmicroorganisms, and appropriate precautions should be takento prevent cross-infection between patient and operator andfrom patient to patient. These ‘standard precautions’ are pro-moted throughout organisations. Hand hygiene both beforeand after direct patient contact, and before any procedure, isparticularly important. Other precautions include the use ofpersonal protective equipment (PPE), correct handling and dis-posal of waste and ensuring a clean working environment ismaintained between patients.All users of ultrasound equipment must be trained in repro-

cessing procedures. They should receive formal training inmedical device cleaning and disinfection to ensure safe andeffective reprocessing of the transducers. It is expected thatminimum standard training will be completed by all ultrasoundhealthcare workers which includes hand hygiene and aseptictechniques. Annual updates are recommended.

12. Transducer / probe coversAll intracavity transducers should be covered with a single-usehigh-quality transducer cover. This may include some, but notall brands of condoms, specific transducer covers or surgicaldrapes. Prior to the application of a latex transducer cover,specific enquiry should be directed to the patient regardinglatex sensitivity and, if appropriate, special non-latex coversneed to be utilised.At the end of the procedure, using a gloved hand, the dispos-

able cover should be removed and discarded, taking care not tocontaminate the handle, cable or cord of the transducer.Although the use of a disposable cover reduces the level of

risk of contamination, covers can be perforated or containsmall, unrecognised defects. Due to the reported breakage rateof transducer covers, for maximum safety, cleaning and high-level disinfection of the transducer is recommended betweeneach use.30 Covers used on transducers introduced into critical



aseptic fields must be sterile and applied in a manner that pre-vents the contamination of the sterile barrier. It appears the riskof patient to patient transmission of infection post ultrasoundguided procedures, where a sterile transducer cover is used, islow. To date, there are no studies evaluating the effectiveness ofa variety of transducer covers used during an ultrasound guidedprocedure. However, in view of a recent investigation showinga majority of ultrasound machines in Emergency Departmentswere contaminated with blood,27 appropriate infection controlmeasures should be implemented. This would include a steriletransducer cover for every real-time ultrasound guided proce-dure, followed by HLD, unless the transducer is some distanceaway from the needle and contamination with blood or bodyfluid not possible.

13. Ultrasound gel recommendationsUltrasound gels may be sterile or non-sterile and have been thesource of past outbreaks of infection. Ultrasound gels, that aredefined as sterile, are unopened ultrasound gel packets orsachets that are specifically labelled as ‘sterile’. Ultrasound gelproducts that are labelled as non-sterile or that are not labelledat all with respect to sterility are not sterile. The use of non-sterile gel should be limited to low-risk general examinationson intact skin. If a non-sterile gel is being used on a patientwho is on any transmission-based precautions, a single-use gelbottle or sachet should be used. Due to the risk of bacterial con-tamination and growth within a warm environment, heating ofgel is not recommended.29 In circumstances where warm gel isnecessary, the use of dry heat is the preferred method.31 Aftereach use, lids should be closed on reusable gel bottles.The basic minimum standards to minimise the infection

transmission risk through the use of contaminated ultrasoundgel are as follows:• Always follow the manufacturer’s instructions for care anduse;

• Ensure reusable dispenser bottles are completely emptied,thoroughly washed and dried daily / weekly according toyour facility’s infection control practices;

• Clean all reusable equipment according to the manufacturer’sinstructions;

• For procedures that require the use of sterile gel, ensure thatonly unopened containers / sachets labelled ‘sterile’ are used;

• Any unused portion of single-use sterile gel packets must bediscarded and not reused for another examination or patient.

DisclaimerThese joint guidelines are intended to provide best practiceguidelines on the reprocessing of ultrasound transducers. Therequirements in these guidelines have been based on the stan-dards AS/NZS4187:2014 and AS/NZS4185:2006. The informa-tion within this document has been developed and reviewed bythe Australasian College for Infection Prevention and Control(ACIPC) and the Australasian Society for Ultrasound in

Medicine (ASUM) Working Committee and approved byACIPC Board and ASUM Council. Although every effort hasbeen made to ensure that these guidelines are accurate, neitherASUM or ACIPC, nor its employees or members accepts anyliability for the consequences of any misleading statements oropinions.These guidelines will be reviewed jointly by ASUM and

ACIPC every 4 years unless evidence suggests an earlier reviewis required.

Guideline AuthorsThese joint guidelines were developed by a working committeerepresenting ASUM and ACIPC. The document was producedby:Dr Jocelyne M Basseal, Australasian Society for Ultrasound

in Medicine (ASUM), Sydney NSWAdj Assoc Prof Susan Campbell Westerway, Faculty of

Dentistry & Health Sciences, Charles Sturt University NSWMarija Juraja, Clinical Service Coordinator (CICP, GCNS) –

Infection Prevention & Control Unit, Division of Acute Medi-cine, The Queen Elizabeth Hospital, Central Adelaide LocalHealth Network (CALHN), SAAssoc Prof Thea F van de Mortel, School of Nursing and

Midwifery, Griffith University, QLDTerry E McAuley, Director STEAM Consulting Pty Ltd.Assoc Prof James Rippey, Emergency Medicine Physician,

Sir Charles Gairdner Hospital, WASimon Meyer-Henry, CICP-E, Infection Prevention & Man-

agement, Royal Perth Hospital, WADr Samuel Maloney, Clinical Microbiologist, Gold Coast

University Hospital, Visiting Research Fellow in the Institutefor Glycomics, QLDAmanda Ayers, Infection Control Consultant, Hand Hygiene

Program Coordinator, Infection Prevention & Control, BendigoHealth, VICSusan Jain, MN, Centre for Healthcare Epidemiology and

Staff Services, Prince of Wales Hospital, Sydney, NSWDr Karen Mizia, Consultant Obstetrician, Gynaecologist and

Sonologist, Ultrasound Care, Randwick, Sydney, NSWDenise Twentyman, Acting Safety Quality Infection Control

Officer, Tennant Creek Hospital, Central Australia Health Ser-vice, NT.

AcknowledgementsThe authors would like to acknowledge the assistance inreviewing the Guidelines from Dr Adrian Goudie (Fiona Stan-ley Hospital, Western Australia), Dr Fabricio Da Silva Costa(Monash Ultrasound for Women and Perinatal Services, Mon-ash Medical Centre, Melbourne, Victoria), Prof Jon Hyett(Department of High Risk Obstetrics, Royal Prince AlfredHospital, Sydney, NSW) and Ms Fiona Law (President MedicalImaging Nurses’ Association NSW & ACT, Prince of Wales/Sydney Children’s Hospitals, NSW, Australia).



CitationThese Guidelines should be cited as: Basseal JM, Westerway SC,Juraja M, van de Mortel T, McAuley TE, Rippey J, et al. Guide-lines for reprocessing ultrasound transducers. Australas J Ultra-sound Med 2017; 20: 30–40.

14. References1 Australian/New Zealand Standard AS/NZS 4815:2006 Office-based

health care facilities – Reprocessing of reusable medical and surgi-cal instruments and equipment, and maintenance of the associatedenvironment, Standards Australia and Standards New Zealand.

2 Centers for Disease Control and Prevention (CDC). Pseudomonasaeruginosa Respiratory Tract Infections Associated with Contami-nated Ultrasound Gel Used for Transesophageal Echocardiography— Michigan, December 2011–January 2012 (Morbidity andMortality Weekly Report No. 61(15);262-264); 2012. Availablefrom: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6115a3.htm

3 Cheng A, Sheng W-H, Huang Y-C, Sun H-Y, Tsai Y-T, Chen M-L,et al. Prolonged postprocedural outbreak of Mycobacterium mas-siliense infections associated with ultrasound transmission gel. ClinMicrobiol Infect 2016; 22: 382.e1–11.

4 Chittick P, Russo V, Sims M, Robinson-Dunn B, Oleszkowicz S,Sawarynski K, et al. An outbreak of Pseudomonas aeruginosa res-piratory tract infections associated with intrinsically contaminatedultrasound transmission gel. Infect Control Hosp Epidemiol 2013;34: 850–3.

5 Gaillot O, Maru�ejouls C, Abachin �E, Lecuru F, Arlet G, SimonetM, et al. Nosocomial outbreak of Klebsiella pneumoniae producingSHV-5 extended-spectrum b-lactamase, originating from a con-taminated ultrasonography coupling gel. J Clin Microbiol 1998; 36:1357–60.

6 Jacobson M, Wray R, Kovach D, Henry D, Speert D, Matlow A.Sustained endemicity of Burkholderia cepacia complex in a pedi-atric institution, associated with contaminated ultrasound gel.Infect Control Hosp Epidemiol 2006; 27: 362–6.

7 Nannini EC, Ponessa A, Muratori R, Marchiaro P, Ballerini V,Flynn L, et al. Polyclonal outbreak of bacteremia caused byBurkholderia cepacia complex and the presumptive role of ultra-sound gel. Braz J Infect Dis 2015; 19: 543–5.

8 Olshtain-Pops K, Block C, Temper V, Hidalgo-Grass C, Gross I,Moses AE, et al. An outbreak of achromobacter xylosoxidans asso-ciated with ultrasound gel used during transrectal ultrasoundguided prostate biopsy. J Urol 2011; 185: 144–7.

9 Organ M, Grantmyre J, Hutchinson J. Burkholderia cepacia infec-tion of the prostate caused by inoculation of contaminated ultra-sound gel during transrectal biopsy of the prostate. Can Urol AssocJ 2010; 4: E58–60.

10 Weist K, Wendt C, Petersen LR, Versmold H, R€uden H. An out-break of pyodermas among neonates caused by ultrasound gel con-taminated with methicillin-susceptible Staphylococcus aureus.Infect Control Hosp Epidemiol 2000; 21: 761–4.

11 Cervini P, Hesley GK, Thompson RL, Sampathkumar P, KnudsenJM. Incidence of infectious complications after an ultrasound-guided intervention. Am J Roentgenol 2010; 195: 846–50.

12 Ferhi K, Roupret TM, Mozer P, Ploussard G, Haertig A, De LaTaille A. Hepatitis C transmission after prostate biopsy. Case RepUrol, 2013; 2013: e797248.

13 Hiyama Y, Takahashi S, Uehara T, Ichihara K, Hashimoto J, Masu-mori N. A case of infective endocarditis and pyogenic spondylitisafter transrectal ultrasound guided prostate biopsy. J Infect Che-mother 2016; 22: 767–9.

14 Bancroft EA, English L, Terashita D, Yasuda L. Outbreak ofEscherichia coli infections associated with a contaminated trans-esophageal echocardiography probe. Infect Control Hosp Epidemiol2013; 34: 1121–3.

15 Paz A, Bauer H, Potasman I. Multiresistant Pseudomonas aerugi-nosa associated with contaminated transrectal ultrasound. J HospInfect 2001; 49: 148–9.

16 Seki M, Machida N, Yamagishi Y, Yoshida H, Tomono K. Nosoco-mial outbreak of multidrug-resistant Pseudomonas aeruginosacaused by damaged transesophageal echocardiogram probe used incardiovascular surgical operations. J Infect Chemother 2013; 19:677–81.

17 Australian/New Zealand Standard: AS/NZS4187:2014 Reprocess-ing of Reusable Medical Devices in Health Service Organisation.Standards Australia and Standards New Zealand.

18 Gillespie JL, Arnold KE, Noble-Wang J, Jensen B, Arduino M,Hageman J, et al. Outbreak of Pseudomonas aeruginosa infectionsafter transrectal ultrasound-guided prostate biopsy. Urology 2007;69: 912–4.

19 Medicines and Healthcare products Regulatory Agency. Reusabletransoesophageal echocardiography, transvaginal and transrectalultrasound probes (transducers) – failure to appropriately decon-taminate Medical safety alert – GOV.UK (No. MDA/2012/038);2012. Available from: https://www.gov.uk/drug-device-alerts/medical-device-alert-reusable-transoesophageal-echocardiography-transvaginal-and-transrectal-ultrasound-probes-transducers-failure-to-appropriately-decontaminate.

20 Ohara T, Itoh Y, Itoh K. Contaminated ultrasound probes: a possi-ble source of nosocomial infections. J Hospital Infect 1999; 43: 73.

21 Stigt JA, Wolfhagen MJ, Smulders P, Lammers V. The identifica-tion of Stenotrophomonas maltophilia contamination in ultrasoundendoscopes and reproduction of decontamination failure by delib-erate soiling tests. Respiration 2015; 89: 565–71.

22 M’Zali F, Bounizra C, Leroy S, Mekki Y, Quentin-Noury C, KannM. Persistence of microbial contamination on transvaginal ultra-sound probes despite low-level disinfection procedure. PLoS ONE2014; 9: e93368.

23 Amis S, Ruddy M, Kibbler CC, Economides DL, MacLean AB.Assessment of condoms as probe covers for transvaginal sonogra-phy. J Clin Ultrasound 2000; 28: 295–8.

24 Casalegno J, Le Bail Carval K, Eibach D, Valdeyron M-L, LamblinG, Jacquemoud H, et al. High risk HPV contamination of endo-cavity vaginal ultrasound probes: an underestimated route of noso-comial infection? PLoS ONE 2012; 7: e48137.

25 Frazee BW. Emergency department ultrasonagraphic probe con-tamination and experimental mode of probe disinfection. AnnEmerg Med 2011; 58: 56–8.

26 Alfa MJ. Intra-cavity ultrasound probes: cleaning and high-leveldisinfection are necessary for both the probe head and handle to



reduce the risk of infection transmission. Infect Control Hosp Epi-demiol 2015; 36: 585–6.

27 Keys M, Sim B, Thom O, Tunbridge M, Barnett A, Fraser J. Effortsto Attenuate the Spread of Infection (EASI): a prospective, obser-vational multicenter survey of ultrasound equipment in Australianemergency departments and intensive care units. Crit Care Resusc2015; 17: 43–6.

28 Rutala WA, Weber D. Reprocessing semicritical items. Am J InfectControl 2016; 44: e53–62.

29 Westerway S, Basseal JM, Brockway A, Hyett JA, Carter DA.Potential risks associated with an ultrasound examination – abacterial perspective. J Ultrasound Med Biol 2016; 43: 421–6.

30 Storment JM, Monga M, Blanco JD. Ineffectiveness of latex con-doms in preventing contamination of the transvaginal ultrasoundhead. South Med J 1997; 90: 206–8.

31 Oleszkowicz S, Chittick P, Russo V, Keller P, Sims M, Band J. Infectionsassociated with use of ultrasound transmission gel: proposed guidelinesto minimize risk. Infect Control Hosp Epidemiol 2012; 33: 1235.

15. Appendices

Appendix A Reference Guide Tables for cleaning ultrasound transducersThese tables were developed as a reference guide only to assist with ultrasound-specific procedures undertaken by various ultra-sound specialties.Please note that all cleaning and disinfection products must be intended for use on medical devices, registered on the Australian

Register of Therapeutic Goods (ARTG) and approved by the Therapeutic Goods Administration (TGA). All transducers must becleaned according to the manufacturer’s instructions.

Table 1: Reference guide to cleaning ultrasound transducers in the Emergency Medicine Department.Transducer Procedure Use of transducer cover Recommended cleaning method

Low-Level Disinfection (LLD) orHigh-Level Disinfection (HLD)

External Normal intact skin No LLD

Open wound, for example ulcers Yes HLD

Intact infected skin No HLD

Yes HLD*

US-guided interventional procedureFor example, joint aspiration; abscess drainage; foreign body removal;

suprapubic bladder tap; nerve block

Yes HLD*

Peripheral IV line insertion Yes HLD*

CVC / PICC insertion Yes HLD*

Pleural tap, ascites tap or drainage Yes HLD

Intracavity Transvaginal Yes HLD

* LLD can be performed if the transducer is classified as non-critical. Non-critical transducers do not contact non-intact skin, bloodor mucous membranes. If the transducer comes in direct contact with non-intact skin, blood or mucous membranes transducersshould be cleaned with HLD irrespective of the use of a transducer cover. If transducer cover is broken during a procedure, thenHLD must be performed.



