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Is Biocompatibility study performed on medical devices for possible contaminants?

Ajit Basrur

Staff member
Admin
#1
As part of the molding activities, we use Compressed Air that is tested routinely per ISO 8573 requirements.

During a recent customer audit, we were asked if we have done a Biocompatibility study on the devices for the possible compressed air contaminants like Oil, Particles and Water ?

Our reasoning was that since the Compressed Air meets the requirements of ISO 8573, that should be fine but the customer insisted on the Biocompatibility testing.

I havent heard of it and would like to hear from others if this has to be performed ?
 
Elsmar Forum Sponsor
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MIREGMGR

#2
Re: Is Biocompatibility study performed on devices for possible contaminants ?

I haven't heard of such a requirement, but our devices are all external- or non-patient-contact.

I've never seen such a requirement mentioned in a guidance.

I do understand how your customer, if they're especially rigorous or paranoid, might decide they need that qualification for an implantable or fluid-communicating part. After the metal-on-metal-joint-implant nano-metal-particle fiasco, I've been expecting an industry evolution toward requirements for proof of no nano-metal presence, especially for implantables.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: Is Biocompatibility study performed on devices for possible contaminants ?

Biocompatibility testing is not intended for fault conditions. What if the material itself, for some odd reasons, is not what it is specified to be?... Should one test for biocompatibility of all materials that can remotely be there?... It has no end.

Any risk should be managed. If the client is not happy with the current measures and controls, this is negotiable. However, you should be the one having the final say on how to mitigate. For instance, more filtering and tighter monitoring can be implemented if air contamination is suspected.

My take is that your client's behaviour is non-rational. Now it's your job to get them the ladder to climb off that tree :)

Cheers,
Ronen.
 

Ajit Basrur

Staff member
Admin
#4
Re: Is Biocompatibility study performed on devices for possible contaminants ?

Thanks MIREGMGR and Ronen.

My thinking has been on the same lines as yours. Let me see how far I go with our customer :)
 

kuyakut

Involved In Discussions
#5
During the initial stage of molding for a certain fluid path components, we were advise to do biocompatibility since we are using a anti - static air blower on that certain parts. But after we proved to them that we have upfront measures and controls that the air is not contaminated.The customer agreed to remove biocompatibility test on the molded part.
 
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