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1、 Technical Information Report AAMI TIR30:2003 AAMI Association for the Advancement of Medical Instrumentation A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices AAMI Technical Information Report AAMI TIR30:2003 A compendium of processes,
2、 materials, test methods, and acceptance criteria for cleaning reusable medical devices Approved 8 October 2003 by Association for the Advancement of Medical Instrumentation Abstract: This report is intended as a resource for manufacturers of medical devices who must validate the instructions for re
3、processing that they include with their devices. In addition to describing available processes, materials, test methods, and acceptance criteria for cleaning medical devices that are labeled by the manufacturer for reuse and reprocessing, the report also discusses some of the underlying problems and
4、 challenges associated with validating a cleaning method. Extensive references and an annotated bibliography on device design also are included. Keywords: device design, materials compatibility, test soil AAMI Technical Information Report A technical information report (TIR) is a publication of the
5、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
6、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 commen
7、ts. 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 co
8、mmittee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults wi
9、th a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat 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 T
10、IR 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
11、 NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or 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 informat
12、ion 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 a
13、uthorities, 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, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Published by Associati
14、on for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2004 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all o
15、r 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 externa
16、lly) 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
17、 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 1570202117 Contents Page Glossary of equivalent standards.v Committee representationvii Acknowledgments.ix Forewordx Introduction .xi 1 Scope1 1.1 Genera
18、l 1 1.2 Inclusions.1 1.3 Exclusions1 2 Definitions, abbreviations, and symbols1 3 Device materials .3 3.1 Overview3 3.2 Types of materials3 3.3 Changes in materials and their surfaces produced by reprocessing3 3.4 Selection of materials.4 3.4.1 General considerations4 3.4.2 “Cleanability” considerat
19、ions4 4 Device design .5 4.1 Overview5 4.2 Design features offering difficulty in cleaning .5 4.3 Design considerations6 4.4 Bibliography .7 5 Available cleaning processes7 5.1 Overview7 5.2 Cleaning agents .7 5.2.1 General considerations7 5.2.2 Enzyme products.8 5.2.3 Detergents .8 5.2.4 Detergent-
20、disinfectants8 5.2.5 Rinsing.9 5.2.6 Assessment of cleanliness and residuals 9 5.2.7 Additional processing.9 5.3 Cleaning methods 9 5.3.1 General considerations9 5.3.2 Manual cleaning.9 5.3.3 Mechanical cleaning 10 5.4 User verification of cleaning processes11 5.4.1 General considerations11 5.4.2 Ma
21、rkers12 5.4.3 Cleaning verification tests for users.13 5.5 Cleaning tools and accessories15 5.6 Worker education.15 6 Test soils.16 6.1 Overview16 6.2 Scientific data for choice of test soil.16 6.3 Test soils and methods for washer-disinfectors .17 6.4 Other test soils and methods for reusable devic
22、es.19 7 Test methods, equipment, and acceptance criteria.19 7.1 Overview19 7.2 Soil application.20 7.3 Test carriers.20 7.3.1 Surrogate carriers20 7.3.2 Medical devices .20 7.4 Assays of residual soil and bioburden20 7.4.1 General considerations20 7.4.2 Destructive methods20 7.4.3 Tracer methods21 7
23、.4.4 In-situ methods 21 7.4.5 Indirect sample elution.21 7.4.6 Viable bioburden assessments21 7.4.7 Specific tests for protein, lipids and oil, carbohydrate, and endotoxin22 7.5 Acceptance criteria.22 7.6 Simulated-use test protocol23 8 Regulatory considerations.24 8.1 Overview24 8.2 U.S. FDA guidan
24、ce documents24 8.3 National guidance documents and standards 24 8.4 International standards.24 9 References25 Annex A Annotated bibliography on device design33 Tables 1 Examples of reusable medical devices .3 2 Types of enzymes used in enzymatic cleaners.8 3 In-use tests available to assess efficacy
25、 of cleaning of medical devices* .14 4 In-use tests available to assess efficacy of washer-disinfectors used for medical device reprocessing*15 5 Test soils for washer-disinfectors17 6 Test soils for reusable devices19 2004 Association for the Advancement of Medical Instrumentation ? AAMI TIR30:2003
26、 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of
27、equivalency to the International Standard. NOTEDocuments are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. design
28、ation Equivalency IEC 60601-1-2:2001 ANSI/AAMI/IEC 60601-1-2:2001 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 in addition to the natural selection processes that cause these species to emerge, one must
29、 now consider the possibility of bioterrorism and the development of organisms specifically created to resist cleaning and sterilization practices. Suggestions for improving this TIR are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 1110 N. Glebe Road, Suite 2
30、20, Arlington, VA 22201-4795. 2004 Association for the Advancement of Medical Instrumentation ? AAMI TIR30:2003 xi Introduction Medical devices, as defined by the U.S. Food, Drug, and Cosmetic Act (21 USC 301); the Medical Device Amendments of May 28, 1976; and subsequent amendmentsand as regulated
