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Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device

#1
Good day all,

I have a little problem here. It appears that one of our device indicated activation of complement after 90 mins.


1579738439067.png



Although this test is not part of ISO10993-4 requirments for this particular device, BSI requested for justifications to support the biocompatibility of the device. I appreciate if you could share your experience/ ideas.

Here are the concentration of sc5b-9 after 30, 60, 90 mins of incubation of the test article and predicate..


1579738244979.png



Regards,
Judy
 

twanmul

Involved In Discussions
#2
I'm assuming that BSI are your Notified Body and have raised this during an inspection. I'm also assuming you're referring to a Medical Device here under your first assessment under the MDR as bio-compatibility is neither a requirement under the MDD or IVDD and we're too far away from the IVDR for this to apply.
I think the best place to start would be to go back to your risk assessment for the device and see whether this has been considered in any way (if so, look at the Risk Management Report section as this should tell you why you've selected specific risk scores and either the risk/benefit ratio or the rationale for not being able to reduce the risk any further). You should also probably look at whether factors such as exposure times were picked up as risks within your design validation as part of the design review of that stage and were then transposed through to your risk analysis.
It's a bit hard to advise you much further as the topic is very specific but your question is very general. If you've identified the root cause, then please reply and it might be easier to advise.
 
#3
I'm assuming that BSI are your Notified Body and have raised this during an inspection. I'm also assuming you're referring to a Medical Device here under your first assessment under the MDR as bio-compatibility is neither a requirement under the MDD or IVDD and we're too far away from the IVDR for this to apply.
I think the best place to start would be to go back to your risk assessment for the device and see whether this has been considered in any way (if so, look at the Risk Management Report section as this should tell you why you've selected specific risk scores and either the risk/benefit ratio or the rationale for not being able to reduce the risk any further). You should also probably look at whether factors such as exposure times were picked up as risks within your design validation as part of the design review of that stage and were then transposed through to your risk analysis.
It's a bit hard to advise you much further as the topic is very specific but your question is very general. If you've identified the root cause, then please reply and it might be easier to advise.
I'm sorry but bio-compatibility is definitely a requirement under the MDD...

Annex I - Essential Requirements
▼B II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
7. Chemical, physical and biological properties


▼B — the choice of materials used, particularly as regards toxicity and, where appropriate, flammability, — the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device.

Also taking into fact that ISO 10993 is a harmonized standard and it's use for the determination of risk for bio compatibility of a medical device would make it state of the art.

In regards to the original poster; what type of device is this? What is the contact time/placement of the device? Can you adequately access the risk of the device to the patient if it's use time is under 90 minutes?
 
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