The FDA – even less oversight proposed for medical devices

[pinto]

“I think a device such as an Impella will always be underutilized until there is a randomized controlled trial which shows improvements in hard clinical outcomes.”

Bravo, Dr. Warraich! (And reply to his comment: That is, if doctors critically evaluate such devices.)

Doctors (being human) are not necessarily scientists, so some may overlook required elements for scientific research. And of course, even if a study uses the gold standard of research (randomized double-blind trials), pitfalls in the methodology can otherwise disqualify it.

I know from personal experience–recently meeting two general surgeons who were so enamored with use of mesh that they appeared naive about its complications. How can a doctor use a device without imagining that “stuff happens”? This could be just the tip of the iceberg because mesh so dominates IH medical practice that mesh is all they know. And hardly therefore can we expect such doctors to critically evaluate their own practice, let alone new devices or technology.

Good intentions, thanks for the post. Warraich’s article was heartening and informative. Europe’s previous failed oversight system offers insight forward.

[Good intentions]

Another fairly recent article about changing the 510(k) process. It’s not really clear who will benefit though. Seems to be more short-term based.

https://www.cnbc.com/2018/11/26/fda-to-overhaul-510k-medical-device-approval-process.html

And it looks like the head of the FDA has been pushed out. Wants more family time after just two years.

https://spinalnewsinternational.com/scott-gottlieb-resigns-fda/

This is why we can’t depend on the FDA to save us. If they can help, that’s great. But nobody should expect the help.

[Chaunce1234]

It is hard not to be cynical about this.

Speaking of the FDA, they do have some publicly searchable databases for reporting adverse medical events with medication and medical device products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

And another searchable database:

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm

You can also search the 510k database too for approvals “equivalent” products.

Each of those databases can be interesting to browse through.