1、ANSI/AAMI SW87:2012Application of quality management system concepts to medical device data systemsAmerican National StandardObjectives 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
2、 are clearly understood. 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
3、(2) the encouragement 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 avoi
4、ded. 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
5、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, warni
6、ngs 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;
7、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 b
8、e 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
9、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 usua
10、lly 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 s
11、ubjects 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 standar
12、d 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 ap
13、plication 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 h
14、as 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
15、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
16、 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 provision
17、s. 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 potentia
18、l 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 volu
19、ntary 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 r
20、esources 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 w
21、ith 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, S
22、tandards 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 appeal
23、s 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 a
24、nd 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 SW87:2012 Application of quality management system concepts to medical device data systems Developed by Associatio
25、n for the Advancement of Medical Instrumentation Approved 23 May 2012 by American National Standards Institute, Inc. Abstract: This recommended practice provides information that will allow the medical device data system manufacturer to implement a quality management system that is commensurate with
26、 the risk presented by the device, the complexity of device and manufacturing processes, and the size and complexity of organization. Keywords: MDDS, quality management, medical device, medical device data systems AAMI Recommended Practice This Association for the Advancement of Medical Instrumentat
27、ion (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, purcha
28、sing, or using products, processes, or procedures not conforming to the standard. 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
29、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 info
30、rmation 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 procureme
31、nt 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 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by the Association for the Advancement of
32、 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 prohibit
33、ed 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 civ
34、il and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org, or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-
35、525-1067. Printed in the United States of America ISBN 157020439X Contents Glossary of equivalent standards . v Committee representation vii Foreword x 1 Introduction . 1 1.1 Purpose of this document 1 1.2 Scope of this document 1 1.3 The intended audience for this document 2 1.4 The regulatory and
36、standards context for this document . 3 2 Quality management system . 3 2.1 Management 3 2.1.1 Concepts 3 2.1.2 Discussion and points to consider . 5 2.1.3 Reference points 8 2.2 Document and record controls . 8 2.2.1 Concepts 8 2.2.2 Discussion and points to consider . 8 2.2.3 Reference points 9 2.
37、3 Design controls 10 2.3.1 Concepts 10 2.3.2 Discussion and points to consider . 11 2.3.2.1 Design planning for an MDDS 11 2.3.2.2 Design input for an MDDS . 12 2.3.2.3 Risk management of an MDDS 14 2.3.2.4 Design output of an MDDS 15 2.3.2.5 Design review of an MDDS 16 2.3.2.6 Design verification o
38、f an MDDS . 17 2.3.2.7 Design validation of an MDDS . 18 2.3.2.8 Design transfer of an MDDS 18 2.3.2.9 Design changes for an MDDS 19 2.3.2.10 Design history of an MDDS 19 2.3.3 Reference points 20 2.4 Supplier and purchasing controls . 20 2.4.1 Concepts 20 2.4.2 Discussion and points to consider . 2
39、1 2.4.3 Reference points 22 2.5 Corrective and preventive action (CAPA) . 22 2.5.1 Concepts 22 2.5.1.1 Corrective action process . 22 2.5.1.2 Preventive action process 22 2.5.2 Discussion and points to consider . 22 2.5.3 Reference points 23 3 Glossary 23 4 Acronyms 25 5 References 26 Figures 1 Qual
40、ity management policies and processes . 2 2 Model of a process-based quality management system 5 3 Example of a quality policy . 5 4 Example of a document pyramid 9 Tables 1 Example of quality manual organization . 7 2 Design control areas of focus . 11 2012 Association for the Advancement of Medica
41、l Instrumentation ANSI/AAMI SW87:2012 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 corresp
42、onding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 109
43、93-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equi
44、valency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/(R)2012 and ANSI/AAMI ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) Major technical variations C1 Identical to Corrigendum 1 b) an MDDS might change more frequently than traditional medic
45、al devices; c) risk might not be easily assessed because use of an MDDS involves the interconnection of previously disparate systems beyond the direct control of the MDDS developer; and d) there might not be a physical MDDS product. The task for organizations that develop or provide an MDDS is to ad
46、opt the guiding principles and intent of accepted standards for medical device quality management systems while acknowledging the unique challenges that exist in the MDDS domain. Existing quality management system standards identify key areas of focus for ensuring quality, and these remain relevant
47、to MDDSs. However, tools and methods used to address these areas of concern might be different. This guidance will address five key areas of focus and provide suggestions to organizations that develop or provide an MDDS about how to establish a quality management system that is consistent with creat
48、ing a safe and effective MDDS, meeting user requirements, and providing value, as well as beginning to support compliance with regulatory requirements. This recommended practice is primarily intended for MDDS developers who have not previously implemented a medical device quality management system.
49、Quality is a journey. This document provides a way to take the first steps. It focuses on five foundational elements of a quality management system: management responsibility, document control, design control, supplier control, and corrective and preventive action. As implementation progresses, reference should be made to the more detailed guidance, standards, and regulations presented in Section 5. As used within the context of this document, “shall” indicates requirements to be strictly followed in order to conform to the recommended practice; “should” indicates that amo
