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84 July 2007 MANAGING INFECTION CONTROL Objectives After completion of this self-study activity, the learner will be able to: 1. Describe why now, more than ever before, the Operating Room (OR) and Sterile Processing Department (SPD) need to partner together to improve surgical instrument processing. 2. Define patient safety issues and ethical responsibilities associated with surgical instrument processing. 3. Describe the importance of understanding personnel and design considerations of the instrument processing area. 4. Identify key organizations that publish guidelines and recommended practices that establish state-of-the-art prac- tice for processing areas. Test Questions True or False 1. The surgical setting is one of the most potentially hazardous environments for patients. 2. The Joint Commission (JCAHO) is the primary source of consensus and timely information on medical instrumen- tation and technology. 3. Sterilization not only depends on the efficacy of the sterilization process used, but also on proper training of personnel and efficient facility design. 4. The Association for the Advancement of Medical Instrumentation (AAMI) recommends that all personnel Education & Training by Rose Seavey, RN, MBA, CNOR, ACSP Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded one and one- half (1.5) contact points for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one and one- half (1.5) contact hours for a period of five (5) years from the date of publication, and to be used only once in a re c e rtification period. This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 102. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. performing sterile processing activities be certified as a condition of employment. 5. Heavy-duty, waterproof gloves will greatly increase the potential for punctures. 6. From both safety and cost-effectiveness standpoints, the instrument processing functions (i.e. decontamina- tion, preparation and packaging, and sterilization processing) should be performed in one department. 7. Only authorized personnel in specific attire should be allowed in areas where decontamination, preparation and packaging, sterilization processing, sterile storage, and distribution are carried out. 8. Processing space needs are frequently underestimated. 9. Relative humidity should be controlled between 70% and 80% in all work areas. 10. Ensuring instrument reprocessing is completed by knowledgeable, responsible people and in a workplace that facilitates effective and efficient processing is the responsibility of both SPD and OR. Introduction We live in a rapidly changing world. Technology is altering almost every aspect of our lives, and it is quite evident in our perioperative world. Just think about the technology explosion that has enabled invasive or mini- mally invasive procedures to be done in various settings including the operating room, ambulatory surgery centers, cardiac catheterization units, endoscopy suites, physician’s offices and radiology departments. Whether we are dealing with very high-tech surgical devices (i.e. robotics) or common everyday surgical instruments, reprocessing these items is a very vital part of the surgical/invasive procedure. Patient safety depends on surgical instruments that are properly cared for and effectively reprocessed. This takes knowledgeable, responsible people and a workplace that facilitates effective and efficient processing to properly perform these tasks. Surgical instrument reprocessing is the responsibility of both the Operating Room (OR) and the Sterile Processing Department (SPD). Responsibility to Patient Safety Can any healthcare professional deliver effective hands- on patient care in today’s high-technology environment without the backup of countless support people? Of course, the answer is no. Developing effective partnerships is vital to OR and SPD Working Together to Improve Instrument Processing

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Page 1: OR and SPD Working Together to Improve Instrument Processing - CSAO

84 July 2007MANAGING INFECTION CONTROL

ObjectivesAfter completion of this self-study activity, the learner will

be able to:1 . Describe why now, more than ever before, the Operating Room

(OR) and Sterile Processing Department (SPD) need to partnertogether to improve surgical instrument processing.

2. Define patient safety issues and ethical responsibilities associated with surgical instrument processing.

3. Describe the importance of understanding personnel anddesign considerations of the instrument processing area.

4. Identify key organizations that publish guidelines and recommended practices that establish state-of-the-art prac-tice for processing areas.

Test Questions True or False

1. The surgical setting is one of the most potentially hazardousenvironments for patients.

2. The Joint Commission (JCAHO) is the primary source of consensus and timely information on medical instrumen-tation and technology.

3. Sterilization not only depends on the efficacy of the sterilization process used, but also on proper training ofpersonnel and efficient facility design.

4. The Association for the Advancement of MedicalInstrumentation (AAMI) recommends that all personnel

Education & Training

by Rose Seavey, RN, MBA, CNOR, ACSP

Many thanks to the team at 3M Health Care for workingwith Managing Infection Control to provide the followinga c c redited course. IAHCSMM has awarded one and one-half (1.5) contact points for completion of this continuing education lesson toward IAHCSMM re c e rt i f i c a t i o n . T h eCBSPD has preapproved this inservice for one and one-half (1.5) contact hours for a period of five (5) years from the date of publication, and to be used only once in are c e rtification period. This inservice is 3M Health CareProvider approved by the California Board of RegisteredNurses, CEP 5770 for one (1) contact hour. This form isvalid up to five (5) years from the date of publication.Instructions for submitting results are on page 102.

