Medical Device End of Life and Complaints

jkc3usc

Involved In Discussions
#1
If a medical device has reached its EOL and a call is received about the product. Should this be logged as a complaint?

The device is no longer serviced nor provided replacement parts.

Thoughts?
 
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Mark Meer

Trusted Information Resource
#2
A similar topic was discussed a bit in a recent thread (refer to the later posts in the thread re: warranty & non-conformances).

In my opinion, it's worth still filing a complaint (to log the issue, perform reporting assessment and, if possible, help the customer - e.g. paid servicing, purchase a replacement...etc.).

However, (again, in my opinion) you would not need to file a product non-conformance record, as the product can be reasonably expected to fail after its service-life has expired.
 

jkc3usc

Involved In Discussions
#3
What would be the reasoning for the product non-conformance record? Just to state no further action will be needed due to EOL?
 

Mark Meer

Trusted Information Resource
#4
To clarify: I'm suggesting that a product non-conformance is NOT required, because the device, as a whole, could be reasonably expected to fail after specified EOL.

However, if I were to play devil's advocate, the case for issuing a non-conformance record might be:

1. The failure is due to a sub-component whose EOL is greater than the device into which it is incorporated. Useful - as pointed out by Jim Wynne in the thread I linked - if this component is used in other products that may have greater EOL.

2. (As argued in the thread I linked, but I disagree with) Meeting customer expectations is a requirement, and if you are not meeting customer expectations this is a non-conformity. Presumably, if you take this approach, the NCRs would, like you say, just state no further action due to EOL. ...and then in review, if you have a huge number of such "NC"s, it might be cause to consider CA (e.g. design change) to extend life expectancy. ...but like I say, I don't agree with this, and think this would be handled sufficiently by just documenting the complaints.

MM
 

QuinnM

Involved In Discussions
#5
Hi jkc3usc,

Interesting…

If stating EOL, is this the company’s perspective, that the device is no longer for sale. Is this the customer’s perspective to stop using the device at EOL? What if the device needs to be recalled after EOL?

Thoughts…

Quinn
 
#6
What would be the reasoning for the product non-conformance record? Just to state no further action will be needed due to EOL?
When you shift the outlook from your device to the patient and user, you can think of the following actions...
Advisory notice issued as a response to the complaint
Publishing the same
Channelising a exchange scheme for a new device as a part of EOL action.
 
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