ANSI RD47-2008 Reprocessing of hemodialyzers (FDA RECOGNIZED).pdf

1、Association for the Advancementof Medical InstrumentationANSI/AAMI RD47:2008Reprocessing of hemodialyzersObjectives 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 underst

2、ood. The objectives of AAMIs technical development program derive from AAMIs 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 encouragemen

3、t of new technologies. It is AAMIs 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 sta

4、ndard 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 th

5、e 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,

6、 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 o

7、n 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

8、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

9、 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

10、 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 steriliza

11、tion 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 pra

12、ctice 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 stand

13、ard 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 nat

14、ionally (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 respon

15、ds 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

16、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

17、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 existin

18、g 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 b

19、e 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 indi

20、vidual 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

21、 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

22、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 publicati

23、on 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 a

24、ccordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. AAMI Recommended Practice ANSI/AAMI RD47:2008 (Revision of ANSI/AAMI RD47:2002 and RD47:2002/A1:2003) Reprocessing of hemodialyzers Developed by Association for the Advanc

25、ement of Medical Instrumentation Approved 8 May 2008 by American National Standards Institute, Inc. Abstract: This recommended practice is addressed to the physician responsible for reprocessing hemodialyzers. It covers personnel and patient considerations, records, equipment, physical plant and env

26、ironmental safety, reprocessing material, patient identification and hemodialyzer labeling, reprocessing and storage procedures, disposition of rejected dialyzers, preparation for subsequent use, patient monitoring, and quality assurance and quality control. This document does not endorse either sin

27、gle use or reuse of dialyzers. Keywords: blood, dialysis, labeling, medical equipment, packaging, personnel, records, reprocessing, reuse, test AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substanti

28、ally 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 th

29、e 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 withd

30、raw 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 de

31、veloped 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 respo

32、nsible 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 www.aami.org 2008 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication

33、 is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illega

34、l 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 penalti

35、es, 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 157020313x Contents Page Glos

36、sary of equivalent standards viii Committee representation vii Foreword. viii Introduction: Need for this AAMI recommended practice ix 1 Scope1 1.1 Inclusions .1 1.2 Exclusions1 2 Normative references1 3 Definitions .2 4 Records.4 4.1 Dialyzer reprocessing manual 4 4.2 Reprocessing record 5 4.3 Equi

37、pment maintenance record .5 4.4 Personnel health monitoring records5 4.5 Complaint investigation record .5 4.6 Quality assurance and quality control record5 5 Personnel qualifications and training.5 5.1 Qualifications5 5.2 Training 5 5.2.1 Curriculum .5 5.2.2 Documentation.6 6 Patient considerations

38、.6 6.1 Medical issues6 6.2 Patient education .6 7 Equipment.6 7.1 Water systems .6 7.2 Reprocessing systems .6 7.2.1 Utility requirements 6 7.2.2 Process control testing.6 7.2.3 Maintenance 7 7.2.4 Repairs 7 8 Physical plant and environmental safety considerations .7 8.1 Reprocessing area and ventil

39、ation .7 8.2 Storage area 7 8.3 Laboratory area8 8.4 Personnel protection 8 8.5 Environmental safety8 9 Reprocessing supplies8 9.1 Specifications and testing.8 9.2 Inventory control.9 10 Hemodialyzer labeling.8 10.1 Time of labeling8 10.2 Label composition 8 10.3 Information recorded 8 11 Reprocessi

40、ng 9 11.1 Transportation and handling.9 11.2 Rinsing and cleaning9 11.3 Performance measurements9 11.3.1 Performance test after each use10 11.3.2 Ultrafiltration.10 11.3.3 Blood path integrity test .10 11.4 Germicide.10 11.4.1 Interior (blood/dialysate compartment).10 11.4.2 Exterior 11 11.5 Inspect

41、ion.11 11.6 Disposition of rejected dialyzers.12 11.7 Storage 12 12 Preparation for dialysis and testing for chemical germicides and potentially toxic residues 12 12.1 Visual inspection 12 12.2 Verification of patient identification.12 12.3 Verification of germicidal contact12 12.3.1 Presence test o

42、f each hemodialyzer 12 12.3.2 Process control and sampling12 12.4 Priming the dialyzer and rinsing the germicide.13 12.4.1 Testing for residual germicide13 12.5 Written procedure for tests for germicide or other residues13 13 Monitoring .13 13.1 Dialysis.13 13.2 Symptoms 14 13.2.1 Fever and chills14

43、 13.2.2 Other symptoms.14 13.2.3 Recording 14 13.3 Dialyzer failures14 13.4 Clinical results14 14 Quality assurance .14 14.1 Records15 14.2 Schedule of quality assurance activities.15 14.3 Patient considerations15 14.4 Equipment15 14.5 Physical plant and environmental safety considerations 15 14.6 R

44、eprocessing supplies .15 14.7 Hemodialyzer labeling16 14.8 Reprocessing .16 14.9 Preparation for dialysis.16 Annexes A Rationale for the development and provisions of this recommended practice.17 B Systems diagram for reprocessing dialyzers.30 C Self-assessment of compliance with recommendations for

45、 hemodialyzer reprocessing 31 Bibliography .53 Tables 1 OSHA environmental exposure limits (29 CFR 1910, 1 July 1998), except as indicated 7 2 Quality assurance audit schedule .15 11.2.1 Dialyzer precleaning 9 11.2.2 Initiation of cleaning 9 11.2.3 Water quality for cleaning .9 11.2.4 Cleaning agent

46、s 9 2008 Association for the Advancement of Medical Instrumentation ANSI/AAMI RD47:2008 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

47、AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; theref

48、ore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 6060

49、1-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC T