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Use of expired perminant implantable sterile medical products

J

JimBa

#1
Hi,
If a hospital or centre decided to use a perminant implantable sterile medical product (slightly) out of expiry date, what are the regulatory implications. Obviously this is 'off label' use and its use would have been autherised by the hospital managment, one would hope with some sort of risk assement. What actions would be considered incumbant on the manufacturer? Mention in PMS review? Contact hospital to divirce manufacturer from any implication of resposibility for ANY device related issue no matter what it is? Just make record internally in case any device related issue?
Comments gratefully recieved. Please assume this is in the UK.
Kind regards
 
#2
Re: Use of expired products

As you noted, it is off label use. Ultimately the risk lies with the surgeon who made the clinical decision to implant the device. If there is a problem with infection (I assume the sterile barrier is the cause of the use by date) then it will be the surgeon that answers

As a manufacturer you should ask
1. Why was it used? Was the medical team aware that they were using an out of date implant in advance? If not then you should consider that your labelling is insufficient
2. Not within scope of the directive, but possibly 13485 -was it a consignment kit? should your sales rep or whoever, been monitoring and rotating the stock more effectively?

In the past I have, with a similar event, logged the event as a non conformance, noted that it is off label use and therefore out of our control, but then feed it into trending and continual improvements - if you are aware of a number of hospitals using an out of date product then you should question what you can do to improve that situation - extend shelf life if possible, change labelling to highlight expiry, reduce inventory so that you don't ship stock that has a short life
 
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