AAMI Protective barriers Guidance...

Advancing Safety in Health Technology

Protective Barriers

Guidance Collection

Includes:AAMI TIR11:2005/(R)2015Selection and use of protective apparel and surgical drapes in health care facilities

ANSI/AAMI PB70:2012Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

ANSI/AAMI ST65:2008/(R)2018Processing of reusable surgical textiles for use in health care facilities

PREVIEW COPYThis is a preview edition of an AAMI guidance document and is intended to allow potential purchasers to evaluate the content

of the document before making a purchasing decision.

For a complete copy of this AAMI document, contact AAMI at +1-877-249-8226 or visit www.aami.org.

Selection and use of protective apparel and surgical drapes in

health care facilities

AAMI TIR11:2005

Technical Information Report




AAMI Technical Information Report AAMI TIR11:2005

Selection and use of protective apparel and surgical drapes in health care facilities

Approved 17 October 2005 Association for the Advancement of Medical Instrumentation

Abstract: This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.

Keywords: barrier properties, drapes, isolation gowns, protective apparel, surgical attire

(Revision of AAMI TIR11:1994)




AAMI Technical Information Report

A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology.

Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it.

A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents.

Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute.

A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board.

Another difference is that although both standards and TIRs are periodically reviewed, a standard must be acted on—reaffirmed, revised, or withdrawn—and the action formally approved usually every 5 years but at least every 10 years. For a TIR, AAMI consults with a technical committee about 5 years after the publication date (and periodically thereafter) for guidance on whether the document is still useful—that is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation.

A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues.

CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field of technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document.

All 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.

Comments on this technical information report are invited and should be sent to AAMI, Technical Programs, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795.

Published by

Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795

© 2005 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 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America

ISBN 1–57020–241–9




Contents

Committee representation ........................................................................................................................................vii

Acknowledgments ...................................................................................................................................................viii

Foreword ...................................................................................................................................................................ix

1 Introduction and scope.......................................................................................................................................1

2 Definitions of terms ............................................................................................................................................1

3 Types of surgical protective materials ................................................................................................................3

3.1 Introduction .................................................................................................................................................3 3.2 Multiple-use materials .................................................................................................................................3 3.2.1 General considerations .....................................................................................................................3 3.2.2 Historical materials ...........................................................................................................................4 3.2.3 Current materials ..............................................................................................................................4 3.3 Single-use materials ...................................................................................................................................4 3.4 Reinforcement of multiple-use and single-use products..............................................................................5

4 Safety and performance characteristics .............................................................................................................5

4.1 Introduction .................................................................................................................................................5 4.2 Barrier effectiveness ...................................................................................................................................5 4.2.1 Resistance to liquid and microbial penetration..................................................................................5 4.2.2 Resistance to penetration by airborne, aerosol-borne, or dry particles .............................................9 4.3 Abrasion resistance ....................................................................................................................................9 4.4 Strength ......................................................................................................................................................9 4.4.1 General considerations .....................................................................................................................9 4.4.2 Breaking strength..............................................................................................................................10 4.4.3 Tear strength ....................................................................................................................................10 4.4.4 Puncture and tear resistance ............................................................................................................10 4.5 Drapeability .................................................................................................................................................10 4.6 Comfort .......................................................................................................................................................11 4.7 Staining, discoloration, and residues .........................................................................................................12 4.8 Electrostatic properties ...............................................................................................................................12 4.9 Flammability................................................................................................................................................12 4.10 Generation of particulates and visible lint...................................................................................................13 4.11 Shrinkage...................................................................................................................................................13 4.12 Biocompatibility ..........................................................................................................................................13 4.13 Sterility assurance......................................................................................................................................13 4.14 Performance in use....................................................................................................................................14 4.15 Strike-through investigation .......................................................................................................................14

5 Product evaluation and selection of protective apparel and surgical drapes ......................................................15

5.1 Introduction .................................................................................................................................................15 5.2 Information from manufacturers and suppliers............................................................................................15 5.3 Product evaluation ......................................................................................................................................16 5.4 Cost comparisons .......................................................................................................................................16 5.5 Staff input....................................................................................................................................................16 5.6 Performance priorities in relation to product function ..................................................................................16 5.7 Periodic reassessment................................................................................................................................17

6 Guidelines for choosing levels of barrier performance needed for particular health care applications ...............19

6.1 Introduction .................................................................................................................................................19 6.2 Exposure control plan .................................................................................................................................19 6.3 Classification and labeling of barrier performance by manufacturers..........................................................19 6.4 Examples of possible barrier performance levels for particular applications ...............................................19 6.5 Special considerations for isolation gowns..................................................................................................22

Glossary of equivalent standards..............................................................................................................................v




7 Care and handling of protective apparel and surgical drapes ............................................................................22

7.1 Introduction .................................................................................................................................................22 7.2 General considerations ...............................................................................................................................23 7.3 Handling of contaminated protective apparel and surgical drapes at the point of use.................................23 7.4 Disposal of single-use products ..................................................................................................................23 7.5 Processing of multiple-use products ...........................................................................................................23 7.5.1 Quality assurance program...............................................................................................................23 7.5.2 Tracking the number of uses.............................................................................................................23 7.5.3 Laundering ........................................................................................................................................24 7.5.4 Inspection, testing, folding, and assembly.........................................................................................24

Annexes

A Historical background.........................................................................................................................................25

B Test methods .....................................................................................................................................................29

C Bibliography .......................................................................................................................................................31

Tables

1 Example of a product evaluation table ...............................................................................................................18 2 Classification of barrier performance of surgical gowns, other protective apparel, surgical drapes, and

drape accessories..............................................................................................................................................20 3 General relationships between barrier performance and anticipated exposure risks .........................................21 4 General relationships between the barrier performance of isolation gowns, mode of disease transmission, and anticipated exposure risks.....................................................................................................22 B.1 Summary table of standard test methods that may be used to evaluate safety and performance

characteristics ....................................................................................................................................................29 Figures 1 Bloodborne pathogen size comparison (1.0 µM reference sphere)....................................................................7 2 Bloodborne pathogen strike-through conversion chart .......................................................................................8




Committee representation

Association for the Advancement of Medical Instrumentation

AAMI Protective Barriers Committee

This technical information report was developed by the AAMI Protective Barriers Committee. Approval of the TIR does not necessarily mean that all committee members voted for its approval.