Table 2: Reference guide to cleaning ultrasound transducers in the Radiology Department.Transducer Procedure Use of transducer cover Recommended cleaning method

Low-Level Disinfection (LLD) orHigh-Level Disinfection (HLD)

External Intact skin No LLD

Open wound, for example ulcers Yes HLD


Yes HLD*

External*Needle-guided procedures

MSK injection Yes HLD*

Joint aspiration; abscess drainage; foreign body removal;suprapubic bladder tap; nerve block

Yes HLD*

Peripheral IV line insertion Yes HLD*

CVC / PICC insertion Yes HLD*

Pleural tap, ascites tap or drainage Yes HLD


Transrectal / TRUSS Yes HLD

Intraoperative Yes HLD

*LLD can be performed if the transducer is classified as non-critical. Non-critical transducers do not contact non-intact skin, bloodor mucous membranes. If the transducer comes in direct contact with non-intact skin, blood or mucous membranes transducersshould be cleaned and with HLD irrespective of the use of a transducer cover. If transducer cover is broken during a procedure,then HLD must be performed.

Table 3: Reference guide to cleaning ultrasound transducers in the O&G Department.Transducer Procedure Use of transducer cover Recommended cleaning method Low-Level

Disinfection (LLD) or High-Level Disinfection(HLD)


Non-intact skin Yes HLD

External*Needle-guided procedure

AmniocentesisCVS

Suprapubic bladder tap for urine retention

Yes HLD*



*LLD can be performed if the transducer is classified as non-critical. Non-critical transducers do not contact non-intact skin, bloodor mucous membranes. If the transducer comes in direct contact with non-intact skin, blood or mucous membranes transducersshould be cleaned with HLD irrespective of the use of a transducer cover. If transducer cover is broken during a procedure, thenHLD must be performed.



Table 4: Reference guide to cleaning ultrasound transducers in the Vascular Department.Transducer Procedure Use of transducer

coverRecommended cleaning method Low-Level Disinfection (LLD) or

High-Level Disinfection (HLD)



Yes HLD*

Ulcerated skin Yes HLD

InternalUltrasound-guided surgical procedure

IVUS probe Not reusable – discard after use



Table 5: Reference guide to cleaning ultrasound transducers in the Cardiac Department.Transducer Procedure Use of transducer

coverRecommended cleaning method Low-Level Disinfection (LLD) or

High-Level Disinfection (HLD)



Yes HLD*

Internal TOE Yes HLD

No HLD

Epicardial echo Yes HLD

Intracardiac Interventional Not reusable – discard after use





Appendix B Flow chart reference guide for reprocessing ultrasound transducers

Flow chart 1:

Cleaning the ultrasound transducer a�er an ultrasound examina�on

Examina�on performed using a clean transducer

EXTERNAL

Intact skin

NON-CRITICAL

EXTERNAL

Intact

Infected skin

Transducer cover

INTRACAVITY

Mucous membranes, open wounds

SEMI-CRITICAL

INTRAOPERATIVE

Sterile �ssue or blood

CRITICAL

LOW-LEVEL DISINFECTION

Ensure that all grooves and crevices on the transducer have been

thoroughly cleaned.Follow transducer cleaning

recommenda�ons and use soap and water, approved detergent wipes or other LLD cleaning and disinfec�on

systems.

HIGH-LEVEL DISINFECTION

Ensure that all grooves and crevices on the transducer have been thoroughly cleaned prior to HLD.

Follow transducer cleaning recommenda�ons, only use an approved HLD system and follow the manufacturer’s instruc�ons for use.

YES NO

Transducer cover Transducer cover

NOTE: All cleaning and disinfec�on products must be intended for use on medical devices, registered on the Australian Register of Therapeu�c Goods (ARTG) and approved by the Therapeu�c Goods Administra�on (TGA). All transducers must be cleaned according to the manufacturer’s instruc�ons.



Flow chart 2:

National Safety & Quality Health Service Standards

Governancefor SafetyandQualityinHealthCare

PartneringwithConsumers

Preventing&ControllingHealthcareassociatedinfections

MedicationSafety

PatientIdentification&ProcedureMatching

Clinical Handover Bloodand BloodProducts

Preventing&ManagingPressureInjuries

Recognising& Respondingto ClinicalDeterioration

PreventingFalls&HarmfromFall

U U U U

Ultrasound-guided invasive procedure

No risk of body fluid contamina�on

Transducer is on intact skin and the needle is a significant distance from the ultrasound

transducer, meaning contamina�on of the ultrasound transducer by body fluid or blood will

not occur.

Risk of body fluid contamina�on

Real-�me ultrasound-guided procedure where the needle is close to or touching the ultrasound transducer / cover

and contamina�on with blood or body fluid is possible. All procedures where the transducer is intracavity.

LOW-LEVEL DISINFECTION

Ensure that all grooves and crevices on the transducer have been thoroughly cleaned.

Follow transducer cleaning recommenda�ons and use soap and water, approved detergent wipes or other LLD cleaning and disinfec�on

systems.

HIGH-LEVEL DISINFECTION

Ensure that all grooves and crevices on the transducer have been thoroughly cleaned prior to HLD.

Follow transducer cleaning recommenda�ons and only use an approved HLD system and strictly follow

the manufacturer’s instruc�ons for use.

YES

Possible transducer / cover contact with blood or body fluid Transducer cover required

NO

NOTE: All cleaning and disinfec�on products must be intended for use on medical devices, registered on the Australian Register of Therapeu�c Goods (ARTG) and approved by the Therapeu�c Goods Administra�on (TGA). All transducers must be cleaned according to the manufacturer’s instruc�ons.

Cleaning the ultrasound transducer a�er an ultrasound-guided procedure



3. Walles / 2014 : extract of

guidelines

4. Scotland / 2016 : extract of

guidelines

NHSScotland Guidance for

Decontamination of Semi-Critical

Ultrasound Probes; Semi-invasive and

Non-invasive Ultrasound Probes

March 2016

NHSScotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and


Contents

Terminology used within the guidance document .................................................................. 4

1.0 PURPOSE.................................................................................................................. 5

2.0 BACKGROUND ..............................................................................................................5

3.0 ROLES AND RESPONSIBILITIES FOR HEALTHCARE WORKES INVOLVED WITH

DECONTAMINATION OF SEMI-CRITICAL ULTRASOUND PROBES (semi-invasive

and non-invasive) ...................................................................................................... 7

4.0 SEMI-CRITICAL ULTRASOUND PROBE (semi-invasive and non-invasive)

DECONTAMINATION POLICY .................................................................................. 8

APPENDIX 1: STANDARD OPERATING PROCEDURE FOR PURCHASE OF A SEMI-

CRITICAL (semi-invasive and non-invasive) PROBE DECONTAMINATION SYSTEM ....... 13

APPENDIX 2 - STANDARD OPERATING PROCEDURE: VALIDATION, TESTING AND

MAINTENANCE OF SEMI CRITICAL (semi-invasive and non-invasive) PROBE

DECONTAMINATION EQUIPMENT .................................................................................. 15

APPENDIX 3 – STANDARD OPERATING PROCEDURE: TRAINING FOR STAFF

UNDERTAKING SEMI CRITICAL (semi-invasive and non-invasive) PROBE

DECONTAMINATION ........................................................................................................ 17

APPENDIX 4 – STANDARD OPERATING PROCEDURE: SEMI CRITICAL (semi-invasive

and non-invasive) PROBE DECONTAMINATION - PRODUCT (probe) RELEASE ............. 19

APPENDIX 5 – STANDARD OPERATING PROCEDURE: TRANSPORT AND STORAGE

OF SEMI CRITICAL (semi-invasive and non-invasive) ULTRASOUND PROBES .............. 20

APPENDIX 6 – STANDARD OPERATING PROCEDURE: DECOMMISSIONING AND

DISPOSAL OF SEMI CRITICAL (semi-invasive and non-invasive) ULTRASOUND PROBE

DECONTAMINATION EQUIPMENT .................................................................................. 22

APPENDIX 7 – STANDARD OPERATING PROCEDURE: DECOMMISSIONING AND

DISPOSAL OF SEMI CRITICAL (semi-invasive and non-invasive) ULTRASOUND PROBE

DECONTAMINATION ALOGORITHM ................................................................................ 23

Disclaimer

The contents of this document are provided by way of general guidance

only at the time of its publication. Any party making any use thereof or

placing any reliance thereon shall do so only upon exercise of that party’s

own judgement as to the adequacy of the contents in the particular

circumstances of its use and application. No warranty is given as to the

accuracy, relevance or completeness of the contents of this document and

NHS National Services Scotland, shall have no responsibility for any

errors in or omissions therefrom, or any use made of, or reliance placed

upon, any of the contents of this document.

HPS/HFS: Version 1.0. March 2016 page 2 of 25



Terminology used within the guidance document

“Semi-critical” device is a reusable medical device which comes into contact with a mucous

membrane or broken skin under the Spaulding Classification.3 The Spaulding Classification system is used to determine the risk associated with used medical devices and theassociated decontamination method required. For the purposes of this guidance document semi-invasive ultrasound probes and non-invasive probes in contact with broken skin are categorised as semi-critical devices.

“Semi-invasive ultrasound probe” is an ultrasound probe which is used to ultrasound scan internal organs via non-sterile natural orifices i.e. the oesophagus, the vagina and the rectum. These are not sterile areas however the probes must undergo high level disinfection to ensure the probes are sufficiently decontaminated prior to use on the next patient.

“Non-invasive probe” is an ultrasound probe which is manufactured with the intention ofscanning the patients skin to determine any underlying structures/anomalies. However theadvancement of ultrasound scanning means they are increasingly used for scanning the skinwhich can be broken through the insertion of vascular devices or for the assessment ofcomplex wounds. This increases the risk of contamination of the probe with the blood which requires a high level disinfection process.

The terms “User” and “Operator” are distinct and defined terms used throughout this

guidance and associated SOPs.

The “User” is the manager responsible for decontamination and production of fit-for-purpose

probes (e.g. Unit manager, Lead Sonographer or Senior Charge Nurse).

The “Operator” is the person physically performing the decontamination processes (e.g.

Sonographer, nurse or healthcare worker).

An “Operator” is not a “User”. However, in small units or in exceptional circumstances a

“User” can be an “Operator” if sufficiently trained.




1.1 PURPOSE

This guidance sets out the operational procedures covering decontamination ofSemi-critical probes using High Level Disinfection (HLD). This covers specifically;Semi-Invasive Ultrasound Probes (SIUPs) and non-invasive ultrasound probes usedin semi-critical procedures.

• SIUPs - transoesophageal echocardiography (TOE),- transvaginal (TV) and- transrectal (TR) ultrasound probes.

• Non-invasive probes used on broken skin;- for vascular access,- cannulation or- wound assessment)

Throughout the guidance document and associated Appendices/SOPs the term“probes” will be used when referring to general probe guidance. Where specificprobes are required to be discussed they will be mentioned specifically.

In addition to the guidance, generic Standard Operating Procedures (SOPs) are provided as appendices and are referenced throughout the guidance document. Thegeneric SOPs are intended to provide healthcare staff with the procedures requiredfor the full decontamination process. An algorithm has been included as Appendix 7for healthcare workers involved in using and/or decontaminating semi critical probes. The algorithm provides a poster representation to be used in the clinical and decontamination area for staff to use as a quick reference guide. A further threeSOPs detailing three different methods of HLD (hydrogen peroxide mist, ultraviolet-Clight and manual multi-wipes) have been produced and links to the SOPs are provided throughout this document.

2.0 BACKGROUNDUltrasound probes are increasingly becoming a cornerstone in the diagnosis and treatment of patients in healthcare settings. Despite the beneficial impact on patient care, infection control concerns exist over the use of probes and their role as a vector

for pathogen transmission.1 Under the Spaulding classification ultrasound probes that come into contact with broken skin or intact mucous membrane are considered semi

critical devices and should undergo high level disinfection (HLD) between patients2;3.This decontamination process significantly reduces microbial contamination (i.e.mycobacteria, fungi, viruses and bacteria) and renders it safe for reuse, although

small numbers of bacteria spores may still be present.2;3

2.1 Literature review on the decontamination of Semi-Invasive Ultrasound

Probes

A scientific literature review was undertaken by HPS on the decontamination of Semi-Invasive Ultrasound Probes which found SIUPs present a number of challenges interms of decontamination. Many cannot be sterilised as they are delicate, expensive,heat sensitive devices with electrical components that cannot withstand standard

heat and steam decontamination techniques.4;5 However, unlike most flexibleendoscopes, probes have parts (e.g. handle, electrical components) that cannot beimmersed in any liquid for cleaning or disinfection as this could result in corrosion or




damage to electrical connections.5;6 Some Endoscope Washer Disinfectors (EWDs)can accommodate TOE probes by allowing immersion of the probe shaft in fluids,while protecting the handle and socket from exposure to fluids, however the handles

still require manual decontamination.5;6 Studies have shown residual contamination on SIUPs when HLD is not performed and cases of cross infection have been reported where transmission was thought to have been caused by improper

reprocessing of ultrasound transducers.5;7

The evidence from the literature review shows:

• There is high level (1+ and level 2) published evidence to support the use of

Ultra Violet light systems for decontamination of SIUPs

• There is low level published evidence (level 3) to support the use of

automated chemical systems (hydrogen peroxide) for decontamination of

SIUPs

• There is low level published evidence (level 3) to support the use of a manual

detergent/disinfection/rinse (multi-wipe ) system for decontamination of SIUPs

• There is no published scientific evidence available to review to support the

use of an EWD for decontamination of TOE Probes

• Non-invasive ultrasound probes were not included within the remit of the

literature review. However the Spaulding classification system (referenced

within the literature review) describes any device which comes into contact

with broken skin as semi-critical.3 This is the same for semi-invasive probes

and the rationale for inclusion within the guidance document.

Levels of evidence

The following grades were given to the available evidence within the literature review using SIGN methodology.

1+ Well conducted meta analyses, systematic reviews of RCTs, or RCTs witha low risk of bias

2 Well conducted case control or cohort studies with a low risk ofconfounding, bias, or chance and a moderate probability that the relationshipis causal

3 Non-analytic studies, e.g. case reports, case series

The Medicines and Healthcare Products Regulatory Agency (MHRA) released a

Medical Device Alert Ref: MDA/2012/037 on the 28th June 2012 in relation to the decontamination of reusable TOE, TV and TR ultrasound probes (transducers) inresponse to the death of a patient from hepatitis B which may have been associated

with a failure to appropriately decontaminate a TOE probe.8

2.2 Health Facilities Scotland (HFS) national survey.

Health Facilities Scotland (HFS) conducted a national survey of TOE, TV and TRultrasound probes to identify current decontamination practice for SIUPs across NHS


There is high level (1+ and level 2) published evidence to support the use of

Ultra Violet light systems for decontamination of SIUPs



Scotland which concluded that there is an ongoing risk to patient safety with regard todecontamination of these SIUPs.

