ATTACHMENT A ANSI-AAMI ST79-2017.pdf

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SI/A

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I ST79: 2017 American National Standard

ANSI/AAMI ST79:2017

& 2020 Amendments A1, A2, A3, A4 (Consolidated Text)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

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American National Standard ANSI/AAMI ST79:2017 (Revision of ANSI/AAMI ST79:2010/(R)2014 & A1:2010 & A2:2011 & A3:2012 & A4:2013)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Abstract: This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote sterility assurance and to guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement.

Keywords: ambulatory care facilities, cleaning, continuous quality improvement, decontamination, dental office, immediate-use steam sterilization (IUSS), moist heat sterilization, packaging, quality control, quality system, saturated steam, sterile storage, sterilization containers, surgical instruments, table-top sterilizers

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AAMI Recommended practice

This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI recommended practice does not in any respect preclude anyone, whether they have approved the recommended practice or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions.

CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this recommended practice no later than five years from the date of publication. Interested parties can obtain current information on all AAMI documents by calling or writing

AAMI.

All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations.

Published by

AAMI

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© 2017 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, visit the Copyright Clearance Center.

With the permission of Canadian Standards Association, (operating as CSA Group), material is reproduced from CSA Group standard Z314.8-00, Decontamination of reusable medical devices which is copyrighted by Canadian Standards Association, 178 Rexdale Blvd., Toronto, ON, M9W 1R3. This material is not the complete and official position of CSA Group on the referenced subject, which is represented solely by the standard in its entirety. While use of the material has been authorized, CSA Group is not responsible for the manner in which the data is presented, nor for any interpretations thereof. No further reproduction is permitted. For more information or to purchase standards from CSA Group, please visit http://shop.csa.ca/ or call 1-800-463-6727.

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ISBN 978-1-57020-675-7

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Contents Page

Glossary of equivalent standards .................................................................................................................................. ix

Committee representation ............................................................................................................................................ xii

Foreword ...................................................................................................................................................................... xv

Introduction: Need for the recommended practice

1 Scope

1.1 General

1.2 Inclusions

1.3 Exclusions

2 Definitions and abbreviations

3 Design considerations

3.1 General considerations

3.2 Work area design and functional workflow

3.2.1 Design criteria

3.2.2 Functional workflow patterns

3.2.3 Traffic control

3.3 Utilities

3.3.1 Mechanical systems

3.3.2 Electrical systems

3.3.3 Steam for sterile processing

3.3.4 Utility monitoring and alarm systems

3.3.5 General facility design requirements

3.3.6 Special area requirements and restrictions

3.3.7 Emergency eyewash/shower equipment

4 Personnel considerations

4.1 General considerations

4.2 Qualifications

4.2.1 Supervisory personnel

4.2.2 Sterile processing personnel

4.3 Education and training

4.3.1 Sterile processing personnel

4.3.2 Service personnel

4.3.3 Other personnel

4.4 Health and personal hygiene

4.5 Attire

4.5.1 General considerations

4.5.2 Decontamination area/room

4.6 Standard and transmission-based precautions

5 Receiving

5.1 General considerations

5.2 Receiving of purchased or loaned items

5.2.1 General considerations

5.2.2 New, repaired, and refurbished reusable items

5.2.3 Loaned or borrowed instrumentation

5.2.4 Rigid sterilization container systems

5.2.5 Disposable items

5.3 Disposition of sterile items (issued but not used)

6 Handling, collection, and transport of contaminated items

6.1 General considerations

6.2 Separation of waste and reusable items at point of use

6.3 Point-of-use care and handling of contaminated reusable items

6.4 Containment

6.5 Transport

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6.5.1 Segregation of clean/sterile items

