When to Use Device Risk Management and/or Human Factors in Device Design

IEC 62366-1 outlines a process (9 stages) to follow to perform a Use Engineering / Human Factors analysis.  The specifics for the actual UE/HF tests (formative / verification or summative / validation) is found in other standards and guidances.  UE/HF is only needed where the user interface presents challenges of use[r] error and/or the device is specifically listed by the US FDA as needing such. 

In other cases it does not have to be used, e.g., where the use(r) interface (device shape, weight, color, knob usage, graphic output, alarm output, keyboard input, on-unit labeling, etc.), is intuitive, familiar, not prone to excessive use[r] error, et al.  

On the other hand, device Risk Analysis / Management per ISO 14971 (patient / user / environment  safety (and regulatory compliance), is always required, for both new product development as well as in significant changes - this will be more emphasized with the new device QMSR (new 21 CFR 820), but it is a current expectation of the FDA.

Both these tools, when used, are to be used to feed into any new designs or design changes, to use the design process to reduce use risk or use error or both. 

Possible UE/HF File Format (IEC 62366-1):  1) Intro, device description, approvals, discussion of device under evaluation, executive summary of findings, and similar background; 2) A section on each of the 9 stages in IEC 62366-1 (discuss specific tests used under Stage 5 -  5.7.1, 5.7.2 and 5.7.3 - of IEC 62366-1 in the UE/HF File); 3) Conclusions (mitigations...).

Possible Device Risk Management File (ISO 14971, or ICH Q9):  Intro, as above, assumptions, risk management team, preferably including a clinician familiar with the device's use; 2) Hazard Analysis; 3) Expand Hazards with a Fault Tree Analysis; 4) Expand Hazards with three FMEAs / FMECAs:  I) Design FME[C]A, II) Process FME[C]A, and III) Use  FME[C]; 5)Review/Report - Residual Risks, Benefit / Risk analysis / statement.   Use FTA and FME[C]As with the addition of a "Normal Usage Causing Problems" Matrix.  This format has been reviewed in detail by the FDA in 2003 and extensively used and subject to FDA and Notified Body inspections and remediation projects since then with no negative comments / findings / 483s. 

-- John E. Lincoln