2013_BestPractices for HLD(1)

8/12/2019 2013_BestPractices for HLD(1)

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Best Practices forHigh-Level Disinfection

(HLD)


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Objectives

At the end of this program, participants will be able to:

explain the Spaulding classification system for thereprocessing of reusable medical devices,

understand the importance of effective cleaning anddecontamination prior to HLD,

identify commonly used agents for HLD,

discuss SGNA recommended steps for the HLD of

flexible endoscopes.


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Spaulding Classification System

In 1968, Dr. Earle Spaulding devised a rationalapproach to disinfection and sterilization that isstill in use today. He believed that instrumentsand equipment should be reprocessed accordingto the nature of the item and the level of riskassociated with their intended use.

This is referred to as Spaulding's classification system

and it has been refined and retained over the years,because it is so clear and logical. The three (3) categorieshe described were critical, semi-critical and non-critical.


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Critical items are medical devices that enter sterile tissueor the vascular system. These items should be sterilewhen used. Examples include, but are not limited to:surgical instruments, cutting endoscopic accessories that

break the mucosal barrier, endoscopes used in sterile bodycavities, cardiac, vascular or urinary catheters, implants,needles and ultrasound probes used in the sterile bodycavities.
http://www.google.com/url?sa=i&rct=j&q=cardiac+catheters&source=images&cd=&cad=rja&docid=tBMvuXVzzK4jdM&tbnid=U-WbhaHRxUGt8M:&ved=0CAUQjRw&url=http://www.fda.gov/ohrms/dockets/ac/04/briefing/4018B1_01.htm&ei=BJVRUaG9IYT30gGppYHQBw&bvm=bv.44158598,d.dmg&psig=AFQjCNGepJuUF8ma6nfI05X34oKXwsIs3w&ust=1364387445893337


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Semi-critical items are medical devices that come intocontact with non-intact skin or mucous membranes.These items should be high level disinfected when used.Examples include, but are not limited to: vaginal andrectal probes, anesthesia equipment, laryngoscopes,

bronchoscopes and gastrointestinal endoscopes (andaccessories).


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Non-critical items are medical devices that come intocontact with only intact skin. These items should receiveintermediate level disinfection, low-level disinfection orcleaning. Intact skin acts is considered an effective

barrier to most organisms. Examples of non-critical iteminclude, but are not limited to: tourniquets and blood

pressure cuffs, linens, bed pans and stethoscopes.


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The terminology adopted by the CDC and widely used,describes disinfectants in terms of their activity as set out

below. This program will focus on high-level disinfection(HLD).

High-level disinfectantsare chemical sterilants, which whenused for a shorter exposure period than would be requiredfor sterilization, kill all microorganisms with the exceptionof high numbers of bacterial spores.

Intermediate-level disinfectantsmay kill mycobacteria,vegetative bacteria, most viruses, and most fungi but do notnecessarily kill bacterial spores

Low-level disinfectantsmay kill most vegetative bacteria,some fungi, and some viruses.

Three Levels of Disinfection
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Pre-cleaning must occur at point of use in order to keep

blood and other organic material from drying. Blood and

body fluids, as well as saline, are highly corrosive and can

damage instruments. Dried blood and debris is difficult, if

not impossible to clean during decontamination, which cancause disinfection or sterilization not to be achieved.

Surgical instruments should be wiped as needed with

sterile surgical sponges moistened with sterile water duringthe procedure to remove gross soil. Instruments with

lumens should be irrigated with sterile water.

Cleaning and Decontamination


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Flexible endoscopesused on the sterile field should be

pre-cleaned to the following recommended steps:

1. Wipe external surfaces with a lint-free cloth saturated

with sterile water.2. Alternate suctioning the channels with sterile water

and air.

3. Hand the endoscope and accessories to the circulatoras soon as possible, so he/she may pre-clean (follow

the steps on the next slide).



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Flexible endoscopesused in GI/Endoscopy Centers

should be pre-cleaned in the Procedure Room wearing

appropriate PPE and using the following recommended

steps:

1. External surface of insertion tube should be cleanedwith a soft cloth or sponge and an enzymatic detergent.

2. Internal suction/biopsy channels cleaned by suctioning

copious amounts of enzymatic detergent and air.

3. Air/water channels flushed with enzymatic solution,

then flushed using low-pressure compressed air or a

syringe if air is not available.



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4. Complex design components or channels should be

flushed or purged with water and/or enzymatic

detergent solution per the MFGs IFU.

5. The tip of the endoscope should be inspected for

damage to any surface and any working part, and forcleanliness.

6. The video protective cap (if applicable) should be

attached after removing the endoscope from the light

source and suction.

7. Remove all detachable parts and immerse in enzymatic

detergent solution until transport.



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Flexible endoscopes are someof the most complex devices

for health care workers to

reprocess, due to their unique

design and multiple reprocessingsteps.

