You might not really want to know. :)
There is MedSun, which I have yet to take a close look at, in part for that reason. Plus the knowledge that they chose set up a second database is probably a bad sign, so that the nature of the second one may border on the irrelevant. One of those things you feel like you have to look at, but not sure the effort will ultimately prove to be very useful. (Anyone who has ever walked into a company to discover that they have multiple databases, usually none of which have all the data needed for usefully managing products, and none of which talk to the other, knows what I mean. Therein lay all the panic over UDI.)
The EU model, I agree, is a better one. But without transparency, it's just a model. It could serve a company well, if it embraces it. (Trying not to LOL here.) But it won't do much for patients. Eudamed 2.0, color me skeptical. At least with MAUDE, we know what we have and don't have, good, bad, ugly.
PS If you want to have some real fun, follow NEST, the third time at the postmarket bat, this time with a whole bunch of cooks in the kitchen, including CDRH, industry, academia, providers, patients, insurers. Uh-oh. Three strikes...?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 22-Feb-2019 15:23
From: Vidyalakshmi Jayaraman
Subject: Is "FDA is still letting doctors implant untested devices into our bodies"?
I have long wondered what the FDA does for market surveillance of devices other than MDRs and recalls (forgive my ignorance if the FDA does more). Serious complaints could still go unreported by obligated parties. Though its a lot of work and costs a pretty penny, I think the EU model of sustained post-market evaluation of devices via clinical evidence seems more logical.
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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
Original Message:
Sent: 22-Feb-2019 09:44
From: Glen Park
Subject: Is "FDA is still letting doctors implant untested devices into our bodies"?
You make a great point about the lack of ability of pre-market clinical trials to predict rare adverse events as well as events associated with long-term use. The Industry does not do a very good job of communicating the idea of inherent risks of the unknown to consumers.
It would be an interesting exercise for someone to take on the task of developing a model to compare the relative safety of marketed devices vs drugs. That could be a complicated model, though, given the inherent differences between these types of medical products and whether more or less pre-market clinical trials would make any difference.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
Original Message:
Sent: 21-Feb-2019 10:00
From: Ginger Glaser
Subject: Is "FDA is still letting doctors implant untested devices into our bodies"?
My take is that this is going to be an ongoing chorus that ultimately will hurt the US device industry. Why? Because our society has become more and more risk averse with an ever-growing idea that everything should be "100% safe." This is visible more broadly in the need for everyone to "blame" someone else for bad things and an overall "victim" mentality - which is only getting worse.
Most likely, this will result in increasing demands for additional data, and clinical data, for more and more types of devices. Which will slow down many new and improved devices getting to the market, and result in less safe devices being used for longer times, ironically. But the patients who don't get a device they don't know they could have had don't have many advocates, and can't make the plaintiffs bar money, so they will be the losers in the long run.
I do find it ironic that they keep lauding clinical trials for drugs, when I suspect just as many, if not more (certainly on a percentage basis) drugs have been withdrawn from the market for safety reasons, despite all those trials. It remains a fact that long term complications by definition emerge in the long term and won't always be found no matter the size of up front clinical studies. Unfortunately, this will no doubt mean the requests for more, and longer, data will continue. I do applaud FDA for continuing to try and find a balance but I suspect the outside forces will always be against them.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 20-Feb-2019 08:27
From: Glen Park
Subject: Is "FDA is still letting doctors implant untested devices into our bodies"?
I would be interested in the Forum's take on this recent OpEd piece from the Washington Post.
Perspective | The FDA is still letting doctors implant untested devices into our bodies
| Washington Post |
remove preview |
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| Perspective | The FDA is still letting doctors implant untested devices into our bodies |
| January 4 Ten years ago, Kathleen Yaremchuk raced to the bedside of a patient inexplicably gasping for breath. Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, Yaremchuk performed an emergency tracheotomy on the woman, cutting a hole in her windpipe, inserting a breathing tube and saving her life. |
| View this on Washington Post > |
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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