Human Factors / Usability Engineering Question:

QUES:  As you mentioned on the webinar, the usability engineering is done as needed based on the product. So how should we decide if we need the usability engineering on specific product? Take anesthesia needles as an example, we know this is a mature design on the market for a long time. Is there any way to prove that this similar design won’t cause any use error? By MAUDE or adverse events?"

 

ANS:  The question is -  "How similar is the new design to the old one, as to whether it raises new issues of safety and efficacy, especially around ease / safety of use?" Not -  that a current design precludes an occasional use error, as there will always be an infrequent use error with any device, even one with an optimized design for safety / intuitive use. If the new product's design is substantially unchanged, and has a long field use history, so that it's use / use interface issues would be the same as the predicate's design, then there's no need for a usability engineering study.  Your SOP on HF / UE should discuss and allow these approaches, then you have to follow your SOP. Document your rationale.

FDA's 2016 Guidance on HF / UE:  

"As part of their design controls, manufacturers conduct a risk analysis that includes the risks associated with device use and the measures implemented to reduce those risks. ANSI/AAMI/ISO 14971, Medical Devices – Application of risk management to medical devices, defines risk as the combination of the probability of occurrence of harm and the severity of the potential harm. However, because probability is very difficult to determine for use errors, and in fact many use errors cannot be anticipated until device use is simulated and observed, the severity of the potential harm is more meaningful for determining the need to eliminate (design out) or reduce resulting harm. If the results of risk analysis indicate that use errors could cause serious harm to the patient or the device user, then the manufacturer should apply appropriate human factors or usability engineering processes according to this guidance document. This is also the case if a manufacturer is modifying a marketed device to correct design deficiencies associated with use, particularly as a corrective and preventive action (CAPA)."  

--  https://www.fda.gov/media/80481/download , pg 2, para 1

 

Yes, MAUDE / adverse events would be one of several (see the UE File template example in my slides) possible sources to check.  If there could be a questions as the need to do a UE analysis, and you chose not to, you could do a one or two page plus "UE File" stating the limited analysis done to reach the conclusion that a full-blown study was not needed.

Patient / Device Risk Management (ISO 14971) is always done on new device and major change to existing devices.  Human factors / usability engineering is done as needed, per the above in red.  Each activity is described in a File, which is part of Design Control (or CGMP Change Control) depending on where or when in the product's life cycle the initial design or design change is initiated. 

 

-- jel@jelincoln.com 

To the first paragraph under "answer", added new last sentence on "document your answer." - JEL 05/01/24