Strict adherence to the scope

MFGs validated instructions

for use (IFU) is required.


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After pre-cleaning at point of use, contaminated itemsshould be immediately transported to the decontaminationarea before any remaining organic material dries on thesurface, box lock, crevices or channels of the instruments.Surgical instruments should be covered with a wet towel

or treated with an instrument cleaner prior to transport.

Contaminated items can expose health care workers andcan contaminate the environment during transport. A

sealed container should be used to avoid contaminatingthe environment or exposure to health care workers. PerOSHA, the transport container must be labeled to indicate

biohazardous contents.

Transport


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Meticulous cleaning and decontamination must proceed

HLD or sterilization. Medical device manufacturers are

required to provide healthcare facilities with validated

reprocessing instructions for use (IFU).

It is important to have and follow each device MFGs IFU

to ensure worker and patient safety. This is especially true

for complex devices with multiple pieces that have joints,

crevices, lumens, ports and channels. Proper PPE isrequired for all cleaning and decontamination steps.



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Pasteurization is a heat-automated HLD process that uses

time and heat (i.e. 160-170F/21.7-25C) for 30 minutes

for HLD of heat-sensitive semi-critical devices. Medical

washer/pasteurizers have wash, rinse and pasteurization

cycles. Some pasteurizers offer quality assurance datarecorders that document the temperature and cycle time.

Heat HLD


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For chemical HLD, health care facilities must purchase

FDA cleared HLD products as listed on the FDA website.

Products selected should be compatible and efficacious

with the materials or items to be disinfected.

The use of incompatible chemicals can damage the

surfaces of the instrument, causing corrosion, scratches

and other surface irregularities. Such damage can be a

challenge for cleaning, HLD, interfere with properfunction, and reduce the life and cosmetic appearance

of the device.

Chemical HLD


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FDA-cleared Chemical sterilants and HLDs

Device Type # of Registered

Products

Chemical

Sterilization

High Level

Disinfection

Glutaraldehyde 17 X X

Hydrogen Peroxide 4 X X

Ortho-phthaldehyde

(OPA)

3 X

Peracetic Acid 2 X X

Sodium Hypochlorite 1 X

Chemical Vapor

w/Formaldehyde

2 X

Hydrogen Peroxide GasPlasma

1 X

Hydrogen Peroxide

without Plasma

1 X

Ozone Gas 1 X

Source: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.htm


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HLD requires appropriate temperature, contact time, and

length of use following solution activation. MFGs IFU

should be followed when preparing disinfectant solutions,

calculating expirations dates, and labeling solution soaking

containers.

Chemical HLD


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Glutaraldehydehas been widely used for a long time in

health care facilities as a HLD for reusable medical devices.

Most solutions are acidic and must be activated to become

sporicidal. There are a variety of brand names available in

a variety of concentrations, with and without surfactants.

Chemical HLD

HLD and Steriliant

requires no mixing or

activation


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Ortho-phthaladehyde (OPA) has demonstrated superior

mycobactericidal activity compared to glutaraldehyde and

requires no mixing or activation. OPA has been shown to

last longer before reaching its MEC and the concentration

of the active ingredient does not decrease with age alone.

Chemical HLD


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Other solutions FDA-cleared for HLD include hydrogen

peroxide, peracetic acid and sodium hypochlorite in a

variety of concentrations and combinations. The FDA

website has a listing of manufacturers, active ingredients

and contact conditions for each cleared solution.

Chemical HLD


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Because most HLDs are reused, they must be tested and

recorded prior to each use to assure that they remain

above their MEC. If the test strip fails, the HLD solution

should not be used, even if its within the reuse life.

Chemical HLD


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Reprocessing of Flexible Endoscopes

Chemical HLD is recognized as the standard for the

reprocessing of flexible gastrointestinal endoscopes by

SGNA, ASGE, ACG, AGA, APIC and AST. Also, the

CDC and The Joint Commission recognize HLD as

appropriate for gastrointestinal endoscopes.


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Standards of Infection Control in

Reprocessing of Flexible

Gastrointestinal Endoscopes

Are you following the updated 2012 SGNA Standards?


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SGNA Standards of Infection Control

in Reprocessing of Flexible Endoscopes

5. Manual HLD:

1. Completely immerse the endoscope and all

removable parts in a basin of HLD.a. The basin must be of a size to accommodate the

endoscope without undue coiling, and must have a

tight-fitting lid to contain the chemical vapors.

b. To prevent damage, the endoscope should be notbe soaked with other sharp instruments.


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5. Manual HLD

2. Flush disinfectant into all channels of the

endoscope until it can be seen exiting the oppositeend of each channel. Take care that all channels are

filled with the chemical, and that no air pockets

remain within the channels.