Managing Infection Control and 3M Health Care willbe working collaboratively to provide continuing educationcourses in monthly editions of Managing Infection Control.

performing sterile processing activities be certified asa condition of employment.

5. H e a v y - d u t y, waterproof gloves will greatly increasethe potential for punctures.

6. From both safety and cost-effectiveness standpoints,the instrument processing functions (i.e. decontamina-tion, preparation and packaging, and sterilizationprocessing) should be performed in one department.

7. Only authorized personnel in specific attire should beallowed in areas where decontamination, preparationand packaging, sterilization processing, sterile storage,and distribution are carried out.

8. Processing space needs are frequently underestimated.9. Relative humidity should be controlled between 70%

and 80% in all work areas.10. Ensuring instrument reprocessing is completed by

knowledgeable, responsible people and in a workplacethat facilitates effective and efficient processing is theresponsibility of both SPD and OR.

IntroductionWe live in a rapidly changing world. Technology is

altering almost every aspect of our lives, and it is quiteevident in our perioperative world. Just think about thetechnology explosion that has enabled invasive or mini-mally invasive procedures to be done in various settingsincluding the operating room, ambulatory surgery centers,cardiac catheterization units, endoscopy suites, physician’soffices and radiology departments. Whether we are dealingwith very high-tech surgical devices (i.e. robotics) orcommon everyday surgical instruments, reprocessing theseitems is a very vital part of the surgical/invasive procedure.Patient safety depends on surgical instruments that areproperly cared for and effectively reprocessed. This takesknowledgeable, responsible people and a workplace thatfacilitates effective and efficient processing to properlyperform these tasks. Surgical instrument reprocessing is theresponsibility of both the Operating Room (OR) and theSterile Processing Department (SPD).

Responsibility to Patient Safety Can any healthcare professional deliver effective hands-

on patient care in today’s high-technology environmentwithout the backup of countless support people? Of course,the answer is no. Developing effective partnerships is vital to

OR and SPD Working Together to ImproveInstrument Processing

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86 July 2007MANAGING INFECTION CONTROL

safe patient care. The universally acknowledged motto of m e d i c i n e ’s Hippocratic Oath states, “First, do no harm.” The mostimportant thing we do is to provide safe care to our patients.

The Association of periOperative Registered Nurses’(AORN’s) Position Statement on Patient Safety states: “Thesafety of patients undergoing operative or other invasive procedures is a primary responsibility of the perioperativeregistered nurse. Registered nurses form a professional bond with patients, who place their physical and emotional well-being in the hands of registered nurses and their surgicalcolleagues and who believe that the care provided will be safeand effective. The patient/caregiver bond is founded on thepatient’s trust in the registered nurse and the surgical team.Protecting the patient and promoting an optimal surg i c a loutcome further strengthens that bond.”1

When we talk about “surgical colleagues” and the“surgical team,” we must include the instrument reprocessingstaff. They are a very important part of the surgical team andshould be held accountable for patient safety along with theregistered nurse, the surgeon, the anesthesiologist and the scrubtech. In order to improve patient safety, OR and SPD mustharmoniously work together.

Improving RelationshipsFrequently the relationship between OR and the instrument

processing area, often called Sterile Processing Department(SPD), is less than ideal. OR and SPD are sometimes like twopeople in a bad marriage, in desperate need of counseling.However, both departments rely on each other and must findcommon ground.

The surgical setting is one of the most potentiallyhazardous environments for patients. Infection, hemorrhage,and wrong patient/surgery/site are some of the most seriouslikely complications. Other potential risks that contribute tounsafe practice include human factors, such as communicationpatterns, institutional culture and staffing patterns.1

The Joint Commission (JCAHO) states that communicationbetween and among team members is one of the most vital components of a safe, team-based OR environment.

One of the most frequent causes of errors is a breakdown in communications.2

Now, more than ever, a closer relationship between ORand SPD needs to be developed. Due to limited resources, timeconstraints, technology changes, and misinformation, we facechallenges that can be met through collaborative partnerships.Understanding what other healthcare professionals can offer isa vital step toward working harmoniously together. Improvedrelationships between OR and SPD can and does make a difference in safe patient care.

No matter how large or small the setting, one of the most important responsibilities of an OR manager is being an advocate for patients. Part of that obligation is to ensure the staff members processing the surgical instruments areknowledgeable, reliable and ethical, and that they have theresources, including proper processing space and design, to appropriately reprocess instruments. Surgical service hasthe influence and clout to change things if needed, even ifthey do not report directly to them. Registered nurses have a moral duty and ethical responsibility to protect their patientsfrom harm.

