Lax oversight of medical devices responsible for thousands of deaths

Shock & awe

I am in awe of the FDA.

Every time I think they’ve gone as low as they can possibly go, agency officials find new ways to shock and horrify me.

This time it’s medical devices.

In addition to food and drugs, the agency also regulates a wide variety of medical devices, from surgical gloves to pacemakers to radiation equipment. And they do a frightening job of it. Just wildly inept.

Here’s how the lead author of a new study sums up the casualties caused by devices that were approved, then later recalled: “We know thousands of people have died. And those are deaths that did not have to happen.”

Thousands dead! Performance reviews don’t get much worse than that.

Total recall

The new study appears in the Archives of Internal Medicine, and it really is astonishing.

Researchers examined a list of high-risk device recalls between 2005 and 2009. When 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 the five-year study period, the FDA recalled more than 110 devices that “the FDA determined could cause serious health problems or death.”

Keep in mind, this isn’t like the recall of a drug that you can just stop taking – some of these devices are implanted in patients. So in many cases a recall is a very big deal, requiring additional surgery.

The shocker is that 8 of those devices had been FDA approved without any oversight at all. None! And an additional 80 were approved 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 on the study notes that a similar review was recently conducted by AdvaMed, the medical device industry trade group. That report found that over the past 12 years only 77 devices out of nearly 50,000 approved were subject to highest-risk recalls.

An AdvaMed spokesman 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 no one is put in danger by a device, 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 these options: 1) Conduct appropriate reviews and learn to live with a backlog of new devices waiting for approval, or 2) Go ahead and approve the devices with little or no review and learn to live with the certainty that patients will be harmed and many will die.

Insanely, they’ve chosen option 2 as the logical 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