31、by the U.S. Food and Drug Administration (FDA)range from simple wooden tongue-depressing blades to complex and sophisticated electronic equipment such as magnetic resonance imaging (MRI) and proton emission tomographic (PET) equipment. Diagnostic test kits are also included within the device definit
32、ion. Devices may be applied to the surface of the body; be inserted into an orifice or through the skin; or find their way into the tissues, spaces, or organs of the bodies of humans or animals by ingestion, inhalation, skin absorption, or implantation. Devices may contact blood, mucosal tissue, mus
33、cle or other connective tissue, adipose tissue, bone, teeth, and other tissues, and may remain in contact for short time periods or for up to a lifetime. Devices are used for a wide range of diagnostic and therapeutic applications within the medical, dental, and veterinary fields, including a variet
34、y of surgical and life-saving applications. Devices are also used to administer various medicines, drugs, vaccines, biologicals, and nutritional supplements. Certain products (such as prefilled syringes) are considered combination drugdevices. Manufacturers of reusable medical devices must provide i
35、nstructions on how to reprocess their devices between patient uses. Two types of risks are associated with the reuse of a medical device: (a) the risk of disease transmission from one patient to another or from environmental sources to a patient; and (b) the risk of inadequate or unacceptable device
36、 performance following reprocessing. Reprocessing involves several steps, including cleaning, testing for device performance, and disinfection and/or sterilization. Cleaning a device is the critical first step in reprocessing any device after it has been used on a patient. Failure to remove foreign
37、material (e.g., soil, organic and inorganic materials, lubricants, microorganisms) from both the outside and the inside of the device can interfere with the effectiveness of subsequent disinfection and/or sterilization. Cleaning is normally accomplished by manual wiping, brushing, or flushing or by
38、using mechanical aids (e.g., ultrasonic cleaners, washer-decontaminators, washer-sterilizers) in conjunction with water and detergents to remove foreign material. In the past, a device was considered “clean” if the person who was performing the cleaning task observed no visible foreign material. Tod
39、ay, however, many devices have long or narrow opaque lumens, crevices, hinges, acute angles, serrated edges, junctions between insulating sheaths, coils, or other designs that make it difficult or impossible to rely on the traditional visual endpoint. In addition, visual observation might not be ade
40、quately sensitive to detect levels of soil that could interfere with subsequent reprocessing. There are few tests that can be used to validate cleaning. To validate cleaning of a given device, one must have a test soil and a quantitative test method for detecting residual soil after cleaning. If val
41、idated cleaning protocols were available today, they could help ensure that adequate cleaning is accomplished and a device can be reliably disinfected and/or sterilized before it is used on the next patient. The manufacturer must validate the instructions for reprocessing a reusable device before ma
42、rketing it. In addition, manufacturers must consider a) that exposure to chemicals, such as cleaning agents, could change the material used in the device; b) whether the materials of construction will absorb or adsorb chemical agents, which could then gradually leach from the material over time; and
43、 c) how cleaning processes could affect the function of the device. This compendium of processes, materials, and test methods for cleaning reusable medical devices is meant to provide device manufacturers with information to facilitate the validation of cleaning processes to be used for their reusab
44、le medical devices. xii 2004 Association for the Advancement of Medical Instrumentation ? AAMI TIR30:2003 2004 Association for the Advancement of Medical Instrumentation ? AAMI TIR30:2003 1 AAMI Technical Information Report AAMI TIR30:2003 A compendium of processes, materials, test methods, and acce
45、ptance criteria for cleaning reusable medical devices 1 Scope 1.1 General This technical information report (TIR) is a compilation of available information regarding test protocols, test soils, and acceptance criteria that can be used by medical device manufacturers to validate cleaning processes fo
46、r reusable medical devices. 1.2 Inclusions This TIR covers the validation of cleaning processes for medical devices that are intended and labeled by the manufacturer for reprocessing and reuse. Such devices include those that are intended for routine reprocessing and reuse (e.g., surgical instrument
47、s) and certain implant accessories (e.g., orthopedic screws) that are provided as parts of sets and are intended and labeled by the manufacturer for reprocessing if not used during a particular procedure. Included within the scope of this TIR are the following topics: a) device design and material c
48、onsiderations; b) available cleaning processes; c) test soils; d) test methods; e) test equipment; f) acceptance criteria; and g) regulatory considerations. This TIR also provides references and an informative annex. 1.3 Exclusions This TIR does not cover the performance of procedures for cleaning r
49、eusable medical devices in health care facilities, nor does it cover procedures for reprocessing single-use medical devices and hemodialyzers in health care facilities. For information on these topics, see ANSI/AAMI ST35:2003, FDA (2000b), and ANSI/AAMI RD47, respectively. NOTEThe test protocols, test soils, and acceptance criteria described in this TIR do not necessarily apply to the validation of cleaning processes for medical devices contaminated with prions, such as the prion that causes Creutzfeldt-Jakob disease (CJD), and thus such devices may require
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