Proactive / Preventive Post Market Surveillance question

[tecgu]

Hello,


I am new to the Post Market Surveillance world and although being aware of the regulations I have little experience. I would truly appreciate if you could answer a couple of questions or point me in the right direction. My company at the moment want to strengthen the PMS but more specifically the "Preventive action" area.

How do you go about collecting active survey information for preventive actions? or what type of data you consider relevant of a "preventive" nature?
Distribution of surveys in conferences and customers? literature research? what type of KPIs?
Do you know where could i find a questionnaire example for a medical device?

I would really appreciate your experience

Thanks a lot!

 

[Sidney Vianna]

Welcome to The Cove. Look at this thread for an example of data that could lead you to take preventive actions.

 

[yodon]

Taking preventive action just means a nonconformity hasn't occurred. There are certainly many avenues that might reveal improvements or the potential for nonconformities.

One source, as you maybe alluded to, is looking at device report databases (e.g., MAUDE) for similar products.

Another could be from internal testing.

Use data (possibly from surveys or complaints) can identify uses you may not have expected which could lead to preventive actions in the UI.

If your device is serviced, observations of things wearing out sooner than planned could lead to some preventive actions.

 

[tecgu]

Thank you a lot! You have given me great starting points!

 

[Wolf.K]

For our PMS report I use this check list:
Each chapter has a summary and evaluation section. Products comparable to our product are included (new publications with e.g. new side effects?; any new reports in the databases, e.g. recalls). Most parts are prepared by our product managers. I am QM but prepare the final PMS report, because we think it is good that the QM knows everything ;-)

1. Products comparable with our product
2. Important peer-reviewed publications (Medline, Embase)
3. General internet search (blogs and else where users might post information)
4. Competitive products "instructions for use ifu" analysis
5. Trade shows and conferences
6. Field evaluations and market surveys
7. Scientific studies (our product)
8. Competent authorities database search (MAUDE, BfArM, TGA, Healthy Canadians...)
9. Sales people trainings
10. Complaints and other customer inputs
11. Service and installation (as applicable)
12. Bug fixes (as applicable)
13. Customer surveys
14. Risk management file (any updates?)

Hope this helps!