At the time this document was published, the AAMI Protective Barriers Committee had the following members:

Chair: Frances Ann Koch, RN Members: Donna-Rae Barnett, Kaiser Permanente, Falls Church, VA Michael Belkin, MD, FACS, Brigham and Women’s Hospital Mark H. Berman, MS, BBA Fiberweb Peter L. Brown, W.L. Gore & Associates Inc. Bradley J. Bushman, Standard Textile Co. Inc. Cosmo R. Camelio, Association of the Nonwoven Fabrics Industry Ramona Conner, RN, MSN, CNOR, Association of periOperative Registered Nurses

Jacqueline Daley, Association for Professionals in Infection Control and Epidemiology Nanlin Deng, DuPont Nonwovens

Nadia S. El-Ayouby, National Institute of Occupational Safety and Health Simon S. Fung, PhD, 3M Health Care John Hamilton, SRI/Surgical Express Jeffrey Hills, RM, Nelson Laboratories Inc. Susan Hubbard, RN, Duke University Medical Center David W. Johnson, Kimberly-Clark Corporation Frances Ann Koch, RN, Presbyterian Hospital of Dallas Barbara Lawless, Precision Fabrics Group Philip C. Mann, Kappler Safety Group Marian G. McCord, PhD, North Carolina State University College of Textiles Martha T. O’Lone, U.S. Food and Drug Administration Joseph A. Palomo, Cardinal Health Carolyn Pritchyk, Kaiser Permanente Carl Richard, ASQ, CQE, Ahlstrom Windsor Locks LLC Barbara Rusynko, RN, MSEd, CNOR, Inova Fairfax Hospital, Falls Church, VA Laura N. Simmons, Simcon International Linda Slone, RN, CNOR, Sibley Memorial Hospital, Washington, DC Donna Swenson, CSPDM, Sterile Recovery Division, Hospital Laundry Services Lisette Swenson, Molnlycke Health Care Nathaniel Terry, Burlington Industries Inc. William N. Thompson, TYCO Healthcare/Kendall Alternates: Andrew Giles, DuPont Nonwovens Michael Groesbeck, Cardinal Health Laura Kappler-Roberts, Kappler Safety Group Michael Mathis, Kimberly-Clark Corporation Scott S. Sardeson, 3M Health Care Michael Smith, RM, Nelson Laboratories Inc.

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

© 2006 Association for the Advancement of Medical Instrumentation ■ AAMI TIR11:2005 vii




Acknowledgments

The AAMI Protective Barriers Committee wishes to gratefully acknowledge the extensive contributions of Jay R. Sommers, PhD, who served on the committee for many years as the representative of Kimberly-Clark Corporation.

viii © 2006 Association for the Advancement of Medical Instrumentation ■ AAMI TIR11:2005




Foreword

This technical information report (TIR) was developed by the AAMI Protective Barriers Committee. The TIR is intended to provide technical information that will assist health care personnel in the selection and use of surgical gowns, other protective apparel, and surgical drapes. It covers subjects such as types of materials used in the construction of protective apparel and drapes, safety and performance characteristics of protective materials, selection and evaluation of protective apparel and drape products, guidelines for choosing the level of barrier performance needed for anticipated exposure risks, care of protective apparel and drapes, proper disposition of used protective apparel and drapes, and pertinent references.

The first edition of this TIR was published in 1994 and was titled Selection of surgical gowns and drapes in health care facilities. This second edition incorporates changes to take into account the publication of ANSI/AAMI PB70, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, and ANSI/AAMI ST65, Processing of reusable surgical textiles for use in health care facilities. Also, the scope of this edition has been expanded to include other types of protective apparel in addition to surgical gowns, such as isolation gowns and decontamination garments, and to cover use considerations, such as the relationship between barrier performance levels and particular health care applications. In addition, an attempt has been made to reflect new trends in health care, changes in practices, and the state of the art in materials used for both single-use and multiple-use protective apparel and drapes.

The safety and performance of a surgical gown, other item of protective apparel, or surgical drape depend not only on the materials from which it is fabricated but also on product design. There is considerable variation in design among commercially available protective apparel and drapes. The particular gown or drape design chosen should be commensurate with the product’s level of barrier performance, the intended application, and the manner in which the product will be integrated with other protective products (e.g., surgical masks and face shields) into a complete protective system. This TIR addresses the characteristics of protective materials in some detail, touches on the importance of design, and discusses various performance issues applicable to protective apparel and drapes, including test methods for barrier properties and other important attributes. It is recommended that health care personnel screen products on the basis of material and product test data (see Section 4) and then evaluate the performance of selected products through a formal process (see Section 5). Health care personnel should also use the information in Section 6, “Guidelines for choosing levels of barrier performance needed for particular health care applications,” in the decision-making process. A new table, “General relationships between barrier performance and anticipated exposure risks” (Table 3), can assist clinicians in choosing drapes and protective apparel that are labeled in accordance with ANSI/AAMI PB70 and that are appropriate for the health care procedure and for the level of protection required for both patient and staff. The examples cited in the table are only general suggestions and should not be interpreted as absolutes or policy statements. Clinical end-users of surgical gowns, other protective apparel, and drapes must always comply with federal, state, and local regulations. They also should take into account the relevant health care literature, as well as current recommended practices, guidelines, and statements promulgated by professional associations and other relevant organizations, such as the Centers for Disease Control and Prevention. The bibliography of this TIR provides many of these pertinent documents. During the development of the TIR, the committee’s goal was to produce a reference that would enhance excellence in patient care practices involving protective apparel and drapes. This TIR is thus intended for clinical professionals as well as for managers and purchasing agents who influence the selection and proper use of protective apparel and drapes. Like any other AAMI technical information report, this TIR is not a performance standard. It is not intended to establish minimum safety and performance criteria, and none of its provisions should be so interpreted. This TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving technology and because it does not treat all issues associated with protective apparel and drapes in depth, readers are encouraged to consider information from other sources and, in particular, to keep abreast of the relevant health care literature. Suggestions for improving this TIR are invited. Comments and suggested revisions should be sent to AAMI, Technical Programs, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795.

