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

By Wire News Sources on May 3, 2012

by Lena Groeger

Each prescription drug you take has a unique
code that the government can use to track problems. But artificial hips and
pacemakers? They are implanted without identification, along with many other
medical devices. In fact, the FDA doesn’t know how many devices are implanted
into patients each year – it
simply doesn’t track that data.

The past decade has seen numerous high profile cases of malfunctioning
medical devices, which have led to injury or even death. Critics say the FDA’s
minimal monitoring of devices contributes to these problems.

“If you’re lucky,
you might find a sticker on the operating room note that was left over from the
product,” said Richard Platt, who runs the Harvard Pilgrim Health Care
Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices
already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But
many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the
FDA,” said cardiologist Frederic Resnic of Brigham
and Women’s Hospital, who has worked with the FDA on medical device safety
monitoring. “The FDA is relying on anecdotal and very variable information about
the safety of medical devices.”

If manufacturers get word from a doctor or
hospital about a death or injury that occurred as a result of their product,
they are legally obligated to investigate the event and report it to the FDA. But
the process isn’t straightforward, as has become clear in the recent
controversy over the malfunctioning St. Jude’s Riata defibrillator leads (wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device
was recalled.

According to attorney William Vodra, a regulatory
law expert and member of the Institute
of Medicine panel that published a report on medical device safety

last year, the number of doctors who actually contact
manufacturers is small.

And after being notified of patient harm, manufacturers
can minimize their own responsibility if they point the blame elsewhere, said
health policy expert Diana Zuckerman, president of the National Research Center
for Women & Families.

For example, if someone dies from complications
in a surgery to remove an implant, the manufacturer may argue that it was the
surgery – not the implant – that killed the patient.

“You have a system that is not rigorous, the
standards are not always understood, and they are interpreted differently by
different people,” Zuckerman said.

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

“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.

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

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.”

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