How to make risk analysis for design changes to existing devices

yodon

Staff member
Super Moderator
#11
When we do risk analysis for a medical device, we always include a hazard analysis; i.e., how could the patient or operator be harmed. Normally, with electrical devices, there's a potential for shock or electrical burn. I would expect with a BP cuff, you could have excess pressure applied, causing brusing or blood vessel rupture. We also typically address some of the more indirect hazards such as an incorrect reading (user has high BP but is unaware, potentially leading to stroke or heart attack. Annex C of 14971 has a lengthy list of questions you can consider when determining hazards.

Certainly, the device incorporates measures to ensure such scenarios do not cause harm. For example, it appears that the device was designed to be in compliance to IEC60601. If you get it tested to show conformance, then probably the electrical risks are mitigated. If you have a safety valve to ensure the cuff can't apply excessive pressure, you have mitigated the pressure risk. Your design verification can show these things.

To me it looks more like a failure mode analysis. And that's certainly a valid risk management activity. I just don't know if it would be sufficient in the eyes of the FDA. Also, I would question the premise of including the column for "how is the risk evaluated." The biggest concern is how the risk is mitigated. For example, one of the risks you list says "User can't receive the result of measurement" (from voice function). Instead of saying 'since it is just an additional feature, there's no risk' you could say that the user could get the reading from the display (or whatever the visual is). Your mitigation in this case is the visual. Now if this is targeted to sight-impaired users, that may not be a reasonable mitigation. But I think that's the approach the FDA is expecting.

Hope that makes sense.
 
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Palt88

#12
There's 2 topics:
- the risk assessment: as already state you need to assess the new risks in a DFMEA
- don't forget it's a design change, so normally through a Design control sheet or something similar, you have to list the intended use of this add, Design input and output, any target input if required,and verification and validation that you have done for each topic.

I guess you may have a design change procedure to guide you ?

I would suggest you go to "Design control guidance for medical device manufacturers" (march 11,1997) from CDRH FDA. The guidance relates to FDA 21 CFR 820.30 and sub-clause 4.4 of ISO 9001
 
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C

celia4237

#13
You are so helpful.

Can anyon give me some guide on FEMA in the field of medical device. Is there any guidelines or standards exsit?
 
C

celia4237

#15
Palt88, Thank you for your answer, and it is very kind of you. ;)

I will go to your website link for more information. And i really appreciate your advice.

Thanks a lot.
 
R

Roland Cooke

#16
The devil on my shoulder is sniggering at the thought that you equipped this device with a thick Glaswegian accent.

As long as you did your design validation in Scotland you should be fine, who needs risk management?! :lmao:

 
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