ATTACHMENT B ANSI-AAMI ST91-2015.pdf

ANSI/AAMI

ST91:2015

Flexible and semi-rigid endoscope processing in health care facilities

American National Standard

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American National Standard ANSI/AAMI ST91:2015

Flexible and semi-rigid endoscope processing in health care facilities

Approved 30 March 2015 by Association for the Advancement of Medical Instrumentation

Approved 8 April 2015 by American National Standards Institute Inc.

Abstract: Provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.

Keywords: flexible endoscopes, high-level disinfection, semi-rigid endoscopes, sterilization

AAMI

AAMI Standard

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Published by

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© 2015 by the Association for the Advancement of Medical Instrumentation

All Rights Reserved

Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under federal law (17 U.S.C. § 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI at 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067.

Printed in the United States of America

ISBN 1-57020-585-X

Contents Page

Glossary of equivalent standards .............................................................................................................................. vi Committee representation ......................................................................................................................................... vii Foreword ................................................................................................................................................................... ix Introduction 1 Scope

1.1 Inclusions

1.2 Exclusions

2 Definitions and abbreviations 3 Design of endoscope processing area

3.1 General considerations

3.2 Work flow

3.2.1 General considerations

3.2.2 Physical separation

3.2.3 Traffic control

3.3 Physical facilities

3.3.1 Space requirements

3.3.2 Sinks and accessories

3.3.3 Electrical systems

3.3.4 Floors and walls

3.3.5 Ceilings

3.3.6 Doors

3.3.7 Temperature, relative humidity, and ventilation

3.3.8 Lighting

3.3.9 Hand hygiene facilities

3.3.10 Emergency eyewash/shower equipment

3.3.11 Environmental cleaning

4 Personnel

4.1 General considerations

4.2 Policies and procedures

4.3 Education, training, and competency verification

4.4 Standard precautions

4.5 Hand hygiene

4.6 Attire

4.6.1 General considerations

4.6.2 Personal protective equipment

4.7 Immunizations

5 Cleaning and high-level disinfection

5.1 General considerations

5.2 Precleaning at the point of use

5.3 Transporting used endoscopes

5.4 Leak testing

5.4.1 General considerations

5.4.2 Manual (dry) leak testing

5.4.3 Mechanical (wet) leak testing

5.4.4 Mechanical (dry) leak testing

5.4.5 Mechanical leak testing using an AER

5.4.6 Leak test failures

5.5 Manual cleaning

5.6 Manual rinsing

5.7 High-level disinfection and liquid chemical sterilization

5.7.1 General considerations

5.7.2 High-level disinfection

5.7.3 Liquid chemical sterilants/liquid chemical sterilization

5.7.4 Manual liquid chemical sterilization/high-level disinfection

6 Automated endoscope reprocessors 7 Sterile endoscope sheaths used as protective microbial barriers 8 Terminal sterilization by gaseous chemical sterilization processes

