ANSI ST90-2017 Processing of health care products-Quality management systems for processing in health care facilities.pdf

1、ANSI/AAMI ST90:2017Processing of health care productsQuality management systems for processing in health care facilitiesAmerican 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

2、 recommended practice 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

3、to patient care, and (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 rest

4、rictive 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

5、 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, instru

6、ctions 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 unif

7、ormity 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 establishin

8、g 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 devic

9、e 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 recomme

10、nded 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 industria

11、l 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 wh

12、ether 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

13、 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 represen

14、tatives, 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 limi

15、ted, 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. Despit

16、e 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

17、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

18、 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 produc

19、t 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

20、 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

21、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 A

22、AMI 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 exh

23、austion 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

24、 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 ST90:2017 Processing of health care products Quality management systems for processing in hea

25、lth care facilities Approved 11 June 2017 by Association for the Advancement of Medical Instrumentation Approved 18 July 2017 by American National Standards Institute Inc. Abstract: This document specifies minimum requirements for quality management systems (QMSs) to effectively, efficiently, and co

26、nsistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and non-manufacturer-related device failures. Keywords: sterilization, medical device processing, quality systems, documentation, monitoring, meas

27、urement, communication, resources 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

28、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 re

29、vised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, r

30、ecommended 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 governm

31、ent 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 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the

32、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 In

33、strumentation 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. Violator

34、s 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 Dr., Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the

35、 United States of America ISBN 978-1-57020-676-4 Contents Page Glossary of equivalent standards . v Committee representation . vi Foreword . ix Introduction 1 1 Scope. 2 1.1 Inclusions 2 1.2 Exclusions 2 2 Normative references. 3 3 Definitions and abbreviations . 4 4 Quality management system . 7 4.

36、1 General considerations . 7 4.2 Documentation requirements 7 5 Management responsibility 9 5.1 Management commitment . 9 5.2 Quality policy . 9 5.3 Planning 9 5.4 Responsibility, authority, and communication . 9 5.5 Management review 10 6 Resource management 11 6.1 Provision of resources. 11 6.2 Hu

37、man resources 11 6.3 Infrastructure . 11 6.4 Work environment . 11 7 Product realization . 13 7.1 Planning for new devices, equipment, and materials 13 7.2 Determining customer requirements 13 7.3 Developing surgical sets and other device processing techniques . 14 7.4 Purchasing 15 7.5 Processing a

38、nd servicing 16 7.6 Control of monitoring and measuring equipment 19 8 Measurement, analysis, and improvement 21 8.1 General considerations . 21 8.2 Monitoring and measurement . 21 8.3 Control of nonconforming processes, medical devices, and equipment . 21 8.4 Analysis of data 22 8.5 Improvement . 2

39、2 Annexes A Document and record retention . 24 B Risk management 26 C Product quality assurance testing for steam sterilization in health care facilities . 29 D Six major steps in creating a quality management system 33 Bibliography . 36 Figures B.1 Qualitative severity levels by semi-qualitative pr

40、obability levels 28 C.1 Sample outline of a steam sterilization product quality assurance testing protocol.32 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST90:2017 v Glossary of equivalent standards International Standards adopted in the United States may include normat

41、ive references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International

42、 Standard. www.aami.org/standards/glossary.pdf vi 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST90:2017 Committee representation Association for the Advancement of Medical Instrumentation Quality Systems for Device Processing Working Group This standard was developed by

43、 the AAMI Quality Systems for Device Processing Working Group under the auspices of the AAMI Sterilization Standards Committee. Approval of the standard does not necessarily mean that all working group members voted for its approval. At the time this standard was published, the AAMI Quality Systems

44、for Device Processing Working Group had the following members: Cochairs: Damien Berg, CRCST Richard William Schule, MBA, CST, FCS Members: Damien Berg, CRCST, St. Anthony Hospital Angela H. Brightwell, Medtronic Inc Nancy Chobin, RN, CSPM, CFER, Sterile Processing University LLC Sean Colwell, WuXi A

45、ppTec Inc Linda Condon, Johns Hopkins Hospital Corinne M. Connor (Independent Expert) Lena Cordie, Qualitas Professional Services LLC Michael DOnofrio, Presage Health Mary Dadone, Noxilizer Inc Jacqueline Daley, Sharp Metropolitan Medical Campus Gordon Ely, MiMedx Group Lisa Foster, Adiuvo QS b) the

46、 development or implementation of any specific system instruction, work instruction, or policy supporting a particular process and/or piece of equipment; c) the development or implementation of any specific education, training, or competency test supporting a particular process and/or piece of equip

47、ment; d) the development or implementation of any specific audit process or tool supporting a particular process and/or piece of equipment; or e) the reprocessing of single-use devices by a health care facility. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST90:2017 3 2

48、Normative references The following documents contain provisions that, through reference in the text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. Association for the Advancement of Medical Instrumentation. Medical devicesQuality management sy

49、stemsRequirements for regulatory purposes. ANSI/AAMI/ISO 13485:2016. Arlington (VA): AAMI, 2016. American National Standard. Association for the Advancement of Medical Instrumentation. Medical devicesApplication of risk management to medical devices. ANSI/AAMI/ISO 14971:2007/(R)2016. Arlington (VA): AAMI, 2007. American National Standard. Association for the Advancement of Medical Instrumentation. Ethylene oxide sterilization in health care facilities: Safety and effectiveness. ANSI/AAMI ST41:2008/(R)2012. Arlington (VA): AAMI, 2008. American National Standard. Associa