2.3 Health Protection Scotland (HPS) SBAR on sheaths

Health Protection Scotland (HPS) undertook a rapid review of the literature in 2014 regarding sheaths and produced a Situation Background Assessment and Recommendations (SBAR) regarding their use. The literature was related to lumened and non lumened scopes however it is agreed by the expert steering group it isrelevant to probes. HPS concluded there was no comprehensive assessment of theevidence for sheaths in relation to infection control and healthcare associated infection (HAI). Therefore if HLD is being undertaken between patients then a sheathis not required to reduce cross transmission risks. A sheath only requires to be used if clinically indicated to aid the diagnostic procedure. The CDC guidelines for thedisinfection and sterilisation in healthcare facilities support this advice which states “when probe covers are available, use a probe cover or condom to reduce the level of microbial contamination. Do not use a lower category of disinfection or cease tofollow the appropriate disinfectant recommendations when using probe covers

because sheaths and condoms can fail”.3

The standard of SIUPs decontamination across NHSScotland is inconsistent, difficultto validate and does not give assurance of the recommended high level disinfection of SIUPs, meaning SIUPs remain a possible cross infection risk. This guidancedocument provides NHS Scotland Health Boards with an evidence based approach to the decontamination of semi-critical probes. The guidance has incorporated thefindings of the 2012 HFS study, the recommendations from the MHRA Medical Device Alert, the evidence from a full systematic literature review on the decontamination of SIUPs and the expert opinion of the Endoscopy and Primary Care Working Group and the HAI Reusable Medical Devices Expert Advisory Steering Group. Where evidence was lacking the guidance was developed using theexpert opinion of national experts from the HAI Reusable Medical Devices Expert Advisory Steering Group and associated subgroups.

3.0 ROLES AND RESPONSIBILITIES FOR HEALTHCARE

WORKES INVOLVED WITH DECONTAMINATION OF SEMI-

CRITICAL ULTRASOUND PROBES (semi-invasive and non-

invasive)

3.1 Decontamination Lead/Nominated Person is responsible for:

• The overall decontamination of reusable medical devices for the health board

(i.e. Decontamination manager or Infection Control Manager)

• Providing effective and technically compliant decontamination services for probes in accordance with best practice guidance

• Implementing an operational policy for decontamination for probes in accordance with the policies outlined in Section 4.0 (Decontamination Policy)

• Monitoring the implementation of the policy. This can be done using the policies outlined in section 4.0




3.2 User is responsible for:

• The responsibility for decontamination of probes rests with the person designated as the “User” (e.g. Unit manager, Lead Sonographer or Senior Charge Nurse (SCN)).

• The User’s responsibilities include ensuring that the management of probe decontamination is in accordance with equipment manufacturer’s instructions, the probe manufacturer’s instructions and this National Services Scotland (NSS)guidance document. These cover the entire decontamination equipment lifecycle from acquisition to disposal.

• The User should identify the Decontamination Lead for the health board toensure the user has the appropriate contact regarding decontamination expertise.

3.3 Operator is responsible for:

• Performing probe decontamination procedures; decontamination equipment cleaning; routine maintenance and testing; ensuring probes are fit for purpose and maintaining records for traceability purposes (i.e. sonographer, nurse or HCW).

• The Operator should be trained in probe decontamination and deemed competent by the User (unit manager). See Appendix 3; SOP: training for staff undertaking semi-critical ultrasound probe (semi-invasive and non-invasive) decontamination).

4.0 SEMI-CRITICAL ULTRASOUND PROBE (semi-invasive and

non-invasive) DECONTAMINATION POLICY

4.1 Semi-critical probes should be decontaminated using a HDL method.

There are four methods available;

• using ultraviolet light;

Semi-critical ultrasound probe (semi-invasive and non-invasive) HighLevel Decontamination Procedure

• using hydrogen peroxide;Semi-critical ultrasound probe (semi-invasive and non-invasive) HighLevel Decontamination Procedure

• using manual multi-wipes;

Semi-critical ultrasound probe (semi-invasive and non-invasive) HighLevel Decontamination Procedure

• Endoscope washer disinfectors (EWD) can be modified toaccommodate TOE probes. This method of decontamination must beundertaken following approval of the TOE probe manufacturers and theEWD manufacturers to ensure compatibility and that probe warranties are not compromised. Areas using EWD for reprocessing TOE probes mustensure validated processes are in place to provide assurance that HLD




has been achieved. Users must note that despite using an EWD for decontamination of TOE probes a manual cleaning and disinfection of the handles must take place.

The evidence to support the 4 methods of decontamination can be found

within the Background section 2.1 (evidence from the literature review).

4.2 Purchase of a probe decontamination system should be based on the following

criteria;

• Evidence to support effectiveness of the decontamination system from

this guidance document and decontamination system manufacturers. This

can be found in section 2.1

• Safety of use (for staff and patients) of the decontamination system

including any possible process residue

• Compatibility with the range of ultrasound probes

• Validation of disinfection process and practicality within the clinical setting

• Compatibility of wipes used for cleaning/disinfecting the internal surfaces

of the decontamination equipment

• Costs (purchase and maintenance)

• Environmental and energy impacts

4.3 Purchase of a probe decontamination system (see appendix 1) Standard

Operating Procedure (SOP) for purchase of a Semi-critical ultrasound probe (semi-

invasive and non-invasive) decontamination system) is the responsibility of the User

(unit manager) and undertaken with advice from the decontamination lead,

procurement lead/manager, Authorising Engineer Decontamination (AE(D)), medical

physics and Infection Control Doctor or nurse with regard to the criteria stated in 4.1.

4.4 Probe decontamination is carried out in accordance the manufacturers of the

decontamination systems instructions, the re-processing instructions provided by the

probe manufacturers and with this guidance document. Should conflicting advice

occur the User should discuss the issue with the Decontamination Lead and the

infection prevention and control team (IPCT) and a solution agreed. This should be

done in collaboration with probe and decontamination system manufacturers.

4.5 Probes that can be disconnected (where recommended by the manufacturer) from

the ultrasound machine should be purchased as a matter of preference where

possible. This is to allow used probes to be transported to a designated

decontamination area for reprocessing, reducing cross infection risks to patients and

health and safety risks to staff.

4.6 Compatible probe sheaths/condoms - Use of a sheath/condom does not negate

the need for probes to undergo HLD as there is limited evidence on their

effectiveness as a barrier to reducing the risk of HAI. A sheath should be used if

clinically indicated for diagnostic purposes in accordance with manufacturers’

instructions and should be the correct size for the probe to be used. The sheath

should be visually inspected for damage after use. Where damage is identified it

should be recorded in the decontamination records/patient notes.




4.7 Decontamination equipment is validated, tested, maintained and operated in

keeping with latest relevant standards and guidance and manufacturer’s instructions.

Validation, testing and maintenance of probe decontamination systems is the

responsibility of the User (unit manager). The SOP for validation should be followed

in line with chosen decontamination procedure. See Appendix 2 (for generic SOP) for

Validation, testing and maintenance of semi-critical ultrasound probe (semi-invasive

and non-invasive) probe decontamination equipment, and decontamination systems

SOPs for ultra violet light, hydrogen peroxide and manual multi-wipes.

4.8 Records are established and maintained to demonstrate the efficacy of the

decontamination process and to identify the remedial action undertaken following

failure of any part of the decontamination process. The Operator is responsible for

recording any non-conformances with the decontamination process. The User (unit

manager) is responsible for establishing and ensuring records are maintained and up

to date. Records are securely stored either in electronic or paper form and readily

accessible to permit traceability (for probes, decontamination equipment and

patients). Guidance on record keeping can be found within the appendices and SOPs

where applicable.

4.9 All staff undertaking probe decontamination are trained and their competence

assessed by the User in the relevant procedures. This training is recorded. See

Appendix 3 - SOP: Training for staff undertaking decontamination of semi-critical

ultrasound probes (semi-invasive and non-invasive).

4.10 Probes should be decontaminated prior to the first use of the day, between

patients and following the last patient of the day regardless of being stored on the

ultrasound machine or in storage containers recommended by the manufacturers

(this should not be the manufacturers carry case).

4.11 Probe decontamination should be conducted away from the clinical area in a

dedicated decontamination room where possible. However, it is recognised that due

to limitations in some healthcare facilities and possible operational constraints, probe

decontamination is carried out in the clinical area. If unable to relocate

decontamination away from the clinical area then the User, Decontamination Lead

and the local IPCT should be involved in the risk assessment and development of

local protocol and processes using manufacturers instructions. Where this is the case

the HAI risk assessment should be placed on the local Risk Register by the User in

the ongoing pursuit of the preference for a dedicated decontamination room.

4.12 Probe decontamination should be undertaken following the SOP for either;

• An Ultra-violet light decontamination system

• A hydrogen peroxide decontamination system

• A manual multi-wipe system

An algorithm is available (see Appendix 7) for the decontamination of semi-critical

(semi-invasive and non-invasive) probes using HLD. This can be printed as a poster

for display within the clinical area and supports the three system SOPs described.

• EWD within the endoscopy decontamination unit (EDU)


4.10 Probes should be decontaminated prior to the first use of the day, betwtt een

patients and following the last patient of the day regardless of being stored on the

ultrasound machine or in storage containers recommended by the manufacturers

(this should not be the manufacturers carry case).



For departments using an EWD for the decontamination of TOE probes local

procedures should be in place for the pre cleaning of probes. This should be

agreed with the Decontamination Lead and the IPCT. The SOP for transport and

storage should be followed (see Appendix 5: SOP for transportation and storage

of semi-critical ultrasound probe (semi-invasive and non-invasive)). This will

ensure the appropriate steps are taken for transport to and from the Endoscopy

Decontamination Unit (EDU) where the TOE probe will be reprocessed by

trained decontamination staff. The SOP also describes the procedure for storage

of TOE probes on return to the unit.

4.13 The Product (probe) Release procedure defines the acceptance criteria to be

met before the probes are fit for use on the next patient. The product release

procedure is performed by the Operator and monitored by the User in line with

Appendix 4- SOP: semi-critical ultrasound probe (semi-invasive and non-invasive)

decontamination; product (probe) release. Product release processes can also be

found in the SOP for decontamination using UVC, chemical disinfection (hydrogen

peroxide) and multi wipe (chlorine dioxide) systems. For TOE probes

decontaminated within an EWD the product release will be performed by the staff

within the decontamination facility and all local procedures must be followed before

the TOE probe is returned to the department for use.

4.14 Probes are returned to the ultrasound machine for storage following cleaning

of the holder (see Appendix 5: SOP for transportation and storage of semi-critical

ultrasound probes (semi-invasive and non-invasive)). Any additional probes should

be transported clean and dry in a designated container (i.e. an endoscope transport

tray) to a designated storage area. The area for storage of clean probes should be

either provided by or recommended by the manufacturer. Manufacturers instructions

should be consulted regarding storage of probes. If this guidance and manufacturers

instructions are contradictory the User should discuss the issue with the

Decontamination Lead, the manufacturer and the IPCT.

4.15 The design of the decontamination facility used, be it in a separate room or

incorporated in a clinical procedures room, should have a clearly designated flow

from used (dirty) through the cleaning and disinfection process to clean and available

for storage and use.

The area designated for the decontamination of probes should be designed following

discussion with the Decontamination Lead and the IPCT. The User is responsible for

ensuring the decontamination facility is “fit for purpose” and should refer to the

principles set out in SHPN13 Part 3 – Decontamination Facilities -Endoscope

Decontamination Units. 9 This provides design guidance on sizing decontamination

facilities, room layouts and a room data sheet specifying furniture/fittings and surface

finishes.




4.16 Tracking and Traceability- A system allowing the tracking and tracing of probes

through the decontamination process to the patient should be in place.

4.17 Decontamination equipment sent away for repair should be cleaned and be

accompanied by a Decontamination certificate.

4.18 Transport and Storage Semi-critical probes SOP should be followed in line with the

SOP: Transport and Storage of semi-critical ultrasound probes (semi- invasive and

non-invasive) (see Appendix 5).

4.19 Decommissioning and disposal of probe decontamination systems should be

carried out by the Operator and monitored by the User who has overall responsibility.

Decommissioning and disposal of probe decontamination systems SOP should be

followed in line with procedure (see Appendix 6). Large waste electrical goods are

classed as hazardous waste and there is a duty of care under the ‘Duty of Care – A

Code of Practice (Oct 2012’) (http://www.scotland.gov.uk/Publications/2012/ and

Environmental Waste (Scotland) Regulations 2012 to dispose of them responsibly.

Contact the Waste officer and refer to Scottish Health Technical Note 3 NHSScotland

waste management guidance Part C: Compendium of regulatory requirements

(February 2015) for further information.

4.20 Patient and staff exposure to materials must be minimised and the Control of

Substances Hazardous to Health (COSHH) regulations must be complied with.


APPENDIX 7: NHSScotland Semi-critical Ultrasound Probe

(semi-invasive and non-invasive) Decontamination Algorithm

Probe used on Mucous

membranes or broken

skin?

Non- invasive procedurei.e. Intact skin (No blood or body fluid

exposure anticipated)

- Abdo U/S

- Pelvic U/S

If required ensure recommended sheath is

correct size for probe required

Semi-critical procedure

(semi –invasive and non-invasive)i.e. Mucous membranes

- TOE/TV/TR probes

i.e. Non intact skin

- Venepuncture/Cannulation

- Wound/cavity assessment

If required ensure recommended sheath is

correct size for probe

Pre – clean- Following U/S scan remove & dispose

sheath in clinical waste stream.

- Inspect probe and cable

- Remove U/S gel residue by wiping with a

non-linting cloth

- Dispose of probe accessories in clinical

waste stream

- Disconnect probe (if possible) and take to

area approved for probe decontamination

- Inspect probe & cable for damage

Following one of the HLD methods set

out in NHSScotland Guidance for

decontamination of Semi-critical (semi-

invasive and non-invasive) Ultrasound

Probes

- Ultra-violet light

- Hydrogen Peroxide

- Manual wipe (chlorine

dioxide)

High Level Disinfection (HDL) Procedure

- Replace cleaned probe in probe holder

- Dispose of waste in clinical waste stream

The procedures set out in this algorithm should be undertaken

following;

· Standard Infection Control Precautions (SICP) within the National

Infection Prevention and Control Manual (NIPCM)

http://www.nipcm.hps.scot.nhs.uk/

· The NHSScotland Guidance for decontamination of Semi-critical (semi-

invasive and non-invasive) Ultrasound Probes

· SOPS: Decontamination procedure for HLD of semi-critical Ultrasound

Probes (semi-invasive and non-invasive) using;

· Ultra-violet light [add link]

· Hydrogen Peroxide [add link]

· Manual wipe (chlorine dioxide) [add link]

No

Blood or body fluids

noted during

procedure?

Yes

No

Yes

Cleaning procedure - Clean probe & cable with a compatible

detergent wipe

- Rinse and dry probe and cable

- Inspect probe & cable for damage

- Clean probe holder with a compatible

detergent wipe

- Rinse and dry probe holder

TOE probes where pre

arranged can be transferred

to an endoscopy

decontamination unit (EDU)

for decontamination

*Pre arranged requires the

Decontamination Lead and

the IPCT to approve local

procedures.

Follow cleaning guidance in the NIPCM

5. Ireland / 2017 : extract of

guidelines

HSE Guidance for Decontamina on of Semi cri cal Ultrasound Probes;

Semi invasive and Non invasive Ultrasound Probes QPSD GL 028 1

Note: The diagram used in this document is © Crown Copyright Source—Department of Health United Kingdom

Health Service Executive

Guidance for

Decontamination of Semi critical

Ultrasound Probes;

Semi invasive and Non invasive

Ultrasound Probes




Page 2

Directorate: Quality Improvement Division

Title: HSE Guidance for Decontamina on of Semi cri cal Ultrasound

Probes; Semi invasive and Non invasive Ultrasound Probes.

