1、ANSI/AAMI AT6:2013Autologous transfusion devicesAmerican 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 understood. The objectives of AAMIs te
2、chnical 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 encouragement of new technologies. It is AA
3、MIs 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 standard for a medical device reco
4、mmends 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 the device conforms with the safe
5、ty 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, and other data considered impo
6、rtant 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 on these tests can represent a c
7、onsiderable 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 rationale. A recommended practi
8、ce 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 its performance will be mainta
9、ined. 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 healthcare professionals, it m
10、ay 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 sterilization processing, methods of col
11、lecting 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 practice is relevant to the specif
12、ic 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 standard or recommended practice is
13、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 nationally (and sometimes internat
14、ionally). 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 responds generally to perceived risks
15、 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 once every five years), a stand
16、ard 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 reveal whether the document rem
17、ains 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 existing equipment typically form the
18、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 be used as one resource, but the
19、 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 individual institution or firm. Aga
20、in, 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 information and policy guidanc
21、e 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 Programs. An official interpret
22、ation 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 publication of notice of interpretation
23、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 accordance with this procedure a
24、nd which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI AT6:2013 (Revision of ANSI/AAMI AT6:2006/(R)2011) Autologous transfusion devices Developed by Association for the Advancement of Medical Instrumentation Approved 27
25、August 2013 by American National Standards Institute Abstract: This standard establishes labeling and performance requirements, test methods, and terminology that will help define a reasonable level of safety and efficacy for autologous transfusion devices. Specifically, it includes requirements for
26、 sterile, disposable systems and associated electromechanical hardware designed to collect and filter or process, or both, extravasated blood for reinfusion of erythrocytes or filtered whole blood into the patients circulation. Aspects of these systems related to collection, anticoagulation (systemi
27、c and device), storage, processing and filtration, and reinfusion are within the scope of this standard. Keywords: autologous, transfusion, blood, hemoglobin, reinfusion, infusion AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of tho
28、se substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard.
29、AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the
30、 date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at HUwww.aami.orgUH. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by
31、 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 responsible for
32、 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 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is sub
33、ject 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 illegal under
34、 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 penalties, and
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36、ited States of America ISBN 1570205035 Contents Glossary of equivalent standards iv Committee representation . v Foreword . vi 1 Scope 1 1.1 General . 1 1.2 Inclusions 1 1.2.1 Emergency/trauma devices . 1 1.2.2 Intraoperative retrieval devices 1 1.2.3 Postoperative devices 1 2 Normative references .
37、 1 3 Definitions . 2 4 Requirements . 3 4.1 Labeling requirements 3 4.1.1 Electromechanical device markings 3 4.1.2 Disposable blood contact components 4 4.1.3 Operators manual/instructions for use 4 4.1.4 Service manual 5 4.1.5 Collection container labeling 5 4.2 Performance requirements . 5 4.2.1
38、System integrity . 5 4.2.2 Cleanliness 5 4.2.3 Device anticoagulation . 5 4.2.4 Filtration . 6 4.2.5 Interface characteristics . 6 4.2.6 Material safety requirements . 6 4.2.7 Electrical safety 6 4.2.8 Electromagnetic compatibility 6 5 Tests . 6 5.1 Compliance with labeling requirements 7 5.2 Compli
39、ance with performance requirements 8 5.2.1 System integrity . 8 5.2.2 Cleanliness 9 5.2.3 Device anticoagulation . 9 5.2.4 Filtration . 9 5.2.5 Interface characteristics . 10 5.2.6 Material safety requirements . 10 5.2.7 Electrical safety 10 Annexes A Rationale for the development and provisions of
40、this standard 11 Bibliography 18 iv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI AT6:2013 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current lis
41、t 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 Standard. www.aami.org/standards/glossary.pdf 2013 Association for the Advan
42、cement of Medical Instrumentation ANSI/AAMI AT6:2013 v Committee representation Association for the Advancement of Medical Instrumentation AAMI Blood Filter/Cell Salvaging Committee This standard was developed by the Blood Filter/Cell Salvaging Committee. Committee approval of this standard does not
43、 necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Blood Filter/Cell Salvaging Committee had the following members: Cochair: Ralph Slepian, MD Members: Corey Bercaw, Zimmer, Inc. Dawn Desiderio, MD, Memorial Sloan Kettering Cancer
44、Center Trevor Huang, PhD MBA, Medtronic Perfusion Systems Melissa S. Pessin, MD PhD, Memorial Sloan Kettering Cancer Center Betsy Poindexter, U.S. Food and Drug Administration/Center for Biologics Evaluation and Research David Louis Reich, MD, Mount Sinai School of Medicine George Silvay, MD, PhD, M
45、ount Sinai Medical Center Ralph Slepian, MD, New York Presbyterian Hospital Catherine Wentz, US Food and Drug Administration/Center for Devices and Radiological Health Alternates: Lauren Clark, Terumo BCT Lindsey Lorenz, Zimmer Orthopaedic Surgical Products Jaroslav G. Vostal, MD, PhD, U.S. Food and
46、 Drug Administration/Center for Biologics Evaluation and Research NOTEParticipation by federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies. vi 2013 Association for the Advancement of Medical Instrumentati
47、on ANSI/AAMI AT6:2013 Foreword This AAMI standard was developed by the Blood Filter/Cell Salvaging Committee as the result of a periodic review of ANSI/AAMI AT6:2006/(R)2011. Now in its fourth edition, this document was originally approved as an American National Standard in May, 1982 under the titl
48、e Autotransfusion devices. The objective of this standard is to provide labeling and performance requirements, test methods, and terminology that will help establish a reasonable level of safety and efficacy for autologous transfusion devices. The most significant differences between the third and f
49、ourth editions of this standard are updates intended to reflect current technology and updates to references. As used within the context of this document, “shall” indicates requirements strictly to be followed to conform to the standard. “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”