Sterile Processing is a dynamic profession. The constant changes in information and technology mean theseprofessionals must keep updated on the regulations and procedural innovations. It is crucial to keep abreast of changes,to ensure patient safety and for building and maintaining anefficient, safe work environment.3

ResourcesThere are many resources available that offer standards

and guidance documents that are routinely reviewed andupdated as well as educational opportunities to improvesurgical instrument reprocessing.

AORN is the global leader in promoting excellence inperioperative nursing practice. “AORN’s mission is to supportregistered nurses in achieving optimal outcomes for patientsu n d e rgoing operative and other invasive pro c e d u re s . ” T h e ycan be found online at www.aorn.org.

There are two professional organizations for CentralService/Sterile Processing (CS/SP): the American Society for Healthcare Central Service Professionals (ASHCSP) and the International Association for Healthcare CentralService Materiel Management (IAHCSMM). Both of these professional groups are nationally and internationallyrecognized for providing training and technical manuals.

A S H C S P ’s mission statement is, “ To be the pre m i e rprofessional organization that promotes effective health carecentral service, sterile processing and inventory managementpractices through education, professional and org a n i z a t i o ndevelopment, advocacy and communication.” They can befound online at www.ashcsp.org.

Education & Training

OR and SPD are sometimeslike two people in a badmarriage, in desperateneed of counseling.

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88 July 2007MANAGING INFECTION CONTROL

IAHCSMM’S mission is, “ To provide the members of the Association and healthcare facilities with organized educational opportunities, professional development, a forumfor information exchange, member services in response tomember identified needs and priorities; and to re p re s e n tCentral Service Materiel Management in the pro f e s s i o n a lcommunity.” They can be found online at www.iahcsmm.org.

There are two certification programs available for CS/SP.They are offered by IAHCSMM and the Certification Board forSterile Processing and Distribution Inc. (CBSPD). CBSPD’smission is, “ To promote and encourage high standards ofethical and professional practice through a recognized, cred -ible credentialing program that encourages the competency ofpersonnel performing sterile processing and distribution activ -ities.” They can be found online at www.sterileprocessing.org.

Both of these organizations offer several different certifications such as CS technician, supervisor, manager,instruments, and ambulatory setting, and apparently now thereis even one for the GI processing area.

The Association for the Advancement of MedicalInstrumentation (AAMI) is the primary resource for the industry,the professions, and government for national and internationalstandards. AAMI is the primary source of consensus standardsand timely information on medical instrumentation and t e c h n o l o g y. It can be found online at www. a a m i . o rg .

ANSI/AAMI ST79:2006A A M I ’s newest steam sterilization publication,

C o m p rehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2006)was released last summer and is now available to order. ST79is a complete guideline for all steam sterilization activities inhealthcare facilities. AAMI has combined five recommendedpractices into this new standard. No matter what the size of the facility or the size of the sterilizer, this document is a must-have resource for all healthcare personnel who work with steam sterilization. This is the publication that every SPand OR should have in its reference library. The orderinginstructions will follow this in-service.

The five recommended practices incorporated into the newstandard are:1. ANSI/AAMI ST46 Steam sterilization and sterility

assurance in health care facilities;2. ANSI/AAMI ST42 Steam sterilization and sterility

assurance using table-top sterilizers in office-based,ambulatory-care medical, surgical, and dental facilities;

3. ANSI/AAMI ST37 Flash sterilization: Steam sterilizationof patient care items for immediate use;

4. ANSI/AAMI ST35 Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings;

5 . ANSI/AAMI ST33 Guidelines for the selection and use ofreusable rigid sterilization container systems for ethyleneoxide sterilization and steam sterilization in health c a re facilities.

Sterilization Is a ScienceSterilization doesn’t just happen. There is no magic box

that automatically kills microorganisms and renders instrumentssafe to use on patients. AAMI defines sterilization as a “validated process used to render a product free from viablem i c r o o rg a n i s m s . ”4 Sterilization is an art and a science thatinvolves many factors. All of the aspects around sterilization areimportant to not only achieve sterilization, but also maintain thesterility of the products up to the time they are needed.Sterilization not only depends on the efficacy of the sterilizationprocess used, but also on many other issues such as: Proper training of personnel; Efficient facility design; Good infection prevention and control practices; E ffective quality control and process improvement

systems that take into consideration all steps of the reprocessing process;

Proper documentation and reporting practices that allowtraceability of each facility-sterilized item to the patient itwas used on.1

Processing departments vary not only in their physicaldesign, but also in the level of knowledge and training of thestaff. In addition, they differ in what the department is called. Is it Sterile Processing, Central Service, Central Supply,Surgical Instrument Processing or something else? In addition,they can report to many different departments: Surg i c a lServices, Materials Management, Infection Control, Nursing,Administration or others. No matter what it is called, who itreports to, or how large or small it is, sterilization departmentsall have specific personnel and physical design considerationsto facilitate effective and efficient processing.