Document Reference Number: QPSD GL 028 1

Version Number: 1

Document Purpose: Guidance for Decontamina on of Semi cri cal Ultrasound Probes

Author: HSE Quality Improvement Division Decontamina on Safety

Programme.

Approval Date: January 2017

Target Audience: All relevant healthcare workers in the public health service who are

involved in the decontamina on of Ultrasound Probes.

Descrip on:

Guidance for Decontamina on of Semi cri cal Ultrasound Probes is

based on best available evidence and professional best prac ce. With

kind permission this document has been adapted to the Irish

Healthcare context, from Health Facili es Scotland’s Guidance

Document for Decontamina on of Ultrasound Probes published

March 2016.

Revision Date: January 2019

Contact Details:

Caroline Conneely

Na onal Decontamina on Safety Programme Lead

Quality Improvement Division,

Health Service Execu ve,

Dr Steevens Hospital,

Dublin

Eircode: DO8 W2A8

Ireland.

Email: [email protected]

Reader Informa on




Page 3

Table of Contents Page

Terminology and Acronyms used within the Guidance Document ................................... 4

1. Purpose .......................................................................................................................... 6

2. Background .................................................................................................................... 8

3. HIQA Standards for Safer Be er Health Care ............................................................. 9

4. Literature Review ........................................................................................................ 17

5. Roles and Responsibili es .......................................................................................... 18

6. Decontamina on Policy .............................................................................................. 20

Appendices

Appendix I Purchase of probe decontamina on system......................................................... 25

Appendix II Valida on, tes ng and maintenance of Ultrasound Probe decontamina on

systems .................................................................................................................. 27

Appendix III Training for Healthcare Workers involved in decontamina on of Ultrasound

Probes..... ............................................................................................................... 29

Appendix IV Procedures for release of disinfected Ultrasound Probes .................................... 31

Appendix V Transport and storage of Ultrasound Probes ........................................................ 32

Appendix VI Decommissioning and disposal of Ultrasound Probe decontamina on

equipment ............................................................................................................. 34

Appendix VII Decontamina on algorithm for Ultrasound Probes.............................................. 35

Decontamina on Procedures ............................................................................................. 36

1. Procedure for HLD using Automated Hydrogen Peroxide Systems ....................................... 36

2. Procedure for HLD using Ultraviolet Light .............................................................................. 41

3. Procedure for HLD using a manual (Chlorine Dioxide) mul wipe system............................. 46

Figures

Figure 1: Themes for Quality and Safety ..................................................................................... 9

Resources ............................................................................................................................. 50

Page 3

Procedure for HLD using Ultraviolet Light




Page 4

Terminology and Acronyms used within the Guidance Document

“Semi cri cal” the device is a reusable medical device which comes into contact with a mucous

membrane or broken skin under the Spaulding ClassiÞca on.3

The Spaulding ClassiÞca on

system is used to determine the infec on risk associated with used medical devices and the

associated decontamina on method required. For the purposes of this guidance document

Semi invasive Ultrasound Probes and Non invasive Probes in contact with broken skin are

categorised as Semi cri cal devices.

“Semi invasive Ultrasound Probe” is an Ultrasound Probe which is used to ultrasound scan

internal organs via non sterile natural oriÞces i.e. the oesophagus, the vagina and the rectum.

These are not sterile areas however the probes must undergo high level disinfec on to ensure

the probes are su ciently decontaminated prior to use on the next pa ent.

“Non invasive probe” is an Ultrasound Probe which is manufactured with the inten on of

scanning the pa ents skin to determine any underlying structures/anomalies. However the

advancement of ultrasound scanning means they are increasingly used for scanning the skin which

can be broken through the inser on of vascular devices or for the assessment of complex wounds.

This increases the risk of contamina on of the probe with blood which requires a high level

disinfec on process.

The terms “Responsible Person” and “Operator” are dis nct and deÞned terms used

throughout this guidance and associated procedures.

The “Responsible Person” is the Manager responsible for ensuring the probes are

decontaminated, Þt for purpose and safe for re use on the pa ent (e.g. Unit Manager, Lead

Sonographer or Senior Charge Nurse).

The “Operator” is the person physically performing the decontamina on processes (e.g.

Sonographer, Nurse or Healthcare Worker). Equally it is the responsibility of the Operator to

ensure decontamina on procedures are performed according to HSE Guidelines and manufacturer

instruc ons. An “Operator” is not a “Responsible Person”. However, in small units or in

excep onal circumstances a “Responsible Person” can be an “Operator” if su ciently trained.

AE(D) Authorising Engineer for Decontamina on

CDU Central Decontamina on Unit

EDU Endoscope Decontamina on Unit

EWD Endoscope Washer Disinfector

HCAI Healthcare Associated Infec ons




Page 5

HCW. Healthcare Worker

HIQA Health Informa on and Quality Authority

HLD High Level Disinfec on

IPCT Infec on Preven on and Control Team

PPE Personal Protec ve Equipment

RIMD Reusable Invasive Medical Devices

SIUP Semi invasive Ultrasound Probe

TOE Transoesophageal Echocardiography

TR Transrectal

TV Transvaginal




Page 15

Features of a service mee ng this Standard include:

Cleaning and Disinfec on: HLD using the manual mul wipe system is the least preferred op on for

disinfec ng Semi cri cal Ultrasound Probes. Interna onally it is recognised that the use of an

automated validated process for decontamina ng RIMD will provide enhanced risk reduc on of

infec on transmission. It is recommended that a local risk assessment is performed if this op on is to

be used as an interim measure prior to implementa on of an automated process.

Semi cri cal Ultrasound Probes must be compa ble with the detergents and decontamina on

methods that are used.

Commissioning and Valida on: At a minimum decontamina on equipment must be installed and

commissioned by a Competent Person who provides documented evidence that they have been

trained to commission and validate this equipment. Therea er the Responsible Person will ensure

that at a minimum an annual valida on and service of all decontamina on equipment is performed

by a Competent Person. All commissioning, servicing and re valida on and documents must be

retained by the Responsible Person for 11 years plus the life me of the equipment. Review

documenta on to ensure it is complaint to all relevant na onal and interna onal standards.

Records are established and maintained to demonstrate the e cacy of the decontamina on process

and to iden fy the remedial ac on undertaken following failure of any part of the decontamina on

process. The Operator is responsible for recording any non conformances with the decontamina on

process.

Tracking and Traceability: A system must be in place to ensure Probes are tracked through the

decontamina on process and linked to the pa ent on whom the devices have been used. The

organisa on should work toward implemen ng an electronic tracking system that will integrate with

the Na onal Electronic Track and Trace system for RIMD’s.

Theme 3: Safe Care and Support

Standard 3.1.6 Safe and e ec ve management of medical devices in accordance with

legisla ve requirements, na onal policy/guidelines and best na onal/

interna onal evidence.

Cleaning and Disinfec on: HLD using the manual mul wipe system is the least preferred op on for

disinfec ng Semi cri cal Ultrasound Probes. Interna onally it is recognised that the use of an

automated validated process for decontamina ng RIMD will provide enhanced risk reduc on of

infec on transmission.




Page 20

6.0 Decontamina on Policy for Semi cri cal Ultrasound Probes (Semi invasive

and Non invasive)

6.1 Semi cri cal Probes must be manually cleaned prior to using a HLD method.

There are four HLD methods available (in no par cular order of preference):

Using Ultraviolet Light:

Semi cri cal Ultrasound Probe (Semi invasive and Non invasive) High

Level Decontamina on Procedure.

Using Hydrogen Peroxide:


Level Decontamina on Procedure

Endoscope Washer Disinfectors:

(EWD) can be modiÞed to accommodate TOE Probes. This method of

decontamina on must be undertaken following approval of the TOE

Probe manufacturers and the EWD manufacturers to ensure

compa bility and that probe warran es are not compromised. Areas

using EWD for reprocessing TOE probes must ensure validated processes

are in place to provide assurance that HLD has been achieved.

Responsible Person must note that, despite using an EWD for

decontamina on of TOE Probes, a manual cleaning and disinfec on of

Probe handles must be in place.

Using Manual Mul wipes:


Level Decontamina on Procedure. This is the least preferred op on for

decontamina ng SIUP’s.

6.2 Purchase of a Probe decontamina on system should be based on the following

criteria:

Evidence to support e ec veness of the decontamina on system.

Training supports, to ensure e ec veness of the decontamina on

process

Safety of use (for healthcare workers and pa ents) of the

decontamina on system including any possible process residue.

Compa bility with the range of Ultrasound Probes.

Valida on of disinfec on process and suitability within the clinical

se ng.

There are four HLD methods available

Using Ultraviolet Light:




Page 21

Compa bility of wipes used for cleaning/disinfec ng all surfaces of

the decontamina on equipment.

Costs (purchase and maintenance).

Environmental and energy impacts.

(Note: Ensure the number of Probes purchased for a par cular machine meets the

decontamina on turnaround mes. The purchased Probes must be

compa ble with the decontamina on processes available in the hospital with

emphasis on automated validated processing)

6.3 Purchase of a Probe decontamina on system (Appendix I)

The Procedure for purchase of a Semi cri cal Ultrasound Probe (Semi invasive and

Non invasive) decontamina on system is the responsibility of the Responsible

Person (Unit Manager) and undertaken with advice from the Decontamina on

Lead, Procurement Lead/Manager, Authorising Engineer Decontamina on (AE(D)),

medical physics and infec on control microbiologist/nurse with regard to the

criteria stated in 6.1 and 6.2.

6.4 Probe decontamina on is carried out in accordance with the manufacturers

opera onal instruc ons for their decontamina on systems , the re processing

instruc ons provided by the probe manufacturers and this guidance document.

Should conßic ng advice occur the Responsible Person should discuss the issue with

the Decontamina on Lead and the Infec on Preven on and Control team (IPCT)

and a solu on agreed. This should be done in collabora on with Probe and

decontamina on system manufacturers.

6.5 Probes that can be disconnected (where recommended by the manufacturer) from

the ultrasound machine should be purchased as a ma er of preference where

possible. This is to allow used probes to be transported to a designated

decontamina on area for reprocessing, reducing cross infec on risks to pa ents

and health and safety risks to healthcare workers (Appendix I).

6.6 Compa ble probe sheaths/condoms

Use of a sheath/condom does not negate the need for probes to undergo manual

cleaning and HLD as there is limited evidence on their e ec veness as a barrier to

reducing the risk of HCAI. A sheath should be used for diagnos c purposes in

accordance with manufacturers’ instruc ons and should be the correct size for the

Probe to be used. The sheath should be visually inspected for damage a er use.

Where damage is iden Þed it should be recorded in the decontamina on records/

pa ent notes.




Page 22

6.7 Decontamina on equipment is validated, tested, maintained and operated in

keeping with the latest relevant standards and guidance and manufacturer’s

instruc ons. Valida on, tes ng and maintenance of probe decontamina on systems is

the responsibility of the Responsible Person (Unit Manager) with guidance and support

provided by the Decontamina on Lead and the Infec on Preven on and Control Team.

The process for valida on should be followed in line with chosen decontamina on

procedures (Appendix II and Decontamina on Procedures for HLD).

6.8 Records are established and maintained to demonstrate the e cacy of the

decontamina on process and to iden fy the remedial ac on undertaken following

failure of any part of the decontamina on process. The Operator is responsible for

recording any non conformances with the decontamina on process. The Responsible

Person (Unit Manager) is responsible for establishing and ensuring records are

maintained and up to date. Records are securely stored either in electronic or paper

format and readily accessible to permit traceability (for probes, decontamina on

equipment and pa ents). Guidance on record keeping can be found within the

appendices and procedures where applicable. SIUP’s must be tracked through the

decontamina on life cycle and linked to the pa ent on whom the device has been

used.

6.9 All healthcare workers undertaking probe decontamina on are trained and their

competence assessed by the Responsible Person in the relevant procedures and

training is recorded (Appendix III).

6.10 Probes, their accessories, leads and connectors should be decontaminated prior

to the Þrst use of the day, between pa ents and following the last pa ent of the

day regardless of being stored on the ultrasound machine or in storage containers

recommended by the manufacturers (this should not be the manufacturers carry

case).

6.11 Probe decontamina on should be conducted away from the clinical area in a

dedicated decontamina on room where possible. However, it is recognised that

due to limita ons in some healthcare facili es and possible opera onal constraints,

probe decontamina on is carried out in the clinical area. If unable to relocate

decontamina on away from the clinical area then the Responsible Person,

Decontamina on Lead and the local IPCT should be involved in the risk assessment

and development of local protocol and processes to minimise risk .

Where this is the case the HCAI risk assessment should be placed on the local Risk

Register by the Responsible Person in the ongoing pursuit of the preference for a

dedicated decontamina on room.

6.10 Probes, their accessories, leads and connectors should be decontaminated prior 6.10 Probes, their accessories, leads and connectors should be decontaminated prior

to the Þrst use of the day, between pa ents and following the last pa ent of the

day

6. ECMUS (European Committee for

Medical Ultrasound Safety)/ 2017

European Committee for Medical Ultrasound Safety (ECMUS)

© 2017 ECMUS | www.efsumb.org/ecmus | ECMUS Editors : C Kollmann & K Salvesen

Best Practice recommendations for cleaning and disinfection of ultrasound

transducers whilst maintaining transducer integrity Introduction These guidelines give an overview of regulations and procedures for cleaning and disinfecting ultrasound equipment with a specific focus on maintaining the optimal function and condition of transducers while reducing the risk of viral and/or bacterial contamination. In general, users should follow the cleaning and disinfection regulations from their hospital´s hygiene department, but these do not necessarily address transducer aspects related to transducer cleaning and disinfecting procedures specifically. Transducer housing materials can be changed, or slightly damaged over time due to improper procedures. Classification of transducers The purpose of cleaning and disinfection procedures is to eliminate microorganisms and bacterial spores from medical devices. Without correct disinfection, the risk of nosocomial transmission of genito-urinary pathogens or cross-infections between patients may exist for e.g. endocavity ultrasound applications [1-2]. Transducers are treated differently to the risk for microbial contamination according to the Spaulding [3] classification system (Fig.1), and this should be tailored to the clinical requirements [4]. Fig.1 : classification of ultrasound transducers and hygienic requirements

examination

classification (Spaulding)

type of transducer

hygienic requirements

hygiene procedures

intact skin

non-critical

transabdominal others: monitor,

console

cleaning and/or low/intermediate level disinfection, potentially: cover

manual (wiping) but automatic methods are preferred.

non-intact skin, mucuos

membranes, blood contact

semi-critical A semi-critical B

endovaginal, endocavity, endorectal

high-level disinfection +

nonsterile cover

automatic methods approved by

manufacturers preferred

sterile areas of the body, intra-

operative, biopsy, puncture

techniques

critical

intraluminal, biopsy-holder

sterilisation + sterile cover

automatic methods approved by

manufacturers

disposable none

(delivered sterile) none

(one use) The European Centre for Disease Prevention and Control (ECDC), national bodies such as the german Robert Koch Institute, ultrasound societies and the hygiene departments of hospitals have published regulations and policies, that are mandatory, or good practice, guidelines [5-10]. The user should follow these regulations. However, negative interactions with the ultrasound material components that could alter the image performance are not usually addressed. It is important that the biological effectiveness and the material compatibility of the disinfectant are optimal for routine use. Transducer malfunction related to suboptimal cleaning and disinfection procedures Ultrasound transducers are sophisticated, sensitive medical products needing specific care during cleaning and disinfection. However, most procedures do not take into account complications arising from material changes, e.g. bleaching, warming-up cycles or yellowing over time. Regular cleaning and chemical disinfection can expedite ageing of transducer materials in general, and make the transducer electrically



unsafe. The image quality can decrease due to micro-fissures and holes produced by repetitive thermal stress during automatic processes or chemical reactions. Using the wrong cleaning cloth (with a rough surface) or wrong disinfectants, may also damage the surface of ultrasound transducers over time. The ultrasound operator needs to consider these aspects. Best Practice Recommendations

General - Soft wipes, approved disinfectants and transducer covers must be easily to hand. Special hygienic requirements (such as sterile transducer cover or gels) must be available for specific procedures

- stay informed about relevant hygienic procedures - be sure that dispensing nozzles do not come into contact with patients - be sure that the disinfectants in use are approved by the manufacturer of the ultrasound equipment and are in accordance with your hospital regulations. Have the disinfectant name and order numbers easily to hand.