6.5.2 Transportation scheduling and routes

6.5.3 Transportation equipment

6.5.4 Hand transport

6.5.5 Dedicated lifts

6.5.6 Transport between buildings

6.5.7 Off-site transportation

7 Cleaning, disinfection (microbicidal processes), and other decontamination steps

7.1 General considerations

7.2 Policies and procedures

7.3 Manufacturer’s written IFU

7.4 Decontamination

7.4.1 General considerations for all devices and utensils

7.4.2 Special considerations

7.5 Preparation for cleaning

7.5.1 Presoaking

7.5.2 Sorting and disassembly

7.6 Cleaning

7.6.1 General considerations

7.6.2 Devices with lumens

7.6.3 Cleaning agents

7.6.4 Methods of cleaning

8 Preparation and assembly of instruments

8.1 General considerations

8.2 Instruments

8.3 Devices with lumens

8.4 Basins and basin sets

8.5 Textile packs

9 Packaging

9.1 General considerations

9.2 Selection of sterile barrier systems

9.3 Package labeling

9.4 Package closures

9.5 Sterilization wrap

9.5.1 General considerations

9.5.2 Woven wraps

9.5.3 Nonwoven wraps

9.5.4 Paper–plastic pouches

9.6 Wrapping techniques

9.6.1 Simultaneous double-wrapping: envelope fold

9.6.2 Simultaneous double-wrapping: square fold

9.6.3 Sequential wrapping: envelope fold

9.6.4 Sequential wrapping: square fold

9.7 Sterility maintenance covers

9.8 Rigid sterilization container systems

10 Sterilization

10.1 Loading the sterilizer

10.1.1 General considerations

10.1.2 Paper–plastic pouches

10.1.3 Instrument sets

10.1.4 Textile packs

10.1.5 Utensils and glassware

10.1.6 Rigid sterilization container systems

10.1.7 Liquids

10.1.8 Powders and oils

10.2 Sterilization parameters

10.2.1 General considerations

10.2.2 Sterilization cycles

10.2.3 Immediate-use steam sterilization

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10.3 Unloading the sterilizer

10.3.1 Unloading sterilizers having a chamber volume larger than 2 cubic feet

10.3.2 Unloading table-top sterilizers (sterilizers having a chamber volume of less than or equal to 2 cubic feet)

10.4 Handling and inspection after unloading the sterilizer

11 Storage and transportation

11.1 Sterile storage

11.1.1 Storage facilities

11.1.2 Sterility maintenance covers

11.1.3 Shelf life

11.2 Distribution

11.2.1 Handling and inspection

11.2.2 Distribution containers

11.3 Transport of sterile packaged items

11.3.1 General considerations

11.3.2 Tables and carts (open or closed)

11.3.3 Hand transport

11.3.4 Dedicated lifts

11.3.5 Off-site transportation

12 Installation, care, and maintenance of sterilizers

12.1 General rationale

12.2 Instruction manuals

12.3 Installation

12.4 Routine care

12.5 Preventive maintenance

12.5.1 General considerations

12.5.2 Scheduled maintenance

12.6 Calibration

12.7 Record-keeping

13 Process monitoring, testing, and quality control

13.1 General considerations

13.2 Monitoring of mechanical cleaning equipment

13.3 Product identification and traceability

13.3.1 General considerations

13.3.2 Package labeling and expiration dating, if applicable

13.3.3 Sterilizer records

13.3.4 Record retention

13.4 Sterilization process monitoring

13.5 Sterilization process monitoring devices

13.5.1 Physical monitors

13.5.2 Chemical indicators

13.5.3 Biological indicators

13.5.4 Process challenge devices

13.6 Routine load release

13.6.1 Process monitoring devices

13.6.2 Release criteria for nonimplants

13.6.3 Release criteria for implants

13.6.4 Sterilization process failure

13.7 Routine sterilizer efficacy monitoring

13.7.1 General considerations

13.7.2 Routine biological monitoring of sterilizers larger than 2 cubic feet

13.7.3 Routine biological monitoring of table-top sterilizers (less than or equal to 2 cubic feet)

13.7.4 Routine biological sterilizer efficacy monitoring of gravity-displacement cycles

13.7.5 Actions to take when BIs, CIs, or physical monitors indicate a sterilization process failure

13.7.6 Routine Bowie-Dick testing of dynamic-air-removal sterilizers

13.8 Qualification testing

13.8.1 General considerations

13.8.2 Qualification testing of sterilizers have a chamber volume larger than 2 cubic feet

13.8.3 Qualification testing of table-top sterilizers (sterilizers having a chamber volume less than or equal to 2 cubic feet)

13.9 Periodic product quality assurance testing of routinely processed items

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13.9.1 General considerations