Personnel ConsiderationsAccountability for performing sterilization processes

should be assigned to competent individuals who have knowl-edge of all aspects of disinfection and sterilization proceduresand safety precautions.

To d a y ’s Sterile Processing demands critical thinking skills!S u rgical instruments are more complicated than ever. We nolonger just deal with what I refer to as the basic “knives, forks andspoons” of surg e r y. We deal daily with extremely complex deviceswith many delicate compound parts and long narrow intricatelumens. The more complex an item is, the more difficult it is toclean and sterilize. Most of these new devices come with veryspecific and sometimes difficult reprocessing instructions.

Education & Training

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89July 2007 MANAGING INFECTION CONTROL

S P professionals need to know how all instruments are taken apart and put together, whether they need to be lubricated, how they are cleaned, if they need to go through theultrasonic, what type of sterilization process is recommended,etc. The Sterile Processing Department (SPD) often has to juggle sterilization loads to make sure the correct m a n u f a c t u r e r’s parameters are met, sometimes having to makejudgment calls. The “process” of instrument processing iscomplex in itself, and it takes many thought processes that demand experience and education.

There are detailed guidelines for personnel qualifica-tions, training and education, as well as minimum criteria forpersonnel health and personal hygiene. The following is apartial summary of the recommendations for personnelconsiderations found in ANSI/AAMI ST79:2006 Section 4.

Qualifications (Section 4.2)Supervisory personnel (Section 4.2.1)

“All preparation and sterilization activities, including decontamination, inspection, preparation, packaging, sterilization

Education & Training

storage and distribution, should be supervised by competent, qualified personnel. Personnel assigned to supervisory functionsshould be prepared for this responsibility by education, trainingand experience.”4 “At the very least the supervisor should: a) be certified in Central Service Management; b) demonstrate current knowledge and sufficient relevant

experience in the healthcare setting;c ) participate in continuing education programs and

courses including:• federal and local regulations;• personnel and material management;• financial management; • leadership and management skills; • infection control;• safety; • principles and methods of sterile processing;

d) demonstrate comprehensive understanding of relevant state and federal regulations, particularly OSHA blood borne pathogens exposure control plan and engineeringand work-practice controls.”4

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90 July 2007MANAGING INFECTION CONTROL

It is imperative that SPD supervisors maintaincompetency by participating in continuing educationalo fferings. In addition, they should participate in healthcarecommittees such as risk management, quality improve-ment, safety, product evaluation and standardization.

Sterile processing personnel (Section 4.2.1)S P responsibilities should only be assigned

to qualified individuals who have demonstrated competencies in all areas, including decontamination,preparation, packaging, sterilization, sterile storage anddistribution of sterile medical devices.

Qualifications include demonstrated knowledge ofand documented competence in:a ) all aspects of decontamination; sorting, disassembly/

r e a s s e m b l y, manual and mechanical cleaningmethods, microbicidal processes, equipment o p e r a t i o n , standard/ transmission-based precau-tions, and engineering and work-practice controls;

b) the operation of all sterilizing systems used by the healthcare facility;

c ) principles of sterilization and infectious diseasetransmission, infection control and all aspects of sterilization;

d) worker safety as it relates to medical deviceprocessing and sterilization.

“It is recommended that all personnel performingsterile processing activities be certified as a condition ofemployment. At a minimum, all such personnel shouldsuccessfully complete a central service certificationexamination within two years of employment and should maintain that certification throughout theiremployment.” See Figure 1.

Figure 1. Certifications

Education & Training

Because of the advances in surgical and information technology,the emergence of new diseases and microorganisms, as well as theincreased responsibilities for all phases of sterile processing, there is agrowing importance for sterile processing staff to be knowledgeableand competent.

Training and continuing education (Section 4.3)Sterile Processing personnel (Section 4.3.1)

Sterile processing staff should receive initial orientation as wellas on-the-job training to establish the worker’s competency-basedknowledge and skills. The orientation must cover the department policies and procedures about infection control, safety, attire, personalhygiene, and compliance with state and federal regulations. T h e yshould also receive continuing education at regular intervals to reviewand update their knowledge and skills and to maintain their competency and certification. Employees should also receive trainingfor all new instrumentation, devices and equipment.

