The Safe Patient Project: Information About Medical Devices And The FDA

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I've already posted here on the blog about the "compromise" FDA "Safety" bill and how it allows medical devices to be put on the market without clinical testing.

Which is alarming enough. But here's some more news.


FDA Tells Medical Device Manufacturers It Will Help Them Speed Up Product Approvals Source: Washington Post


A comment was on that last article that I, for one, would like an answer to:


I have been a patient advocate for 5 years, attended the FDA/OSHI/CDRH Patient Representative training, first MDUFA meeting, testified twice (TX and CA) at FDA/CDRH Town Hall meetings. I am a member of several national health consumer organizations. None of us were informed about the 12/3/12 Senate briefing until late Thursday.


MDIC Medical Device Innovation Consortium has done a poor job of engaging stakeholders when it charges $5000 for membership knowing that fee will eliminate patient stakeholders.


The timing of this briefing is suspect and I question the need for any nonprofit 501(c)3 to further the medical device industry profit goals while limiting access to harmed patients and consumers. FDA staffers and elected Senators must explain their participation in this exclusionary briefing.

Yeah, no kidding. Dianne Feinstein?
Yeah, I've tried writing to her before. Maybe I'll write her again.
Maybe I'll just keep writing letters to elected "reps" until I turn blue in the fingertips.



"What's for dinner?"
"Ribs"
image source: Wikipedia















Then there's this: "FDA warns Medtronic on manufacturing guideline violations"; source; Reuters. Date: 8/21/12.

And then this: FDA warns Medtronic over implantable drug infusion pump snafu; source; fiercemedicaldevices.com. Date: 8/21/12.

The FDA ...getting in Medtronic's face?
Trying to ...regulate?



The new panel the FDA put together to help speed up product approvals includes: .....want to guess?

Medtronic!!
Among others.


The Medical Device Innovation Consortium was created by LifeScience Alley, a Minnesota-based group that includes companies like Minneapolis-based Medtronic Inc., the world’s largest medical device company. The group also includes research institutions like the Mayo Clinic and the University of Minnesota.


Apparently, it doesn't include patient advocate groups. The patient advocate commenting above in the white text wants to know why she wasn't notified of the hearing until just a few days before it happened. She's right to be pissed. Or he.
Can't tell.

Here's another interesting thing. Every time I go to the Safe Patient Project website, SafePatientProject.org, their site looks different. The only, and I mean the only reason I found the article about the no-clinical-testing-required-Safety-Bill, is that I spotted my name in the lower right corner of the site where "most recent comments" are noted.

I was originally searching for the article in Google. Didn't find the right keywords, I guess, because it didn't come up. Then I searched for it on the site, just typing "FDA" into the search bar. I got a whole bunch of interesting results, a few of which I just linked above, but I couldn't find that article. The comments I left on the article said:



Reply
Cindi Burkey says:
September 14, 2012 at 5:31 pm
Please help me out with something here. It seems to me this article is saying that medical devices can be approved for sale with no clinical testing needed at all.
I’m sure I’ve misunderstood this. Could someone clarify for me?

It can’t be legal to sell medical implants that have not been clinically tested. Can it?

Reply
Cindi Burkey says:
November 8, 2012 at 6:40 pm
So…the sound of silence. Maybe no one’s looked at this site. I’m still wondering about this bill.



I wondered why that article didn't come up in the search results when I put in FDA.

But I was pleased to find it through the comment thingy.

And there's lots of good info on that site. In fact I like it a lot.

Take charge of your medical care....it's a jungle out there.