Cleaning - After removing the cover, the transducer must be wiped with a soft cloth after each examination to remove any residual gel or debris. Water or a low-/intermediate-level disinfectant can be used. - Do not forget to

(1) disconnect the transducer from the equipment if the whole cable needs to be cleaned (2) wipe the monitor and the console, including keyboard panel, transducer holders, hand rest and gel container (to prevent smear-/cross-contamination) (3) take the time needed to achieve the required efficacy i.e. guaranteed completion of disinfection (4) discard gloves after the cleaning process

Disinfection - All internal transducers (e.g. vaginal, rectal, transesophageal transducers) and intra-operative transducers, require a high-level of disinfection before they can be used in a new patient (Fig.1).

Local regulations from the hygiene department must be followed strictly, and it must be ensured that the disinfectants comply with the manufacturer´s guidance for the transducer.

- Automatic processes such as hydrogen peroxide (H2O2, e.g. Nanosonics Trophon EPR) or ultraviolet (UV, e.g. Antigermix) methods are preferred, where approved by the manufacturer to guarantee a reproducible standardised and fast process [11-15], as long as a full documentation of

the disinfection process is available (preferably in digital form).

Sterilisation - Follow the regulations stipulated by the hospital and the manufacturer for the type of transducer and process if necessary. Disposable transducers - Disposable transducers are delivered in a sterile condition and must be handled according to

manufacturer’s instructions. It is important to know the appropriate disinfection methods for transducers

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It is essential to look for the correct transducer number, because similar housing designs with different covering/plastic materials are used and may react differently with disinfectants. Have a look at the manufacturers specific approved disinfectants for optimal transducer / console care. This can be accessed.

- in the hand book of the ultrasound equipment or transducer user manuals - on the manufacturer´s website - by the manufacturer’s service technician

References [1] Casalegno J-S, Le Bail Carval K., Eibach C. et al. High risk HPV contamination of endocavity vaginal ultrasound probes:

an underestimated route of nosocomial infection? Plos One (2012) 7/10, e48137 [2] M`Zali F; Bounizra C, Leroy S et al. Persistence of microbial contamination on transvaginal ultrasound probes despite low-

level disinfection procedure. Plos One (2014) 9/4, e93368 [3] Spaulding EH. Chemical disinfection and antisepsis in the hospital. J Hosp Res (1957) 9:5–31. [4] Dancer SJ: Hospital cleaning in the 21st century. Eur J Clin Microbiol Infect Dis (2011) 30:1473-1481 [5] European Centre for Disease Prevention and Control (ECDC): Core competencies for infection control and hospital

hygiene professionals in the European Union, Technical document Stockholm March 2013 (doi 10.2900/7778). www.ecdc.europa.eu

[6] Robert Koch Institut (RKI): Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Bundesgesundheitsbl. (2012) 55:1244-1310 http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Medprod_Rili_2012.pdf?__blob=publicationFile (Last accessed: 06.06.2017)

[7] DGSV flow chart: Correction Needed to DGSV Flow Chart 2012 in January 2013. Zentralsterilisation 1/2013, 64-68 http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/DGSV_pdf.pdf?__blob=publicationFile (Last accessed: 06.06.2017)

[8] The Regulation and Quality Improvement Authority: Regional Healthcare Hygiene and cleanliness standards, www.rqia.org.uk

[9] Abramowicz JS, Evans DH, Fowlkes JB Marsal K, TerHaar G: Guidelines for cleaning transvaginal ultrasound transducers between patients. UMB 43/5 (2017), 1076-1079

[10] EFSUMB Guidelines on Interventional Ultrasound (INVUS), part I, General Aspects, Ultraschall in Med (2015) 36: E1-E14 (doi: 10.1055/s-0035-1553593)

[11] Johnson S, Proctor M, Bluth E et al. Evaluation of a hydrogen peroxide-based system for high-level disinfection of vaginal ultrasound probes. J Ultrasound Med (2013) 32/10: 1799-1804

[12] Nanosonics Trophon. http://www.trophon.com (Last accessed: 06.06.2017) [13] Vickery K, Gorgis VZ, Burdach J et al. Evaluation of an automated high-level disinfection technology for ultrasound

transducers. J Infect Public Health (2014) 7/2: 153-160 [14] Kac G; Gueneret M, rodi A et al. Evaluation of a new disinfection procedure for ultrasound transducers using ultraviolet

light. J Hospital Infection (2007) 65:163-168 [15] Antigermix S1.http://www.germitec.com (Last accessed: 06.06.2017) Definitions cleaning removal of contamination from a surface or housing disinfection the process of reducing or eliminating viable microorganisms to a specified level (low-, intermediate- or high-

level). low-level disinfection a process that will inactivate most vegetative bacteria, some fungi, and some viruses, but

cannot be relied on to inactivate resistant microorganisms (e.g., mycobacteria or bacterial spores; Glossary CDC). intermediate-level disinfection a process that inactivates vegetative bacteria, most fungi, mycobacteria, and

most viruses (particularly the enveloped viruses), but not bacterial spores (Glossary CDC). high-level disinfection the destruction of all vegetative microorganisms, mycobacterium, small or nonlipid

viruses, medium or lipid viruses, fungal spores, and some bacterial spores (Glossary CDC). sterilisation validated process that eliminates and destroys all viable microorganisms from a transducer

surface including bacterial spores.

http://www.ecdc.europa.eu/

http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Medprod_Rili_2012.pdf?__blob=publicationFile

http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Medprod_Rili_2012.pdf?__blob=publicationFile

http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/DGSV_pdf.pdf?__blob=publicationFile

http://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/DGSV_pdf.pdf?__blob=publicationFile

http://www.rqia.org.uk/

http://www.trophon.com/

http://www.germitec.com/

7. WFUMB (World Federation of

Ultrasound in Medecine and

Biology)/ 2017

Ultrasound in Med. & Biol., Vol. -, No. -, pp. 1–4, 2017� 2017 World Federation for Ultrasound in Medicine & Biology

Printed in the USA. All rights reserved0301-5629/$ - see front matter

/j.ultrasmedbio.2017.01.002
http://dx.doi.org/10.1016
d Technical Note

GUIDELINES FOR CLEANING TRANSVAGINAL ULTRASOUND TRANSDUCERSBETWEEN PATIENTS

JACQUES S. ABRAMOWICZ,* DAVID H. EVANS,y J. BRIAN FOWLKES,z KAREL MAR�SAL,x

and GAIL TERHAAR{

ON BEHALF OF THE WFUMB SAFETY COMMITTEE

*Department of Obstetrics and Gynecology, University of Chicago, Chicago, Illinois, USA; yDepartment of CardiovascularSciences (Emeritus), School of Medicine, University of Leicester, UK; zBasic Radiologic Sciences Division, Department ofRadiology, University of Michigan Health System, Ann Arbor, Michigan, USA; xDepartment of Obstetrics and Gynecology(Emeritus), Lund University, University Hospital, Lund, Sweden; and {Therapy Ultrasound, Division of Radiotherapy &

Imaging, Joint Department of Physics, Royal Marsden Hospital, Institute of Cancer Research, Sutton, Surrey, UK

(Received 1 January 2017; in final form 5 January 2017)

Aof Obsland Auchica

Abstract—The purpose of this article is to provide guidance regarding the cleaning and disinfection of transvagi-nal ultrasound probes. These recommendations are also applicable to transrectal probes. (E-mail: [email protected]) � 2017 World Federation for Ultrasound in Medicine & Biology.

Key Words: Infection control, Ultrasound, Transducer cleaning.

INTRODUCTION

Transvaginal ultrasound (TVUS) transducers (also desig-nated as endovaginal probes in some countries) areroutinely used in clinical obstetrics and gynecology.Strict decontamination is essential between patientsbecause these transducers may come into contact withmucous membranes. The main pathogens of concernare human immunodeficiency virus (HIV), cytomegalo-virus (CMV), human papillomavirus (HPV), entericgram-negative pathogens (e.g., Escherichia coli, Klebsi-ella spp.), for both transvaginal and transrectal ultrasoundexaminations. In addition, specific concerns includegonorrhea and syphilis for TVUS and Clostridium diffi-cile for transrectal ultrasound (Leroy 2013).

CLASSIFICATION OF MEDICAL DEVICESACCORDING TO INFECTION RISK

Medical devices may be classified according to theinfection risk they present. Systems used for this purposeinclude the original 1957 classification: non-critical,semi-critical and critical (Spaulding 1957), also referredto as low risk, medium risk and high risk (McDonnell andBurke 2011). Accordingly, cleaning of these instruments

ddress correspondence to: Jacques S. Abramowicz, Departmenttetrics and Gynecology, University of Chicago, 5841 SouthMary-venue Chicago, IL 60637, USA. E-mail: [email protected]

1

between uses depends on the aforementioned classificationstatus and ranges from simple wiping to sterilization.

Non-critical devices pose the lowest risk to patients,because the only contact is with intact skin (such asabdominal probes). Low- or intermediate-level disinfec-tion is recommended. Most bacteria (but not bacterialspores) and fungi, as well as certain types of viruses,including human immunodeficiency virus (HIV), willbe eradicated. If added decontamination is desired (fora wider range of viruses and mycobacteria), additionaluse of disinfectants, such as alcohol, aldehyde, phenolicand quaternary ammonium compound-based disinfec-tants, is recommended (McDonnell and Burke 2011).This represents mid-level disinfection (inactivation ofbacteria, most viruses, most fungi,Mycobacterium tuber-culosis and some bacterial spores).

Semi-critical devices are those that pose a higherrisk because of contact with non-intact skin or mucousmembranes (as is the case with TVUS probes). High-level disinfection with destruction/removal of all micro-organisms except bacterial spores is recommended usingvarious chemical components (see details below).

‘‘Critical devices’’ pose the highest risk. They areused in sterile body areas, such as the intravascular space.Sterilization of these devices is imperative.

Transvaginal ultrasound transducers are categorizedas semi-critical or medium risk (Leroy 2013). The realrisk of infection associated with TVUS transducers

2 Ultrasound in Medicine and Biology Volume -, Number -, 2017

used without a protective covering or decontamination isunknown. No case of related specific infection (cross-contamination between patients) has been reported inthe literature, but ultrasound transducers can becomecontaminated with bacterial pathogens and, hence, are apotential vector for transfer of microorganisms (Fowlerand McCracken 1999; Ohara et al. 1998). It is therecommendation of experts that specific measures betaken to avoid such an occurrence (Westerway et al.2014). Given the fact that transducers should routinelybe encased in a disposable probe cover, the risk may beconsidered less critical. However, leakage rates of0.9%–2% for condoms and 8%–81% for commercialprobe covers have been reported (Chalouhi et al. 2009;Rooks et al. 1996). These are relatively old studies andnumbers may be different today, but the only morerecent publication indicated a 9% risk of condomperforation in patients undergoing transrectal biopsyunder ultrasound guidance (Masood et al. 2007), andrecent data comparing the two types of covers are notavailable. The presence of human papillomavirus hasbeen reported after low-level disinfection (Casalegnoet al. 2012). Therefore, high-level disinfection of thetransducer between uses is required. A new condom orprobe cover should be applied after each use of the instru-ment, for a new patient (American Institute of Ultrasoundin Medicine [AIUM] 2009). Review of clinical practicesreveals various protocols, many of which are consideredinadequate (Gray et al. 2012). Often, failures in eradica-tion of microorganisms result from poor education andnon-optimal adherence to reprocessing guidelines or pro-tocols (Ofstead et al. 2010). An additional considerationis the fact that the transducer handle and cable can alsobecome contaminated and may also require disinfection(Alfa 2015) (see below).

RECOMMENDATIONS

After a patient has been examined, and before theTVUS transducer is used in the next patient, the followingprocedures should be performed: (i) removal of the trans-ducer cover, (ii) transducer cleaning, (iii) transducerdisinfection, and (iv) application of new transducer cover.

After removal of the transducer cover, the transduceris cleaned. Running water is usually sufficient to removeany residual gel or debris from the transducer. Addition-ally, a damp soft cloth with a small amount of mild non-abrasive liquid soap (such as household dishwashingliquid) may be used, followed by running water. A papertowel or soft cloth should be used to dry the transducer.The additional use of a high-level disinfectant will ensurefurther reduction in microbial load, and because of poten-tial leakage of the protective sheath (see above), high-level disinfection is recommended. The disinfection

method may need to be adapted to local conditions,with the assistance from infection control authorities.High level disinfectants recommended by various ultra-sound manufacturers include:

� Glutaraldehyde 2.4%–3.2% products, such as Cidex(Advanced Sterilization Products, ASP, a division ofCilag International, a Johnson & Johnson company,New Brunswick, NJ, USA), Metricide (MetrexResearch, Orange, CA, USA)] and Procide (MedlineIndustries, Mundelein, IL, USA). Mode of action ispowerful binding of the aldehyde to the outer cellwall of the organism. These products are sporicidal,bactericidal, fungicidal, tuberculocidal and virucidaland has been found to achieve high-level disinfectionin 20 min at 20�C and to be long-lasting and reusablefor up to 14 days when monitored with CIDEX Solu-tion Test Strips. These products have mostly been re-placed by the next type of product.

� Non-glutaraldehyde agents such as Cidex OPA(o-phthalaldehyde). The mechanism of action ofo-phthalaldehyde is similar to that of glutaraldehyde.It achieves high-level disinfection in 5 min at 20�Cand has long-lasting efficacy (reusable for up to14 days when monitored with CIDEX OPA TestStrips). The Advantages over the glutaraldehydeagents are its mild odor and its lack of a requirementfor activation or mixing, thus reducing handling.Furthermore, it has low vapor pressure for minimalinhalation exposure risk.

� Chlorine dioxide, used extensively in the UnitedKingdom and Australia (Tristel Trio and Duo, TristelSolutions Unit 1B, Snailwell, UK), acts as an oxidizingagent. It reacts with several cellular constituents,including the cell membrane of microorganisms andhas sporicidal, mycobactericidal, virucidal, fungicidaland bactericidal efficacy. Chlorine dioxide has beenproven effective against microorganisms of concernin ultrasound, such as hepatitis B and C, HIV, humanherpesvirus, simian virus 40 (surrogate of human papil-lomavirus), Candida albicans, Aspergillus spp., Staph-ylococcus aureus, Pseudomonas aeruginosa, Bacillusspp., Clostridium difficile, Mycobacterium tubercu-losis, Mycobacterium avium, Neisseria gonorrhoeae,Gardnerella vaginalis, Streptococcus agalactiae andAcanthamoeba castellanii (one of the causative organ-isms of Acanthamoeba keratitis). The use is relativelysimple with (i) a pre-decontamination wipe for grosscontamination with a tissue impregnated with an enzy-matic detergent; then (ii) use of another wipe which iseffective in 30 s against all organisms mentionedabove; and (iii) a rinse wipe that is a sterile packed,non-woven tissue impregnated with de-ionized water.It has been reported to be very effective in high-leveldisinfection of flexible endoscopes (Coates 2001) and

Cleaning transvaginal US transducers d J. S. ABRAMOWICZ et al. 3

nasendoscopes (Hitchcock et al. 2016) and would, pre-sumably, be equally effective in TVUS probes. Itshould be noted that both these studies were supportedby a grant from Tristel Solutions (Snailwell, UK), butaccording to authors, Tristel Solutions had no role inthe study design, data analysis, interpretation of resultsor manuscript preparation. A slightly simpler method,by the same manufacturer, consists of using a tissueimpregnated with citric acid onto which is applied anactivator solution (sodium chlorite), under a foamform. When mixed, chlorine dioxide chemistry isgenerated.