© 2006 Association for the Advancement of Medical Instrumentation ■ AAMI TIR11:2005 ix




AAMI Technical Information Report AAMI TIR11:2005

Selection and use of protective apparel and surgical drapes in health care facilities 1 Introduction and scope

Traditionally, surgical gowns, other protective apparel, and surgical drapes have been intended to help prevent wound infections by providing a barrier between nonsterile and sterile areas. However, given the increasing concerns related to bloodborne pathogens such as the human immunodeficiency virus (HIV) and the increasing number of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections among health care personnel, the protection of the surgical team and other health care personnel has become an important issue.

Protective apparel and surgical drapes are fabricated from either multiple-use materials or single-use materials. Each of these two basic types of products has advantages and disadvantages. Within the material types available, design and performance characteristics vary considerably. This variation stems from trade-offs in economy, comfort, and the degree of protection required for particular surgical and other health care procedures. Consequently, health care personnel are faced with a complex decision-making process when choosing the types or performance levels of products that will best serve their needs.

This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices.

This TIR is also meant to serve as a resource that health care professionals can use when directing questions to manufacturers about the performance characteristics of specific products and when choosing products for use in particular surgical and other invasive or patient care procedures.

The scope of this TIR includes

a) types of protective materials,

b) safety and performance characteristics,

c) product evaluation and selection,

d) guidelines for choosing the level of barrier performance, and

e) care of protective apparel and surgical drapes.

Definitions of terms and informative annexes are also provided.

This TIR might not cover all the requirements that a health care facility could deem necessary to select a product, nor does it address criteria for evaluating experimental products.

2 Definitions of terms

2.1 barrier properties: Ability of a protective product to resist the penetration of liquids and liquidborne microorganisms.

2.2 binding: Material used to cover a raw edge (e.g., at the neck area) in lieu of hemming.

2.3 blood: Human blood, human blood components, and products made from human blood.

1 For new or changed products introduced to the market after May 28, 1976, manufacturers are required to submit a premarket notification to FDA. Products found to be substantially equivalent to existing products are “cleared” by FDA for marketing. This clearance for marketing does not constitute FDA approval of the product’s safety and effectiveness.

© 2006 Association for the Advancement of Medical Instrumentation ■ AAMI TIR11:2005 1




Association for the Advancementof Medical Instrumentation

ANSI/AAMI PB70:2003/(R)2009

Liquid barrier performanceand classification of

protective apparel and drapesintended for use in

health care facilities




The Objectives and Uses of AAMI Standards andRecommended Practices

It is most important that the objectives and potential uses of an AAMIproduct standard or recommended practice are clearly understood.The objectives of AAMI's technical development program derivefrom AAMI's overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application of current technologiesto patient care, and (2) the encouragement of new technologies. It isAAMI's view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that arbitrary and restrictive uses are avoided.

A voluntary standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measurementtechniques that can be used to determine whether the device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance characteristics, instructions for use, warningsand precautions, and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to facilitateuniformity in reporting; reaching consensus on these tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for establishing the criteria must bedocumented in the rationale.

A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a device is usedsafely and effectively and that its performance will be maintained.

Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial personnel onsuch subjects as sterilization processing, methods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.

In determining whether an AAMI standard or recommendedpractice is relevant to the specific needs of a potential user of thedocument, several important concepts must be recognized:

All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities). The application of a standard or recom-mended practice is solely within the discretion and professionaljudgment of the user of the document.

Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose work has been reviewed nationally(and sometimes internationally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the sense that it responds generally to perceived risks andconditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecisionmaking.

Despite periodic review and revision (at least once every fiveyears), a standard or recommended practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This review will reveal whether the document remainsrelevant to the specific needs of the user.

Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with existing equipment typically form the basis for thesafety and performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as "unsafe". A voluntary standard can be used asone resource, but the ultimate decision as to product safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individual institution or firm. Again, the rationaleaccompanying each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.

In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informationand policy guidance and in the context of professional experience andjudgment.

INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICES

Requests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpretation must be approved by letterballot of the originating committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation in the "Standards Monitor" section of the AAMI News. TheAssociation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and which is notpublished, by appropriate notice, as an official interpretation in theAAMI News.




American National Standard ANSI/AAMI PB70:2003/(R)2009

Liquid barrier performance and classification of protective apparel and drapes

intended for use in health care facilities

Developed by Association for the Advancement of Medical Instrumentation

Approved 23 October 2003 and reaffirmed 21 October 2009 by American National Standards Institute, Inc.

Abstract: This standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. By specifying a consistent basis for testing and labeling protective apparel and drapes and providing a common understanding of barrier properties (e.g., efficacy against liquid or liquidborne microorganism penetration) based on this new classification system, the standard is intended to ultimately assist end-users in determining the types of protective product most appropriate for a particular task or situation.

Keywords: surgical gowns, surgical drapes, protective apparel, decontamination gowns,other potentially infectious materials (OPIM)




AAMI Standard

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

CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards and recommended practices 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 Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 © 2003 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, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-208-7




Contents

Page

Glossary of equivalent standards .....................................................................................................................v

Committee representation .............................................................................................................................. vii Acknowledgments ......................................................................................................................................... viii Foreword ......................................................................................................................................................... ix 1 Scope........................................................................................................................................................1

1.1 General ..........................................................................................................................................1 1.2 Inclusions .......................................................................................................................................1 1.3 Exclusions ......................................................................................................................................1

2 Normative references................................................................................................................................2 3 Definitions .................................................................................................................................................2 4 Requirements............................................................................................................................................4

4.1 Labeling requirements....................................................................................................................4 4.1.1 Device labeling.................................................................................................................4 4.1.2 Package labeling..............................................................................................................4 4.1.3 Technical information.......................................................................................................4 4.1.4 Education.........................................................................................................................5

