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How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really

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The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health. An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn’t have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney. A disclaimer on the site specifically states that the data is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots. Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medical claims to track drugs, vaccines, and devices. Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA’s pilot program for the national system. The data isn’t there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress. A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we’ve developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

This post was originally published by ProPublica.

 

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8 comments

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9:17AM PDT on May 10, 2012

Thank you for the article...

8:29AM PDT on May 10, 2012

that figures, our money wasted again.

6:28AM PDT on May 10, 2012

it is about the money money

6:12AM PDT on May 10, 2012

It is true that more oversight is needed, however, as a person whose job it is to monitor patients with devices, I can tell you that patients who feel well will not return to the physician.

All medical devices are designed with a specific work-life. Patients are specifically TOLD what that work-life is prior to surgery. They in fact sign papers that specifically spell out the risks of implantation and the expected life of the device within their bodies.

Unfortunately most patients work under the 'if it aint broke' hypothesis. I cannot even count how many times I've called a patient to say, "It's been five years and that device is getting old. The Doc would like to see you," and had the patient respond, "Well I feel fine. I'll call if I have any problems."

I must document that the patient refused to be seen, and this often negates any warrantee provision on the device. Even knowing this, patients often decline surveillance.

6:00AM PDT on May 10, 2012

no big surprise.

5:54AM PDT on May 10, 2012

With all the implants being done I think the devices should be thoroughly checked out so that the patients will not incur more problems.

5:28PM PDT on May 9, 2012

Thanks for this great article.

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