Usability Testing of Medical Devices
Usability Testing of Medical Devices
复制标题
医疗器械的可用性测试
DOI：
10.1201/b10458
复制
发表时间：
2010
期刊：
影响因子：
--
通讯作者：
Allison Y Strochlic
中科院分区：
文献类型：
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作者：
E. Wiklund;J. Kendler;Allison Y Strochlic
简介 什么是可用性测试？什么是医疗器械？为什么要进行医疗器械可用性测试？可用性对监管机构重要吗？医疗器械是否需要进行可用性测试？您是否需要测试微小的设计更改？您如何向市场研究人员辩护可用性测试方法？风险管理和可用性测试 可用性测试和风险管理之间有什么关系？可用性测试可以识别与使用相关的危险吗？什么是危险的使用错误？可用性测试是评估危险使用错误发生可能性的可靠方法吗？商业要求 您能根据测试结果制定营销主张吗？测试如何影响开发进度？可用性测试是否提供责任保护？测试成本 可用性测试的报价请求应包括哪些内容？可用性测试的费用是多少？投资回报率是多少？可用性测试的剖析 可用性测试的常见要素有哪些？测试会话的正确持续时间是多长？您必须是可用性专家才能进行测试吗？是否需要“脑外科医生”来评估医疗设备？如果无法更改设计，为什么要进行测试？你如何设定期望？什么可以推迟可用性测试？测试类型 形成性可用性测试和终结性可用性测试有什么区别？什么是基准可用性测试？什么是“开箱即用”可用性测试？一次测试可以包含多名参与者吗？可以进行团体测试吗？如何进行“快速而肮脏”的可用性测试？编写测试计划 测试计划应包括哪些内容？从监管角度来看，可用性测试计划的关键要素是什么？可用性测试计划是否需要机构审查委员会 (IRB) 批准？如何保护知识产权 选择参与者样本并招募参与者 合适的样本量是多少？顾问小组成员可以在可用性测试中发挥作用吗？孩子应该参加可用性测试吗？老年人应该参加可用性测试吗？如何对有障碍的人进行可用性测试？您如何招募测试参与者？你们如何招募医生？你们如何招聘护士？如何招募外行人员？如何防止“缺席”？测试环境 在医疗环境模拟器中进行测试有什么好处？实际使用环境如何测试？您应该在参与者的工作场所进行测试吗？您可以通过网络进行可用性测试吗？您可以在实际使用中测试设备吗？如果“设备”无法移动怎么办？添加真实性 为什么以及如何分散测试参与者的注意力？ “标准化病人”能发挥什么作用？人体模型有什么用？如何模拟侵入性操作？如何模拟血液？如何模拟皮肤和注射？如何模拟损伤？如何模拟硬件交互？如何模拟其他医疗设备？选择任务 您是否必须测试所有内容？测试参与者应该执行哪些任务？为什么要关注有潜在危险的任务？评估使用安全时如何选择任务？测试是否应该包括维护和服务任务？你能测试长期可用性吗？如何测试警报？如何测试警告标签？您如何测试使用说明？如何测试符号？如何测试易读性？您如何评价包装？如何测试设备的吸引力？进行测试 试点测试的价值是什么？谁应该观察测试过程？可用性测试期间会出现哪些类型的可用性问题？测试之前、期间和之后可能会出现什么问题？测试人员承担什么风险？是否有时测试人员应该全部是女性或全部男性？用户界面设计师是否应该对自己的设计进行可用性测试？您应该何时以及如何协助测试参与者？您可以修改正在进行的测试吗？您能可靠地检测到使用错误吗？您能为测试参与者提供培训吗？您应该提供学习工具的访问权限吗？与测试参与者互动 什么时候适合要求参与者出声思考？提出问题的正确方式是什么？可用性测试中是否有幽默的地方？如何最大限度地减少参与者的疲劳？您如何保护参与者免受伤害？如果测试参与者受伤怎么办？记录测试 您应该收集哪些数据？任务时间有什么用？录制会议视频的好方法是什么？如何录制参与者与移动设备的交互？分析测试数据 哪种统计分析最有用？你如何处理异常值？您如何处理与设计无关的使用错误？报告结果 一份好的测试报告需要具备什么条件？测试报告应该包括设计建议吗？可用性测试结果会产生误导吗？你如何传达坏消息？您如何解释缺乏统计显着性？制作精彩视频需要注意什么？验证测试 设计验证与设计验证有何不同？您需要在申请研究器械豁免之前进行测试吗？临床试验可以取代总结性可用性测试吗？您可以在临床试验的同时进行可用性测试吗？您可以在不进行形成性可用性测试的情况下进行总结性可用性测试吗？资源索引
Introduction What is usability testing? What is a medical device? Why conduct usability tests of medical devices? Does usability matter to regulators? Is usability testing of medical devices required? Do you have to test minor design changes? How do you defend usability testing methods to market researchers? Risk Management and Usability Testing What is the relationship between usability testing and risk management? Can usability testing identify use-related hazards? What is a dangerous use error? Is usability testing a reliable way to assess the likelihood that a dangerous use error will occur? The Commercial Imperative Can you develop marketing claims based on test results? How does testing affect the development schedule? Does usability testing offer liability protection? Testing Costs What should a request for quotation for usability testing include? What does a usability test cost? What is the return on investment? Anatomy of a Usability Test What are the common elements of a usability test? What is a test session's proper duration? Do you have to be a usability specialist to conduct a test? Does it take a "brain surgeon" to evaluate medical devices? Why test if you cannot change the design? How do you set expectations? What can postpone a usability test? Types of Tests What is the difference between formative and summative usability testing? What is a benchmark usability test? What is an "out of the box" usability test? Can a test session include more than one participant? Can you conduct a group test? How do you conduct a "quick and dirty" usability test? Writing a Test Plan What should a test plan include? What are the key elements of a usability test plan from a regulatory perspective? Do usability test