4.2 Performance requirements.............................................................................................................5 4.2.1 Barrier performance .........................................................................................................5 4.2.2 Tracking mechanism for multiple-use products................................................................6 4.2.3 Construction.....................................................................................................................6

5 Tests .........................................................................................................................................................7 5.1 Tests for the labeling requirements ................................................................................................7 5.2 Tests for the performance requirements ........................................................................................7

5.2.1 Barrier performance .........................................................................................................7 5.2.2 Tracking mechanism for multiple-use products................................................................8 5.2.3 Construction.....................................................................................................................8

Annexes

A Rationale for the development and provisions of this standard .................................................................9 B Examples of barrier performance classification of surgical gowns, other protective apparel,

and surgical drapes.................................................................................................................................13 C Examples of sampling plans ...................................................................................................................18 D Bibliography ............................................................................................................................................19

Tables

1 Classification of barrier performance of surgical gowns, other protective apparel, surgical drapes, and drape accessories....................................................................................................6

B.1 Barrier performance classification of surgical gowns ..............................................................................14 B.2 Barrier performance classification of isolation gowns..............................................................................16 B.3 Barrier performance classification of surgical drapes..............................................................................17 C.1 Sampling plans for sample size code letter G, acceptable quality level (normal inspection) 4.0 .............18




Figures

B.1 Example of a gown intended for surgical applications.............................................................................13 B.2 Example of a gown intended for isolation applications ............................................................................15 B.3 Example of a surgical drape....................................................................................................................17




© 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI PB70:2003 vii


Association for the Advancement of Medical Instrumentation

Protective Barriers Committee

This standard was developed by the AAMI Protective Barriers Committee. Committee approval of this standard does not necessarily mean that all committee members voted for its approval.

At the time this document was published, the AAMI Protective Barriers Committee had the following members:

Chair: Frances Ann Koch, RN Members: Donna-Rae Barnett, Kaiser Permanente

Mark H. Berman, MS, BBA Nonwovens Stacey Bolen-Wolverton, Medline Industries Dorris Brown, Maxxim Medical Inc. Peter L. Brown, W.L. Gore & Associates Inc. Bradley J. Bushman, Standard Textile Co. Inc. Cosmo R. Camelio, Association of the Nonwovens Fabrics Industry William Carroll, American Reusable Textile Association Maryanne K. Coughlin, Inova Health System Nanlin Deng, DuPont Nonwovens Nadia S. El-Ayouby, National Institute of Occupational Safety and Health Loretta L. Fauerbach, MS, CIC, Association for Professionals in Infection Control and Epidemiology Dorothy M. Fogg, RN, MA, Association of periOperative Registered Nurses Simon S. Fung, PhD, 3M Health Care Barbara J. Goodman, RN, CNOR, Rising Sun, MD Carolyn T. Green, Precision Fabrics Group Barbara J. Gruendemann, RN, G4 Productions John Hamilton, SRI/Surgical Express Carol T. Herman, U.S. Food and Drug Administration Jeffrey Hills, RM, Nelson Laboratories Inc. Susan Hubbard, RN, Duke University Medical Center Robert Hyslop, Polymer Group Inc./PGI Nonwovens Gregory K. Jones, PhD, Clopay Plastic Products Company Laura Kappler-Roberts, Kappler Safety Group Lauretta Kinier, RN, Inova Mount Vernon Hospital Frances Ann Koch, RN, Presbyterian Hospital of Dallas Marian G. McCord, PhD, North Carolina State University College of Textiles Elizabeth McCullough, PhD, Kansas State University Kenneth K. Meyer, MD, FACS, American College of Surgeons Mary J. Ogg, RN, CNOR, Burke, VA Joseph A. Palomo, Cardinal Health Carolyn Pritchyk, Kaiser Permanente Carl Richard, ASQ, CQE, Ahlstrom Windsor Locks LLC Barbara Rusynko, RN, MSEd, CNOR, Inova Fairfax Hospital Robert J. Sharbaugh, PhD, CIC, Hill-Rom Company Linda Slone, RN, CNOR, Sibley Memorial Hospital Jay R. Sommers, PhD, Kimberly-Clark Corporation Donna Swenson, CSPDM, Sterile Recovery Division, Hospital Laundry Services Nathaniel Terry, Burlington Industries Inc. William N. Thompson, TYCO Healthcare/Kendall

Alternates: Andrew Giles, DuPont Nonwovens Michael Groesbeck, Cardinal Health Boyd Harris, Maxxim Medical Inc. Scott Hinkle, Kappler Safety Group John D. Langley, Kappler Safety Group Felicidad A. Marshall, RN, MSN, U.S. Food and Drug Administration Scott S. Sardeson, 3M Health Care

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




viii © 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI PB70:2003

Acknowledgments

The committee gratefully acknowledges Peter L. Brown (W.L. Gore & Associates Inc.), who served as co-chairman of the committee from 1998 to 2002 and whose enormous contributions of time, effort, and technical expertise to this standards-development project were essential to its ultimate success. His dedication and commitment are very much appreciated.

The committee also gratefully acknowledges Michael H. Scholla (DuPont Nonwovens), who served as an AAMI committee representative and whose contributions to this standards-development project were invaluable.

Finally, the AAMI Protective Barriers Committee dedicates this standard to the late Dr. William Beck, the original chair of the AAMI Aseptic Barrier Committee, for his decades-long commitment to defining and providing aseptic barriers for patients and the health care team, his vital research, and his tireless and important communications on aseptic barrier issues through publications and public speaking.




© 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI PB70:2003 ix

Foreword

This standard was developed by the AAMI Protective Barriers Committee and establishes a classification system and the associated minimum requirements for the liquid barrier performance of protective apparel and drapes based on industry-accepted test methods. It is intended to assist manufacturers in testing and labeling their devices so that health care personnel can make more informed decisions when selecting the appropriate product for the anticipated task at hand.

Protective apparel is intended to be worn by health care workers to help preserve the integrity of the sterile field and inhibit the transfer of blood, body fluids, other potentially infectious materials (OPIM), and associated microorganisms. Drapes and drape accessories are also intended to inhibit the transfer of microorganisms, body fluids, and OPIM. Drapes and drape accessories are used as protective patient coverings to isolate a site of surgical incision from microbial and other cross-contamination.

