How your Post Market Surveillance data can help you with the usability of your established medical device
Usability of medical devices is a hot topic
Recently we have been seeing an increase in the number of manufacturers undergoing technical file reviews for long-standing devices and having non-conformities raised by their Notified Body for not addressing usability. Sound familiar? Suddenly faced with the prospect of conducting a usability study that is expensive and time consuming they reach out for guidance. So today I wanted to share with you a solution that you may not be aware of.
ISO 62366 and UOUP (User Interface of Unknown Origin)
Did you know that ISO 62366-1:2015 has the option for USER INTERFACES or parts of USER INTERFACES for your device that were commercialised prior to the standard being published to be considered as UOUP (USER INTERFACE OF UNKNOWN ORIGIN) and instead of having to comply with all the requirements of the main sections of the standard you can evaluate your device according to Annex C. Those lovely people that wrote the standard were smart to understand that this standard is meant to be used during the development of your device and obviously your device has already been developed. So, Annex C – this bad boy allows you to assess the usability of your device by reviewing your post market surveillance data. What you say! I know, good right.
But a word of caution – if any changes to your device’s USER INTERFACE or its parts have been made then they are subject to Clauses 5.1 – 5.8 of the standard. Only the unchanged parts of the USER INTERFACE remain in UOUP and can undergo this review.
Post Market Surveillance Data and Usability
So, Annex C asks you to establish a Use Specification and to review your post production data including complaints and field reports for incidents or near incidents. So, if you have been good at gathering your post market data and let’s face it that’s all Notified Bodies and other blog sites have been telling us to do in preparation for MDR, then you should have the data to assess the usability of your device based on your feedback from your users. Link this with your risk assessment and you now have a Usability Engineering File for your device and comply with the standard.
What originally seemed like a mammoth task or a show stopper for some, is not quite so scary.