Using Risk Management in ISO 10993 - Medical Device Accessory

[tabcoil_1]

I've asked our quality manager at my company if we can perform a risk analysis in support of NOT performing biocompatibility testing on an accessory for a class 2 medical device. I was told that the 10993 standard only includes examples that conclude testing is required and based on his past experiences the auditor will always ask for full biocompatible test results. So our QM is very reluctant to use any other means to satisfy biocompatibility other than testing. So we've never been allowed to use RM to justify not testing. Reading the standard, this appears possible and I'm sure many companies have been able to successfully do this.

Any tips on how you were able to do this? What information did you dig up to support not testing? I would think that an accessory, made from polycarbonate, that the patient will never be able to touch, should be something that can be justified? Or am I wrong?

 

[Marcelo]

You can use the standard (not only RM) to support not doing testing. In fact, the objective of the standards is to reduce testing.

You need to apply the full 10993-1 process, including, for example, the material characterization, risk analysis and evaluation, and literature search (and also the steps in the flowchart, between other requirements). If the biological risk is considered acceptable (if the qualified person - the toxicologist, conclude so) due to the data already in existence, you don't need to perform testing.

It's not so simple as it sounds, but it's obviously feasible. Then again, you can also conclude that the data is not enough to consider then risk acceptable, and then some testing may be needed.

 

[yodon]

This may be where theory and practice don't exactly mesh.

My somewhat limited experience is that a Technical File reviewer drops down to the biocompatibility part of the essential requirement checklist and if he or she doesn't see biocompatibility data from an accredited test lab, boom, you're done. Given their current backlog, this isn't too surprising. Assuming they take the time to review the rationale to not test, they still might not conclude that the claims are sufficiently supported.

I, for one, would be curious to hear of anyone's experience with going the non-test route.

 

[tabcoil_1]

reviewer drops down to the biocompatibility part of the essential requirement checklist and if he or she doesn't see biocompatibility data from an accredited test lab, boom, you're done

This is the feeling I'm getting from our QM. It's just not worth the hassle in trying to justify it (it may take longer to gather the required information than actually having someone else do the testing)

 

[Ronen E]

This is the feeling I'm getting from our QM. It's just not worth the hassle in trying to justify it (it may take longer to gather the required information than actually having someone else do the testing)

It boils down to a benefit/cost analysis. In some cases the tests involved are very expensive (>US$50,000 per test) and long (>6 months) and thus manufacturers (especially small start-up companies) have a clear incentive to exhaust all other options before taking the test route.

Your case might be different, of course.