Bringing Legacy Medical Devices into Usability Compliance. Shannon Clark 4/29/2015
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1 Bringing Legacy Medical Devices into Usability Compliance Shannon Clark 4/29/2015
2 Agenda What is a legacy device? Background on Usability Engineering Standards What is the roadmap for bringing legacy devices into compliance? How do I actually follow the roadmap?
3 What is a Legacy Medical Device? A Legacy medical device is a device that was developed without following the Usability Engineering Process
4 Example 1: Existing Device Image source:
5 Example 2: Modified Hardware Image source: cataract-surgery/phacoemusification-cataract-surgery
6 Example 3: Modified Software Image Source:
7 Usability Engineering Process Standard, IEC Application of usability engineering to medical devices
8 History of IEC Present IEC 62366:2007 IEC 62366:2014 IEC :2015
9 History of IEC Present IEC 62366:2007 IEC 62366:2014 IEC :2015 Annex K Usability Engineering Process for Legacy Devices
10 IEC 62366:2014, Annex K: Usability of Unknown Provenance (UOUP)
11 Usability Engineering File
12 Usability Engineering File for legacy device
13 Summary of Known Use Errors Identify, record, and evaluate hazard-related use scenarios from the field
14 Use-Related Risk Analysis Review Risk Analyses to ensure that hazards and hazardous situations associated with Usability have been identified and documented Prepare a FULL Use- Related Risk Analysis
15 Incomplete Use-Related Risk Analysis: Hazard Harm Severity Likelihood RPN User Error led to device malfunc3on Pa3ent injury User uses device past expira3on Pa3ent injury 9 1 9
16 Incomplete Use-Related Risk Analysis: Hazard Harm Severity Likelihood RPN User Error led to device malfunc3on Pa3ent injury User uses device past expira3on Pa3ent injury 9 1 9
17 Primary Operating Functions Document the Primary Operating Functions
18 Application Specification (Use Specification) Record the Application Specification Ensure its contents are in the Instructions for Use
19 Usability Engineering File List document part numbers in a record
20 Recommended Project Workflow Review existing Risk Analyses Identify Primary Operating Functions, Users, and Use Environments Draft Use-Related Risk Analysis Research Complaints and Draft Summary of Known Use Errors Finalize Use-Related Risk Analysis & Summary of Known Use Errors Is Residual Risk Acceptable?
21 Recommendations Use the user manual as a starting point Add Application Specification to the User Manual Requirements Document Update Usability Engineering Standard Operating Procedure to address Legacy products
22 Recommendations Legacy Device Known Use Error Summary Design Input
23 Proposed Outline for a Known Use Error Summary I. Introduction II. Methodology III. Field Actions/Recalls related to use error IV. CAPAs related to use error V. Use-related MDRs VI. Use-related General Complaints (if needed) VII. Conclusion as to whether product is safe with respect to usability
24 The Question
25 The Question Is our on-market product safe enough?
26 Post-Market Surveillance Process Complaint Tracking and Trending Escalation Meeting CAPA? Field Action? Continue to Monitor?
27 Post Market Surveillance If we adequately capture, process, and track use-related complaints,
28 Post Market Surveillance If we adequately capture, process, and track use-related complaints, then we know that our products present acceptable usability risk profiles to patients and users
29
30 Classic Post-Market Pitfall Malfunction replicated Take Action Yes Complaint Device Returned for Evaluation? Malfunction not replicated No Complaint is Unconfirmed/No Trouble Found No Further Action
31 Known Use Error Summary Retrospectively try to find the events that were previously missed The ultimate question here is, Was there a complaint trend that we missed, which should have led to a CAPA or Escalation, but then it did not?
32 Complaint Hierarchy Complaints Non-safety-related complaints MDRs Product Malfunctions Adverse Events Harm occurred
33 Complaints Risk Analysis Complaints N/A MDRs Hazardous Situations (including near-misses) Adverse Events Harm
34 Use-Related Risk Analysis Adverse events inform likelihood of occurrence for risks # Instances of harm # Instances of use # Adverse Events # Instances of use
35 Example Use-Related Risk Analysis Task Use Error Hazardous Situa;on Harm Severity Likelihood Risk Index Tubing falls out Insert Yellow Tubing Yellow Tubing and tube Significant in the receptacle and confirm insufficiently outputs do not seated in the provide delay as the the Moderate Improbable 3 - Tolerable situa3on is properly seated receptacle adequate flow resolved. Press the Yellow Tubing valves into the outer receptacles User unable to push valves into receptacles and installs incorrect por3on of tubing instead Flow is Loss of restricted, func3onality leading to lower leads to minor flow rate and devia3on in lack of effect. workflow. # Adverse Events # Instances of use Negligible Remote 4 - Broadly Acceptable
36 Drawbacks Complaints can be under-reported Complaints can be vague, incomplete, and inaccurate
37 Addressing Vague Complaints ORIGINAL RISK: NEW RISK: Use Error Hazardous Situa;on Harm Severity Likelihood Risk Index Tubing falls out Yellow Tubing and tube insufficiently outputs do not seated in the provide Significant delay as the the Moderate Improbable 3 - Tolerable situa3on is receptacle adequate flow resolved. Hazardous Situa;on Harm Severity Likelihood Risk Index Inadequate flow leads to delay. May occur due to: - Insufficiently sea3ng the tubing - Damage to the port due to Moderate Remote 3 - Tolerable - - dropping Use of the incorrect disinfectant wipe during cleaning Tubing is kinked Significant delay as the the situa3on is resolved.
38 Residual Risk Acceptability If # Adverse Events # Instances of use UNACCEPTABLE then we know that our product presents UNACCEPTABLE usability risk profiles to patients/users
39 Residual Risk Acceptability If # Adverse Events # Instances of use UNACCEPTABLE then re-design the device.* *If re-design is not possible, updating the IFU (if such a change would be effective in mitigating the risk). If addressing the use error is not possible, perform a Risk/Benefit Analysis
40 Conclusion Legacy medical devices should conform to IEC The Post-Market Surveillance process is essential for confirming product safety
41 Questions? Shannon E. Clark, P. E. (650)
42 BACKUP SLIDES
43 THE FUTURE: IEC :2015, Annex C Usability of Unknown Provenance (UOUP) No longer have to update Accompanying document No longer have to record Primary Operating Functions
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