� Hydrogen peroxide 7.5% solution works by producingdestructive hydroxyl free radicals. These attack mem-brane lipids, DNA and other essential cell components.Hydrogen peroxide is active against a wide range ofmicroorganisms, including bacteria, yeasts, fungi, vi-ruses and spores.

� Common household bleach (5.25% sodium hypochlo-rite) diluted to yield 500 ppm chlorine (10 mL in 1 L oftap water), although effective, IS NOT recommendedby manufacturers because of potential damage to metaland plastic parts of the transducer.

The labels on these various chemicals and manufac-turer’s recommendations for cleaning TVUS probesshould be consulted. A list of U.S. Food and Drug Admin-istration (FDA)-approved disinfectants for reusable med-ical devices is available (FDA 2015). A similar documentwas issued by the International Organization forStandardization (2004).

Caution is necessary when handling some of thesechemical disinfectants (e.g., Cidex) because they arepotentially toxic and many require precautions such asadequate ventilation, personal protective wear (gloves,face/eye protection, etc.) and thorough rinsing beforere-use of the transducer (see label for specific instruc-tions). As a further caution, Most systems for chemicaldisinfection are such that the transducer handle is not inthe solution and may remain contaminated, a risk forthe end-user, as well as the patient (Buescher et al. 2016).

Recent studies have reported the persistence of HPVviruses with many of the traditionally accepted methodsof disinfection described above (Ma et al. 2012; Meyerset al. 2014; Ryndock et al. 2016). In addition, theremay be lapses in training and lack of adherence toprotocols (if they exist) regarding recommendedmethods of transducer disinfection. The Centers forDisease Control and Prevention (2015) issued an alertregarding this specific issue in September 2015. There-fore, alternative methods may have to be implemented.

One such method for sterilizing the probe is short-wave ultraviolet radiation (UVC, 200–280 nm) technol-ogy (Kac et al. 2010). After the transducer is cleaned

with a towel/wipe impregnated with a disinfectant spray,UVC light is applied for 10 min. This results in rapid andcomplete eradication of bacteria and viruses. The entiretransducer is enclosed in the commercially available ap-pliances; hence, the handle is also disinfected. This tech-nology, however, may not be available in many regionsof the world, and human exposure to UVC light levelsabove recommended limits may cause erythema andkeratoconjunctivitis.

A newly commercialized chemical method for high-level disinfection (Trophon EPR, Nanosonics, Alexan-dria, NSW, Australia) is based on an automated andclosed system. It has been shown to be effective againstall: Clostridium difficile; methicillin-resistant Staphylo-coccus aureus (MRSA, responsible for several difficult-to-treat infections); vancomycin-resistant Enterococcus(VRE); Mycobacterium terrae (surrogate pathogen forMycobacterium tuberculosis); Staphylococcus aureus(one of the five most common causes of health care-acquired infections); Pseudomonas aeruginosa (a mostcommon component of biofilms, highly resistant to anti-biotics), Salmonella choleraisuis; Mycobacterium avium(opportunistic pathogen affecting immune compromisedpatients and extremely difficult to control); Geobacillusstearothermophilus (heat-resistant microorganism);Clostridium sporogenes (anaerobic bacterium, highlyresistant to heat, drying, toxic chemicals and detergents);Bacillus subtilis (protective endospore allows it to surviveunder extreme anaerobic or aerobic conditions); Asper-gillus niger; Trichophyton mentagrophytes (one of theleading causes of hair, skin and nail infections in humansand difficult to control using chemicals); Candida albi-cans (causal agents of opportunistic oral and genital in-fections in humans); poliovirus (enterovirus recognizedas the most resilient of viruses to disinfect., includingHPV) (Johnson et al. 2013; Vickery et al. 2014). Theprocess is tolerable, very efficient, rapid (approximately7 min), environmentally friendly and quality-ensuredand disinfects the transducer handle (Ngu et al. 2015).Of note, several of the referenced studies (Johnson et al.2013; Meyers et al. 2014; Ngu et al. 2015; Ryndocket al. 2016; Vickery et al. 2014) were supported bygrants from a commercial company (Nanosonics).

It is important to remember that regular householddetergent wipes are used by many practitioners, but arenot considered high-level disinfectants and can damagetransducers.

The transducer should be covered with a barrier. Thiscan be a commercially available condom or a dedicatedcommercial probe cover. Condoms should be non-lubricated and non-medicated. Condoms have been foundto be less vulnerable to leakage than commercial probecovers (see above) and are superior to standard examinationgloves and equivalent to surgical gloves. One needs to be

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Texte surligné

4 Ultrasound in Medicine and Biology Volume -, Number -, 2017

cautious of latex allergy. Some recommend a double coverwhen there is concern that disinfection is less than optimal.

Additional precautionsThe ultrasound machine keyboard should undergo

low-level disinfection after each examination. The trans-ducer holder (if used) and the gel container should un-dergo low-level disinfection at the beginning and end ofeach day.

CONCLUSIONS

Removal of transducer cover (step 1), cleaning of thetransducer (step 2) and application of a new transducercover (step 4) are steps that are absolutely required. Disin-fection (step 3) is alsomandatory, and themethod to be usedshould be discussed with local infection control authorities.

REFERENCES

American Institute of Ultrasound in Medicine (AIUM). Practice guide-line for ultrasonography in reproductivemedicine. J UltrasoundMed2009;28:128–137.

Alfa MJ. Intra-cavitary ultrasound probes: Cleaning and high-leveldisinfection are necessary for both the probe head and handle toreduce the risk of infection transmission. Infect Control Hosp Epide-miol 2015;36:585–586.

Buescher DL, Mollers M, Falkenberg MK, Amler S, Kipp F, Burdach J,Klockenbusch W, Schmitz R. Disinfection of transvaginal ultra-sound probes in a clinical setting – comparative performance ofautomated and manual reprocessing methods. Ultrasound ObstetGynecol 2016;47:646–651.

Casalegno JS, Le Bail Carval K, Eibach D, Valdeyron ML, Lamblin G,Jacquemoud H, Mellier G, Lina B, Gaucherand P, Mathevet P,Mekki Y. High risk HPV contamination of endocavity vaginal ultra-sound probes: An underestimated route of nosocomial infection?PLoS One 2012;7:e48137.

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Chalouhi GE, Salomon LJ, Marelle P, Bernard JP, Ville Y. [Hygiene inendovaginal gynecologic and obstetrical ultrasound in 2008].J Gynecol Obstet Biol Reprod (Paris) 2009;38:43–50.

Coates D. An evaluation of the use of chlorine dioxide (Tristel One-Shot) in an automated washer/disinfector (Medivator) fitted with achlorine dioxide generator for decontamination of flexible endo-scopes. J Hosp Infect 2001;48:55–65.

Food and Drug Administration (FDA). Reprocessing medical devices inhealth care settings: Validation methods and labeling; guidance forindustry and Food and Drug Administration staff; availability.Docket No. FDA-2011-D-0293. Document No. 2015-06029. FedRegist 2015;80:13864–13865.

Fowler C, McCracken D. US probes: Risk of cross infection and ways toreduce it—Comparison of cleaning methods. Radiology 1999;213:299–300.

Gray RA, Williams PL, Dubbins PA, Jenks PJ. Decontamination oftransvaginal ultrasound probes: review of national practice andneed for national guidelines. Clin Radiol 2012;67:1069–1077.

Hitchcock B, Moynan S, Frampton C, Reuther R, Gilling P, Rowe F.A randomised, single-blind comparison of high-level disinfectantsfor flexible nasendoscopes. J Laryngol Otol 2016;130:983–989.

International Organization for Standardization (ISO). Sterilization ofmedical devices: Information to be provided by the manufacturerfor the processing of resterilizable medical devices. Geneva: Author;2004. ISO 17664.

Johnson S, Proctor M, Bluth E, Smetherman D, Baumgarten K,Troxclair L, Bienvenu M. Evaluation of a hydrogen peroxide-based system for high-level disinfection of vaginal ultrasoundprobes. J Ultrasound Med 2013;32:1799–1804.

Kac G, Podglajen I, Si-Mohamed A, Rodi A, Grataloup C, Meyer G.Evaluation of ultraviolet C for disinfection of endocavitary ultra-sound transducers persistently contaminated despite probe covers.Infect Control Hosp Epidemiol 2010;31:165–170.

Leroy S. Infectious risk of endovaginal and transrectal ultrasonography:Systematic review and meta-analysis. J Hosp Infect 2013;83:99–106.

Ma ST, Yeung AC, Chan PK, Graham CA. Transvaginal ultrasoundprobe contamination by the human papillomavirus in the emergencydepartment. Emerg Med J 2012;30:472–475.

Masood J, Voulgaris S, Awogu O, Younis C, Ball AJ, Carr TW. Condomperforation during transrectal ultrasound guided (TRUS) prostate bi-opsies: A potential infection risk. Int Urol Nephrol 2007;39:1121–1124.

McDonnell G, Burke P. Disinfection: Is it time to reconsider Spaulding?J Hosp Infect 2011;78:163–170.

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8. European Society of Radiology Ultrasound / Nov 2017

GUIDELINE

Infection prevention and control in ultrasound - bestpractice recommendations from the European Societyof Radiology Ultrasound Working Group

Christiane M. Nyhsen1& Hilary Humphreys2,3 & Roland J. Koerner4 & Nicolas Grenier5 &

Adrian Brady6 & Paul Sidhu7& Carlos Nicolau8

& Gerhard Mostbeck9&

Mirko D’Onofrio10 & Afshin Gangi11 & Michel Claudon12

Received: 25 July 2017 /Revised: 3 October 2017 /Accepted: 5 October 2017 /Published online: 27 November 2017# The Author(s) 2017. This article is an open access publication

Abstract

Objectives The objective of these recommendations is to

highlight the importance of infection prevention and control

in ultrasound (US), including diagnostic and interventional

settings.

Methods Review of available publications and discussion

within a multidisciplinary group consistent of radiologists

and microbiologists, in consultation with European patient

and industry representatives.

Recommendations Good basic hygiene standards are essential.

All US equipment must be approved prior to first use, including

hand held devices. Any equipment in direct patient contactmust

be cleaned anddisinfected prior to first use andafter every exam-

ination. Regular deep cleaning of the entire US machine and

* Christiane M. Nyhsen

[email protected]

Hilary Humphreys

[email protected]

Roland J. Koerner

[email protected]

Nicolas Grenier

[email protected]

Adrian Brady

[email protected]

Paul Sidhu

[email protected]

Carlos Nicolau

[email protected]

Gerhard Mostbeck

[email protected]

Mirko D’Onofrio

[email protected]

Afshin Gangi

[email protected]

Michel Claudon

[email protected]

1 Radiology Department, City Hospitals Sunderland, Kayll Road,

Sunderland SR4 7TP, UK

2 Department of Clinical Microbiology, The Royal College of

Surgeons in Ireland, Dublin, Ireland

3 Department of Microbiology, Beaumont Hospital, Dublin, Ireland

4 Infection Prevention and Control Department, Department of

Microbiology, City Hospitals Sunderland, Kayll Road,

Sunderland SR4 7TP, UK

5 Service d’Imagerie Diagnostique et Interventionnelle de l’Adulte

Groupe Hospitalier, Pellegrin Place Amelie Raba-Leon,

33076 Bordeaux, Cedex, France

6 Department of Radiology, Mercy University Hospital, Grenville

Place, Cork T12 WE28, Ireland

7 King’s College Hospital, Denmark Hill, London SE5 9RS, UK

8 Clinic Villarroel 170, 8036 Barcelona, Spain

9 Wilhelminenspital, Montleartstr. 37, 1160 Vienna, Austria

10 Radiology, Policlinico G.B. Rossi, VERONA, piazzale LA SCURO

10, 37134 Verona, Italy

11 NHC, 1, Place de l’Hôpital, 67091 Strasbourg, France

12 Children Hospital, University Hospital - Nancy Brabois, Rue du

Morvan, 54511 Vandoeuvre Les Nancy, Cedex, France

Insights Imaging (2017) 8:523–535

https://doi.org/10.1007/s13244-017-0580-3

environment should be undertaken. Faulty transducers should

not be used.Asoutlined in presented flowcharts, low level disin-

fection is sufficient for standard US on intact skin. For all other

minor and major interventional procedures as well as all endo-

cavityUS, high level disinfection ismandatory.Dedicated trans-

ducer covers must be used when transducers are in contact with

mucousmembranes or body fluids and sterile gel should be used

inside and outside covers.

Conclusions Good standards of basic hygiene and thoroughde-

contamination of all US equipment as well as appropriate use of

US gel and transducer covers are essential to keep patients safe.

Main messages

• Transducers must be cleaned/disinfected before first use and

after every examination.

• Lowleveldisinfection is sufficient for standardUSon intact skin.

• High level disinfection is mandatory for endo-cavity US and

all interventions.

• Dedicated transducer covers must be used for endo-cavity

US and all interventions.

• Sterile gel should be used for all endo-cavity US and all

interventions.

Keywords Ultrasound . Infection prevention and control .

Disinfection . Patient safety . Guidelines

Introduction

A recent publication has shown that bacterial contamination of

ultrasound (US) transducers is significantly higher than con-

tamination of public toilet seats and bus poles [1]. Once any

surface is contaminated, pathogens can survive a prolonged

period of time [2, 3]. Even in proven cases of infection trans-

mission, the exact route may remain unclear and insufficiently

decontaminated needle guides as well as post-procedures fol-

low-up US examinations without high level decontamination

merit consideration [4, 5]. This highlights the need for thor-

ough standardised decontamination protocols.

National guidance and legislation regulating decontamina-

tion procedures vary throughout Europe. European guidance

on interventional US procedures has already been published

stressing amongst other issues the importance of good hygiene

[6]. However, detailed European guidance on transducer de-

contamination, choice of US gel and transducer covers is lack-

ing. There remains a wide range of practice amongst European

US practitioners, as shown in a survey of the European

Society of Radiology (ESR) US Working Group (WG) [7].

Methods

Radiologists from the ESR US WG, together with expert mi-

crobiologists, formed a multi-disciplinary group who as a first

step undertook the survey mentioned above [7]. This identi-

fied considerable variations in practice and apparent confusion

as to what is best practice.

A detailed literature review of available US-specific evi-

dence was carried out with a variety of PubMed searches of

publications from 1990 to 2017, including international and

national surveys and guidelines, observational studies, case

reports and opinion pieces. In the absence of research system-

atically addressing the specifities of US procedures and their

respective environments and the presence of such a heteroge-

neous evidence base, it was not possible to grade the evidence

or to indicate the strength of existing guidelines. Therefore,

the decision was taken to formulate the best practice recom-

mendations hereby presented.

