1、ANSI/AAMIEQ56:2013Recommended practice for a medical equipment management programAmerican 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 are clearly under
2、stood. 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 encouragem
3、ent 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 s
4、tandard 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
5、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, warnings and precaution
6、s, 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
7、 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 be documented in th
8、e 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 th
9、at 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 towar
10、ds 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 sterili
11、zation 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 p
12、ractice 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 sta
13、ndard 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 n
14、ationally (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 resp
15、onds 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 leas
16、t 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 wil
17、l 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 exist
18、ing 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
19、 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 resources of the in
20、dividual 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
21、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, Standards Policy an
22、d 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 publica
23、tion 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
24、 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 EQ56:2013 (Revision of ANSI/AAMI EQ56:1999/(R)2004) Recommended practice for a medical equipment management program Developed by Ass
25、ociation for the Advancement of Medical Instrumentation Approved 13 March 2013 by American National Standards Institute, Inc. Abstract: This recommended practice specifies minimum criteria for a management program designed to minimize certain risks associated with equipment that is used during the r
26、outine care of patients in a health care organization. The recommended practice addresses the structure of the program, documentation requirements, staffing, and resources allocated to those responsible for maintaining medical equipment. Keywords: accreditation, maintenance, medical equipment AAMI R
27、ecommended 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 existence of an AAMI recommended practice does not in any respect preclude anyone, whether they have
28、 approved the recommended practice or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTI
29、CE: 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 years from the date of publication. Interested parties may obtain current information on all AAMI standa
30、rds 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 voluntary, and their application is solely within the discretion and professional judgment of the user of t
31、he 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 its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 43
32、01 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the 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
33、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 externally) without the prior written permi
34、ssion 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, complete the reprint request form at www.aami.org o
35、r contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-483-7 Contents Page Glossary of equivalent standards . v Committee representation . vi Foreword vii Introduction viii 1 Sco
36、pe 1 1.1 General 1 1.2 Inclusions . 1 2 Normative reference . 2 3 Definitions . 3 4 Leadership 4 4.1 Policies and procedures 4 4.2 Communications and reporting 4 4.2.1 General considerations . 4 4.2.2 Communication between the service provider and the health care organization 4 4.3 Management 5 4.3.
37、1 Customers . 5 4.3.2 Staff . 6 4.4 Performance improvement 7 4.5 Emergency management. 7 5 Inventory . 8 5.1 Evaluation and selection 8 5.2 Acquisition . 8 5.2.1 Negotiable items 8 5.2.2 Acceptance testing 9 5.3 Non-hospital owned equipment . 10 5.4 Record keeping . 10 5.4.1 General considerations
38、. 10 5.4.2 Data to record 10 5.4.3 Inventory inclusion . 12 5.4.4 Inventory accuracy 12 5.4.5 Database . 13 6 Equipment Safety . 14 6.1 User training 14 6.1.1 Operation of equipment . 14 6.1.2 Responding to equipment problems 14 6.2 Recalls and alerts 14 6.3 Incidents 14 6.3.1 Investigating 14 6.3.2
39、 Reporting . 15 6.4 Infection control . 15 7 Inspection and planned maintenance program . 16 7.1 Inspection procedures 16 7.1.1 General considerations . 16 7.1.2 Documentation 16 7.2 Inspection schedules . 16 7.3 Record Retention . 17 iv 2013 Association for the Advancement of Medical Instrumentatio
40、n ANSI/AAMI EQ56:2013 8 Repair Program 18 8.1 Repair procedures 18 8.1.1 General considerations . 18 8.1.2 Alternative service methods 19 8.2 Service contracts . 19 8.2.1 General considerations . 19 8.2.2 Negotiating 19 8.2.3 Monitoring 19 8.3 Backup equipment . 19 8.4 Removal from service 19 9 Reso
41、urces . 21 9.1 Staff . 21 9.1.1 Staffing levels 21 9.1.2 Staff qualifications . 21 9.1.3 Orientation . 22 9.1.4 Ongoing education and training 22 9.1.5 Documentation 23 9.2 Budget . 23 9.3 Space 23 9.4 Test equipment, tools, and supplies 24 Annexes A Computerized maintenance management systems 25 B
42、Benchmarking . 26 D Medical equipment management standards crosswalk 28 Bibliography . 35 C Sample statistical models for evaluating inventory accuracy 27 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI EQ56:2013 v Glossary of equivalent standards International Standards ad
43、opted in the United States may include normative 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
44、and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI EQ56:2013 Committee representation Association for the Advancement of Medical Instrumentation Medical Equipment Management Committe
45、e This recommended practice was developed by the AAMI Medical Equipment Management Committee. Approval of the recommended practice does not necessarily mean that all committee members voted for its approval. At the time this recommended practice was published, the AAMI Medical Equipment Management C
46、ommittee had the following members: Chairs: Jeffrey L. Eggleston, MS PE, Covidien Paul W. Kelley, CBET, Washington Hospital Members: Stuart Albert, MBA CBET-E CHSP Chester Arnold, Harris County Hospital District Kendall Ashe, CS Medical LLC Bruce H. Barkalow, CCE PhD PE, BH Barkalow P.C. Britton E.
47、Berek, CCE MBA, Sodexo Healthcare Robert W. Borushko, GE Clinical Services Inc.-Oakwood Healthcare Systems John M. Brown, Steris Corporation John T. Collins, MSEE, American Society for Healthcare Engineering Robert M. Dondelinger, CBET-E MS, US Military Entrance Processing Command Jeffrey L. Egglest
48、on, MS PE, Covidien Dr. Hudson Garrett, Jr., Nice-Pak Products Inc. Stephen L. Grimes, FACCE FHIMSS FAIMBE, ABM Health Ethan Hertz, PE CCE MAS MS, Duke University Health System, Duke University Hospital Julio A. Huerta, EE MPH, ARAMARK, Inc. Paul W. Kelley, CBET, Washington Hospital, Fremont, CA Bar
49、bara Maguire, ISS Solutions Asaad Saadallah Mathbout, Aste Lane McCarthy, CCHT, Hortense “should” indicates that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” is used to indicate that a course of action is permissible within the limits of the recommended practice; and “can” is used as a statement of possibility and