In the United States, surgical apparel, surgical drapes, and drape accessories are medical devices and, under the Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of May 28, 1976, are subject to regulation by the U.S. Food and Drug Administration (FDA), including but not limited to FDA requirements for premarket notification (section 510(k) of the Act) and medical device reporting. Barrier efficacy has long been recognized as important in helping to prevent infections and is now mandated by Occupational Safety and Health Administration (OSHA) regulations limiting occupational exposure to bloodborne pathogens (29 CFR 1910.1030). See also the Centers for Disease Control and Prevention’s (CDC’s) Guideline for the prevention of surgical site infection (CDC, 1999; Mangram, et al., 1999).

Surgical gowns, other protective apparel, surgical drapes, and drape accessories are devices intended to promote infection control practices and help protect patients and health care workers. This standard is based on key barrier performance tests that are used to classify the subject products into levels of performance. Knowledge of these defined levels of performance will allow informed and consistent choices about the type of protective product necessary for the situation at hand.

As used within the context of this document, “shall” indicates requirements strictly to be followed in order 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; 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.

The concepts incorporated in this standard 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 5 years.

Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795.

NOTE—This foreword does not contain provisions of the American National Standard, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (ANSI/AAMI PB70:2003), but it does provide important information about the development and intended use of the document.




© 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI PB70:2003 1

American National Standard ANSI/AAMI PB70:2003/(R)2009

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities 1 Scope

1.1 General

This standard establishes minimum barrier performance requirements, a classification system, and associated labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities.

1.2 Inclusions

This standard covers surgical drapes, drape accessories, and all types of protective apparel that are labeled with liquid barrier claims or liquidborne microbial barrier claims (e.g., single-use and multiple-use surgical gowns, decontamination garments, isolation gowns, aprons, sleeve protectors, laboratory attire, and other garments) and that are regulated by the U.S. Food and Drug Administration (FDA) as medical devices under 21 CFR 878.

NOTE 1—Surgical apparel is classified by the FDA under 21 CFR 878.4040, and surgical drapes and drape accessories are classified under 21 CFR 878.4370.

NOTE 2—For additional important information regarding the scope of this standard, see Annex A, A.1.1 and A.1.2. Other informative annexes are also included in this standard.

1.3 Exclusions

This standard does not cover

a) protective apparel for the hands, such as surgical gloves, patient examination gloves, and other medical gloves;

b) protective apparel for the head, face, and eyes, such as goggles, face shields, surgical caps or hoods, surgical masks, and respirators;

c) protective apparel for the feet, such as operating room shoes, shoe covers, and surgical boots;

d) other types of protective clothing worn by health care personnel, such as (1) apparel that is not intended or labeled as a barrier to liquid or microorganisms (e.g., surgical scrubs, cover coats) and (2) apparel or equipment that is used when handling hazardous chemicals, chemotherapeutic agents, or hazardous wastes;

e) absorbent operating room (OR) towels;

f) all of the requirements necessary to ensure the safety and effectiveness of the products within the scope of this standard;

g) the interfaces between products, such as the gown/glove interface;

h) all of the labeling or other information that a health care facility might deem necessary or desirable in product selection;

i) protection from dry particulate and dry microbial penetration;

j) manufacturing, quality assurance, or purchasing specifications;

k) criteria for evaluating experimental products; or




ANSI/AAMI ST65:2008/(R)2018Processing of reusable Surgical textiles for use in health care facilities

American National Standard

Advancing Safety in Health Technology




Objectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMI's technical development program derive from AAMI's overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMI's view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are avoided.

A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be documented in the rationale.

A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained.

Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices.

In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized:

All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document.

Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making.

Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user.

Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as "unsafe". A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision.

In summary, a standard or recommended practice is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the "Standards Monitor" section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News.




American National Standard ANSI/AAMI ST65:2008/(R)2018 (Revision of ANSI/AAMI ST65:2000)

Processing of reusable surgical textiles for use in health care facilities

Developed by AAMI

Approved 4 December 2008 and reaffirmed 2 December 2013 and 6 September 2018 by American National Standards Institute Inc.

Abstract: This recommended practice provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in health care facilities. This recommended practice specifically addresses design criteria for functional work areas; staff qualifications, education, training, dress codes, and other personnel considerations; receiving and handling of soiled surgical textiles; laundry processing considerations; transport of both soiled and clean surgical textiles; installation, care, and maintenance of laundry equipment; quality control; and regulatory considerations. Definitions of terms and a bibliography are also provided.

Keywords: laundry, surgical drapes, surgical gowns, wrappers




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 may 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

AAMI4301 N. Fairfax Drive, Suite 301Arlington, VA 22203-1633www.aami.org

© 2009 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 Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067.

Printed in the United States of America

ISBN 978-1-57020-336-7




Contents

Page

Glossary of equivalent standards ................................................................................................................... vii

Committee representation ............................................................................................................................... ix

Foreword ......................................................................................................................................................... xi

Introduction: Need for the recommended practice ......................................................................................... xii

1 Scope........................................................................................................................................................1 1.1 General ..........................................................................................................................................1 1.2 Inclusions .......................................................................................................................................1 1.3 Exclusions ......................................................................................................................................1

2 Definitions, symbols, and abbreviations ....................................................................................................2

3 Design considerations...............................................................................................................................5 3.1 General rationale............................................................................................................................5 3.2 Work area design and functional work flow ....................................................................................6

3.2.1 Definitions of work areas..................................................................................................6 3.2.2 Design criteria for work areas...........................................................................................7 3.2.3 Functional work flow patterns...........................................................................................8 3.2.4 Traffic control ...................................................................................................................8