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SGNA Standards of Infection Control in

Reprocessing of Flexible Endoscopes

5A. Manual HLD:

a. Complete microbial destruction cannot occur

unless all surfaces are in complete contact with thechemical.

b. Since internal contact cannot be visually confirmed

because of scope design, purging until a steady flow

of solution observed is necessary.


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5A. Manual HLD:

3. Cover the soaking basin with a tight-fitting lid

to minimize chemical vapor exposure.

Note that:

a. Exposure to chemical vapors may present a

health hazard.b. The reprocessing area should have engineering

controls to ensure good air quality.


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5A. Manual HLD:

4. Soak the endoscope in the HLD solution for

the time/temperature required to achieve HLD.Use a timer to verify soaking time.

5. Purge all channels completely with air before

removing the endoscope from the HLD solution.Note that purging the channels preserves the

concentration and volume of the chemical, and

prevents exposure from dripping and spilling.


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5A. Manual HLD:

6. RINSE(same as after Manual Cleaning)

a. Thoroughly rinse the endoscope and all removableparts with clean water to remove residual debris and

detergent.

b. Purge water from all channels using forced air.

Dry the exterior of the endoscope with a soft, lint-free cloth to prevent dilution of the liquid chemical

germicide used in subsequent steps.


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6. Drying:

a. Purge all channels with air until dry.

Note that:1) Bacteria such asPseudomonas aeruginosa have beenidentified in both tap and filtered water, and may multiplyin a moist environment.

2) Avoid the use of excessively high air pressure whichcan damage the internal channels of flexible endoscopes.


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6. Drying:

b. Flush all channels, including accessory channels,with alcohol until the alcohol can be seen exiting the

opposite end of each channel.1) 70% isopropyl alcohol is used to assist in drying theinterior channel surfaces.

2) It must be properly stored in a closed container

between uses, because when exposed to air, it rapidlyevaporates, and if less than recommended % level,cannot be relied upon to assist in the drying process.

3) Alcohol flushes should be used even when sterile

water is used for rinsing.


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6. Drying:

c. Purge all channels with air. Note that alcohol

mixes with the remaining water on the channel

surfaces and acts to encourage evaporation of the

residual water as air flows through the channel.

d. Remove all channel adapters.


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6. Drying:

e. Dry the exterior of the endoscope with a soft,

clean lint-free towel.f. Thoroughly rinse and dry all removable parts.

Do not attach removable parts (e.g. valves, etc.)

to the endoscope during storage as this can trap

liquid inside.


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7. Storage:

Hang the endoscope in a vertical position to facilitate

drying (with caps, valves, and other detachable componentsremoved, per MFGs IFU).

a. The storage area should be clean, well

ventilated and dust free.

b. Correct storage will prevent damage.c. The interval of storage before use has

limited investigations and warrants further

data.


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5B. Automated HLD:

Automated Endoscope Reprocessors (AERs)

standardize the disinfection process and decreasepersonnel exposure to HLDs.

NOTE:

It is necessary to followall steps for the manual

cleaning prior to using

an AER.


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5B. Automated HLD:

An AER should have the following features:

a. Circulate fluids through all endoscope channels at an equalpressure without trapping air. Channel flow sensors providean added measure of compliance.

b. Detergent and disinfectant cycles should be followed bythorough rinse cycles and forced air to remove all used

solutions.

c. Disinfectant should not be diluted with any fluids.


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An AERshould have the following features:

d. Machine should be self-disinfecting.

e. No residual water should remain in hoses and reservoirs.f. Cycles for alcohol flushing and forced air drying are desirable.

g. Should also feature a self-contained or external water

filtration system.

In addition, a method to automatically store or print data

verification of cycle completion, is desirable.


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To use an AER:

1. Follow steps for manual cleaning of endoscope.

2. Prepare the AER according to the MFGs guidelines.3. Place the endoscope in the AER and attach all channeladapters according to the MFGs IFU.

a. The elevator channel of a duodenoscope has a very small

lumen. Since most AERs cannot generate pressure required toforce fluid through the lumen, a 2-5 ml syringe must be usedto manually reprocess (all steps) the elevator channel unlessthe AER is validated to perfuse this channel.


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To use an AER:

4. Place valves and other removable parts into thesoaking basin of the AER. Unless the AER has adedicated space for accessories, reprocess theseitems separately.

5. If the AER has a cycle that uses enzymaticdetergent, it should be a product that is compatiblewith the AER and the endoscope.

6. Set the AER for the appropriate time andtemperature depending on the chemical used.

7. Start the AER and allow it to complete allcycles or phases. Note that if cycles or phasesare interrupted, HLD cannot be ensured andthe full cycle must be repeated.


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To use an AER:

8. If AER does not include a final alcohol rinse,

this step should be done manually followed bypurging all the channels with air until dry.