These recommendations have been derived from reviewing

the evidence base as obtained above and applying key princi-

ples of prevention of cross-infection in the healthcare setting

where there is no published specific evidence derived from the

US environment. Subsequently, these consensus recommen-

dations were discussed and agreed by the WG members who

undertook this task, stressing that they need to be incorporated

into local guidelines and must be compliant with respective

national legislation. Transducers can be vectors of infection

transmission with most serious outbreaks relating to endo-

scopic US procedures [8–11]. Risk evaluations have been

attempted but subsequently disputed; hence, the exact risks

will remain uncertain [12–14].

Evidenceshows thatadequateprotocols combinedwithstaff

training can achieve efficient disinfection [1]. It is the hope of

the ESR US WG that publication of these recommendations,

despite their limitations in terms of the evidence base, will raise

awareness and improve the trainingof allUSpractitioners, thus

ultimately contributing to improvements in patient safety.

Transmission of infection through US procedures

In principle, once any surface has been colonised, pathogens can

survive for periods of time longer than many might expect [2].

This applies in particular to synthetic materials including US

transducer surfaces and other parts of the US equipment.

Survival times on dry inert surfaces of bacteria such as

Escherichia coli, Pseudomonas aeruginosa and Staphylococcus

aureus, includingmethicillin-resistant S. aureus (MRSA) can be

several months or longer, and that of viruses such as hepatitis A,

herpes simplex virus (HSV) and rotaviruses several weeks

(Table 1). Even fungi such as Candida albicans can survive up

to120days. In addition, post-contamination survivalwill be even

longerwithco-existent organicmaterial suchas skincells orbody

fluids, providing a protective nidus for microbes which even dis-

infectants may not fully penetrate.

Ultrasound examinations and procedures carry different risks

depending on the likelihood of exposure to the normal bacterial

524 Insights Imaging (2017) 8:523–535

flora of patients (as discussed below), contact with body fluids

and the degree of invasiveness of the US procedure. Adopting a

modified Spaulding classification1 [15], procedures can be clas-

sified into:

Non-critical: non-invasive, contact of US transducer with

intact skin only, requiring low level disinfection.

or

Critical: invasive, such as US-guided punctures or injec-

tions, contact of the US transducer with mucous membranes

and body fluids, or a combination of both.

The reasoning for these recommendations is as follows:

US-assisted invasive procedures range from minimal in-

vasive fine needle aspirations to endoscopic and intra-

operative use of US. When assessing the risk of transmis-

sion of infective agents, all these procedures have in com-

mon the breaching of the intact skin or mucous mem-

branes. Taking acupuncture as an example of a minimally

invasive procedure: fine acupuncture needles have been

demonstrated to carry viral material after treatment of hep-

atitis C-positive patients [16]. In cases of directly US-

assisted punctures, contact of the transducer with infected

materials cannot be excluded. Consequently any US-

assisted invasive procedure or any procedure potentially

causing micro-trauma to the skin or mucous membranes

has to be categorised as critical.

The category Bsemi-critical^ as detailed in the Spaulding

classification describes devices that are in contact with intact

mucous membranes of non-sterile body sites such as the va-

gina. Because the integrity of these mucous membranes can-

not be taken for granted and procedure-associated micro-trau-

ma can never be excluded, this category has been omitted. The

generally accepted recommendations for disinfection are sim-

ilar to those for critical procedures, i.e., transducers require

high level disinfection (HLD) or sterilisation.

Potential microbes causing US-related invasive

infection

Normal human microbial flora

The skin and almost every epithelial layer of the humanbody are

colonisedwith a physiological bacterial flora, which varies from

site to site. Healthy individuals may also carry potential patho-

gens, e.g., up to 20% of the healthy population carry

Streptococcus pyogenes (Group A streptococcus) and/or

Staphylococcus aureus in their throat. Healthy individuals may

carrytoxigenicstrainsofClostridiumdifficileorevenSalmonella

typhi, themost famous example being TyphoidMary [17].With

the exception of herpes viruses, human papilloma virus (HPV)

and some others, humans do not carry viruses.

A distinction should also be made between Bendogenous

infections^, which may occur when microbes of the patient’s

normal flora enter normally sterile spaces, from those referred to

as Bexogenous infections^, when pathogens are introduced from

outside the patient, i.e., from other patients, healthcare workers

or the inanimate environment. The risk of endogenous infections

for example is unavoidable in the case of trans-rectal ultrasound-

guided biopsies, where the needle may introduce microbes from

the normal rectal flora into the normally sterile prostate/peri-

prostatic space [18, 19]. This would be different from a previ-

ously known hepatitis C virus (HCV) negative patient who pre-

sents with acute viral hepatitis following an ultrasound-guided

procedure, where this new infection is caused by a pathogen

most likely acquired from another patient [4, 5].

Individuals who are asymptomatic carriers of potential path-

ogens may have developed a degree of immunity and be less

susceptible to develop an infection caused by their endogenous

flora. However, if these organisms are transmitted to another

patient, through a contaminated US transducer or by other

means, theymay cause an infection, and are therefore classified

as Bpotential pathogens^. An example is S. aureus, which is

carried by up to 30% of healthy individuals in the nose, and

which may cause post-surgical wound site infections.

The physiological flora and potential pathogens vary from

site to site (Table 2).

1The Spaulding Classification was proposed by Earle Spaulding in 1939 and

is still widely used in the literature and guidance documents

Table 1 Survival of pathogens on dry inanimate surfaces (shortened

from Kramer et al. BMC Infectious Diseases 2006)

Type of pathogen Duration of persistence

Bacteria:

Campylobacter jejuni up to 6 days

Clostridium difficile (spores) 5 months

Escherichia coli 1.5 h – 16 months

Haemophilus influenzae 12 days

Mycobacterium tuberculosis 1 day – 4 months

Neisseria gonorrhoeae 1–3 days

Pseudomonas aeruginosa 6 h – 16 months (dry floor up to 5 w)

Staphylococcus aureus,

including MRSA

7 days – 7 months

Fungi:

Candida albicans 1–120 days

Viruses:

SARS associated virus 72–96 h

HAV 2 h – 60 days

HBV > 1 week

HIV > 7 days

Herpes simplex virus 1 & 2 4.5 h – 8 weeks

Papillomavirus 16 > 7 days

Rotavirus 6–60 days

Insights Imaging (2017) 8:523–535 525

Definition of decontamination procedures

Cleaning

Removal of dirt and any visible materials thus rendering

items macroscopically clean. The use of detergents will

remove most viable bacteria. Thorough cleaning must

always precede any disinfection or sterilisation proce-

dure. Otherwise, they are likely to be ineffective as

the presence of protein or other material prevents the

penetration of the disinfectant or sterilant to the surface

to be cleaned.

Disinfection

Inactivation of most viable bacteria. This will include most

pathogens likely to be transmitted via US procedures.

Resistance to antibiotics does not correlate with resistance to

disinfectants or biocides. However, there is some concern that

the overuse or abuse of disinfectants may lead to resistance.

Pathogen survival is dependent on inoculation size and the

presence of protein. The latter protects microbes from the

action of disinfectants; hence, thorough cleaning prior to any

disinfection procedure is paramount.

There are different levels of disinfection:

– Low level disinfection (LLD): Elimination of most bac-

teria, some fungi and some viruses.

– Intermediate level disinfection: Elimination of most bac-

teria including mycobacteria, most fungi and some virus-

es but not bacterial spores.

– High level disinfection (HLD): Elimination of all viable

pathogens apart from spores.

Sterilisation

Elimination of all microbes including bacterial and fungal

spores. This is usually achieved through autoclaving (using

steam under high pressure) or exposing instruments to high

temperatures; thus it is not suitable for US transducers.

Current methods of sterilisation do not inactivate prions.

Chemical sterilisation by exposingmedical devices to chem-

ical agents such as peracetic acid, hypochloric acid, etc., is

possible. Nevertheless, is it not considered to be fully equiva-

lent to heat/steam sterilisation and chemicals may cause trans-

ducer surface damage. Furthermore, most of the agents used for

chemical sterilisation are likely to pose a health hazard to both

patients and staff through direct skin contact or inhalation.

Recommendations

Worldwide there are an increasing number of infection

prevention surveys and guidance documents available,

Table 2 Body sites and their physiological flora and potential pathogens

Normal flora Potential pathogens Pathogens

Skin Coagulase-negative Staphylococcus spp.

(S. epidermidis etc.), diphtheroids,

Gram-positive and Gram-negative

anaerobes

S. aureus

Throat and upper airways Viridians streptococci, Neisseria spp.,

Gram-positive and Gram-negative

anaerobes

S. aureus, S. pyogenes, Haemophilus.

influenzae, N. menigitidis

Mycobacterium tuberculosis

Gastrointestinal tract Escherichia coli and related

Gram-negative bacilli, Pseudomonas

aeruginosa, Enterococcus faecalis and

other Enterococcus spp., Clostridium

perfringens, C. difficile, and other

Clostridium spp., Gram-positive and

Gram-negative

anaerobes

Salmonella typhi and other Salmonella

spp., Campylobacter spp., Shigella

spp., pathogenic strains of E.coli such

as E.coli O157, C.difficile

Male perineum and external genitalia Faecal and skin flora as outlined above,

Candia spp.

S. aureus, E. coli Sexually transmitted pathogens such as

N. gonorrhoeae, Chlamydia trachomatis and other

Chlamydia spp., Mycoplasma genitalis, HSV I + II

Female perineum, external genitalia

and vagina

Faecal and skin flora as outlined above,

Candida spp., Lactobacillus spp.

S. aureus, E. coli Sexually transmitted pathogens such as

N. gonorrhoeae, Treponema pallidum, Chlamydia

trachomatis and other Chlamydia spp.,Mycoplasma

genitalis, HPV, HSV I + II

Body fluids including blood Blood borne viruses, i.e. hepatitis B virus, HCV, human

immunodeficiency virus

Please note: These are examples. It is not an exhaustive list


most recently from the Australasian Society for

Ultrasound in Medicine and the Australasian College

for Infection Prevention and Control [20, 21]. Detailed

Scottish guidance was published in 2016 [22–24], and

subsequently adapted for Ireland [25]. Welsh guidance

is available from 2014 but mainly focuses on endoscope

decontamination [26]. References to hygiene can be

found in 2016 Society and College of Radiographers

and British Medical Ultrasound Society Guidelines for

Professional Ultrasound Practice [27]. UK results of the

large World Federation for Ultrasound in Medicine and

Biology (WFUMB) survey were published in 2016 [28].

In Germany, Merz et al., like others, favours automated

systems for high level disinfection, in particular devices

using hydrogen peroxide (Trophon® EPR), now approved

by the US Food and Drug Administration [29, 30].

Another important aspect of automated systems is the

standardised and reproducible decontamination process

thus avoiding operator-associated errors or variations.

Ultraviolet (UV) light is less effective in eradicating mi-

crobes in comparison to hydrogen peroxide [31].

However, comparing different methods of decontamina-

tion is outside the scope of this publication. A publication

by Rutala last year emphasises the need for HLD of all

semi-critical and critical devices, already detailed in the

original American guidance from 2008 [32, 33]. The

American Institute of Ultrasound in Medicine (AIUM)

also formulated guidance in 2014 [34] and French guid-

ance and a survey were recently published [35, 36]. As

previously mentioned, guidance from the European

Federation of Societies for Ultrasound in Medicine and

Biology (EFSUMB) in the interventional US setting is

available [6], but no recent European Directive relating

to this topic could be found.

General principles

It is the responsibility of every US practitioner to ensure that

cross-contamination risks are minimised. Any equipment used

and the environment must be safe for all patients. General

principles of infection prevention should be followed at all

times.

Recommendation 1.1

& High standards of professional cleanliness such as good

hand hygiene of the operator before and after every patient

contact are essential.

& Thorough decontamination of US transducers and any

equipment in direct patient contact before and after every

patient, to the level required for specific procedures and in

compliance with manufacturer specifications to avoid

transducer surface damage, should be carried out. This

includes regular decontamination of the US keyboard/

console and any cables.

& Where possible, single use disposable equipment is pref-

erable (biopsy needles, needle guides, etc.), eliminating

the risk of inadequate cleaning and disinfection/

sterilisation.

& Damaged US transducers should not be used as the risk of

inadequate decontamination increases [10].

& Regular deep cleaning of the entire US equipment and the

surrounding environment is essential.

& Use protective transducer covers dependent on the type of

procedure. The use of transducer covers does not replace

thorough decontamination, but merely reduces the con-

tamination load.

& Adequate use of personal protective equipment as re-

quired by the procedure (non-invasive versus invasive) is

mandatory.

& Use sterile US gel depending on procedure and patient’s

risk of acquiring infections.

& Appropriate waste disposal is essential.

The management of patients with variant Creutzfeld-Jacob

disease and other spongiforme encephalopathies is not cov-

ered by these best practice recommendations. US-practitioners

must refer to specific national guidance.

US transducer and other US equipment decontamination

Recommendation 2.1

The clinical environment and all deployed equipment must

meet the infection prevention requirements of the respective

procedure.

Should US be performed with handheld devices (tablets

and mobile phones), these must be assessed and approved

prior to preliminary use. The same cleaning and disinfection

recommendations need to be followed as for normal units.

Contamination of such devices should not be underestimated

[37–39].

Recommendation 2.2

All US equipment in direct or indirect patient contact must be

thoroughly cleaned and disinfected at the start of the exami-

nation and after every patient.

This includes the US transducer with handle, cable

and transducer holder (as far as possible) as well as all

additional devices which may be used during diagnostic

or interventional procedures such as US fusion sensors/

cables, needle guides (if reused), etc. Contamination of

US equipment may be underestimated [40]. In particular,

inadequately cleaned and disinfected needle guides have

been associated with outbreaks of infection [41]. The use


Contamination of such devices should not be underestimated

All US equipment in direct or indirect patient contact must be

thoroughly cleaned and disinfected at the start of the exami-

nation and after every patient.

of single use needle guides is preferable to eliminate the

risks associated with difficult to clean small bore

devices.

The length of the drying time between cleaning and disin-

fection steps depends on the applied disinfectants/method used

and no exact recommendations can be made. Regarding the

choice of disinfectants, some disinfectants (in particular alco-

hol)may be ineffective in eliminatingHPV type16 [42],whilst

also causing transducer surface damage [43], although alcohol

still seems widely used in some countries [44].

Non-critical US examinations: Transducer on intact

surface skin

This applies only to procedures where no contact with body

fluids exists and where no skin disease or known transmissible

infections are present. In these circumstances the general con-

sensus is that LLD is sufficient.

Decontamination steps necessary at the start of the exami-

nation and after every patient are as follows:

Recommendation 3.1

& Thorough cleaning of transducer: It is essential to remove

all gel with soap and running water or detergent wipes

prior to application of disinfectants. The use of detergents

will aid removal of invisible gel remnants that disinfec-

tants cannot penetrate and which may contain pathogens.

Using dry paper to wipe transducers will remove some

contamination [45, 46], however, this is not recommended

as it is less effective than detergent wipes/soap and may

scratch transducer surfaces.

& The transducer should be effectively dried: In order to

avoid dilution of subsequently applied disinfection agents

it is important to allow the transducer to dry. Application

of disinfectants on a wet transducer will make them less

effective or completely ineffective.

& Disinfection of US transducer: For this non-critical cate-

gory, LLD can be achieved using wipes, foam or other

approved agents with antibacterial, antiviral and antifun-

gal properties. Products used should always be in compli-

ance with manufacturers’ recommendations to avoid

transducer surface damage.

& The transducer should be effectively dried: Following ap-

plication of disinfectants, it is essential to allow sufficient

time for the disinfectant to attain maximum effect.