8.1 General considerations

8.2 Packaging for terminal sterilization

8.2.1 General considerations

8.2.2 Sterilization pouches

8.2.3 Sterilization wraps

8.2.4 Rigid sterilization containment systems

8.3 Ethylene oxide gas (EO) sterilization

8.4 Hydrogen peroxide gas sterilization

8.5 Ozone sterilization

9 Processing of endoscope accessories 10 Storage of reprocessed endoscopes

10.1 General Considerations

10.2 Storage of high-level disinfected endoscopes

10.3 Storage of sterilized endoscopes

10.4 Hang time for high-level disinfected endoscopes

10.4.1 General considerations

10.4.2 Existing guidelines

10.4.3 Risk assessment

11 Transport of high-level disinfected endoscopes 12 Quality Control

12.1 General considerations

12.2 Product identification and traceability

12.3 Documentation and record-keeping

12.3.1 Documentation

12.3.2 Expiration dating

12.4 Verification and monitoring of the cleaning process

12.4.1 General Considerations

12.4.2 Cleaning verification

12.4.3 Cleaning verification tests for users

12.4.4 Testing cleaning efficacy

12.5 Monitoring processes that use liquid chemical sterilization/high-level disinfection

12.5.1 Manual processes

12.5.2 Automated processes

12.6 Monitoring gaseous chemical sterilization processes

12.6.1 Use of physical monitors

12.6.2 Gaseous chemical sterilizer malfunction

12.7 Chemical indicators

12.7.1 General considerations

12.7.2 Using chemical indicators

12.7.3 Nonresponsive or inconclusive chemical indicators

12.8 Biological indicators

12.8.1 General considerations

12.8.2 Using biological indicators and process challenge devices

12.8.3 Frequency of use of BIs and PCDs

12.9 Sterilizer testing

12.9.1 General considerations

12.9.2 Qualification test procedure with BIs

12.9.3 Qualification testing acceptance criteria

12.9.4 Routine test procedure with BIs

12.9.5 Routine testing acceptance criteria

12.9.6 Positive BI results

12.9.7 Microbiological testing

12.9.8 Product release

12.10 Product recalls

12.10.1 General considerations

12.10.2 Recall procedure

12.10.3 Recall order

12.10.4 Recall summary report

12.10.5 Outbreak report

12.11 Quality process improvement

12.11.1 General considerations

12.11.2 Risk analysis

12.11.3 Decontamination

12.11.4 Liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization

12.11.5 Functional areas for product and process improvement

Bibliography

Tables 1 IES-recommended illuminance levels for work environments 2 Endoscope storage risk assessment checklist

Glossary of equivalent standards

International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI).

Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard.

www.aami.org/standards/glossary.pdf vi © 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015

AAMI

http://www.aami.org/standards/glossary.pdf

Committee representation

Association for the Advancement of Medical Instrumentation

Endoscope Reprocessing Working Group

This standard was developed by the AAMI Endoscope Reprocessing Working Group under the auspices of the AAMI Sterilization Standards Committee. Approval of the standard does not necessarily mean that all working group members voted for its approval. At the time this standard was published, the AAMI Endoscope Reprocessing Working Group had the following members:

Chairs: Nancy Chobin, RN CSPDM, St Barnabas Healthcare System Mary Ann Drosnock, MS, Olympus America Inc

Members: Jahan Azizi, CBET, University of Michigan Health System James Weldon Baker, AmeriWater Damien Berg, Medical Center of the Rockies Holger Biering, PhD, Holger Biering Harriet Chan-Myers, Johnson & Johnson James W. Collins, RN, Cleveland Clinic Foundation Linda Condon, Johns Hopkins Hospital Jacqueline Daley, Sinai Hospital of Baltimore Robert Dumont, Case Medical Inc Jon Fish, Prezio Health Sarah Friedberg, Stryker Instruments Division Shelley Green, WuXi AppTec Inc Garland Grisby, Kaiser Permanente (US) Barbara Ann Harmer, RN BSN MHA Shanil Haugen, FDA/CDRH Emily A. Hildebrand, Phoenix VA Health Care System Rachel Hill, CareFusion Nupur Jain, Intuitive Surgical Inc Susan G. Klacik, CCSMC FCS ACE, IAHCSMM Stephen M. Kovach, Healthmark Industries Company Inc Carole Kubiak, BSN RN CNOR, Brigham & Womens Hospital Colleen Patricia Landers, RN, Timmins & District Hospital Steve Maley, Crouse Hospital Albert E. May, Andersen Products Inc Gerald E. McDonnell, PhD, Steris Corporation Terry Mistalski, Medivators Inc Emily Mitzel, MS, Nelson Laboratories Inc Frank Myers, USPHS Indian Health Service Phillip Nosel, Microtest Laboratories Inc Gerry A. O'Dell, MS, Gerry O'Dell Consulting Janet M. Prust, 3M Healthcare Wayne Jerome Rogers, Wayne J Rogers Consulting Cheron Rojo, Childrens Hospital Central California Janis Saunier, Medtronic Inc WHQ Campus Rose E. Seavey, RN MBA CNOR CRCST, Seavey Healthcare Consulting, LLC Frank Smith, RN CNOR CRCST, Department of Veteran Affairs Donald Socha, Jr., Getinge USA Cynthia Spry, RN, Spry Consulting Christopher Strafaci, Vision Sciences Inc Karen Swanson, Connecticut Childrens Medical Center Lynne A. Thomas, Integrated Medical Systems Sharon Van Wicklin, MSN RN CNOR/CRNFA, Association of Perioperative Registered Nurses Don T. Williams, CRCST CIS CHL, Overlake Hospital Medical Center Martha L. Young, Martha L Young, LLC