Documentation of all orientation, training and continuing education is required by the Joint Commission (JCAHO 2007).

Service personnel (Section 4.3.2)“Education and training programs for service personnel should

include information on the hazards associated with blood-bornepathogens, the requirements of the OSHA standard on occupationalexposure to blood-borne pathogens (29CFR 1910.1030), the importanceof vaccinations as protective measures, standard/transmission-based(enhanced) precautions, protective work practices, the use of PPE, e m e rgency procedures, and procedures to follow if an exposure occurs.”

Other personnel (Section 4.3.3)To protect the integrity of sterile items, it is important that

personnel who have access to the area but are not assigned to sterileprocessing get an orientation and training on proper attire and propercare, handling, and transportation of sterile packages.

Health and personal hygiene (Section 4.4)Personal hygiene policies should be developed and approved by

infection control, and employee health. These policies should be put inwriting and communicated to the staff. “Handwashing proceduresshould be specified. Hair, body, and nails should be clean at all times. Neither nail polish nor artificial nails should be worn. Fingernailsshould be kept short and clean and should not extend beyond the fingertips (AORN, 2005e).”

Any exposures to bloodborne diseases should be handled inaccordance with Center for Disease Control and Prevention (CDC)and OSHA current regulations.

To minimize the potential for acquiring or transmitting disease,there should be careful attention to workers’ health, safety andpersonal hygiene. Any worker who could potentially come intocontact with blood or body fluids should be encouraged to get hepatitis B immunization.

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Education & Training

Attire (Section 4.5)General considerations (Section 4.5.1)

Uniforms that are provided by the healthcare facility should be worn by all personnel entering thedecontamination, preparation, sterilization and sterilestorage areas (see Figure 2). These uniforms, usuallyknown as scrubs, should be donned at the facility andchanged daily or more often as required (i.e. when wet,grossly soiled, or visibly contaminated with blood orbody fluids). Scrubs that are visibly contaminated mustbe laundered in the facility’s laundry.

“Shoes worn in the department should be clean,should have non-skid soles, and should be sturdy enough to prevent injury if an item drops on the foot. All head and facial hair (except for eyebrows andeyelashes) should be completely covered with a surgical-type hair covering. Jewelry and wristwatches should not be worn in the decontamination, preparation or sterilization area.”

Figure 2. Proper attire signs

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92 July 2007MANAGING INFECTION CONTROL

Education & Training

Figure 3. Proper personnel protective equipment

Decontamination area (Section 4.5.2) Appropriate protective attire will minimize the potential for employee

exposure. Personnel working in the decontamination area should wear the attire recommended in 4.5.1 plus general-purpose utility gloves and a liquid-resistant covering with long sleeves. This could be a backlessgown, jumpsuit or surgical gown. “If there is any risk of splash or aerosols,PPE should include a fluid-resistant face mask and eye protection. PPE used to protect the eyes from splash and aerosols could includegoggles, full-length face shields, or other devices that prevent exposure tosplash from all angles.” See Figure 3.

Following manufacturer’s instructions, reusable gloves, glove liners, aprons, and eye-protection devices should be decontaminated at least daily or before being used by another employee. Heavy-duty,waterproof gloves will greatly decrease the potential for puncture,limit the microbial burden on hands, and decrease the risk of cross contamination. If a glove is torn, it should be immediately replaced afterappropriate handwashing.

“Before leaving the decontamination area, employees should removeall protective attire, being careful not to contaminate the clothing beneathor their skin, and wash their hands.” Once used, face masks are considered

Page 8: OR and SPD Working Together to Improve Instrument Processing - CSAO

contaminated and should not be worn hanging around the neck, stuffed into a pocket or perched on the forehead.

Sterilization area (flash sterilization) (Section 4.5.3) Employees working in areas where items are flash sterilized should wear

a fluid-resistant face mask because unprotected sterile items can become contaminated by respiratory droplets.

Service personnel (Section 4.5.4) PPE should be worn by service personnel whenever they are working on

equipment in the processing area. Each healthcare institution must provide,enforce the use of and properly dispose of PPE by service personnel.

Standard/transmission-based (enhanced) precautions(Section 4.6)

In addition to infection control practices such as washing hands and wearing PPE, OSHA’s bloodborne pathogen requirements should be followed.They include: Precautions to prevent injuries from sharp objects; Contaminated needles generally should not be recapped; Do not bend, break or manipulate needles by hand; Sharp items must be placed in puncture-resistant containers; Hands and any skin surfaces should be immediately and thoroughly washed

if they come in contact with potentially infectious fluids; Eating, drinking, smoking, applying cosmetics or lip balm, and handling

contact lenses must be prohibited in any areas that may contain chemical orbiological material;

Personnel must receive training on bloodborne pathogens.

