Handling of contaminated medical equipment

AhmedRa

Registered
Hi All,

I am currently working with a company who have some gaps in their processes when it comes to the handling of contaminated medical equipment and was looking to get some advice and perhaps how some other companies handle such issues.

To provide some background:

Currently, when a user suspects a medical device is contaminated, the company requests the customer to reprocess the device according to the instructions for use and then bioburden test the device to see if it is still contaminated. If the device is still contaminated and the CFU counts > 100, we ask them to also conduct further identification tests to confirm what the device is contaminated with prior to it being sent back to us.

On most occasions, customers only agree to do bioburden testing and no identification tests as the guidelines in the UK don't require identification testing unless CFU counts are greater then 100. This however, causes issues with transport as we have to send the device to Germany for testing. We have a despatch team, who says they will not agree to exporting any device suspected of being contaminated, unless we can categorically confirm what the device is contaminated with as under the ADR regulations (and IATA for the case), they need to ensure that the device is not contaminated with a category A infectious substance, otherwise it needs specialist packaging. Unfortunately, this specialist packaging is not readily available and needs to be tested etc, hence it causes great delay in our repair and complaints procedure.


Keen to hear how other companies deal with such situations? Specifically, if anyone has experience with sending contaminated medical equipment by Air.
 
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