The ERCP elevator and elevator channel must

be manually perfused and dried per MFGs

instructions.9. Drying and storage procedures are the same as

described in the manual disinfection section.

To get a free copy of the complete SGNA

document, go to: www.sgna.org


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Healthcare facilities are responsible for providing a safe

work and patient care environment. Patients, visitors, and

health care workers should be protected from injuries or

illnesses caused by hazardous chemicals.

When handling HLDs, personnel should wear protective

apparel that may include, but is not limited to:

100% nitrile rubber or 100% butyl rubber gloves when

handling glutaraldehyde. PVC gloves should not beworn because they absorb glutaraldehyde.

Protective eye wear, face mask, and impervious gown.

Chemical HLD Safety


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Glutaraldehydeshould only be used in well ventilated

areas or in freestanding or vented chemical fume hoods.Vapor generated from glutaraldehyde can may aggravate

preexisting respiratory conditions.

AAMIdescribes adequate ventilation as:1. Room large enough to ensure adequate dilution of vapors.

2. 10 air exchanges per hour.

3. Exhaust located at the source of the discharge of vapors.

4. Fresh air return at ceiling level across room from exhaust vents.5. Routine maintenance and surveillance of system.

6. Elimination of cross draft effects.

7. Air must not be recirculated.

Chemical HLD Safety


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Glutaraldehydecan be absorbed by inhalation, ingestion

and through the skin. It has a detectable odor at 0.04 parts

per million volume (ppmv) and is irritating to skin and

mucous membranes at 0.3 ppmv.

Vapors are released whenever solutions are disturbed and

the surface tension is broken, such as mixing, adding and

removing equipment, or disposing of a glutaraldehyde

solution can cause a break in the surface tension.Whenever the glutaraldehyde solution is not being

accessed, it should be covered with a tight-fitting lid.

Chemical HLD Safety


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To avoid these glutaraldehyde issues, many health care

facilities have switched to using an OPAfor HLD. The

RapicideOPA/28 features the fastest disinfection time,

twice the reuse period of other OPA brands and guaranteed

materials compatibility.

Chemical HLD


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Exposure monitoring is not required; however, OPA is

still a potential irritant of eyes, skin, nose and other tissues

resulting in symptoms such as stinging, excessive tearing,

coughing, and sneezing. Like glutaraldehyde, OPAfixes

proteins, allows for biofilm formation and exposure causesstaining on linen, skin, instruments and AERs.

Chemical HLD Safety


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Personnel should receive initial training and competency

validation on procedures, chemicals used, and PPE and

should receive additional training when new equipment,

instruments, supplies, or procedures are introduced.

Employers must provide a written hazard communication

program, hazard evaluation, hazardous materials inventory,

Safety Data Sheets, labels on all containers of hazardous

chemicals, and employee training.

Training and Education


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A quality control program should be established in all

areas where HLD is used. Quality control programs

should be documented and should include, but not be

limited to:

Orientation programs Competency assurance

Continuing education

Quality control checks Investigation of adverse events

Monitoring of solution replacement intervals

Quality Control Program


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Surfaces of complex instruments require meticulous

cleaning in order to minimize infection control risks

to patients and staff. Inadequate cleaning can potentially

leave residual protein on a surface.

Quality control checks, such as

ATP systems and VERiFIND

Protein Detection Kit, provide

rapid and easy to readcleaning verification.

Quality Control Program


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Health care workers responsible for HLD must maintain

the technical skills needed to establish and maintain a safe

practice environment for patients, visitors and peers.

Administrative personnel must ensure competency

validation of personnel participating in decontamination

and HLD of reusable medical devices. The validation of

competencies should include all types of devices the

individual is authorized to reprocess.

CONCLUSION


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THANK YOU!

SPSmedical Supply Corp.

Sterilization Products & Services

6789 W. Henrietta Road

Rush, NY 14543 USA

Fax: (585) 359-0167

Ph: (800) 722-1529

website: www.SPSmedical.com

2013, SPSmedical Supply Corp.

Free CE programs are available in our

Sterilization Classroom on the

SPSmedical website.


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References & Resources

Association for the Advancement of Medical Instrumentation. (2010). Chemical sterilization and

high level disinfection in health care facilities (ANSI/AAMI ST58:2005/(R) 2010). Arlington, VA.

Association of periOperative Registered Nurses. (2013 Edition). Recommended Practices for

High-Level Disinfection.

Society of Gastroenterology Nurses and Association, Inc. (2007) Guideline for High-Level

Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes.

Society of Gastroenterology Nurses and Association, Inc. (2012) Standards of Infection Control

in Reprocessing of Flexible Gastrointestinal Endoscopes.

Occupational Health and Safety Administration (OSHA). (2012). Hazardous waste and emergency

response. www.osha.gov

Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee

(HICPAC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities.

Documents

2013_BestPractices for HLD(1)