Alternates: David E. Barlow, PhD, Olympus America Inc Ralph J. Basile, MBA, Healthmark Industries Company Inc Marcia Benedict, BS MI RAC MT ASCP, Steris Corporation Denise Carey, Medtronic Inc WHQ Campus Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurses Sylvie Dufresne, PhD, TSO3 Inc

© 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015 vii

Christian Escobar, Vision Sciences Inc Tania Lupu, Case Medical Inc Elaine S. Mayhall, PhD, FDA/CDRH Kanwarjit Singh, Johnson & Johnson Grace A. Thornhill, PhD, 3M Healthcare Brian Wallace, Intuitive Surgical Inc Ann Wheeler, Getinge USA

NOTE—Participation by federal agency representatives in the development of this recommended practice does not constitute endorsement by the federal government or any of its agencies.

At the time this document was published, the AAMI Sterilization Standards Committee had the following members:

Co-chairs: Victoria M. Hitchins, PhD, FDA/CDRH Michael H. Scholla, Dupont Protection Technologies

Members: Christopher Anderson, Boston Scientific Corporation Trabue D. Bryans, BryKor LLC Nancy Chobin, RN CSPDM, St Barnabas Healthcare System Charles Cogdill, Covidien Ramona Conner, RN MSN CNOR, Association of Perioperative Registered Nurses Jacqueline Daley, Sinai Hospital of Baltimore Kimbrell Darnell, CR Bard Lisa Foster, Medpoint LLC Joel R. Gorski, PhD, NAMSA Joyce M. Hansen, Johnson & Johnson Douglas F. Harbrecht, Sterility Assurance LLC Deborah A. Havlik, Hospira Worldwide Inc Susan G. Klacik, CCSMC FCS ACE, IAHCSMM Byron J. Lambert, PhD, Abbott Laboratories Colleen Patricia Landers, RN, Timmins & District Hospital Reynaldo Lopez, Cardinal Health (MP&S) Jeff Martin, Alcon Laboratories Inc Patrick J. McCormick, PhD, Bausch & Lomb Inc Gerald E. McDonnell, PhD, Steris Corporation Janet M. Prust, 3M Healthcare Nancy Rakiewicz, Moog Medical Devices Mark Seybold, Baxter Healthcare Corporation Andrew Sharavara, PhD, Propper Manufacturing Co Inc Mark N. Smith, Getinge USA James Sidney Wiggs, BSN CRCST, Legacy Health System Martell Kress Winters, BS SM, Nelson Laboratories Inc William E. Young William T. Young, Sterigenics International

Alternates: Lloyd Brown, Covidien Peter A. Burke, PhD, Steris Corporation Dave Dion, Cardinal Health (MP&S) Gordon M. Ely, WuXi AppTec Inc Thomas J. Frazar, Johnson & Johnson Martha M. Kadas, Sterigenics International Jim Kaiser, Bausch & Lomb Inc Natalie Lind, IAHCSMM Ralph Makinen, Boston Scientific Corporation Mary S. Mayo, CR Bard David Ford McGoldrick, BS, Abbott Laboratories Jerry R. Nelson, PhD, Nelson Laboratories Inc Patrick Polito, Moog Medical Devices Karen Polkinghorne, Dupont Protection Technologies Shaundrea L. Rechsteiner, NAMSA Mike Sadowski, Baxter Healthcare Corporation Craig A. Wallace, 3M Healthcare

NOTE—Participation by federal agency representatives in the development of this recommended practice does not constitute endorsement by the federal government or any of its agencies.

viii © 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015

Foreword

This standard was developed by the AAMI Endoscope Reprocessing Working Group under the auspices of the AAMI Sterilization Standards Committee. The objective of this standard is to provide guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes, flexible bronchoscopes, surgical flexible endoscopes (e.g., flexible ureteroscopes), and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.

