Notes from Limulus Bio Coffee Break "ISO 10993 - finding light and dark in the world of grey"

Limulus Bio Coffee Break September 14, 2022

ISO 10993 - finding light and dark in the world of grey

Clearly and excellent our guest?Michelle Kelly?(toxicologist?at?NAMSA?and formally?head of biological safety?at?MHRA) expressed her experiences and thoughts about how biological evaluations are performed following the ISO 10993 standard series. Are we focusing too much on what may go wrong? And with that said are we excluding innovations that could be beneficial for patients from the market? Regulator / competent authority are very much focused on adverse events. Not surprisingly since MHRA (& other regulators) do not have a list of medical devices and the good they do. First contact is often after an adverse event.

Vaginal mesh was brought up as an example when discussing benefit/risk assessment. At population level risk benefit and adverse event profile may seem ok but on an individual level there were many very serios adverse events e.g. severe pain, reoperation, marriage breakdown, and even suicide. The patient needs to be central, then it will be a correct decision and the risk fits around it.

Do we get enough risk info to the patient so that consent really is informed? A multidisciplinary team is needed to completely understand the benefit/risk scenario, the label and information to the clinician (or patient) needs to fully explain the risk so clear that it is easy to understand. The food industry has come far when it comes to explain content in food so people can avoid allergens.

Another question that was brought up by Michelle is if we really are able to predict all adverse events seen during clinical use by preclinical testing. Lots of adverse events have some immune element coupled to them and the ISO 10993-20 needs to be revised to better reflect how to evaluate for immuntox reactions. Another area that needs to be explored is with regard to neurotoxicity which can be an issue especially when it comes to bioabsorbable materials.

In conclusion, it′s all about weighing the risk with the clinical benefit!

Some comments and questions in the chat that were discussed:

Hasn't the potential for class-action lawsuits tipped the balance a bit? Reporting which can be driven by public awareness and e.g. busy lawyers was brought up. How to get a good post market process (industry/regulator)?

Regarding risk/benefit, is it our role as biocompatibility professionals to comment on whether the clinical benefits of the device outweigh its biological risks? I've more commonly seen a handoff from biocompatibility assessors to regulatory affairs to make the risk/benefit conclusion

How to characterise the benefits with its magnitudes to make them comparable with severities (of risks), and make the judgement behind benefit-risk balance possible?

End with a quote from one of the participants “Regulator has easier job to point out problems, consultant needs to investigate and offer solutions.” What is your thought?

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