Device History Records Maintenance - Discontinued the use of the Product

Q

QACen

#1
Curious as to how other Quality Managers maintain their Device History Records when customers state that they have discontinued the use of the product. Is there anyone willing to share briefly their process? I'm thinking that a letter to file or copy of the email from the customer stating that their device has been dispositioned for whatever reason as proof of evidence that the unit retired or at least will let someone know in the future that it has been discontinued.

Is there a formal way of handling it? Looking at the FDA 21 CFR 820.184, there is specific requirement other than it is the company's responsibility to maintain. Any opinions?

Thank you!
 
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yodon

Staff member
Super Moderator
#2
Re: Device History Records Maintenance

The DHR provides objective evidence that the product was built per the DMR. It has nothing to do with whether a customer is actually using the device or not. Why do you believe this information is required for the DHR?

I can even see some potential pitfalls keeping and relying on that information. For example, could you guarantee that if they said they aren't using it now, they would never use it in the future? In other words, if you had to conduct a recall or perform a field correction, would you use this information to exclude that customer from the activity?
 
#3
For medical devices that are traded in by a customer and then transferred to a new customer as a used device via a process to update components and establish adherence to current electrical standards etc., how is traceability maintained with regard to the DHR?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
For medical devices that are traded in by a customer and then transferred to a new customer as a used device via a process to update components and establish adherence to current electrical standards etc., how is traceability maintained with regard to the DHR?
What I would do: Establish a new DHR for all refurbishment actions (starting from the receiving of the used unit), and include in it a pointer (e.g. a SN) to the old unit - this way the older DHR can be traced back, to provide the full history.
 
#6
What I would do: Establish a new DHR for all refurbishment actions (starting from the receiving of the used unit), and include in it a pointer (e.g. a SN) to the old unit - this way the older DHR can be traced back, to provide the full history.
Hi Ronen, It makes my a job a lot easier.

Kyle
 
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