Initially this document was proposed as a technical information report that would synthesize existing guidance in the area of endoscope processing. As the draft was developed, the working group identified a need in the field for more extensive guidance, and proposed revising the document to be an American National Standard.

As used within the context of this document, “shall” indicates requirements strictly to be followed in order to conform to the standard; “should” indicates that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” is used to indicate that a course of action is permissible within the limits of the standard; and “can” is used as a statement of possibility and capability. “Must” is used only to describe “unavoidable” situations, including those mandated by government regulation.

This standard should be considered flexible and dynamic. As technology advances and as new data are brought forward, the standard will be reviewed and, if necessary, revised.

Suggestions for improving this recommended practice are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633.

© 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015 ix x © 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015

American National Standard ANSI/AAMI ST91:2015

Flexible and semi-rigid endoscope processing in health care facilities Introduction

Flexible and semi-rigid endoscopes are used in various body cavities for diagnostic and therapeutic procedures. In United States, at least 11 million gastrointestinal endoscopies are performed each year and the number of procedures is increasing (Cullen et al, 2009; SGNA, 2012). A risk of all endoscopy procedures is the introduction of pathogens or cross-contamination between patients. Failure to clean, disinfect, or sterilize equipment carries not only risk associated with breach of host barriers but also risk for person-to-person transmission of pathogens and transmission of environmental pathogens (e.g., Pseudomonas aeruginosa). Further consequences of inadequate device processing can include device damage, inefficient use of the device, and toxic reactions in patients.

Endoscopic transmission of infection

Even though gastrointestinal endoscopes represent a valuable diagnostic and therapeutic tool in modern medicine, more health care acquired infections (HAIs) have been linked with the use of contaminated endoscopes than to any other medical device and have been listed in the top ten technology hazards for patients for several years in a row (ECRI). The estimated patient risk, cited by the Centers for Disease Control (CDC) and other organizations, of infection associated with a flexible endoscopy has historically been considered to be rare at 1 in 1.8 million procedures. This estimate of patient risk of infection is not consistent with multiple, more recently published reports of lapses and tens of thousands of patient exposures both in the United States and other countries. In addition, there are other reports of patient exposures to contaminated endoscopes in the media and other public databases that have not been published in peer reviewed literature (Kimmery 1993, Rutala et al, 2007; ASGE, 2011, SGNA, 2012).

When the CDC Division of Healthcare Quality Promotion (formerly the Hospital Infection Program) reviewed its log of investigations between 1980 and 2002, no outbreaks of infection associated with GI endoscopy were found. Since 1990, health care facilities and manufacturers have been required to report to the FDA MAUDE (Manufacturer and User-Facility Device Experience) database any information that reasonably suggests that a device (such as an endoscope, accessory, or automated endoscope washer-disinfector) has caused or contributed to a death, injury, or serious illness of a patient. Review of this open access, non–peer-reviewed database from 1990 to 2002 revealed seven possible occurrences of pathogen transmission during GI endoscopy. Since 2002, the MAUDE database contains multiple references to infections suspected to have occurred after lapses in processing.

Currently, there are no well-designed, published, prospective studies on the incidence of pathogen transmission during GI endoscopy. Estimates of pathogen transmission based on retrospective case reports conclude the current risk estimate may underestimate the true incidence of infection. (Seonae-Vazquesz 2006, Holodny, 2012). Citing the 2008 CDC risk estimate may have led health care facilities not to inform, adequately screen for all potential disease transmitting organisms, or treat patients (Dirlam-Langley et al., 2013).

In some reports where patients have been exposed, they were not tested for all pathogenic organisms but only HIV or Hepatitis B viruses, despite documented outbreaks of non-viral pathogens. Recent reports support the conclusion that current risks are outdated and inaccurate (Ofstead et al., 2013; Dirlam-Langlay et al., 2013). Audits of facilities conducting GI procedures have found widespread lapses in infection control, including endoscope processing and in some cases endoscopes were virtually never processed in accordance with guidelines (Dirlam-Langlay et al., 2013).

The true implications of inadequate processing are unknown because no epidemiologic studies have determined the risk of infections or other patient complications including residual chemical toxicity and device damage effect on patient outcomes (Leffler et al., 2010).

