1、Association for the Advancementof Medical InstrumentationANSI/AAMI ST40:2004/(R)2010Table-top dry heat (heated air)sterilization andsterility assurancein health care facilitiesThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential use
2、s of an AAMIproduct standard or recommended practice are clearly understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective applicati
3、on of current technologiesto patient care, and (2) the encouragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided t
4、hat 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 me
5、asurementtechniques 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 char
6、acteristics, 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
7、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 e
8、stablishing 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
9、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 recomm
10、ended 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
11、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 a
12、n 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
13、). 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
14、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
15、 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 revi
16、sion (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 re
17、view 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 ex
18、isting 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 ca
19、n 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 indivi
20、dual 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 infor
21、mationand policy guidance and in the context of professional experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpre
22、tation 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
23、 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 whi
24、ch is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI ST40:2004/(R)2010 (Revision of ANSI/AAMI ST40:1992/(R)1998) Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities Developed by Assoc
25、iation for the Advancement of Medical Instrumentation Approved 7 October 2004 and reaffirmed 24 March 2010 by American National Standards Institute Inc. Abstract: This recommended practice provides guidelines for dry heat sterilization in health care facilities. It covers functional and physical des
26、ign criteria for work areas; staff qualifications, education, and other personnel considerations; sterilization processing procedures; installation, care, and maintenance of table-top dry heat sterilizers; and quality control. Definitions, a bibliography, and annexes providing supplementary informat
27、ion are also included Keywords: dry heat sterilization, quality control, table-top sterilizers 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
28、 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 practice
29、s 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 5 yea
30、rs 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 volunt
31、ary, 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
32、its rules and regulations. 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 tr
33、ansmission, 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 par
34、t 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
35、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 1570202265 Contents Page Glossary of equivalent standards vi Committee representation. viii Acknowledgment
36、s .ix Forewordx Introduction: Need for this recommended practicexi 1 Scope1 1.1 General 1 1.2 Inclusions .1 1.3 Exclusions1 2 Definitions, symbols, and abbreviations 1 3 Design considerations.3 3.1 General rationale3 3.2 Work area design and functional workflow .4 3.2.1 Definitions of work areas4 3.
37、2.2 Design criteria4 3.2.3 Functional workflow patterns5 3.2.4 Traffic control.5 3.3 Physical facilities 5 3.3.1 Space requirements.5 3.3.2 Mechanical and electrical systems.5 3.3.3 General area requirements 5 3.3.4 Special area considerations.7 3.4 Housekeeping 8 4 Personnel considerations8 4.1 Gen
38、eral rationale8 4.2 Qualifications8 4.3 Training and continuing education .9 4.4 Health and personal hygiene9 4.5 Attire.9 4.5.1 General9 4.5.2 Decontamination area10 4.6 Standard/transmission-based (enhanced) precautions 11 5 Processing recommendations.11 5.1 General rationale11 5.2 Receiving .12 5
39、.2.1 General considerations 12 5.2.2 Newly purchased reusable items and repaired reusable items 12 5.2.3 Disposable items12 5.3 Disposition of sterile items (issued but not used) .12 5.4 Handling, collection, and transport of items previously used in patient care.12 5.5 Cleaning and other decontamin
40、ation processes.13 5.5.1 General considerations 13 5.5.2 Presoaking.14 5.5.3 Sorting and disassembly14 5.5.4 Cleaning.14 5.5.5 Microbicidal processes.17 5.6 Selection of packaging materials17 5.7 Sterilization of packaged items.18 5.7.1 Preparation of items to be sterilized.18 5.7.2 Loading the ster
41、ilizer18 5.7.3 Equipment operation18 5.7.4 Sterilization cycle parameters 19 5.7.5 Unloading the sterilizer 19 5.7.6 User safety factors.19 5.7.7 Common operator errors20 5.8 Sterilization of unwrapped items.20 5.8.1 General considerations 20 5.8.2 Preparation of unwrapped items 20 5.8.3 Cycle param
42、eters for unwrapped items20 5.8.4 Unloading the sterilizer 20 5.9 Sterile storage of packaged items 20 5.9.1 Dust covers20 5.9.2 Storage environment21 5.9.3 Storage shelving 21 5.9.4 Shelf life.21 5.10 Distribution .21 5.10.1 Handling and inspection.21 5.10.2 Distribution containers and cassettes 22
43、 6 Installation, care, and maintenance of sterilizers.22 6.1 General rationale22 6.2 Instruction manuals 22 6.3 Installation22 6.4 Routine care and maintenance 22 6.5 Repair and component replacement 23 6.6 Calibration23 6.7 Recordkeeping .23 7 Quality control .23 7.1 General rationale23 7.2 Product
44、 identification and traceability.24 7.2.1 Lot control numbers .24 7.2.2 Sterilizer records24 7.2.3 Expiration dating 24 7.3 Physical monitoring 24 7.3.1 Use of physical monitors24 7.3.2 Sterilizer malfunction25 7.4 Chemical indicators25 7.4.1 Definition25 7.4.2 Selecting chemical indicators.25 7.4.3
45、 Using chemical indicators 26 7.5 Biological indicators .27 7.5.1 Definition27 7.5.2 Selecting biological indicators27 7.5.3 Frequency of use of biological indicators .27 7.6 Sterilizer efficacy testing.28 7.6.1 General considerations 28 7.6.2 Construction of the PCD 28 7.6.3 Placement of the PCD .2
46、8 7.6.4 Test procedure.29 7.6.5 Acceptance criteria 29 7.6.6 Positive BI results 29 7.6.7 Microbiological testing30 7.7 Periodic product monitoring30 7.8 Product recalls .30 7.8.1 Policies and procedures.30 7.8.2 Recall procedure30 7.8.3 Recall order .30 7.8.4 Recall report 31 7.9 Third-party servic
47、es31 Annexes A The science of dry heat sterilization32 B User verification of cleaning processes.36 C Example of documentation of premature release of implants41 D Bibliography 43 Tables 1 IES-recommended illuminance levels for work environments .6 B.1 In-use tests available to assess efficacy of cl
48、eaning of medical devices* .39 B.2 In-use tests available to assess efficacy of washer-disinfectors used for medical device reprocessing .40 Figures A.1 Batch cycle: Convective dry heat (static air) .33 A.2 Batch cycle: Convective dry heat (forced air) with chamber heat continuously maintained.34 A.
49、3 Batch cycle: Convective dry heat (forced air) with load remaining in chamber during cool-down34 C.1 Implantable devices load record41 C.2 Exception form for premature release of implantable device/tray42 vi 2005 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST40:2004 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
