Many FDA-approved medical devices are accidents waiting to happen

Total Recall

“We know thousands of people have died. And those are deaths that did not have to happen.”

If someone made that statement about a war, or genocide, or a natural disaster, it would be heart wrenching.

But here’s what makes that statement so shocking: It’s about inadequate approvals by the FDA.

I know you’re probably sick of hearing me talk about how the FDA approves dangerous drugs, so today I’m not going to do that.

No, today, I’m going to warn you about the other dirty little FDA secret that is too dangerous to ignore.

Shock & Awe

In addition to food and drugs, the FDA also regulates a wide variety of medical devices. And they do a completely inept job of it, according to a new study.

Researchers examined a list of high-risk device recalls between 2005 and 2009. They matched the recalled items against the FDA’s approval records. It was like opening the door to that closet where you throw everything and hope nobody ever peeks.

Over five years, the agency recalled more than 110 devices that “the FDA determined could cause serious health problems or death.”

In many cases, this isn’t like the recall of a drug that you can just stop taking. Surgically implanted devices require additional surgery.

The shocker is that eight of those devices were FDA-approved without any oversight at all. None! And an additional 80 received a green light in a special fast-track category that requires no human trials or safety inspections.

Even more shocking: Nearly one-third of the high risk recalls were cardiovascular devices.

An NPR report notes that AdvaMed, an industry trade group, conducted a similar review. Results showed that over the past 12 years, only 77 devices out of nearly 50,000 approved were subject to highest-risk recalls.

An AdvaMed spokesperson told the Minneapolis Star-Tribune: “It’s hard to imagine any other regulatory process with as good a record as this.”

So what he’s basically saying is, “Hey, just imagine all the people that DIDN’T die! Don’t we get credit for that?”

NO! If a device is safe, then the device-maker has simply shown up and done his job. If device-makers can achieve that level of competence (and so far they can’t) THEN we’ll give them a pat on the back!

NPR reports that many devices are “waved through” FDA approval because the agency doesn’t have a sufficient budget or staff to conduct pre-market reviews on “the vast majority of the new devices submitted each year.”

In other words, the FDA’s anemic budget forces them to choose from one of two options…

1) Conduct appropriate reviews and learn to live with a backlog of new devices waiting for approval
2) Go ahead and approve devices with little or no review

Insanely, they’ve chosen option 2 as the logical (and deadly) way to go.

Sources: 

“Medical Device Recalls and the FDA Approval Process” Archives of Internal Medicine, Published online ahead of print, 2/14/11, archinte.ama-assn.org

“Risky Medical Devices Untested In Patients Account For Many Recalls” Richard Knox, NPR, 2/14/11, npr.org