Multiple peer-reviewed publications in several countries including the United States have documented breaches in processing that have led to patient exposure to improperly reprocessed flexible and semi-rigid endoscopes and have caused serious infections (Sanderson, 2010; Gonzalez-Candelas et al., 2010; Carbonne et al., 2010; Aumeran et al., 2010; Holodny, 2012; CDC 2014). In nearly all of these cases, failure to comply with manufacturer’s written instructions for use (IFU) or established guidelines or malfunctioning equipment that was undetected has led to numerous outbreaks of infection due to improperly processed flexible and semi-rigid endoscopes.

© 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015 1

A northeastern Illinois outbreak in 2013 of infections with New Delhi metallo-β-lactamase (NDM) producing Carbapenem-resistant Enterobacteriaceae (CRE) was linked with contaminated endoscopes used to perform endoscopic retrograde cholangiopancreatography (ERCP). A total of 44 patients were identified as infected (Rutala 2014). Further outbreaks were similarly linked to ERCP scopes in Pittsburgh (McCool et al., 2012) and Seattle (Aleccia 2015).

Effects of endoscopy-related infection outbreaks and other adverse patient reactions may include:

• microorganisms may be spread from patient to patient by contaminated or improperly processed flexible and semi-rigid endoscopes or malfunctioning equipment (exogenous infections).

• microorganisms may spread from the GI tract through the bloodstream during an endoscopy procedure to susceptible organs, or may spread to adjacent tissues that are breached as a result of the endoscopic procedure (endogenous infections).

• microorganisms may be transmitted from patients to endoscopy personnel and/or from endoscopy personnel to patients.

• chemical substances can remain on devices from various chemicals used during the procedure or processing that can cause toxic reactions in subsequent patients.

• devices may be damaged or rendered difficult to use due to mishandling or inadequate processing.

Minimizing these risks begins with the correct handling procedures in preparation for processing, to include pre-cleaning steps at the point of use (e.g., bedside procedures), disassembly of parts, and safe transport. Cleaning according to the specific manufacturer's written IFU is then required to ensure that patient soil and other materials are removed prior to the antimicrobial processes of high-level disinfection or sterilization. Cleaning is a multi-step process and is critical not only to ensure that subsequent processing steps can be effective but also to remove any potential toxic chemicals or other materials that can lead to adverse patient reactions. Cleaning is followed by disinfection or sterilization to reduce or completely remove microbial contamination. At a minimum, it is recommended that devices are subjected to high-level disinfection after each use. When possible and practical, flexible and semi-rigid endoscopes should be sterilized due to the greater margin of safety built into sterilization. High-level disinfection is a multi-step process and is expected to be able to inactivate most pathogenic bacteria, viruses, and fungi but may not reliably inactivate certain types of microorganisms including bacterial spores. When these devices are used in sterile tissue procedures, sterilization is recommended (CDC 2008).

2 © 2015 Association for the Advancement of Medical Instrumentation ■ AAMI ST91:2015

1 Scope

This standard provides guidelines for precleaning, leak-testing, cleaning, packaging (where indicated), storage, high-level disinfecting, and/or sterilizing of flexible gastrointestinal (GI) endoscopes; flexible bronchoscopes; flexible ear, nose, and throat endoscopes; surgical flexible endoscopes (e.g., flexible ureteroscopes); and semi-rigid operative endoscopes (e.g., choledochoscopes) in health care facilities. These guidelines are intended to provide comprehensive information and direction for health care personnel in the processing of these devices and accessories.

NOTE—For purposes of this standard, “health care facilities” means endoscopy centers, hospitals, nursing homes, extended-care facilities, free-standing surgical centers, ambulatory health centers (clinics), medical offices, and all other areas where flexible and semi-rigid endoscopes are processed.

1.1 Inclusions

This document specifically addresses

a) functional and physical design criteria for endoscope processing areas;

b) education, training, competency verification, and other personnel considerations;

c) processing recommendations;

d) installation, care, and maintenance of automated processing equipment;

e) quality control; and

f) quality process improvement.

Definitions of terms and a bibliography are also provided in this standard.

