1、ANSI/AAMIEC57: 2012Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithmsAmerican 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 rec
2、ommended 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 to p
3、atient 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 restrict
4、ive 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 tha
5、t 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, instructio
6、ns 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 uniformi
7、ty 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 establishing th
8、e 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 device is
9、 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 recommended
10、 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 industrial pe
11、rsonnel 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 whethe
12、r 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 aut
13、horities). 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 representati
14、ves, 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 limited,
15、 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. Despite pe
16、riodic 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 each
17、 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 obs
18、erved 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 product as
19、 “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 spe
20、cific 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 used
21、 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 AAMI
22、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 exhaust
23、ion 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 not
24、 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 EC57:2012 (Revision of ANSI/AAMI EC57:1998/(R)2008) Testing and reporting performance results of
25、cardiac rhythm and ST segment measurement algorithms Developed by Association for the Advancement of Medical Instrumentation Approved 18 December 2012 by American National Standards Institute, Inc. Abstract: This recommended practice establishes a method for testing and reporting the performance of
26、algorithms used to detect cardiac rhythm disturbances, including the ST segment. Keywords: arrhythmia database, arrhythmia monitoring, ST segments, heart rate variability AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a c
27、onsensus 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, purchasing, or using products, processes, or proc
28、edures not conforming to the recommended practice. 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 require that action be taken to
29、 reaffirm, revise, or withdraw this recommended practice no later than five years from the date of publication. Interested parties can obtain current information on all AAMI documents by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other type
30、s 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 procurement authorities, in which case t
31、he 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 2013 by the Association for the Advancement of Medical Instrumentation All Righ
32、ts 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 prohibited by law. It is illegal under fe
33、deral 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 da
34、mages 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, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703525-1067. ISBN 1-57020-478-0 Contents P
35、age Glossary of equivalent standards . v Committee representation . vi Foreword vii 1 Scope 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclusions 1 2 Definitions of abbreviations . 1 3 Algorithm testing . 2 3.1 Databases . 2 3.1.1 General description of available databases 2 3.1.2 Records to be excluded
36、 during testing 3 3.2 Testing requirements . 3 3.3 Test environment . 3 3.4 Multiple-lead analysis 4 3.5 Requirements for the evaluation report . 4 3.5.1 Required statistics . 4 3.5.2 Requirements for all arrhythmia algorithms . 4 3.5.3. Requirements for algorithms with optional capabilities . 5 3.6
37、 Simulated test patterns 7 4 Automated analysis 7 4.1 Use of standard databases 7 4.2 Use of annotation files . 8 4.3 Beat-by-beat comparison. 9 4.3.1 General description . 9 4.3.2 Method for beat-by-beat comparison. 10 4.3.3 Heart rate, and heart rate or RR interval variability . 10 4.3.3.1 Heart r
38、ate measurement . 10 4.3.3.2 Heart rate variability or RR interval variability measurement from databases. 11 4.3.3.3 Heart rate variability or RR interval variability measurement of test patterns 12 4.4 Run-by-run comparison . 14 4.4.1 General description . 14 4.4.2 Terms and symbols . 15 4.4.3 Run
39、 sensitivity summary matrix . 16 4.4.4 Run positive predictivity summary matrix 16 4.5 VF and AF comparisons 16 4.6 ST comparison. 17 Annex A Rationale and additional guidance . 22 Tables Table 1Requirements for all arrhythmia algorithms 5 Table 2Requirements for algorithms with optional capabilitie
40、s 6 Table 3Beat label classifications 9 Table 4AHA and MITBIH database labels distributed for use by HRV algorithms . 12 Table 5Example of noise floor calculation results 13 Table 7Run sensitivity summary matrix 15 Table 8Run positive predictivity summary matrix . 15 Table A.1Records to be included
41、in a complete test 23 Table A.2Example of a line-format, beat-by-beat performance report . 26 Table A.2.1Condensed beat-by-beat summary matrix containing 11 elements . 26 Table A.2.2Summary table (matrix format) of beat-by-beat comparison 27 Table A.3Example of a line-format shutdown report 27 Table
42、 A.4Example of a line-format report . 28 Table A.5Example of VF performance report . 29 Table A.6Example of false VF performance report 29 Table A.7Example of a line-format couplet and run performance report 30 Table A.8Example of results of HRV program run on MITBIH database reference annotations 3
43、1 Table A.9Example of device measurements of synthetic test patterns 31 Table A.10Example of predicted ideal values for synthetic test patterns . 32 Table A.11Example of choice of test patterns 32 Table A.12Example of RMS interval differences 34 Table A.13Example of summary of frequency components .
44、 35 Table A.14Example of a line-format report . 36 Figures 1 Example of scatter plot of ST amplitude measurement . 18 2 Example of scatter plot of ST amplitude measurement . 18 3 Example of scatter plot of ST amplitude measurement (-200 microvolt to + 200 microvolt reference) 19 4 Example of scatter
45、 plot of ST slope measurement error . 20 5 Example of scatter plot of ST slope measurement 21 Table 6example of HRV test results . 14 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI EC57:2012 v Glossary of equivalent standards International Standards adopted in the United S
46、tates 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 and level of equivale
47、ncy to the International Standard. www.aami.org/publications/standards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI EC57:2012 Committee representation Association for the Advancement of Medical Instrumentation Electrocardiograph (ECG) Committee This recom
48、mended practice was developed by the ECG Committee of the Association for the Advancement of Medical Instrumentation. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Electrocardiograph
49、Committee had the following members: Cochairs: Richard A. Sunderland Ahmet Turkmen Brian J. Young Members: Robert William Bain, CBET, Baltimore Medical Engineers “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 is discouraged but not prohibited; “may” is used to indicate that a course of action is permissible within th
