Must-read for all working with medical devices.

Sarah Nourse I think a big problem is that sales reps very quickly get into the mindset of telling customers:. "well, that use isn't FDA cleared but you can feel free to validate it on your own". At that point, customers don't always quite understand what that type of validation that entails and I don't know that sales reps so either. No one has the conversation and then the customer wants to blame the manufacturer. I think it should be the responsibility of the manufacturer to discuss in detail with the customer why they have not validated that use on their own and what a validation would be for them. And this should go in writing so in the end, the final decision comes down to the customer to decide if, presented with all this info, they still choose to use off label. YMMV

So interesting. Adrian Lee, Patrick Gaynor

Must read article

Very Interesting article highlighting the need for transparent communication between all parties concerned : The FDA, device manufacturers, their field employees, and physicians.

Ong Kean Seng Must read article...

A concerning topic. I believe medical device manufacturers do appropriately train their teams on appropriate and effective use of their products. While there will always be outliers that push the envelope (physicians and sales reps), ultimately the responsibility must lie with the clinician unless the representative has misled. At the end of the day, the patient relies on the decisions a surgeon makes with regard to how and when they choose to utilize specific products or techniques. Companies must ensure their representatives appropriately communicate and hospitals and clinicians must ensure the responsibilities and ramifications of off label use are well understood.

Ben Pattinson Agree with all before me. This is a must read for anyone selling medical devices but also for clinicians using them. A really useful follow up article especially for those clinicians who dare to tread into off label use (for the benefit of the patient of course) would be an explanation of the validation process including discussion on implications associated with going "off piste"
Btw, any rep who shrugs their shoulders and says "some surgeons have chosen to use this for X, y or z" perhaps need to take a closer look at themselves and ask, "would I let surgeons use this device for X (non validated/ off label use) on my child?"

FengNan Fang

To answer your question, I think it depends on the situation. Can't put this specific scenario all on the physicians and sales reps I don't think but there are situations where companies shouldn't be held accountable at all. Difficult world out there; have to trust that the majority are in it for the benefit of the patient having better quality of life and not just $$.

Jeremy Moore CBA, CMQ-OE For some further reading on the legal aspect of the Manufacturer, Physician, and Patient interrelationships, check out this article: https://www.reedsmith.com/files/Publication/9566866e-7009-4546-b0f1-3e8e5c3befd6/Presentation/PublicationAttachment/002e8c11-c5b7-4229-92ae-40946c3d33fc/For+The+Defense%2c+April+2013.pdf

Julie Omohundro If a physician doesn't specifically ask whether other physicians are using a device for a specific off-label purpose, I don't see how volunteering this information can be interpreted as anything other than promoting the off-label use.

If the physician specifically asks, then I think the rep should be able to answer factually, yes or no, and what the physician makes of that simple fact is on the physician.