1.2 Exclusions

This standard does not cover

a) The processing of rigid endoscopes (e.g., arthroscopes, laparoscopes), transesophageal echocardiogram probes (TEE), or vaginal probes (See ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities; ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities; and ANSI/AAMI ST41, Ethylene oxide sterilization in health care facilities: Safety and effectiveness).

b) Specific construction and performance criteria for steam sterilizers (see ANSI/AAMI ST8, Hospital steam sterilizers and ANSI/AAMI ST55, Table-top steam sterilizers), ethylene oxide gas sterilizers (see ANSI/AAMI ST24, Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities), rigid sterilization container systems (see ANSI/AAMI ST77, Containment devices for reusable medical device sterilization), or rigid, protective organizing cases that require wrapping before sterilization (see ANSI/AAMI ST77).

c) The use of containment devices for packaging items other than instrument sets or procedural trays.

d) The processing of devices labeled for single use only (see Food and Drug Administration [FDA], 2000c).

NOTE—For more information on the subjects excluded from the scope of this recommended practice, and for additional background information on the inclusions, refer to the references listed in the bibliography.

2 Definitions and abbreviations

2.1 Automated endoscope reprocessor (AER): AERs or endoscope washer-disinfectors are machines designed for the purpose of cleaning and/or disinfecting endoscopes and components. The disinfection process uses a liquid chemical sterilant (LCS) or high-level disinfectant (HLD) solution to achieve at a minimum high-level disinfection.

2.2 bioburden: Population of viable microorganisms on a product and/or a sterile barrier system.

NOTE—When measured, bioburden is expressed as the total count of bacterial and fungal colony-forming units (CFUs) per single item.

2.3 biofilm: Accumulated biomass of bacteria and extracellular material that is tightly adhered to a surface and cannot be removed easily (Donlan, 2002).

© 2015 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST91:2015 3

NOTE—Some microscopic organisms have the ability, when growing in water or water solutions or in vivo (e.g., the bloodstream), to adhere to a surface and then exude over themselves a polysaccharide matrix. The matrix contains cells, living and dead, as well as polysaccharide (sometimes referred to as glycocalyx), and prevents antimicrobial agents, such as sterilants, disinfectants, and antibiotics, from reaching the microbial cells.

2.4 biological indicators (BIs): Test systems containing viable microorganisms providing a defined resistance to a specified sterilization process.

NOTE 1—According to FDA, “a biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.” [21 CFR 880.2800(a)(1)]

NOTE 2—Biological indicators are intended to demonstrate whether or not the conditions were adequate to achieve sterilization. A negative BI does not prove that all items in the load are sterile or that they were all exposed to adequate sterilization conditions.

NOTE 3—See ANSI/AAMI/ISO 14161 for information on the selection, use, and interpretation of biological indicators.

2.5 Bowie-Dick test: Diagnostic test of a dynamic-air-removal steam sterilizer’s ability to remove air from the chamber and prevent air re-entrainment.

2.6 case/cassette: Sterilization containment device that consists of a lid and base tray that has perforations to allow the sterilant to penetrate and that is enclosed in a sterilization wrap (or sterilization pouch) suitable for specified sterilization method[s]) to maintain sterility.

2.7 challenge test pack: Pack used in qualification, installation, and routine quality assurance testing of health care sterilizers. See also process challenge device.

2.8 chemical indicators (CIs): Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment.

ANSI/AAMI/ISO 11140-1, Sterilization of health care products—Chemical indicators—Part 1: General requirements, defines six classes of CIs and specifies performance requirements for them:

Class 1 (process indicators): chemical indicators intended for use with individual units (e.g., packs, containers) to indicate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units.

Class 2 (indicators for use in specific tests): chemical indicators intended for use in a specific test procedure (e.g., the Bowie-Dick test used to determine if air removal has been adequate in a steam sterilization process).

Class 3 (single-variable indicators): chemical indicators designed to react to one of the critical variables and intended to indicate exposure to a sterilization process at a stated value of the chosen variable.

Class 4 (multi-variable indicators): chemical indicators designed to react to two or more of the critical variables and intended to indicate exposure to a sterilization process at stated values of the chosen variables.

Class 5 (integrating indicators): chemical indicators designed to react to all critical variables, with the stated values having been generated to be equivalent to, or exceed, the performance requirements given in the ISO 11138 series for BIs.

