ANSI HE75-2009 Human factors engineering C Design of medical devices.pdf

1、ANSI/AAMI HE75:2009/(R)2013Human factors engineering Design of medical 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 understo

2、od. 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 encouragement

3、 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 stan

4、dard 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 the

5、 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 precautions,

6、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 on

7、 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 the r

8、ationale. 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 that

9、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 towards

10、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 sterilizat

11、ion 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 prac

12、tice 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 standa

13、rd 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 nati

14、onally (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 respond

15、s 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 least o

16、nce 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 will r

17、eveal 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 existing

18、 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 be

19、 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 indiv

20、idual 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 of

21、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 and P

22、rograms. 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 publicatio

23、n 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 ac

24、cordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. AAMISingle user license provided to AAMI standards committee members.American National Standard ANSI/AAMI HE75:2009/(R)2013 (Revision of ANSI/AAMI HE48:1993) Human factors

25、engineering Design of medical devices Developed by Association for the Advancement of Medical Instrumentation Approved 21 October 2009 and reaffirmed 26 November 2013 by American National Standards Institute Inc. Abstract: This recommended practice covers general human factors engineering (HFE) prin

26、ciples, specific HFE principles geared towards certain user-interface attributes, and special applications of HFE (e.g., connectors, controls, visual displays, automation, softwareuser interfaces, hand tools, workstations, mobile medical devices, home health care devices). Keywords: anthropometry, d

27、esign process, ergonomics, human factors engineering, medical device AAMI Recommended 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 reco

28、mmended 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 procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic

29、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 reaffirm, revise, or withdraw this recommended practice no later than five years from the date of pub

30、lication. Interested parties may obtain current information on all AAMI standards 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 applicat

31、ion 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 enforcement of its rules and regulatio

32、ns. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2010 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission

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36、s committee members.Contents Page Glossary of equivalent standardsxiii Committee representation.xv Acknowledgments.xvi Foreword.xvii Introduction .1 1 Scope.5 1.1 General.5 1.2 Inclusions5 1.3 Exclusions.5 2 Normative references.6 3 Definitions and abbreviations.7 General Considerations and Principl

37、es 4 General principles 14 4.1 Introduction.14 4.2 Seek user input.14 4.2.1 Involve users early and often14 4.2.2 Refine designs through usability testing .14 4.3 Establish design priorities .14 4.3.1 Keep it simple.14 4.3.2 Ensure safe use15 4.3.3 Ensure essential communication15 4.3.4 Anticipate d

38、evice failures16 4.3.5 Facilitate workflow 16 4.4 Accommodate user characteristics and capabilities .16 4.4.1 Do not expect users to become masters 16 4.4.2 Expect user errors 17 4.4.3 Accommodate diverse users 17 4.4.4 Maximize accessibility 18 4.4.5 Consider external factors that influence task pe

39、rformance.18 4.5 Accommodate users needs and preferences.19 4.5.1 Prioritize user input.19 4.5.2 Do not rely exclusively on “thought leaders“.19 4.5.3 Let users set the pace 19 4.6 Establish realistic expectations of users .19 4.6.1 Do not rely on training 19 4.6.2 Do not rely on instructions for us

40、e 19 4.6.3 Do not rely on warnings20 4.6.4 Do not rely on users memory.20 4.6.5 Avoid information overload .20 4.6.6 Do not assign users tasks that are better suited to the device .20 4.7 Consider real-world demands .21 4.7.1 Consider the context of use21 4.7.2 Consider worst-case scenarios.21 4.7.3

41、 Make devices as rugged as necessary.22 4.7.4 Limit user workload.22 4.7.5 Consider the potential for device migration into other uses or use environments.22 4.8 Develop compatible designs.23 4.8.1 Accommodate mental models 23 4.8.2 Establish natural or conventional mappings .23 4.8.3 Follow industr

42、y conventions and consensus standards24 4.9 Optimize user interactions to enhance safety and effectiveness 24 4.9.1 Make devices error-tolerant and fail in a safe manner24 4.9.2 Avoid physical strain, repetitive motions, and cumulative traumas.24 AAMISingle user license provided to AAMI standards co

43、mmittee members.4.9.3 Help users anticipate future events 24 4.9.4 Confirm important actions.24 4.9.5 Make critical controls robust and guard them .25 4.9.6 Clarify operational modes.25 4.9.7 Employ redundant coding.25 4.9.8 Design to prevent user confusion .26 4.9.9 Dont neglect device appeal26 4.1

44、0 Summary26 4.11 References.27 5 Managing the risk of use error .29 5.1 Introduction.29 5.1.1 Overview 29 5.1.2 Use-related hazards vs. traditional device-failure hazards .29 5.1.3 Behavioral variability in human users .30 5.1.4 Definition of use error .30 5.2 Types of use errors.30 5.3 General cons

45、iderations for managing use-related hazards.34 5.3.1 Use-error consequences in regulatory submissions .34 5.3.2 General considerations for managing risk 34 5.4 Methods of managing the risk of use errors34 5.4.1 Overview 34 5.4.2 Risk, risk management, and use safety34 5.4.3 Use-error risk management

46、 process 35 5.5 Definition of intended use, user, and the use environment .36 5.6 Identification of use-related hazards .37 5.6.1 Overview 37 5.6.2 Analysis of predecessor and similar devices 37 5.6.3 Analysis of device use tasks.37 5.6.4 Application of best practice for user-interface design .38 5.

47、6.5 Consideration of user workload in device use 38 5.7 Estimation and prioritization of risk of use-related hazards.38 5.7.1 Overview 38 5.7.2 Failure mode effects analysis .38 5.7.3 Fault tree analysis 39 5.7.4 Usability testing 39 5.8 Implementation of risk controls .40 5.8.1 Overview 40 5.8.2 Mo

48、st preferred use-related hazard mitigation strategies.40 5.8.3 Less preferred use-related hazard mitigation strategies.40 5.9 Validation of safety of use (effectiveness of risk controls).41 5.10 Decision on whether risks are acceptable41 5.11 Determination of whether new risks were introduced.41 5.1

49、2 Documentation of the use-related risk management process 41 5.13 Monitoring, identification, and control of use-related issues post-marketing 42 5.14 Summary42 5.15 References.42 6 Basic human skills and abilities44 6.1 Introduction.44 6.2 Design guidelines .44 6.2.1 Overview 44 6.2.2 Vision44 6.2.3 Audition and speech.55 6.2.4 Other sensory modalities58 6.2.5 Human information processing.60 6.2.6 Human memory62 6.2.7 Human response capabilities65 6.2.8 Human vs. machine capabilities .67 6.3 References .68 7 Anthropometry and biomechanics71 7.1 Introduction.71 7.2 General cons