Physical Design Reprocessing of surgical instruments cannot be done just anywhere. Due to

the nature of the tasks taking place, there are specific design considerations thatmust be taken into account. The design must be able to promote effective and efficient processing, support personnel safety, minimize environmentalcontamination, and preserve the sterility of processed items.4

In some facilities the physical processing area is frequently less than ideal. Some challenges are lack of space, lack of equipment, poor design or inappropriate location. This can be the result of many factors such as OR growth,technology advancements, poor maintenance, old facilities, lack of planning withnew facilities, or construction.

Nevertheless, AAMI has specific guidelines for the design and maintenance of processing areas. Prudent healthcare facilities should follow these AAMI recommended practices. The following is a summary of design considerations foundin ANSI/AAMI ST79:2006 Section 3.

General rationale (Section 3.1)For both safety and cost-effectiveness standpoints, the instrument processing

functions (i.e., decontamination, preparation and packaging, and sterilizationprocessing) should be performed in one department.

“Sterilization is a complex process requiring environmental controls (e.g., controlled air changes, exhaust ventilation, temperature and humidity);

93July 2007 MANAGING INFECTION CONTROL

Education & Training

Page 9: OR and SPD Working Together to Improve Instrument Processing - CSAO

e) P reparation and packaging are a : where clean instruments andother medical and surgical supplies are inspected, assembled andwrapped/containerized;

f) Textile assembly area (pack room): where clean reusable textiles areinspected patched, folded, assembled and wrapped;

g) Sterilization area: where sterilizers are located, including spacer forloading, unloading, and lining up carts and for cool-down;

h) Sterile storage are a : where clean and sterile items are stored before distribution;

i) Equipment storage area: where clean medical equipment is storeduntil issued;

j) Administrative area: office space;k) Housekeeping equipment storage area: where housekeeping items

are stored. Note: Decontamination area and “clean” areas shouldeach have separate dedicated housekeeping storage areas.

Decontamination area (Section 3.2.2.2)Decontaminating is a vital part of instrument reprocessing. In regard

to the design of the decontamination area, there are special issues tothink about. Here are some of the keys issues to consider in the design ofthe area:a) Will decontamination be centralized or decentralized, or will there

be a combination of approaches?b) Which departments will be served?c) How will contaminated items be contained and transported?d) Will there be a need for emergency or short-term processing at

the point of use?e) Will a cart washer be installed?f) Will rigid sterilization containers be used? Are they mechanically or

manually cleaned?g) Will the decontamination process be performed manually, mechan-

ically or by a combination of both?h ) Where will reusable patient care equipment be decontaminated? Is

there ample room for decontamination of instruments and equipment?

94 July 2007MANAGING INFECTION CONTROL

appropriate equipment and supplies; adequatespace; qualified, competent personnel who areprovided with on going training and personalprotective equipment (PPE); and monitoring forquality assurance.”

If centralization of sterilization processing isnot possible, all sterilization processing should beunder a centralized control with consistent policiesand procedures.

Work area design and functional workflow (Section 3.2)Definitions of work areas (Section 3.2.1)a) Central service depart m e n t : processes and

controls medical supplies, devices and equipment,sterile and nonsterile;

b) B reakout/decasing are a : where products areremoved from their external shippingcontainers;

c ) Receiving, cleaning and decontamination:where reusable instruments, supplies, equipment, and carts are received, sorted, cleaned and decon-t a m i n a t e d ;

d) Personnel support are a : employee toilet,shower and locker facilities;

Education & Training

Figure 4. Automatic unloading of equipment after decontamination

Figure 5. Pass-thru window

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Education & Training

i) What types of PPE are used,reusable or disposable?

j) Will there be space for staff to donand remove PPE?

k) Where will housekeeping suppliesdedicated for use only in the decontamination area be stored?

l) How many sinks are available?m) How will you dispose of liquid and

solid body wastes?n) Will it have separate temperature

and humidity controls?o) Will there be compressed or forced

air available?

Functional workflow patterns(Section 3.2.3)

The area where contaminated itemsare received and processed should bephysically separated from areas in which

clean items are packaged, sterilized and stored. Decontamination equipment thatmechanically processes items and then automatically unloads them into the clean sideis recommended (see Figure 4 on page 94).

The workflow should be designed so that items are moved progressively frombeing contaminated to being safe to handle. A pass-thru window between decontam-ination area and the clean area is recommended (see Figure 5 on page 94).