3.3 Physical facilities: laundry area ......................................................................................................8 3.3.1 Space requirements .........................................................................................................8 3.3.2 Mechanical systems.........................................................................................................8 3.3.3 Floors, walls, ceilings, and vents......................................................................................8 3.3.4 Ventilation ........................................................................................................................9 3.3.5 Temperature and humidity control....................................................................................9 3.3.6 Lighting systems ..............................................................................................................9 3.3.7 Handwashing facilities......................................................................................................9 3.3.8 Emergency eyewash/shower equipment..........................................................................9 3.3.9 Soil-sort area..................................................................................................................10 3.3.10 Chemical storage area ...................................................................................................10 3.3.11 Storage area for clean textile packs ...............................................................................10 3.3.12 Housekeeping ................................................................................................................10

3.4 Physical facilities: surgical pack assembly area ...........................................................................11 3.4.1 Space requirements .......................................................................................................11 3.4.2 Mechanical systems.......................................................................................................11 3.4.3 Floors, walls, ceilings, and vents....................................................................................11 3.4.4 Ventilation ......................................................................................................................11 3.4.5 Temperature and humidity control..................................................................................11 3.4.6 Lighting systems ............................................................................................................12 3.4.7 Hand hygiene facilities ...................................................................................................12 3.4.8 Storage area for clean textile packs ...............................................................................12 3.4.9 Surgical pack sterilization area ......................................................................................12 3.4.10 Sterile storage area........................................................................................................12 3.4.11 Housekeeping ................................................................................................................12

4 Personnel considerations........................................................................................................................12 4.1 General rationale..........................................................................................................................12 4.2 Qualifications................................................................................................................................13

4.2.1 Supervisors/managers ...................................................................................................13 4.2.2 Personnel.......................................................................................................................13

4.3 Training and education.................................................................................................................13 4.4 Health and personal hygiene........................................................................................................14 4.5 Attire.............................................................................................................................................15

4.5.1 General ..........................................................................................................................15




4.5.2 Personal protective equipment (PPE) ............................................................................15

5 Receiving and handling of reusable surgical textiles...............................................................................15 5.1 General rationale..........................................................................................................................15 5.2 Newly purchased items ................................................................................................................16

5.2.1 Identification and handling .............................................................................................16 5.2.2 Washing.........................................................................................................................16

5.3 Collecting and transporting soiled surgical textiles .......................................................................16 5.3.1 Collecting soiled surgical textiles at the point of use ......................................................16 5.3.2 Transporting soiled surgical textiles ...............................................................................16

5.4 Sorting of soiled textiles ...............................................................................................................17 5.4.1 General considerations ..................................................................................................17 5.4.2 Pre-sort systems ............................................................................................................17 5.4.3 Post-sort systems ..........................................................................................................17

6 Laundry processing recommendations ...................................................................................................18 6.1 General rationale..........................................................................................................................18 6.2 Washing .......................................................................................................................................18

6.2.1 Procedures.....................................................................................................................18 6.2.2 Loading of washing equipment.......................................................................................18 6.2.3 Steps in the washing process: laundry formulas ............................................................18

6.3 Drying...........................................................................................................................................20 6.3.1 Procedures.....................................................................................................................20 6.3.2 Equipment loading .........................................................................................................20 6.3.3 Steps in the drying process: drying formulas..................................................................21

6.4 Process monitoring.......................................................................................................................21 6.4.1 Rationale for process monitoring....................................................................................21 6.4.2 Process monitoring: supplies .........................................................................................21 6.4.3 Process monitoring: equipment operation......................................................................23 6.4.4 Process monitoring: finished products ...........................................................................23

7 Inspection, testing, and maintenance of laundered textiles.....................................................................24 7.1 General rationale..........................................................................................................................24 7.2 Visual inspection ..........................................................................................................................25

7.2.1 Quality standards ...........................................................................................................25 7.2.2 Stains.............................................................................................................................25 7.2.3 Physical defects .............................................................................................................27 7.2.4 Chemical or thermal damage .........................................................................................27 7.2.5 Foreign debris ................................................................................................................27 7.2.6 Labeling .........................................................................................................................28 7.2.7 Tracking system.............................................................................................................28

7.3 Testing .........................................................................................................................................28 7.3.1 Test procedures .............................................................................................................28 7.3.2 Microbiological cleanliness.............................................................................................29 7.3.3 Effective life....................................................................................................................29 7.3.4 Important functional attributes........................................................................................29

7.4 Maintenance.................................................................................................................................31 7.4.1 Patching .........................................................................................................................31 7.4.2 Mending .........................................................................................................................31 7.4.3 Rewash ..........................................................................................................................31 7.4.4 Rejuvenation ..................................................................................................................32 7.4.5 Retirement or alternate use............................................................................................32

8 Preparation and packaging .....................................................................................................................32 8.1 General rationale..........................................................................................................................32 8.2 Procedures...................................................................................................................................32 8.3 Folding .........................................................................................................................................32

8.3.1 General considerations ..................................................................................................32 8.3.2 Guidelines for folding gowns ..........................................................................................32 8.3.3 Guidelines for folding drapes .........................................................................................33

8.4 Pack assembly .............................................................................................................................34




8.5 Wrapping......................................................................................................................................34 8.6 Labeling/identification of packs.....................................................................................................34

9 Handling, transport, and storage of laundered textiles ............................................................................35 9.1 General rationale..........................................................................................................................35 9.2 Procedures...................................................................................................................................35 9.3 Personnel attire and hygiene........................................................................................................35 9.4 Handling clean/sterile textiles .......................................................................................................35 9.5 Transport......................................................................................................................................35

9.5.1 General considerations ..................................................................................................35 9.5.2 Method of transport ........................................................................................................35 9.5.3 Separation of clean/sterile and soiled textiles ................................................................36 9.5.4 Laundry cart cleaning, disinfection, and loading.............................................................36 9.5.5 Truck cleaning and loading ............................................................................................36

9.6 Storage.........................................................................................................................................37 9.6.1 Storage conditions .........................................................................................................37 9.6.2 Storage shelving ............................................................................................................37 9.6.3 Stock rotation .................................................................................................................37

10 Installation, operation, care, and maintenance of laundry equipment .....................................................37 10.1 General rationale..........................................................................................................................37 10.2 Documentation .............................................................................................................................38

10.2.1 Identification...................................................................................................................38 10.2.2 Safety.............................................................................................................................38 10.2.3 Manuals and installation/operating instructions..............................................................38