13.9.2 Process verification

13.9.3 Product families

13.9.4 Verification testing procedure

13.10 Periodic product quality assurance testing of rigid sterilization container systems

13.10.1 General considerations

13.10.2 User responsibilities

14 Quality process improvement

14.1 General considerations

14.2 Quality process

14.2.1 General considerations

14.2.2 Quality system model

14.2.3 Risk analysis

14.3 Supplier communication

14.4 Repair records

14.5 Processing policies and procedures

15 New product evaluation

15.1 General rationale

15.2 Considerations

Tables

1 IES-recommended illuminance levels for work environments

2 Sterilization process monitoring recommendations

3 Types and applications for use of sterilization monitoring devices

4 Potential causes to be investigated for steam sterilization process failures

5 Summary of test configurations for prepurchase evaluation of rigid sterilization container systems

Levels of disinfection according to type of microorganism

E.2 Occupational exposure limits for some chemical sterilants and disinfectants

J.1 16 towel pack survey

J.2 Biological-indicator results from 121°C (250°F) gravity-displacement cycle

J.3 Biological-indicator results from 132°C (270°F) deep-vacuum cycle

J.4 Biological-indicator results from 132°C (270°F) pulsing vacuum cycle

J.5 Comparison of the 16 towel pack with the 12 × 12 × 20 inch pack by Most Probable Number and sterility assessment of spore strips (121°C [250°F] gravity-displacement cycle)

J.6 Fraction-negative results in a 121°C (250°F) gravity-displacement cycle

J.7 Biological-indicator results from 121°C (250°F) steam-flush pressure-pulse cycle

J.8 Biological-indicator results from 132°C (270°F) steam-flush pressure-pulse cycle

N.1 Comparison of terminology and differences between performance requirements of ANSI/AAMI/ISO 11140-1 and FDA (2003) guidance recommendations

O.1 Moisture assessment check list

Figures

1 Workflow

2 Example of single- and double-packaging with paper–plastic pouches

3 Simultaneous double-wrapping: envelope fold

4 Simultaneous double-wrapping: square fold

E.1

5 Sequential wrapping: envelope fold

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6 Sequential wrapping: square fold

7 Examples of sterilizer cart loads

8 Preparation of the 16 towel PCD (BI challenge test pack)

9 Placement of the 16 towel PCD (BI challenge test pack) for routine biological monitoring of sterilizers larger than 2 cubic feet

10 Decision tree for conducting investigations of steam sterilization process failures

11 Composition of the Bowie-Dick test pack

12 Placement of the Bowie-Dick test pack

13 Placement of the 16 towel PCD (BI challenge test pack) for qualification testing

A.1 Example of a work area design and workflow pattern for a sterile processing area in a typical small hospital

A.2 Example of a work area design and workflow pattern for a sterile processing area in a typical medium-sized hospital

A.3 Example of a work area design and workflow pattern for a sterile processing area in a typical regional processing center

A.4 Example of an ambulatory surgery facility

A.5 Example of a dental facility

B.1 The chain of infection, components of the infectious disease process

B.2 Blood-borne pathogen strike-through conversion chart

I.1 Typical rigid sterilization container system processed in a gravity-displacement cycle at 121°C (250°F)

I.2 Muslin-wrapped, 16 pound instrument set processed in a gravity-displacement cycle at 121°C (250°F)

I.3 Typical rigid sterilization container system processed in a prevacuum cycle at 132°C (270°F)

J.1 Temperature profiles for two different configurations of 12 × 12 × 20 inch packs

J.2 Temperature profiles for huck and absorbent 16 towel packs in a 121°C (250°F) gravity-displacement cycle

J.3 Average temperature profile for the 16 towel pack in a 121°C (250°F) gravity-displacement cycle

K.1 Exception form for emergency release of sterilizer load

O.1 Moisture assessment flow chart

Annexes

A Examples of workplace design

B Infection transmission and standard precautions

C Processing CJD-contaminated patient care equipment and environmental surfaces

D User verification of cleaning processes

E Selection and use of chemical disinfectants

F Thermal disinfection

G Devices returned to the manufacturer

H Development of a prepurchase evaluation protocol for rigid sterilization container systems

I Effect of container systems on load come-up time

J Development and qualification of the 16 towel PCD (biological-indicator challenge test pack)

K Example of documentation of emergency release of implants

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L Steam quality

M Toxic anterior segment syndrome (TASS) and the processing of intraocular surgical instruments

N Comparison of the differences between AAMI and FDA classifications of chemical indicators

O Moisture assessment

P General considerations for cleaning and disinfection

Q Alternatives for keeping cool in the sterile processing environment

Bibliography

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Glossary of equivalent standards

International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009.

Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI;

therefore, this list should not be considered exhaustive.

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Committee representation Association for the Advancement of Medical Instrumentation

Steam Sterilization Hospital Practices Working Group

This recommended practice was developed by the AAMI Steam Sterilization Hospital Practices Working Group under the auspices of the AAMI Sterilization Standards Committee. Approval of the recommended practice does not necessarily mean that all working group members voted for its approval.