Figure 7. Source of demineralized water

Figure 6. Compressed air/nitrogen and vacuum

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96 July 2007MANAGING INFECTION CONTROL

Traffic control (Section 3.2.4)Only authorized personnel in specific attire should be allowed in

areas where decontamination, preparation and packaging, steriliza-tion processing, sterile storage, and distribution are carried out. T h er e s p o n s i b i l i t y, authority for enforcing t r a ffic-control of policies andprocedures, and compliance methods should be specified in writing.

Physical facilities (Section 3.3)Space requirements (Section 3.3.1)

Processing space needs are frequently underestimated. The size ofprocessing areas is determined by the needs of each facility. Spaceshould be provided in proportion to the expected volume and theamount of products that will be stored in this area.

Mechanical systems (Section 3.3.2)Due to the growing complexity of today’s medical technology, the

processing area may need pressurized systems such as compressed air,nitrogen and vacuum systems (see Figure 6). “A source of distilled ordemineralized water might be needed.” See Figure 7.

Floors and walls (Section 3.3.6.)Floors and walls should be level and be constructed of

materials that will withstand frequent cleaning with chemical agents.Carpet is not appropriate in work areas. See Figure 8.

Ceilings (Section 3.3.6.2)Ceilings in work areas should be constructed to create a flush

surface with recessed, enclosed pipes and fixtures. “Ceilings should

Education & Training

Figure 8. Appropriate floor and wall construction

Figure 9. Temperature and relative humidity monitor

Reprinted with permission from the Association for the Advancement of Medical Instrumentation, Inc. ©2006 A A M I .www.aami.org. All rights reserved.

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97July 2007 MANAGING INFECTION CONTROL

be constructed of materials that are not of particulate- orfiber-shedding composition.”

Ventilation (Section 3.3.6.4)In general, the clean areas (sterilization, preparation,

p a c k a g i n g and sterile storage) should have positive airflowventilation, and the soiled and decontamination areas should be under negative pressure. See Table 3 Ventilationrequirements for functional areas.

Temperature (Section 3.3.6.5)The temperature in the work areas should be comfort-

able for properly attired personnel. In general work areasshould be between 68°F and 73°F (20°C and 23°C).Comfort is particularly important in the decontaminationarea where the temperature should be between 60°F and65°F (16°C and 18°C).

Relative humidity (Section 3.3.6.6)“Relative humidity should be controlled between 30%

and 60% in all work areas except the sterile storage area,where the relative humidity should not exceed 70%.” Higherrelative humidity can promote microbial growth and a lowerrelative humidity may adversely affect some sterilizationparameters (such as steam penetration) and the performanceof some products (such as BIs and CIs). See Figure 9.

Housekeeping procedures (Section 3.4)Areas where any aspects of decontamination, preparation,

or sterilization are performed should receive the samehousekeeping procedures as the operating room, to ensure a high level of cleanliness at all times.

SummaryInstrument reprocessing is an extremely important

part of patient safety. The patients put their trust in us.Therefore, it is our obligation to make sure the surg i c a linstruments used on them are properly cared for and efficiently reprocessed.

There are several resources available to help youachieve this goal. This in-service covered some of the basic recommended practices for personnel and designconsiderations in the instrument processing area. It is highlyrecommended that each facility have its own copy of thenewly published ANSI/AAMI ST79:2006 C o m p re h e n s i v eguide to steam sterilization and sterility assurance in healthcare facilities.

As leaders in SP and the OR, we must ensure instrumentreprocessing is completed by knowledgeable, responsiblepeople and in a workplace that facilitates effective and efficient processing.

Education & Training

Ordering InformationAAMI

ANSI/AAMI ST79:2006, Comprehensive guide to steamsterilization and sterility assurance in health care facilities

Order code: ST79 or ST79-PDFAvailable in an attractive binder featuring sturdy metal

rings, ledger-weight pages and a laminated tab for each sectionfor easy navigation. AAMI will issue revised pages that can besubstituted into the binder when changes are made.

Also available in PDF format and as part of A A M I ’s electronic CD and subscription products.

Price/Member discount price: $200/$100

AAMI documents can be purchased through AAMI bycredit card using the following four options:1. Internet: http://marketplace.aami.org2. Call: 800.332.2264, ext 217 or 703.525.4890, ext 2173. Fax: 703.525.14244. Mail: AAMI, Customer Service Center, 1100 N. Glebe

Road, Suite 220, Arlington, VA 22201-5762

AORNAORN Standards can be purchased through AORN using

the following options:1. Internet: www.aorn.org/bookstore/ordering.htm2. Call: 800.755.2676, ext 1 or 303.755.6304 ext 1 (Monday-

Friday, 8 a.m. to 4:30 p.m. MST)3. Fax: 303.750.32125. By mail: AORN, Inc., Customer Service/Book Orders,

2170 South Parker Road, Suite 300, Denver, CO 80231-5711

Payment can be made by VISA, MasterCard, AmericanExpress or Discover, either online or by mail/fax/phone.