Class 6 (emulating indicators): chemical indicators designed to react to all critical variables of specified sterilization cycles, with the stated values having been generated from the critical variables of the specified sterilization process.

NOTE 1—FDA recognition of chemical indicators is limited to Class 1 Process Indicators; Class 2 Indicators for use with special tests; and Chemical Integrators, which have resistance characteristics consistent with the "Guidance for Industry and FDA Staff:

Premarket Notification [510(k)] Submissions for Chemical Indicators," issued 12/19/2003.

NOTE 2—See ANSI/AAMI/ISO 15882 for information on the selection, use, and interpretation of chemical indicators.

2.9 cleaning: Removal of contamination from an item to the extent necessary for further processing or for the intended use.

NOTE—In health care facilities, cleaning consists of the removal, usually with detergent and water, of adherent organic and inorganic soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.

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2.10 competency verification: An activity designed to substantiate or confirm the ability of an individual to successfully complete a particular skill, task, complex series of tasks, or behavior necessary to perform effectively.

2.11 containment device: Reusable rigid sterilization container, instrument case, cassette, or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization.

2.12 decontamination: The process of removing pathogenic microorganisms from objects so they are safe to handle, use, or discard (CDC, 2008).

2.13 decontamination area: Area of a health care facility designated for collection, retention, and cleaning of soiled and/or contaminated items.

2.14 education: The knowledge, comprehension, and insight acquired by an individual after studying a specific subject.

2.15 endoscope sheath: A sterile, single-use protective barrier for various type of endoscopes, intended to cover the entire insertion tube of the endoscope. The sheath may contain air, water, or suction channels but most often is single channel. (FDA, 2000b)

2.16 engineering controls: The concept that, to the extent feasible, the work environment and the job itself are designed to eliminate or reduce exposure to hazards.

2.17 expiration date: Date that is calculated by adding a specific period of time to the date of manufacture or sterilization of a medical device or component and that defines its estimated useful life.

2.18 expiration statement: Statement, also known as a day-to-day expiration date, indicating that the contents of a package are sterile indefinitely unless the integrity of the package is compromised.

2.19 exposure control plan: According to OSHA, “a written [plan] designed to eliminate or minimize employee exposure.” (29 CFR 1910.1030)

2.20 exposure time: Period for which sterilization or high-level disinfection process parameters maintain their specific tolerances.

NOTE—In a steam sterilization process, exposure time is the period during which items are exposed to saturated steam at the specified temperature and pressure.

2.21 foot-candle: Standard unit of illumination equivalent to the light produced by one standard candle at a distance of 1 foot.

2.22 gaseous chemical sterilization (GCS): Validated process employing gaseous chemical sterilants (e.g., ethylene oxide [EO], hydrogen peroxide, ozone).

2.23 high-level disinfectant (HLD): "A germicide that inactivates all microbial pathogens, except large numbers of bacterial endospores, when used according to labeling" (Rutala, 1990).

NOTE—According to the FDA, HLD is a liquid chemical sterilant (LCS) used for a shorter exposure time than that required to pass the AOAC International sporocidal activity test as a sterilant.

2.24 high-level disinfection: Process that kills all microbial pathogens but not necessarily high numbers of bacterial spores.

NOTE—For a process that can be used for both liquid chemical sterilization and high-level disinfection, the contact time for high-level disinfection is shorter than that necessary for sterilization, under otherwise identical conditions.

2.25 installation qualification (IQ): Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications.

2.26 labeling: Any literature, including instructions for use, provided with a device as well as all advertising claims published by the manufacturer. (21 CFR 801)

2.27 liquid chemical sterilant (LCS): Solution of a chemical that has been validated to provide microbial kill adequate to obtain FDA clearance for a sterilization label claim.

2.28 liquid-resistant material: Material that inhibits the penetration of liquids. According to ANSI/AAMI PB70, a liquid-resistant material would be defined as a Level 1, 2, or 3 barrier material.

2.29 lot control number (load control number): Numbers, letters, or a combination of both, by which a particular group of products can be traced to a particular manufacturing or sterilization operation.

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2.30 lux: Approximately one tenth of a foot-candle.