At the time this recommended practice was published, the AAMI Steam Sterilization Hospital Practices Working Group had the following members:

Cochairs: Ramona Conner, RN, MSN, CNOR, FAAN Cynthia Spry, MA, MS, RN, CNOR(E), CSPDT Members: Steven Adams

Anas Aljabo, SteriPro Canada Inc Rajee Arunan, Mercy Medical Center Richard Bancroft, STERIS Corporation Ralph J. Basile, MBA, Healthmark Industries Company Inc Nola Bayes, MBA, Sanford Health Gary Benning, Midmark Corporation Damien Berg, CRCST, St. Anthony Hospital Holger Biering, PhD Hassan Bilal, Medline Industries Inc Dave Billman, Innovative Sterilization Technologies LLC Jennifer Burrell, St Lukes Hospital and Health Network Bradley J. Bushman, Standard Textile Co Inc Mike Cain, Getinge USA Dennis Champagne, Avista Pharma Solutions Karen Cherry, SIPS Consults Corp Nancy Chobin, RN, CSPDM, Sterile Processing University LLC Fiona Collins, American Dental Association Linda Condon, Johns Hopkins Hospital Ramona Conner, RN, MSN, CNOR, FAAN, Association of periOperative Registered Nurses Lena Cordie, Qualitas Professional Services LLC Gaye Currier Jacqueline Daley, Sharp Metropolitan Medical Campus Courtney Mace Davis, University of Iowa Hospitals and Clinics Michael D'Onofrio, Presage Health Jennifer Durbin, Mary Rutan Hospital Mark Duro, CRCST, FCS, Crosstex/A Cantel Medical Company Lee Ford, Floyd Medical Center Brian Fortier, Quality Processing Resource Group LLC Sarah Friedberg, Stryker Instruments Division Marcia Ann Frieze, Case Medical Inc.

Joel R. Gorski, PhD, NAMSA Sharon Hadley, Integrated Medical Systems Barbara Ann Harmer, RN, BSN, MHA Seth Hendee, The University of Vermont Medical Center Inc Rachel Hill, Becton Dickinson & Company David M. Jagrosse, Middlesex Hospital Nupur Jain, Intuitive Surgical Inc Jackie Johnson, Flexible Packaging Association Susan G. Klacik, CCSMC, FCS, ACE, International Association of Healthcare Central Service

Materiel Management Marcy Konja, CRCST, CSPDT, CHL, CSPDM, SpecialtyCare Mary Kneece Lane, BS, MHA, CSPDS, CSPDM Jack LeClair Angela M. Lewellyn, LPN, CSPDT, CRCST, Advantage Support Services Inc Steve Loes, Sterilucent Inc JoAnn Maltais, Maltais Consulting Patrick J. McCormick, PhD, Bausch & Lomb Inc.

Gerry McDonnell, PhD, Johnson & Johnson

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Kathleen McMullen, Association for Professionals in Infection Control and Epidemiology Megan Middaugh, Cardinal Health Emily Mitzel, MS, Nelson Laboratories Inc.

Thomas K. "Chip" Moore, Consultant Clarence Murray, FDA/CDRH Frank Myers, UC San Diego Healthcare System Karen Nauss, CRCST, Mount Auburn Hospital John Nies, Belimed Inc Lawayne Perkins, Advantage Support Services Inc Adrian Ponce, Verrix LLC Janet M. Prust, 3M Healthcare Melinda Rogers, Northside Hospital Forsyth Cheron Rojo, Valley Childrens Hospital Don Rotter, Ecolab Rose E. Seavey, RN, MBA, CNOR, CRCST, Seavey Healthcare Consulting LLC Andrew Sharavara, PhD, Propper Manufacturing Co. Inc Chuck Sidebottom, PPO Standards LLC Frank Sizemore, Wake Forest University Baptist Medical Center Gary Socola, HIGHPOWER Validation Testing & Lab Services Inc Alison Sonstelie, Sanford Health Joan M. Spear, B Braun of America Inc.

Steve Spencer, Halyard Health Cynthia Spry, MA, MS, RN, CNOR(E), CSPDT, Independent Clinical Consultant James Stanicki, Cleveland Clinic Foundation Suzanne Stefanik Andy Sun, SciCan Ltd Karen Swanson, Connecticut Childrens Medical Center Donna Swenson (Independent Expert) Jania Torreblanca, University of Michigan Health System Mary Velasco, Henry Ford Macomb Hospital P. Richard Warburton, ChemDAQ Inc Jill Warren, WuXi AppTec Inc Sid Wiggs (Independent Expert) Don Williams, Swedish Medical Center/Cherry Hill Campus Roberto Zumbado, Philips

Alternates: Cheri Ackert-Burr, Cantel Inc Stacey Burgardt, Cardinal Health John Erickson, Univeristy of Iowa Hopsitals and Clinics Nancy Fellows, Johnson & Johnson Susan Flynn, 3M Healthcare David Hilliker, ChemDAQ Inc Stephen M. Kovach, Healthmark Industries Company Inc Kristie Kunzer, Bausch & Lomb Inc Natalie Lind, International Association of Healthcare Central Service Materiel Management Tania Lupu, Case Medical Inc.

