1、ANSI/AAMI/ISO 5841-2: 2014Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leadsAmerican National StandardAAMI/American National Standard ANSI/AAMI/ISO 5841-2:2014 Implants for surgery Cardiac pacemakers Part 2: Reporting of clin
2、ical performance of populations of pulse generators or leads Developed by Association for the Advancement of Medical Instrumentation Approved 21 July 2014 by American National Standards Institute Abstract: Specifies requirements for reports on the clinical performance in humans of population samples
3、 of pulse generators or leads, intended for long-term implantation as cardiac pacemakers. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate. Keyw
4、ords: clinical performance, pacemakers, ICDs, leadsAAMI 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 anyo
5、ne, whether they 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 s
6、tandard may be revised or withdrawn at any time.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 date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by v
7、isiting the AAMI website at www.aami.org 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 the document. Occa
8、sionally, 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 4301 N. Fairfax Dri
9、ve, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including a
10、n 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 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 th
11、e prior written permission 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 f
12、orm at HUwww.aami.orgUH or 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 1-57020-552-3 Contents Page Glossary of equivalent standards iv Committee representation . v Background of
13、 ANSI/AAMI adoption of ISO 5841-2:2014 vi Foreword . vii Introduction . viii 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 General requirements 5 4.1 Frequency of publication 5 4.2 Method of publication 5 4.3 Report organization . 5 4.4 Criteria for inclusion and removal of reported
14、 models and device families . 5 4.5 Source of performance report data 5 4.6 Product performance report Required content 6 4.6.1 Textual and numeric data 6 4.6.2 Estimated device survival probability 6 4.7 Adjustment for under-reported events 8 5 Particular reporting requirements 8 5.1 Reporting puls
15、e generator performance . 8 5.2 Reporting lead performance . 8 5.2.1 Reporting malfunctions Leads . 9 5.2.2 Reporting chronic lead complications based on complaint information 9 5.2.3 Reporting acute lead complications based on complaint information . 10 5.2.4 Reporting leads cumulative survival pro
16、bability 11 Annex A (normative) Statistical method for survival analysis and discussion of application of results obtained 13 A.1 Introduction 13 A.2 Statistical method for device performance reporting . 13 A.3 Discussion of application of results obtained 18 Annex B (informative) Rationale 22 B.1 G
17、eneral . 22 B.2 Specific remarks 22 Bibliography . 26 Glossary of equivalent standards International Standards adopted 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 (a
18、nd 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 iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5841-2:2014 Co
19、mmittee representation Association for the Advancement of Medical Instrumentation Cardiac Rhythm Management Devices Committee The adoption of ISO 5841-2 as an American National Standard was initiated by the AAMI Cardiac Rhythm Management Device Committee. The AAMI Cardiac Rhythm Management Device Co
20、mmittee also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Cardiac Rhythm Management Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 6/JWG 1) played an active part in developing the I
21、SO standard. At the time this document was published, the AAMI Cardiac Rhythm Management Devices Committee had the following members: Chairs: Roger G. Carrillo, MD, University of Miami Hospital Robert A Stevenson, Greatbatch Inc Members: Luis Arabia Cortes, Instituto Oulton Tushar Dharampal, St Jude
22、 Medical Inc Charles S. Farlow, Medtronic Inc WHQ Campus Mark Fichman, BioControl Medical Veronica Ivans, IMD Standards LLC Charles E.H. Kennergren, Sahlgrenska University Hospital Ronald Reitan, Boston Scientific Corporation Mitchell J. Shein, FDA/CDRH Lawrence J. Stotts, PhD, Micro Systems Enginee
23、ring Inc William D. Toff, University of Leicester Frank Tyers, MD FRCSC FACS FACC, University of British Columbia Alternates: Daniel Cooke, Boston Scientific Corporation Soma Kalb, PhD, FDA/CDRH Ashish Shah, PhD, Greatbatch Inc Charles B. Sidebottom, PE, PPO Standards LLC (representing Medtronic Inc
24、) Paul Stadnik, Micro Systems Engineering Inc NOTE-Participation by federal agency representatives in the development of this document does not constitute endorsement by the federal government or any of its agencies. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5841-
25、2:2014 v Background of ANSI/AAMI adoption of ISO 5841-2:2014 As indicated in the foreword to the main body of this document (page viii), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO members that t