By authorized PO, and AORN will bill you ($100minimum purchase). Sorry, we cannot accept POs for educa-tion conferences or services. (Not available for online orders.)

A CD-rom of the standards is available for the first timethis year. ✛

References1. AORN Position Statement on Patient Safety, Association of

periOperative Registered Nurses (AORN) Standards, RecommendedPractices, and Guidelines. 2007.

2. Joint Commission on Accreditation of Healthcare Org a n i z a t i o n s ,“Sentinel event alert: A follow-up review of wrong site surg e r y, ”Joint Commission Perspective (January 2002) p. 10-11.

3. American Society for Healthcare Central Service Professionals,Training Manual for Health Care Central Service Technicians, 4thed. 2001.

4. The Association for the Advancement of Medical Instrumentation.Comprehensive guide to steam sterilization and sterility assurance inhealth care facilities. ANSI/AAMI ST79:2006.

continued on page 102

Page 13: OR and SPD Working Together to Improve Instrument Processing - CSAO

102 July 2007MANAGING INFECTION CONTROL

Education & Training

Rose Seavey, RN, MBA, CNOR,A C S P, is the director of the SterileP rocessing Department at TheC h i l d re n ’s Hospital of Denver. Ms. Seavey is an active memberof the Association of periOperativeR e g i s t e red Nurses (AORN) andc u rrently sits on the NationalNominating Committee. She wash o n o red with A O R N ’s award forOutstanding Achievement in ClinicalNurse Education in 2001. She servedas the President of the A m e r i c a nSociety of Healthcare Central Serv i c eP rofessionals (ASHCSP) in 2003 and is the 2002 recipient of A S H C S PNational Educator of the Year award.Ms Seavey is a member of severalAAMI working group committees that are developing recommended practices and is currently a co-chairfor the AAMI ST8, Hospital steamsterilizers. In addition she has lecturedand authored many articles on varioustopics relating to perioperative s e rvices and sterile processing, locally,nationally and internationally.

1. T2. F3. T4. T5. F

6. T7. T8. T9. F10. T

ANSWERS

Nursing CE Application Form3M Health Care provider approved by the California Board of Registered Nurses, CEP

5770 for 1 contact hour. This form is valid up to five years from the date of publication.1. Make a photocopy of this form.2. Print your name, address and daytime phone number and position/title.3. Add your social security number or your nursing license number.4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to:

Workhorse PublishingManaging Infection ControlPO Box 25310, Scottsdale, AZ 85255-9998

7. Participants who score at least 70% will receive a certificate of completion within30 days of Managing Infection Control’s receipt of the application.

ApplicationPlease print or type.

Name______________ _ _ _ _ _ _ _ _ _ _ _____ _ _ _ _ _ _ _ __ _ _ _ _ _ _ _______________ ___

Mailing Address__________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __

City, State, Country, Zip __________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____

Daytime phone ( )_____________________ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ __

P o s i t i o n / Ti t l e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ __

Social Security or Nursing License Number _________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _____

Date application submitted ___________________________ _ _ _ _ _ _ _ _ _ _ ________

Signature _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ____ _ _ _

Offer expires July 2012

On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this programfor the following:

1) Overall content ___________________

2) Met written objectives ______________

3) Usability of content ________________

Sterile Process and Distribution CEU InformationCEU Applicant Name _________________________________________________

Address_________________ _ _ _ _ _ _____ _ _ _ _ _ _ _ _ _ _ ______ _ _ _ _ __ _ _ ________

City____________________________ State________ Zip Code _______ _ _ _ _ ___

The CBSPD (Certification Board for Sterile Processing and Distribution) haspre-approved this inservice for 1.5 contact hours for a period of five years from the date of publication. Successful completion of the lesson and post test must bedocumented by facility management and those records maintained by the individualsuntil re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD.

For additional information regarding Certification contact: CBSPD, 121 StateHwy 31N, Suite 500, Flemington, NJ 08822 or call 908-788-3847 or visit the Web siteat www.sterileprocessing.org.

IAHCSMM has awarded 1.5 contact points for completion of this continuing e d u c a t i o n lesson toward IAHCSMM recertification.

<07/07>

continued from page 97

Copyright©2007/Workhorse Publishing L.L.C./All Rights Reseved.Reprint with permission from Workhorse Publishing L.L.C. 70-2009-8667-0