Apr 17, 2008

Biocompatibility testing on a formerly radioactive medical device

Patrick in the comments asked a while ago:

We have a radioactive device, and the act of charging with radiation has an impact on the surface chemistry, so we need to conduct biocompat tests. Now, our device has a very rapid decay rate, and with a month or so it is effectively not radioactive any more...but testing house are not willing to test it because of the stigma of having once been radioactive. Any idea how these types of devices should be tested?

I don't understand the device and when exactly it would be used clinically, but I think you'll probably have to find some way to test to ISO 10993. Assuming the device is used clinically after the radiation has dissipated, I'd write up a nice summary report saying as much with relevant radiation references and call every testing lab I could with it. Talk and offer incentives to as many people as possible at each lab until I got a definite no from management, you might be able to get a smaller lab to do it, or even offer to do the extractions yourself or under their supervision at your facility if you have a local lab, non-GLP would be better than nothing. You could try hiring a consultant with good contacts at a testing lab as well, they might be able to persuade the testing lab better than you can. Other than that depending on what device category you fall under maybe you could do the testing yourself, although I admit this is not ideal. I don't have any other ideas beyond those, good luck.

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