Viktoriya Lusignan, Getinge USA Kelly Makimoto, SciCan Ltd Roger Martin, Sterilucent Inc Christena Nash, Halyard Health Ed Nuber, B Braun of America Inc Walt Oko, Innovative Sterilization Technologies LLC Ramesh Panguluri, FDA/CDRH Rod Parker, Stryker Instruments Division Alpa Patel, Nelson Laboratories LLC Kim Patton, Becton Dickinson & Company Mandy Ryan, Stryker Instruments Division Richard Schule, STERIS Corporation Krista Schulte, Boston Scientific Corporation Jana Silor, Zimmer Inc Frank Smith, Department of Veterans Affairs Joe Smith, Belimed Inc Leslie Tavares, WuXi AppTec Inc Dawn Tomac, Association for Professionals in Infection Control Janelle Trboyevich, Boston Scientific Corporation Don Tumminelli, HIGHPOWER Validation Testing & Lab Services Inc

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Sharon Van Wicklin, Association of periOperative Registered Nurses Kristy Vogt, American Dental Association Brian Wallace, Intuitive Surgical Inc Ann Young, The University of Vermont Medical Center Inc

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.

AAMI Sterilization Standards Committee

Cochair: Michael H. Scholla, MS, PhD Members: Anas Aljabo, PhD, SteriPro Canada Inc Brett Anderson, Cochlear Ltd

Hank Balch, University Health System Richard Bancroft, STERIS Corporation Trabue D. Bryans, BryKor LLC Tim Carlson, Becton Dickinson & Company Phil Cogdill, Medtronic Inc Sean Colwell, WuXi AppTec Inc Ramona Conner, RN, MSN, CNOR, FAAN, Association of periOperative Registered Nurses Lena Cordie, Qualitas Professional Services LLC Jacqueline Daley, Sharp Metropolitan Medical Campus Gordon Ely, MiMedx Group Lisa Foster, Adiuvo QS & SA Consulting Joel R. Gorski, PhD, NAMSA Stephanie Homuth (Independent Expert) Clark Houghtling, Cosmed Group Inc Susan G. Klacik, CCSMC, FCS, ACE, International Association of Healthcare Central Service

Materiel Management Byron J. Lambert, PhD, Abbott Laboratories Michelle Luebke, Baxter Healthcare Corporation Patrick J. McCormick, PhD, Bausch & Lomb Inc.

Gerry McDonnell, PhD, Johnson & Johnson Gerry O'Dell, Gerry O'Dell Consulting Adrian Ponce, Verrix LLC Janet Prust, 3M Healthcare Nancy Rakiewicz, IUVO BioScience Michael H. Scholla, MS, PhD, Dupont Protection Technologies Joan Spear, B Braun of America Inc Sid Wiggs (Independent Expert) Martell Kress Winters, SM, Nelson Laboratories LLC Stephen Yeadon, Boston Scientific Corporation William E. Young, Sterigenics International Roberto Zumbado, Philips

Alternates: Stacy Bohl, Boston Scientific Corporation Jonathan Bull, Johnson & Johnson Greg Crego, IUVO BioScience Niki Fidopiastis, Sterigenics International Jeffrey Marx, STERIS Corporation Kimberly Patton, Becton Dickinson & Company Christine Render, Cosmed Group Inc Michael Sadowski, Baxter Healthcare Corporation Sharon Van Wicklin, Association of periOperative Registered Nurses

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.

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Foreword

This recommended practice was developed by the Steam Sterilization Hospital Practices Working Group of the AAMI Sterilization Standards Committee. The purpose of the guidelines in this document is to help ensure the steam sterilization of products in health care facilities and the maintenance of the sterility of processed items until the point of use.