plans require Institutional Review Board (IRB) approval? How do you protect intellectual property Choosing a Participant Sample and Recruiting Participants What is an appropriate sample size? Can advisory panel members play a role in usability tests? Should children participate in usability tests? Should seniors participate in usability tests? How do you conduct a usability test involving people with impairments? How do you recruit test participants? How do you recruit physicians? How do you recruit nurses? How do you recruit laypersons? How do you prevent "no-shows?" Test Environments What is the benefit of testing in a medical environment simulator? How do you test in actual use environments? Should you test in a participant's workplace? Can you conduct a usability test over the Web? Can you test a device while it's in actual use? What if a "device" cannot be moved? Adding Realism Why and how do you distract test participants? What role can a "standardized patient" play? What use is a mannequin? How do you simulate invasive procedures? How do you simulate blood? How do you simulate skin and injections? How do you simulate impairments? How do you simulate hardware interactions? How do you simulate other medical devices? Selecting Tasks Do you have to test everything? What tasks should test participants perform? Why focus on potentially dangerous tasks? How do you choose tasks when evaluating use-safety? Should tests include maintenance and service tasks? Can you test long-term usability? How do you test alarms? How do you test warning labels? How do you test instructions for use? How do you test symbols? How do you test legibility? How do you evaluate packaging? How do you test a device's appeal? Conducting the Test What's the value of pilot testing? Who should observe the test sessions? What kinds of usability problems arise during a usability test? What can go wrong before, during, and after a test? What risk do test personnel assume? Are there times when the testing staff should be all-female or all-male? Should user interface designers conduct usability tests of their own designs? When and how should you assist test participants? Can you modify a test-in-progress? Can you reliably detect use errors? Can you give test participants training? Should you provide access to learning tools? Interacting with Test Participants When is it appropriate to ask participants to think aloud? What's the proper way to pose a question? Is there a place for humor in a usability test? How do you minimize participant fatigue? How do you protect participants from harm? What if the test participant gets hurt? Documenting the Test What data should you collect? What use are task times? What's a good way to video record a session? How do you video record participants' interactions with a moving device? Analyzing Test Data What kind of statistical analyses are most useful? How do you handle outliers? How do you deal with use errors that are not design-related? Reporting Results What makes a good test report? Should test reports include design recommendations? Can usability test results be misleading? How do you deliver bad news? How do you explain a lack of statistical significance? What goes into making a highlight video? Validation Testing How does design validation differ from design verification? Do you need to conduct a test prior to filing for an Investigational Device Exemption? Can a clinical trial supplant summative usability testing? Can you conduct a usability test in parallel with a clinical trial? Can you conduct a summative usability test without conducting a formative usability test? Resources Index