Reuse PCBs in a Medical Device

invitro_spain

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#1
Hi folks,


Do you know what are the requirements for reusing PCBs (Printed Circuit Boards previously installed in a medical device) in new ones?. The focus of interest is EU and US and the standard used is the ISO 13485.


Thank you in advance
 
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Jean_B

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#2
I cannot recall anything specifically on PCB's, but IEC 62309 gives a framework and terminology that can be used in consideration.
A critical part would be risk management, you should probably look at the inputs of your FMEA, as your current one most likely is based on a 'virgin' device. It would also change your occurrence/reliability percentages (if used) in any FTA you have lying around.
Another major part would be your process to release the part for production, as it most likely cannot meet specifications with all the commensurate paperwork like a fresh part would. What are you checking on, what are you dropping, where do you accept a lower grade of performance or a wider tolerance on your pass requirement (and perhaps more importantly: where can you not do so due to risk management).
 

Mark Meer

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#4
I agree with the replies thus far. You have requirements for safety & performance so you need to demonstrate (and document) that this decision doesn't affect product conformity.

- (as outdoorsNW suggests) You have a specified shelf/service life? Does the age of the PCBs or history of use potentially affect this?

- (as Jean_B suggests) What are the potential risks? Re-assess what is the probability and severity of harm if these PCBs are non-conforming due to history of use. Develop a process for confirming they are still in conformance, and maintain records that the PCBs have been checked.

Another thing to consider is if this affects marketing. Can you advertise these units as new? ...or will you designate as something other than "brand new" and sell at discount?
 

invitro_spain

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#5
How old are these PCBs? A few component types, such as certain capacitors types, tend to have age related failures. If these parts are older, you need to investigate if any components are at higher risk of failure due to age, and then do a risk assessment.
Good point. Thank you for your answer.

It seems the PCB has a long lifetime (30 years). The device lifetime is 5 years, no more.
 

invitro_spain

Involved In Discussions
#6
I cannot recall anything specifically on PCB's, but IEC 62309 gives a framework and terminology that can be used in consideration.
A critical part would be risk management, you should probably look at the inputs of your FMEA, as your current one most likely is based on a 'virgin' device. It would also change your occurrence/reliability percentages (if used) in any FTA you have lying around.
Another major part would be your process to release the part for production, as it most likely cannot meet specifications with all the commensurate paperwork like a fresh part would. What are you checking on, what are you dropping, where do you accept a lower grade of performance or a wider tolerance on your pass requirement (and perhaps more importantly: where can you not do so due to risk management).

Thank you Jean B, for your information and sorry for the delay in replying. I totally agree with your opinion. I think Risk Management might be the best thing to do. However, I have some doubts about the final user. is it mandatory to inform adequately in the IFUs for example or is it enough if you have QC passed and a Risk management done?
 

invitro_spain

Involved In Discussions
#7
I agree with the replies thus far. You have requirements for safety & performance so you need to demonstrate (and document) that this decision doesn't affect product conformity.

- (as outdoorsNW suggests) You have a specified shelf/service life? Does the age of the PCBs or history of use potentially affect this?

- (as Jean_B suggests) What are the potential risks? Re-assess what is the probability and severity of harm if these PCBs are non-conforming due to history of use. Develop a process for confirming they are still in conformance, and maintain records that the PCBs have been checked.

Another thing to consider is if this affects marketing. Can you advertise these units as new? ...or will you designate as something other than "brand new" and sell at discount?
Thank you, Mark, for your answer. The device lifetime is 5 years and the PCB lifetime is higher (30 years). So, it seems the age of the PCB does not affect the device.


As you said, there are two things that I consider very important here. First, a Risk management and secondly, assure the QC. In this case, the QC process may be the QC defined for a new device. The re-used device should pass this QC before release. But what about the final user? Do you need to inform adequately in your ifus?
 
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