10.3 Installation ....................................................................................................................................38 10.3.1 General considerations ..................................................................................................38 10.3.2 Utilities ...........................................................................................................................39

10.4 Operation .....................................................................................................................................40 10.4.1 General considerations ..................................................................................................40 10.4.2 Washing, extraction, and drying equipment ...................................................................40 10.4.3 Support systems ............................................................................................................40

10.5 Routine care and maintenance.....................................................................................................42 10.5.1 Routine care...................................................................................................................42 10.5.2 Scheduled (preventive) maintenance.............................................................................42 10.5.3 Unscheduled maintenance (repairs) ..............................................................................42 10.5.4 Calibration......................................................................................................................42 10.5.5 Recordkeeping...............................................................................................................43

11 Quality control .........................................................................................................................................43 11.1 General rationale..........................................................................................................................43 11.2 General quality control criteria......................................................................................................43

11.2.1 Functional performance criteria......................................................................................43 11.2.2 Verification of laundry processes ...................................................................................44

11.3 Policies and procedures ...............................................................................................................44 11.4 Barrier efficacy .............................................................................................................................44 11.5 Tracking uses of reusable surgical textile products ......................................................................45 11.6 Process performance ...................................................................................................................45

11.6.1 Quality assessment........................................................................................................45 11.6.2 Quality process ..............................................................................................................46

12 Medical device regulatory considerations................................................................................................47

Annexes

A Examples of folding procedures..............................................................................................................48

B Bibliography ............................................................................................................................................51

Tables

1 An example of inspection criteria for stains.............................................................................................26




Figures

A.1 Example of a folding procedure for gowns ..............................................................................................48

A.2 Example of a folding procedure for standard laparotomy drapes ............................................................49

A.3 Example of a folding procedure for mayo stand covers ..........................................................................50

A.4 Example of a folding procedure for towels ..............................................................................................50

A.5 Example of a folding procedure for sheets..............................................................................................50




© 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST65:2008 ix


Association for the Advancement of Medical Instrumentation Reusable Surgical Textile Processing Working Group

This recommended practice was developed by the AAMI Reusable Surgical Textile Processing 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 document was published, the AAMI Reusable Surgical Textile Processing Working Group had the following members:

Cochairs: John HamiltonLinda A. Slone, RN, CNOR

Members: Nola Bayes, MBA, Wentworth-Douglass Hospital, Dover, NH Nathan L. Belkin, PhD, Clearwater, FL Peter L. Brown, W.L. Gore & Associates Bradley J. Bushman, Standard Textile Co., Inc. Nancy Chobin, RN, CSPDM, St. Barnabas Health Care System, West Orange, NJ Linda Clement, CRCST, STERIS Corporation Ramona Conner, RN, MSN, CNOR, Association of PeriOperative Registered Nurses Betty D. Edge, North Shore University Hospital, Manhasset, NY Linda Fairbanks, Association for Linen Management John Hamilton, SRI Surgical Charles O. Hancock, H&W Technology LLC Jeffrey Hills, RM, Nelson Laboratories Inc. Nyla Skee Japp, RN, PhD, CSPDM, IMS, Phoenix, AZ David W. Johnson, Kimberly-Clark Corporation Susan G. Klacik, CCSMC, FCS, ACE, International Association of Healthcare

Central Service Materiel Management Colleen Patricia Landers, RN, Canadian Standards Association Mark E. Lanning, Hill-Rom Company Sharon K. Lappalainen, U.S. Food and Drug Administration Teckla A. Maresca, LPN, CSPDM, St. Clare’s Health System, Denville, NJ Joseph A. Palomo, Cardinal Health K. John Pournoor, PhD, 3M Health CareFrank Sizemore, Wake Forest University Baptist Medical Center, Winston-Salem, NCLinda A. Slone, RN, CNOR, Sibley Memorial Hospital, Washington, DCDonna Swenson, CSPDM, West Suburban Hospital Medical Center, Oak Park, ILNora E. Wikander, RN, CSPDM, St. Joseph’s Wayne Hospital, Wayne, NJ

Alternates: Pamela Carter, RN, CNOR, STERIS CorporationTodd Hillam, MBA, Nelson Laboratories Inc.Natalie Lind, International Association of Healthcare Central Service Materiel ManagementSheila A. Murphey, MD, U.S. Food and Drug Administration

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.




x © 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST65:2008

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

Chairs: Victoria M. Hitchins, PhD William E. Young Members: Trabue D. Bryans, WuXi AppTec Inc. Peter A. Burke, PhD, STERIS Corporation

Nancy Chobin, RN, CSPDM, Saint Barnabas Health Care System, West Orange, NJ Charles Cogdill, Boston Scientific Corporation Ramona Conner, RN, MSN, CNOR, Association of periOperative Registered Nurses Jacqueline Daley, Association for Professionals in Infection Control and Epidemiology Kimbrell Darnell, CR Bard Lisa Foster, Sterigenics International Joel R. Gorski, PhD, NAMSA Deborah A. Havlik, Hospira Worldwide Inc. Victoria M. Hitchins, PhD, U.S. Food and Drug Administration Danny Hutson, Cardinal Health Lois Atkinson Jones, MS, Cary, IN Susan G. Klacik, CCSMC, FCS, ACE, International Association of Healthcare Central Service Materiel