26、ook an active role in the development of this standard, which was developed by ISO Technical Committee 150, Implants for surgery, Subcommittee (SC) 6, Active implants, to provide requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads
27、, intended for long-term implantation. U.S. participation in ISO/TC 150/SC 6 is organized through the U.S. Technical Advisory Group to ISO/TC 150/SC 6, administered by the Association for the Advancement of Medical Instrumentation. Experts from the United States made a considerable contribution to t
28、his standard. ANSI/AAMI/ISO 5841-2:2014 was approved by the American National Standards Institute (ANSI) on 21 July 2014. AAMI and ANSI procedures require that standards be reviewed every five years and, if necessary, revised to reflect technological advances that may have occurred since publication
29、. AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI, which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. As used within the context of this document, “shall” indicates
30、requirements strictly to be followed to conform to the recommended practice. “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
31、 (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. “Can” is used as a statement of possibility and capability. Finally, “must” is us
32、ed only to describe “unavoidable” situations, including those mandated by government regulation. The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological
33、developments. To remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Dr, Suite 301, Arlington, VA 222
34、03-1633. NOTEBeginning with the ISO foreword on page viii, this American National Standard is identical to ISO 5841-2:2014. vi 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5841-2:2014 Foreword ISO (the International Organization for Standardization) is a worldwide fe
35、deration of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that com
36、mittee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document
37、and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, P
38、art 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of
39、 the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific
40、 terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 150, Implants for surg
41、ery, Subcommittee SC 6, Active implants. This third edition cancels and replaces the second edition (ISO 5841-2:2000), which has been technically revised. ISO 5841 consists of the following parts, under the general title Implants for surgery Cardiac pacemakers: Part 2: Reporting of clinical performa
42、nce of populations of pulse generators or leads Part 3: Low-profile connectors (IS-1) for implantable pacemakers 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5841-2:2014 vii Introduction ISO 14708-2:2012, 28.19 requires the clinicians manual to document the projected
43、 service life using defined settings. Expectations of available power-source energy are not always fulfilled, and changes in pulse-generator components and assemblies have resulted in an actual service life which is different from the projected service life. Defined production groups of pulse genera
44、tors or leads have required closer follow-up or replacement due to changes in performance exhibited in clinical use. Programmed settings and differing or changing patient therapy needs might also result in a device having more or less than the projected service life as defined by ISO 14708-2. In add
45、ition, clinical management and implant technique can have a significant impact on long term performance of lead and pulse generators. These variables are reflected in the product performance report data. These factors underscore the value of maintaining an accurate and discriminating view of clinica
46、l performance of a population of devices within the scope of this part of ISO 5841, so as to aid patient management. In order to do this, it is necessary to collect implant and explant information as allowed by local law. Physicians and clinicians are encouraged to report their complaints and return
47、 associated explanted devices to the device manufacturers to support the accuracy of product performance reports. It is recognized that certain devices are marketed in geographies where device implant and explant data are not available due to patient privacy laws. This situation requires manufacture
48、rs to apply alternative methods to calculate survival probability. The primary purpose of this part of ISO 5841 is to describe the reporting responsibilities in sharing clinical performance information for patient management. When clinical performance reports discriminate by production group and foc
49、us on recent experience, they are of value in patient management. This part of ISO 5841 concerns the clinical performance of devices, not the clinical reasons for their use. It is realized that reasons for use can be a guide in the design of future products. Reporting parties can give cumulative clinical-experience information based on a variety of assumptions and statistical techniques. This part of ISO 5841 provides a method for categorizing devices, requirements for the statistical techniques (see Annex A) that shall be used to obtain the most benef