To facilitate user access to all AAMI consensus recommendations for steam sterilization in health care facilities, the first edition of ANSI/AAMI ST79, published in 2006, consolidated into one comprehensive guide the following AAMI recommended practices:

• ANSI/AAMI ST46, Steam sterilization and sterility assurance in health care facilities

• ANSI/AAMI ST42, Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities

• ANSI/AAMI ST37, Flash sterilization: Steam sterilization of patient care items for immediate use

• ANSI/AAMI ST35, Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical settings

• ANSI/AAMI ST33, Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities

In the course of the consolidation process, the five recommended practices listed above were updated and revised to reflect current good practice, and several annexes were added to provide additional information to users. The recommended practice serves as a comprehensive guideline for all steam sterilization activities in health care facilities, regardless of the size of the sterilizer or the size of the facility, and provides a resource for all health care personnel who use steam for sterilization.

From 2010 to 2013, numerous amendments of the document were adopted. This third edition of ANSI/AAMI ST79 incorporates these amendments, as well as additional changes such as guidance pertaining to heating, ventilation, and air conditioning (HVAC) and a new Annex on keeping cool in the sterile processing environment. In addition, the document reflects general editorial revisions (e.g., updating of references) and reorganization of content.

This recommended practice reflects the conscientious efforts of health care professionals, in cooperation with medical device and equipment manufacturers, to develop recommendations for optimum performance levels in the processing of reusable medical devices to be steam sterilized. It is not intended that these recommendations be construed as universally applicable in all circumstances. Also, it is recognized that in many cases these recommendations might not be immediately achievable. Therefore, the document should be used to guide personnel towards desirable performance objectives, and all of its provisions should be considered and applied in the light of professional judgment and experience.

As used within the context of this document, “shall” indicates requirements strictly to be followed to conform to the recommended practice. “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 recommended practice. “Can” is used as a statement of possibility and capability. Finally, “must” is used only to describe “unavoidable” situations, including those mandated by government regulation.

The provisions of this recommended practice should be reviewed routinely by departmental managers and adapted to the needs of their particular institutions. Written policies and procedures should be developed and implemented in consultation with appropriate hospital committees (e.g., safety, infection prevention and control, and hazardous materials).

The concepts incorporated in this recommended practice should be considered flexible and dynamic. The recommendations set forth in this document are reviewed and updated periodically to assimilate progressive technological developments. AAMI policies and procedures require that AAMI standards and recommended practices be reviewed and, if necessary, revised at least once every five years.

AAMI has created a notification registry that will send e-mail announcements when new ST79 publication formats are available. To register, visit http://www.aami.org/ST79Notify. Suggestions for improving this recommended practice are invited. Comments or proposals for revisions to any part of the standard may be submitted to AAMI at any time.

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Written comments are to be sent to: Standards Dept., AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203- 1633. Comments may also be e-mailed to: standards@aami.org.

NOTE—This foreword does not contain provisions of the American National Standard, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2017), but it does provide important information about the development and intended use of the document.

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American National Standard ANSI/AAMI ST79:2017

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Introduction: Need for the recommended practice Saturated steam under pressure is one of the oldest and safest methods used in health care facilities to sterilize medical devices. Because this method has been available for so many years, it is thought to be a simple process, one that is well understood and controlled. However, the efficacy of any sterilization process, including saturated steam, depends on a consistent system for lowering and limiting bioburden before sterilization, preparing items for sterilization, selecting the sterilization parameters, and establishing and implementing controls to maintain the sterility of sterilized items until they are used. These four phases are critically interdependent, and each should be accomplished to produce and maintain a sterile product.

The delivery of sterile health care products for use in patient care depends not only on the efficacy of the sterilization process itself but also on

a) efficient facility design,

b) equipment, personnel and other resources,

c) education and training of personnel,

d) infection prevention and control practices designed to prevent health-care-associated infections,

e) effective quality control and process improvement systems that encompass all aspects of device reprocessing from point of use through sterilization to reuse, and

f) documentation and reporting practices that enable traceability of each facility-sterilized medical device to the patient on whom it was used.

Health care facilities differ in their physical design and equipment and in the level of personnel expertise, competence, and training. This recommended practice has been developed to set forth guidelines for facility design, work practices, and process controls that will help ensure that sterile items are consistently produced using saturated steam under pressure.

This recommended practice addresses elements of a quality management system, but it is not intended to provide comprehensive guidance on this subject.

Many of the activities that affect sterilization processing occur in areas separate from the location where sterilization is actually carried out. Therefore, the policies and procedures governing sterilization processing should be developed in consultation with the managers of areas that use sterile medical devices and with appropriate committees or functional groups within the facility (e.g., infection prevention and control, safety, hazardous materials, risk management). In addition, the support of the facility’s administration is vital, especially in those facilities where the establishment of a quality system to implement steam sterilization process validation and parametric release is being considered (ANSI/AAMI/ISO TIR17665-2).

