How do you monitor Medical Device Off-Label use by Customers & Medical Professionals

[ElmerF]

Hi Everyone,

I have received a question from our insurers regarding off-label use of our medical device. "How do you monitor off-label use by customers and medical professionals". We provide indications for use in our labels and contraindications. We do not promote or advocate off-label use. Are there any regulations either in EU or US that require this. All I could find in EU was guidance on medicinal products which suggested reporting only in case of adverse event in which case we would be alerted by the user.

In the US the guidance is "Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects."

I'm not sure how we would go about monitoring this outside of complaints. There does not seem to be a regulatory requirement.

Can anyone weigh in on this?

Thanks for your input,

Best regards,

ElmerF

 

[MIREGMGR]

Re: How do you monitor Medical Device Off-Label use by Customers & Medical Profession

I don't know of an EU, US FDA or HC regulatory requirement to affirmatively monitor off-label use.

Other than via complaints/adverse event reports, I don't see any practical way to do so. Has your insurance company given an indication of what they have in mind?

In any case, if you knew of a proposed off-label use prior to that use, your insurer might obligate you to stop it. I doubt if that would be good for you in the marketplace...I think doctors are relatively protective of their right and responsibility to make medical-practice decisions, and would not be happy to have your insurance company effectively twisting their arm.

 

[Ronen E]

Re: How do you monitor Medical Device Off-Label use by Customers & Medical Profession

I agree with MIREGMGR.

In my experience with medical devices product liability insurance (one international insurer), it was understood - though not spelled out - that the insurance covers only the intended use(s), and that any use outside that scope / against contraindications is the responsibility of the user. The insurer was most interested in understanding the borders of the intended use so that they could assess the risk within these borders. The manufacturer was also very careful to communicate to customers and users that they would be solely responsible for any use other than that communicated in the labeling.

Cheers,
Ronen.

 

[KTcons]

Re: How do you monitor Medical Device Off-Label use by Customers & Medical Profession

I think that your insurers could only refer to post market surveillance procedures. The proposal of the new EU regulation on MD may clarify the meaning of the request:

ANNEX XIII - CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP ? PART B: POST-MARKET CLINICAL FOLLOW-UP:
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2.1. The PMCF plan shall specify the methods and procedures to proactively collect and evaluate clinical data with the aim of:
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(e) identifying possible systematic misuse or off-label use of the device with a view to verify the correctness of its intended purpose.

 

[MIREGMGR]

Re: How do you monitor Medical Device Off-Label use by Customers & Medical Profession

ANNEX XIII - CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP ? PART B: POST-MARKET CLINICAL FOLLOW-UP:
?
2.1. The PMCF plan shall specify the methods and procedures to proactively collect and evaluate clinical data with the aim of:
?
(e) identifying possible systematic misuse or off-label use of the device with a view to verify the correctness of its intended purpose.

I hadn't considered that statement when I responded above. Plainly it'll be applicable if/when the MDR goes into effect.

It's also remarkably naive. Surely regulators should be aware that almost all off-label use occurs not because the device maker was unaware of a further beneficial use of their product, but because the particular use in question cannot be proven consistently safe and effective, even though the device is safe and effective for some other use.

The idea that post-market clinical follow-up will identify off-label use that then can be simply added to the device's indications for use is generally absurd.

 

[Ronen E]

Re: How do you monitor Medical Device Off-Label use by Customers & Medical Profession

I hadn't considered that statement when I responded above. Plainly it'll be applicable if/when the MDR goes into effect.

It's also remarkably naive. Surely regulators should be aware that almost all off-label use occurs not because the device maker was unaware of a further beneficial use of their product, but because the particular use in question cannot be proven consistently safe and effective, even though the device is safe and effective for some other use.

The idea that post-market clinical follow-up will identify off-label use that then can be simply added to the device's indications for use is generally absurd.

It all comes down to how this extra-vague clause is interpreted. What exactly does "to verify the correctness of its intended purpose" mean anyway?... If they would have used the word "validate" instead of "verify", I would have thought your interpretation is probably what they had in mind. Further, I'm not sure whether by "its intended purpose" they referred to the original (excluding the off-label use) or to the potential, extended one. Either way - it's a really bad way to phrase a regulation, IMHO.