Regulatory expectations on user engagement for medical devices
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1 Regulatory expectations on user engagement for medical devices World Usability Day Enschede November 13 Sonja Paus-Buzink PhD Managing Human Factors Specialist Human Factors Engineering UL and the UL logo are trademarks of UL LLC 2013
2 My background - Industrial Design Engineering MSc Friendly Rest Room project PhD Medisign Laparoscopic Surgical Skills programme 2
3 3
4 UL-Wiklund Wiklund R&D became part of UL in 2012 Provide human factors engineering (HFE) support to product designers and manufacturers Specialize in medical technology but work on many other types of products Have served over 100 clients globally Completed over 500 projects involving user interface development and evaluation 4
5 Services HFE Program Development User Research HFE Analysis User Interaction Design Support Use-Safety and Usability Evaluation HFE Education 5
6 Troubling statistics
7 Timeline 1993: ANSI/AAMI HE48:1993 (design guidelines) 1995: Joint AAMI and FDA conference on HF 1996: Quality System Regulation (QSR); indirect requirements for HFE added 1997: End of grace period to incorporate HFE in medical device design process 1999: IOM report on medical error 2001: ANSI/AAMI HE74:2001 (HFE process standard) 2005: FDA perceived as stepping-up enforcement of HFE-related requirements 2006: IEC collateral standard (AAMI HE74 is informative annex) 2007: ISO/IEC 62366:2007 (AAMI HE74 included as informative annex) 2008: EU adopts ISO/IEC 62366:2007 as basis for CE mark 2008: FDA s HFE team moves into Office of Device Evaluation 2009: ANSI/AAMI HE75:2009 (HFE methods and design guidelines) 2012: Adoption of 3rd edition of IEC by Europe and Canada 2013: Adoption of 3rd edition of IEC by USA 7
8 HFE requirements FDA Focus on use-safety & effectiveness Disinterested in usability goals Summative usability testing in US only IEC Broader focus on overall usability Usability goals required Accepts summative test results outside EU 8
9 Safety through better user interface design Regulators believe that the best way to mitigate risk is by implementing design improvements. Usability testing is a reliable way to identify opportunities for improvement. Regulators discourage over-reliance on instructions for use and training to mitigate the risk of harmful user errors. Translation: Do not take a BandAid approach to mitigating use-related risk. 9
10 IEC process 10
11 IEC excerpts Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. The manufacturer shall establish, document and maintain a usability engineering process to provide safety for the patient, user and others related to usability. The results of the usability engineering process shall be recorded in the usability engineering file. The manufacturer shall identify known or foreseeable hazards (part of a risk analysis) related to usability 11
12 End-products prescribed in IEC Analyze user needs and specify design Medical indication Patient indication User profiles Use environment(s) Operating principles Task analysis Functional analysis Characteristics related to safety Primary operating functions Usability requirements Usability goals Usability specification Analyze risks Hazard analysis Use error analysis Known or foreseen hazards and hazardous situations Design the user interface UI models and prototypes Usability test reports User interface design Verify and validate the user interface Usability validation plan Usability validation report 12
13 Analyze user needs and specify design 13
14 Analyze user needs and specify design Observe use in different environments Involve design and engineering staff Focus on Critical Incidents 14
15 Analyze risks 15
16 16
17 17
18 Design the user interface Understand user expectations Identify users mental models 18
19 Verify and validate user interface A manufacturer s opinion of a product s usability is not evidence of usability Clinician s opinion of a product s usability is not evidence of usability 19
20 Verify and validate user interface Usability must be demonstrated through systematic analysis and usability testing Summative usability test without prior formative testing will likely fail 20
21 Questions? 21
22 Contact information US office 300 Baker Avenue, Suite 200 Concord, Massachusetts USA Telephone: +1 (978) EU office Arthur van Schendelstraat MJ Utrecht The Netherlands Telephone: Presenter Sonja Paus-Buzink Managing Human Factors Specialist URL: 22
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