Management Byron J. Lambert, PhD, Abbott Laboratories Colleen Patricia Landers, RN, Canadian Standards Association Lisa N. Macdonald, Becton Dickinson & Company Jeff Martin, Alcon Laboratories Inc. Patrick J. McCormick, PhD, Bausch & Lomb Inc. Rainer Newman, Johnson & Johnson Janet Prust, 3M Health Care Nancy J. Rakiewicz, Ethox International Inc. Michael H. Scholla, MS, PhD, DuPont Nonwovens Mark Seybold, Baxter Healthcare Corporation Andrew Sharavara, Propper Manufacturing Co. Inc. Mark N. Smith, Getinge USA William N. Thompson, Covidien James L. Whitby, MA, MB, FRCP, London, Ontario Martell Kress Winters, SM, Nelson Laboratories Inc. Alternates: Lloyd Brown, Covidien Glenn W. Calvert, Becton Dickinson & Company David Dion, Cardinal Health Steven J. Elliott, WuXi AppTec Inc. Thomas J. Frazar, Johnson & Johnson Kathy Hoffman, Sterigenics International Jim Kaiser, Bausch & Lomb Inc. Joseph J. Lasich, Alcon Laboratories Inc. Chiu Lin, PhD, U.S. Food and Drug Administration Natalie Lind, International Association of Healthcare Central Service Materiel Management Ralph Makinen, Boston Scientific Corporation Mary S. Mayo, CR Bard David Ford McGoldrick, Abbott Laboratories Jerry R. Nelson, MS, PhD, Nelson Laboratories Inc. Karen Polkinghorne, DuPont Nonwovens Michael Sadowski, Baxter Healthcare Corporation John R. Scoville, Jr., STERIS Corporation Jason Voisinet, Ethox International Inc. Craig A. Wallace, 3M Health Care Valerie Welter, Hospira Worldwide Inc. William E. Young, Boston Scientific Corporation

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.




© 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST65:2008 xi

Foreword

This recommended practice was developed by the AAMI Reusable Surgical Textile Processing Working Group under the auspices of the AAMI Sterilization Standards Committee. The objective of this recommended practice is to provide guidance in the handling and processing of reusable surgical textiles.

This recommended practice is the second edition of ANSI/AAMI ST65:2000, Processing of Reusable Surgical Textiles for Use in Health Care Facilities. In addition to a general updating of the glossary and bibliography, the new edition reflects the incorporation of new provisions regarding sharps precautions, stains and discolorations, ANSI/AAMI PB70, and folding, as well as the revision of the recommendations regarding bleaching, pack identification, the transport and storage of textiles, strike-through, and medical device regulatory considerations.

The provisions of this recommended practice should be reviewed by various department managers, as applicable, and adapted to the needs of their particular institutions. Written policies and procedures should be developed and implemented in consultation with representatives of end users.

This recommended practice reflects the conscientious efforts of health care professionals, in cooperation with representatives of hospital-owned laundries and outsourcing services, to develop recommendations for optimum performance levels in the processing of reusable surgical textiles. 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 toward desirable performance objectives, and all of its provisions should be considered and applied in the light of professional judgment and experience.

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 5 years.

As used within the context of this document, “shall” indicates requirements strictly to be followed in order 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; 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.

Suggestions for improving this recommended practice are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795.

NOTE—This foreword does not contain provisions of ANSI/AAMI ST65, Processing of reusable surgical textiles for use in health care facilities, but it does provide important information about the development and intended use of the document.




Introduction: Need for the recommended practice

Hospital-owned laundries, as well as those providing outsourcing services to health care facilities, are providing clean and disinfected surgical textiles, nonsterile reusable surgical textile packs, and/or sterile reusable surgical textile packs to health care facilities. The ability of service providers to furnish reusable products that meet the performance requirements of end users while providing quality patient care has been enhanced by technological advances in reusable textiles and processing equipment. Current and future advancements in this segment of the industry may necessitate modified or alternative processing techniques.

This recommended practice is intended to provide guidelines that will help materiel managers, laundry managers, central service managers, and other health care professionals implement effective quality assurance systems for the processing of reusable surgical textiles. The guidelines provided here may also be useful to hospitals/users in evaluating the capabilities of facilities being considered for the processing of reusable surgical textiles.

It should be noted that laundry facilities that place surgical textiles (whether sterile or nonsterile) into commercial distribution come under the jurisdiction of Food and Drug Administration (FDA) regulations (see Section 12). In addition, laundry facilities in general may be subject to local, state, and/or federal Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) requirements.

xii © 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST65:2008




© 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST65:2008 1

American National Standard ANSI/AAMI ST65:2008/(R)2018

Processing of reusable surgical textiles for use in health care facilities 1 Scope

1.1 General

This recommended practice provides guidelines for properly handling, processing, and preparing reusable surgical textiles for use in health care facilities. These guidelines describe a quality assurance program for the processing of reusable surgical textiles, including processes and techniques for the preparation of clean bulk items for delivery to user sites and the assembly of textile packs for sterilization prior to end use. These guidelines apply to all facilities that process surgical textiles, whether on-premise laundries (OPLs), hospital-owned cooperatives, or commercial facilities.

NOTE 1—Surgical textiles labeled for single use only should not be reprocessed or reused, because it may not be possible to adequately reprocess them and maintain their performance and safety attributes. In addition, the health care facility’s liability may be affected if the manufacturer’s written instructions for use are not followed. See also FDA regulations applicable to the reprocessing of single-use medical devices (www.fda.gov/cdrh/reprocessing/).

NOTE 2—For purposes of this recommended practice, “health care facility” means hospitals, nursing homes, extended care facilities, freestanding surgical centers, clinics, and medical, surgical, and dental offices. For convenience, the term “hospital” is sometimes used in this recommended practice; in all instances, the term should be taken to encompass all other health care facilities.

1.2 Inclusions

This recommended practice specifically addresses

a) design criteria for functional work areas involved with the receiving, staging, and handling of soiled surgicaltextiles; the separation of soiled and clean textiles; the laundering of reusable surgical textiles; and theinspection and preparation of clean bulk items and surgical textile packs;

b) staff qualifications, education, training, dress codes, and other personnel considerations;

c) transporting, receiving, and handling of both newly purchased and soiled surgical textiles;

d) laundry processing (loading, washing, drying) recommendations;

e) inspection, testing, and maintenance of laundered textiles;

f) preparation and packaging of laundered textiles;

g) handling, transport, and storage of laundered textiles;

h) installation, operation, care, and maintenance of laundry equipment;

i) quality control measures, procedures, and practices;

j) medical device regulatory considerations.

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

1.3 Exclusions

This recommended practice does not cover

a) design or construction criteria for equipment used to process reusable surgical textiles;

NOTE—Performance requirements for washer–disinfectors are provided in ISO 15883-1, 15883-2, and 15883-3.Performance requirements for hospital steam sterilizers are provided in ANSI/AAMI ST8.




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