It might not be possible for a health care facility to implement all the provisions of this recommended practice because of environmental restrictions and/or limitations in capital funding. However, it is recommended that the health care facility’s administration be made aware of any current deficiencies so that the allocation of needed resources can be planned.

This comprehensive guide encompasses cleaning, transport, quality monitoring, storage, product evaluation, equipment maintenance, personnel considerations, and steam sterilization in all health care facilities, including, but not limited to, hospitals, ambulatory surgery facilities, physicians' offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, dental offices, and other areas where sterile products are reprocessed, stored, and used.

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Steam sterilization in office-based, ambulatory-care medical, surgical, and dental facilities

Advances in medical, surgical, and dental practice have led to the increased use of alternative health care sites, such as offices, ambulatory-care clinics, and similar clinical settings; many such facilities use table-top steam sterilizers (less than or equal to 2 cubic feet). Office-based practices can differ greatly from hospitals in their physical design and in the education and training of personnel. The general concepts in this comprehensive guide apply to these settings. In some sections, processes or equipment used most frequently within the office-based and ambulatory setting are specifically addressed.

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1 Scope

1.1 General

This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process improvement and new product evaluation.

1.2 Inclusions

This recommended practice specifically addresses

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

b) staff qualifications, education, and other personnel considerations;

c) processing recommendations;

d) installation, care, and maintenance of steam sterilizers;

e) quality control;

f) product evaluation; and

g) quality process improvement.

Definitions of terms, a bibliography, and informative annexes also are provided.

1.3 Exclusions

This recommended practice does not cover

a) specific construction and performance criteria for steam sterilizers (see ANSI/AAMI ST8 and ANSI/AAMI ST55), rigid sterilization container systems (see ANSI/AAMI ST77), or rigid, protective organizing cases that require wrapping before sterilization (see ANSI/AAMI ST77);

b) the use of containment devices for packaging items other than instrument sets or procedural trays;

c) procedures and techniques for handling and laundering contaminated reusable surgical textiles (see ANSI/AAMI ST65), reusable laboratory items, food service items, and items assigned to a patient for the length of stay (e.g., bedpans, thermometers);

d) decontamination of hemodialysis machines, hemodialyzers, and hemodialyzer blood tubing (see ANSI/AAMI/IEC 60601-2-16, ANSI/AAMI RD47, and ANSI/AAMI/ISO 8638, respectively);

e) the use of dry heat for decontamination purposes or for terminal sterilization of reusable medical devices (see ANSI/AAMI ST40);

f) the use of ethylene oxide sterilization in health care facilities for other than decontamination purposes (see

ANSI/AAMI ST41);

g) the use of chemical sterilization and high-level disinfection in health care facilities for other than decontamination purposes (see ANSI/AAMI ST58);

h) the reprocessing of devices labeled for single use only (see Food and Drug Administration [FDA], 2000c);

and

i) aseptic presentation.

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.

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2 Definitions and abbreviations For the purposes of this recommended practice, the following definitions apply.

2.1 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.

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

2.3 biological indicator (BI): Biological sterilization process indicator 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—See ANSI/AAMI/ISO 14161 for information on the selection, use, and interpretation of biological indicators.

2.4 biological indicator control, positive: Biological indicator, from the same lot as a test biological indicator, which is left unexposed to the sterilization cycle and then incubated to verify the viability of the test BI.

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: 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 rigid sterilization container system (or sterilization pouch suitable for a specified sterilization method[s]).

2.7 catalase: Enzyme found in almost all cells except for certain anaerobic bacteria.

2.8 CDC: Centers for Disease Control and Prevention.

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

2.10 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 used in specific tests of sterilization equipment.

ANSI/AAMI/ISO 11140-1:2014, Sterilization of health care products—Chemical indicators—Part 1: General requirements, defines six types of CIs and specifies performance requirements for them:

Type 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.

Type 2 (Bowie-Dick test indicators): 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).

Type 3 (single critical process 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.

Type 4 (multicritical process 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.

Type 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 ANSI/AAMI/ISO 11138 series for BIs.

Type 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. ANSI/AAMI/ISO 11140-1 refers to these indicators as cycle verification indicators.

NOTE 1—FDA recognition of chemical indicators is limited to Type 1 process indicators; Type 2 indicators for use with special tests; and Type 6 emulating indicators (ANSI/ AAMI/ISO 11140-1:2014).