Critical and semi-critical US procedures

This refers to procedures where the transducer (with protective

cover) is in contact with:

& Mucous membranes (all endo-cavity US)

& Any body fluids (all US guided interventional procedures

including injections, tissue sampling, use in theatre)

& Infected/broken skin and wounds

The general consensus is that these procedures require

HLD of US transducers including the handle [47]. An

audit trail (detailed log) should be completed as evidence

that thorough decontamination has been performed by ac-

countable trained personnel. Care should be taken that

storage of US transducers after HLD is adequate to avoid

accidental contamination.



Recommendation 4.1

& The protective sheath should be carefully removed: It is

important to avoid additional transducer contamination

where possible.

& The transducer should be thoroughly cleaned: It is essen-

tial to remove all gel with soap and running water or de-

tergent wipes prior to application of disinfectants. The use

of detergents will aid removal of invisible gel remnants

that disinfectants cannot penetrate and which may contain

pathogens. Using dry paper to wipe transducers will re-

move some contamination [45, 46], however, this is not

recommended as it is less effective than detergent wipes/

soap and may scratch transducer surfaces.

& The transducer should be effectively dried: In order to

avoid dilution of subsequently applied disinfection agents,

it is important to allow the transducer to dry. Application

of disinfectants on a wet transducer will make them less

effective or completely ineffective.

& High level disinfection must be performed for all semi-

critical and critical US procedures as persistent contami-

nation following LLD has been demonstrated, even with

transducer cover use [48–51]. Agents/methods used must

be in compliance with manufacturers’ recommendations.

One of the following may be chosen:

& Approved manual multistep disinfectant wipes (vali-

dated for HLD)

& Standardised automated validated systems (hydrogen

peroxide, ultraviolet light)

& Other approved procedures that have been validated

for HLD including immersion bath

& The transducer should be effectively dried: It is essential to

allow sufficient time for the disinfectant to attain maxi-

mum effect dependent on HLD method used.


Critical and semi-critical US procedures

The general consensus is that these procedures require

HLD of US transducers including the handle [



Standardised automated validated systems (hydrogen

peroxide, ultraviolet light)

Transducer covers

Transducer covers are an integral part of infection pre-

vention, as soiling of the transducer is substantially re-

duced leading to more effective post-procedure decon-

tamination. However, the use of transducer covers does

not eliminate the need for subsequent cleaning and dis-

infection as persistent contamination remains after cover

removal [49–52]. Non-negligible contamination levels

can also be detected after LLD when transducer covers

are used, which is why HLD is essential [48].

The US practitioner is responsible for ensuring that

only dedicated US transducer covers are used which are

of adequate quality. Covers used should display the CE

mark of quality testing or its equivalent. Barriers such

as thin household cling film, plastic wraps or similar are

not acceptable as product quality is not assured.

Although some studies appear to show a lower perfora-

tion rate, the use of condoms as transducer covers is

questionable [53, 54]. Even with dedicated transducer

covers, perforation rates appear to be quite high, al-

though there is a paucity of literature and newer mate-

rials may prove to be safer [55–57].

The following further recommendations are essential:

Recommendation 5.1

& Covers should always be strictly single-use.

& Appropriate covers need to be chosen for patients with

latex allergies.

& The use of transducer covers is obligatory for all endo-

cavity US, including trans-vaginal, trans-rectal, trans-oe-

sophageal, and trans-bronchial US.

& Transducer covers must be used for all major and minor

interventional procedures, whenever transducers may be

in contact with body fluids such as blood, secretions, pus,

etc. This includes all invasive interventions as well as

injections, fine needle aspirations and transducer contact

with infected or broken skin, eczema and wounds.

& Sterile transducer covers must be used for any invasive

procedures detailed above. For all non-invasive examina-

tions including endo-cavity ultrasound, sterile covers are

recommended but not essential. Stocking only sterile

covers may eliminate the risk of accidental use of non-

sterile covers, but there are cost implications.

Ultrasound gel

US gels are generally composed of a polymer to establish

the desired viscosity, substances such as tri-ethanolamine

to stabilise the pH, deionised water, a moisture retaining

agent such as a glycol derivative, and often preservative

agents. As bacteria are able to adjust their metabolism to a

less favourable environment, these gel compounds are

more than sufficient to allow bacterial survival and mul-

tiplication [58, 59].

Even sealed US gel bottles must not be assumed to be

sterile unless clearly stated on packaging. Whilst the risk of

infection transmission through contaminated US gel appears

to be generally low, several outbreaks related to medical gels

have been published [60–66]. Therefore, recommendations

are as follows:

Recommendation 6.1

& Single use bottles are recommended rather than bottles

that are refilled from larger containers. The latter poses a

higher risk of contamination.

& Standard non-sterile bottles are sufficient if the transducer

is in contact with intact skin only and in the absence of

infections or other skin pathology, i.e., non-critical US

examinations.

& Once opened, gel bottles should be used within a short

period of time and ideally discarded at the end of the

working day. Noting the opening date on bottles may be

helpful.

& Care should be taken to avoid contact of the gel dispensing

tip with the patient or other sources of contamination.

& Gels should be stored at room temperature. The multipli-

cation of pathogens in gel bottles increases considerably

when kept warm for patient comfort, thus turning bottle

warmers into incubators [67]. Therefore, if gel warmers

are used, only bottles for immediate use should be

warmed.

& The regular decontamination of any bottle warmer facili-

ties in use is essential whilst considering manufacturers

guidance. Electrical devices should be unplugged and de-

vices may need to cool down prior to decontamination.

& Gel bottles should not be stored upside down in warmers

as the gel dispensing tip may become contaminated

through patient contact or indeed through contact with

pathogens surviving/multiplying at the bottom of

warmers.

& Only dry bottle warmers should be used as any liquids will

become even more easily contaminated [59, 68].

Particular consideration should be given to examinations

and procedures where the choice of sterile gel is indicated:

Recommendation 6.2

& The use of sterile gel is highly recommended for all

semi-critical and critical US procedures, such as


transducer contact with mucous membranes, i.e., all

endo-cavity US, contact with any body fluids, i.e.,

all major and minor US guided interventional proce-

dures, and when scanning infected or broken skin

and wounds.

& The use of sterile gel is strongly advised outside as well as

inside transducer covers due to high reported transducer

cover perforation rates and possible porosity [55–57]. A

new sachet should be opened for every patient but the

same sachet can be used for gel inside and outside the

probe cover.

Conclusion

Published evidence highlights contamination risks of US

transducers, even with the use of transducer covers, and

after LLD. Although published cases of proven infection

transmission through US are limited at present, this

should not induce complacency as the true rates are

unknown. Many practitioners do not seem to adhere to

or be aware of basic infection prevention procedures as

shown in several recent surveys. This emphasises the

need for new and improved standards.

With publication of these best practice recommendations

the ESR US WG aims to stress:

& The importance of basic personal and environmental

hygiene.

& The need for thorough equipment decontamination as ap-

propriate for the respective examination or intervention.

& Risk reduction through appropriate use of transducer

covers and sterile gel where indicated.

US practitioners cannot always know which patients

carry transmissible pathogens or who may be suscepti-

ble to acquiring infections; hence, high standards of

infection prevention and control will ensure that all pa-

tients are kept safe.

These recommendations should be reviewed and lo-

cally adapted in accordance with respective national

guidance, where available, to suit the respective clinical

environment. Three flow charts (see Appendix) are in-

cluded with this set of recommendations to assist US

practitioners and others in achieving best practice.

Published evidence is limited and partly dated, there-

fore publication of evidence-based guidance at present is

challenging, but needed. We hope that more emerging

evidence will make this possible in the near future

through the conduct of audits, surveys and even clinical

trials where possible.

The ESR US WG is already in discussions with the

European Coordination Committee of the Radiological

Electromedical and Healthcare IT Industry (COCIR)

and the ESR Patient Advisory Group. A joint session

with discussion was organised at the European

Congress of Radiology in March 2017 and both groups

were consulted in the process of writing these recom-

mendations. It would be desirable for manufacturers of

US equipment, transducer covers, US gel and cleaning/

disinfection consumables/equipment to collaborate fur-

ther with US practitioners and patient representatives to

improve standards. Additional research studies on the

susceptibility of pathogens to practicable, low/non-toxic

and affordable disinfection measures are needed, and

how these can be best applied in the context of US.

We recognise that implementing thorough US decon-

tamination protocols will necessitate an initial invest-

ment and increasing ongoing consumable costs as well

as additional staff training. However, we believe that the

implementation of clear recommendations will reassure

patients, and contribute to the quality of their care.

Acknowledgements The ESR Executive Council endorsed this paper

in July 2017.

The authors would like to thank the ESR office staff for their excellent

assistance in all organisational matters, Dr. Jane Adam for her continuous

support of this project as former chair of the ESR Quality, Safety and

Standards Committee and all former and current US WG members for

their input. The authors are also very grateful toMrs. Catherine Fisher and

her colleagues from City Hospitals Sunderland Library Services, UK for

their continuous outstanding support, in particular with regards to exten-

sive literature searches and the sourcing of original full text articles. Ms.

Judy Birch from the ESR Patient Advisory Group andMs. Nicole Denjoy

European Coordination Committee of the Radiological Electromedical

and Healthcare IT Industry (COCIR) and colleagues have also contribut-

ed significantly to the discussion, and the authors would like to take this

opportunity to express their gratitude.

Compliance with ethical standards

Funding and conflicts of interest The ESR supported the develop-

ment of these best practice recommendations. No other funding or grants

were received.

Prof H Humphreys is in receipt of research funding from Pfizer and

Astellas and has in recent years received lecturer or consultancy fees from

Cepheid.

Prof N Grenier is a member of the Advisory Board of Supersonic

Imagine, Aix-en-Provence, France.

Prof P Sidhu receives lecture fees from Siemens, Samsung, Bracco,

Philips and Hitachi.

Prof M Claudon receives lecture fees from Philips.

All other authors have no conflicts of interest to declare.

Open Access This article is distributed under the terms of the Creative

Commons At t r ibut ion 4 .0 In te rna t ional License (h t tp : / /

creativecommons.org/licenses/by/4.0/), which permits unrestricted use,

distribution, and reproduction in any medium, provided you give appro-

priate credit to the original author(s) and the source, provide a link to the

Creative Commons license, and indicate if changes were made.


Published evidence highlights contamination risks of US

transducers, even with the use of transducer covers, and

after LLD. Although published cases of proven infection

Ultrasound transducer on intact

surface skin

No contact with body fluids, no skin

disease/known transmissible infections

Ultrasound transducer (with

protective cover) in contact with:

• Mucous membranes (all endo-cavity US)

• Any body fluids (all US guided

interventional procedures including

• Infected/broken skin and wounds

Thorough cleaning of transducer: remove all

gel with soap and running water OR

detergent wipes, to remove invisible

remnants of gel containing pathogens that

disinfectants cannot penetrate. Dry paper is

not recommended as it is less effective and

may scratch transducer surfaces

Drying of transducer: avoids dilution of

subsequently applied disinfection agents

which renders them less effective or

completelyin effective

Careful removal of protective sheath: avoid

additional transducer contamination

Drying of transducer: allows sufficient time

for the disinfectant to attain maximum effect

Low Level Disinfection of US transducer: use

wipes, foam or other approved substances

with antibacterial, antiviral and antifungal

properties. This should be in compliance with

manufacturers’ recommendations to avoid

transducer surface damage

Thorough cleaning of transducer: removal of all

macroscopically visible soiling and US gel with soap

and running water OR detergent wipes. Dry paper

is not recommended.

Drying of transducer: avoid diluting subsequently

applied disinfection agents which renders them

less effective or completely ineffective

High level disinfection in compliance with

manufacturers’ recommendations with one of the

following:

Approved multistep disinfectant wipes

Standardised automated validated systems

(using hydrogen peroxide, ultraviolet light)

Other approved procedures that have been

validated for high level disinfection

Drying of transducer: allow sufficient time for the

disinfectant to attain maximum effect

•

•

•

injections, tissue sampling, use in theatre)

Ultrasound equipment decontamination

• High standards of professional hygiene must be ensured at all times, including good operator hand hygiene before/after

patient contact, adequate use of personal protective equipment, probe covers, etc., as required. Appropriate clinical waste

disposal protocols must be in place.

• The clinical environment and all deployed equipment must meet the infection prevention requirements of the respective

procedure. Should US be performed on handheld devices (tablets and mobile phones) these must be assessed and approved

prior to preliminary use and disinfected before and after each episode of deployment.

• All US equipment in direct or indirect patient contact must be thoroughly cleaned and disinfected before the first patient

and after every patient. This includes the US transducer, cable and transducer holder (as far as possible) as well as all

additional devices, which may be used during diagnostic or interventional procedures, such as US fusion sensors/cables, needle

guides, etc. Regular deep cleaning of the entire US machine and environment is essential.

Appendix


Transducer covers are an

integral part of infection

to more effective post-

procedure decontamination.

Obligatory for:

All endo-cavity US

including trans-

vaginal, trans-rectal,

trans-oesophageal,

trans-bronchial US

Obligatory for:

All US-procedures where

transducers may be in contact

with body fluids such as

blood, secretions, pus etc.

This includes all major and

minor interventional

procedures as well as

injections, fine needle

aspirations and the use of US

transducers on

infected/broken skin and

wounds

Any invasive procedures (breach of

skin or mucosal layers) require

single use sterile transducer covers

For all non-invasive examinations including

endo-cavity ultrasound, single use sterile

covers are recommended but not essential

Choice of cover:

Sterile vs non-sterile

Covers should always be

strictly single use

prevention as soiling of the

transducer is reduced leading

Protective ultrasound transducer covers

• The US practitioner is responsible for ensuring that only dedicated US transducer covers of adequate quality are used.

Practitioners should check that all covers chosen display the CE mark of quality testing or its equivalent.

• Barriers such as thin household cling film/plastic wraps, etc., are not acceptable as these are easily perforated and the product

quality is not assured.


Ultrasound transducer in contact

with normal skin surface

No skin pathologies such as eczema,

wounds, infections etc .

Single use bottles are strongly advised

(rather than refill bottles)

to minimise the cross-contamination risk.

Once opened, gel bottles should be used

within a short period of time and ideally

discarded at the end of the working day.

Bottles should not be warmed for longer

than absolutely necessary as warmers will

serve as incubators thus facilitating the

multiplication of potential pathogens.

Use of sterile gel is strongly advised outside as

well as inside transducer covers due to high

reported transducer cover perforation rates and

possible porosity

A new sachet should be opened for every patient

but the same sachet can be used for gel inside and

outside the probe cover

Ultrasound transducer (with

protective cover) in contact with:

• Mucous membranes (all endo-cavity US)

• Any body fluids (all US guided

interventional procedures including

injections, tissue sampling, use in theatre)

• Infected/broken skin and wounds

Ultrasound gel

• Practitioners cannot assume that US gel is free of pathogens unless it is clearly labelled as Bsterile^.

• Pathogens can survive and multiply within gel. Outbreaks due to this have been documented.

• If used for patient comfort, bottle warmers should be regularly cleaned and disinfected. It is not advisable to keep bottles

warmed for long periods as this will aid multiplication of microbes. Bottles should not be kept in warmers upside down as the

dispensing tip may become contaminated by accidental patient contact or from a previously inserted bottle. Warming in an

immersion bath is not recommended as fluids easily become contaminated.


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9. Society and College of Radiographers and British Medical Ultrasound Society (BMUS) / Dec 2017 : extract of guidelines

Guidelines For Professional

Ultrasound Practice

Society and College of Radiographers and British Medical Ultrasound Society

December 2015

Revision 2, December 2017

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