2.31 manufacturer's written instructions for use (IFU): Written recommendations provided by the manufacturer of a device that provide instructions for operation and safe and effective processing.

2.32 medical device: Instrument, apparatus, material, or other article, whether used alone or in combination, including the software necessary for its application, intended by the manufacturer to be used for human beings for the purpose of

- diagnosis, prevention, monitoring, treatment, or alleviation of disease;

- diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap;

- investigation, replacement, or modification of the anatomy or of a physiological process; or

- control of conception and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

2.33 minimum effective concentration (MEC): “Minimum concentration of a liquid chemical sterilant/high-level disinfectant that achieves the claimed microbicidal activity; the MEC is determined by dose response testing.” [FDA, 2000a].

2.34 minimum recommended concentration (MRC): Minimum concentration at which the manufacturer of a liquid chemical sterilant or high-level disinfectant tested the product and validated its performance.

NOTE—The term “minimum effective concentration” (MEC) is sometimes used interchangeably with “minimum recommended concentration.” The MRC is not necessarily an MEC as determined by dose response testing. Some older IFU may state MEC, not

MRC.

2.35 occupational exposure: Contact, through inhalation, ingestion, skin contact, or absorption, with a potentially hazardous material during the course of employment. Occupational exposure to hazardous materials, including chemical and biological agents and potentially infectious materials, is regulated by OSHA (29 CFR Part 1910).

NOTE—The OSHA blood-borne pathogens standard (29 CFR 1910.1030) specifically defines occupational exposure as “reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties.”

2.36 performance qualification (PQ): Process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.

2.37 personal protective equipment (PPE): According to OSHA, “specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.” [29 CFR 1910.1030].

2.38 preventive maintenance: The routine servicing of equipment for the purpose of maintaining it in good working condition.

2.39 process challenge device (PCD): Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.

NOTE—For purposes of this standard, a PCD is a challenge test pack containing a BI or a BI and a CI. See AAMI TIR31.

2.40 processing: Process carried out on a device to allow its subsequent safe use, which can include cleaning, disinfection, sterilization, and related procedures.

2.41 processing area: Area of a health care facility where devices are decontaminated, cleaned, inspected, assembled into trays, and prepared for high-level disinfection and/or sterilization.

2.42 reprocessing: The process (see processing) of rendering a clinically used device safe and ready for its intended use.

2.43 reusable medical device: Device intended for repeated use on different patients, with decontamination and other processing between uses.

6 © 2015 Association for the Advancement of Medical Instrumentation ■ AAMI ST91:2015

NOTE—Examples include surgical instruments, endoscopes, basins, and electromedical equipment.

2.44 rigid sterilization container system: Sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents.

NOTE—The system generally consists of a bottom or base with carrying handles and a lid that is secured to the base by means of a latching mechanism. A basket or tray to hold instruments or other items to be sterilized is placed inside. A filter or valve system is incorporated into the lid and/or base to provide for air evacuation and sterilant penetration during the sterilization cycle and to act as a barrier to microorganisms during storage, handling, and transport.

2.45 shelf life: When the term is used with respect to a sterilized medical device, the period of time during which the item is considered safe to use.

2.46 solution test strip: Device used to monitor the concentration of the active ingredient(s) in a liquid chemical sterilant/high-level disinfectant solution and determine if the MRC or MEC is acceptable for effective use.

2.47 spore test strip: Test system containing a known number of bacterial spores (at least 105 per strip) of known resistance to a LCS/HLD and used in a defined liquid chemical sterilant processing system.

2.48 standard precautions: "The minimum infection prevention measures that apply to all patient care, regardless of suspected or confirmed infection status of the patient, in any setting where healthcare is delivered.

These evidence-based practices are designed to both protect healthcare personnel and prevent the spread of infections among patients. Standard Precautions replaces earlier guidance relating to Universal Precautions and Body Substance Isolation. Standard Precautions include: 1) hand hygiene, 2) use of personal protective equipment (e.g., gloves, gowns, facemasks), depending on the anticipated exposure, 3) respiratory hygiene and cough etiquette,

4) safe injection practices, and 5) safe handling of potentially contaminated equipment or surfaces in the patient environment." (CDC, 2011)

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