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NOTE 2—The International Standards Organization published a revised version of ISO 11140-1, Sterilization of health care products—Chemical indicators—Part 1: General requirements, in 2014. The ISO document was adopted by the Association for the Advancement of Medical Instrumentation (AAMI) and subsequently approved as an American National Standard, ANSI/AAMI/ISO 11140-1:2014. A key change in the 2014 version of the standard is the use of the term “type” rather than the term “class” of chemical indicator. As chemical indicator manufacturers update their device labeling to reflect the new standard, there will be a transition period during which end-users will observe some chemical indicators labeled as “Class X” and others labeled with the new term “Type X” in the marketplace.

2.11 clean work room: Area of a health care facility where devices are inspected, assembled, and prepared for disinfection and/or sterilization.

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

2.13 come-up time: Time required for the parameters necessary for the selected sterilization cycle to be reached.

2.14 containment device: Instrument case, cassette, or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization.

2.15 contaminated: Presence of potentially infectious, pathogenic organisms (e.g., found in blood or other potentially infectious material) in or on an object.

2.16 critical water: Water that is extensively treated (usually by a multistep treatment process that could include a carbon bed, softening, deionization [DI], and reverse osmosis [RO] or distillation) to ensure that the microorganisms and the inorganic and organic material are removed from the water; a final submicron filtration could also be part of the treatment process. This water is mainly used for the final rinse or for steam generation.

NOTE—See AAMI TIR34 for specifications.

2.17 culture: Growth of microorganisms in or on a nutrient medium that supports their multiplication; to grow microorganisms in or on such a medium.

2.18 culture medium: Substance or preparation used to grow and cultivate microorganisms.

2.19 cycle, steam sterilization, dynamic-air-removal type: One of two types of sterilization cycles in which air is removed from the chamber and the load by means of a series of pressure and vacuum excursions (prevacuum cycle) or by means of a series of steam flushes and pressure pulses above atmospheric pressure (steam-flush pressure-pulse [SFPP] cycle).

2.20 cycle time: Total elapsed time of a sterilization cycle from the time the process is initiated until the cycle is completed. Cycle time can include come-up time, exposure time, come-down time, cooling or drying time, and, in prevacuum sterilizers, pre- and post-vacuum time.

2.21 D value: Time or dose required to achieve inactivation of 90% of a population of the test microorganism under stated conditions. The larger the D value, the more resistant the microorganism is to destruction. The value can be derived by plotting the logarithm of the number of microbial survivors against sterilization exposure time; the time corresponding to a 1-logarithm reduction in numbers can then be directly measured.

2.22 decasing/breakout area or space: Unpacking area or space where products are removed from their external shipping containers before being taken into the preparation and packaging area or the sterile storage area.

2.23 decontamination: Process of cleaning and disinfecting soiled medical devices to render then safe for handling and to the extent necessary for subsequent processing.

2.24 decontamination room: Room designated for collection, retention, and cleaning of soiled and/or contaminated items.

2.25 density: Mass per unit of volume.

2.26 disinfection: Process that kills pathogenic and other microorganisms by physical or chemical means.

NOTE—Disinfection destroys most recognized pathogenic microorganisms but not necessarily all microbial forms, such as bacterial spores. Disinfection processes do not ensure the margin of safety associated with sterilization processes.

2.27 distilled water: Water that has been heated to the boiling point, vaporized to remove nonvolatile impurities, cooled, condensed into a liquid condensate, and collected so that no impurities are reintroduced.

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2.28 drying time: Time required to dry steam-sterilized items before they are handled.

NOTE—As used in relation to gravity-displacement table-top sterilizers (sterilizers with a chamber volume of less than or equal to 2 cubic feet) and sterilizers without an active drying cycle, drying time refers to the time that the sterilizer door is left open to complete the drying of sterilized items.

2.29 dust cover: Protective plastic bag used to protect sterile items from environmental contamination such as moisture, dust, and lint; also known as a sterility maintenance cover.

2.30 engineering controls: Safety-engineered devices designed to prevent or reduce the incidence of worker injury and blood-borne pathogen exposure.

2.31 entrainment: Process by which steam can carry residual chamber air or water droplets from the jacket or supply lines into packs or the process by which changes in air pressure can carry environmental contaminants into a package.

2.32 EPA: U.S. Environmental Protection Agency.

2.33 event-related sterility maintenance: Sterility maintenance that is not based on expiration dating but rather on factors such as the quality of the packaging material, the storage conditions, the methods and conditions of transport, and the amount and conditions of handling.

2.34 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.

2.35 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.

2.36 exposure control plan: According to OSHA, “a written [plan]…