• 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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