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    Posted February 21, 2014 by
    Chicago, Illinois

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    How does the FDA 'approve' medical products? by David McNamee from Medical News Today, Thursday Feb 20, 2014

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    "You may have seen medical products that claim to be "FDA cleared," "FDA registered," "FDA listed" or "FDA approved" - but what do these labels mean? You would be forgiven for feeling confused.


    In this feature, we look at what the differences in Food and Drug Administration (FDA) classification actually mean, what you need to be aware of as a consumer and what the future holds for the regulation and classification of medical products in the US.


    Though you may see labels on a wide variety of medical products - from implantable defibrillators to smartphone apps - bearing legends such as "FDA registered," in reality these claims are often disingenuous. But regulation over the correct terminology is rarely enforced."




    "The Myxo ring
    In 2008, a surgeon named Dr. Patrick McCarthy at Chicago's prestigious academic medical center, Northwestern Memorial Hospital, was found to be installing a device he had invented - the McCarthy Annuloplasty Ring - into the hearts of cardiology patients without the informed consent of the patients.


    "If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered," says Dr. Rajamannan.
    Concerned patients were even more alarmed when they discovered that the ring had also not been submitted to the FDA for review.


    "There are no guideposts for us. You don't learn about this stuff in med school," McCarthy was quoted by the Chicago Tribune as saying, when questioned on why he had bypassed FDA approval.


    The ring's manufacturer, a company called Edwards Lifesciences, later falsely claimed that the device was exempt from the 510(k) process and so did not require FDA clearance.


    When a concerned colleague of McCarthy's, Dr. Nalini Rajamannan, contacted the FDA, an investigation was triggered, which ultimately saw the ring cleared for use - despite having already been sewn into the hearts of 667 patients.


    But further controversy surrounded the FDA's clearance, which simply relied on a clinical study Dr. McCarthy himself had written as evidence that the ring - now rebranded "Myxo dETlogix" - was safe and effective.


    Dr. Rajamannan - who was co-author on that study before withdrawing when she learned that the patients involved were not giving informed consent - later wrote a book detailing the controversy and continues to campaign on behalf of patients installed with the Myxo ring.


    Speaking to Medical News Today, she says that the concerns over the Myxo device have still not been addressed by the FDA:


    "The FDA has written a formal letter stating that they would not be investigating the matter any further. These heart valve rings that are being cleared under the 510k process for Edwards Lifesciences are associated with over 4,000 adverse events and over 645 deaths."


    "The other major heart valve manufacturers have less than 20 events for their rings in the FDA database."


    What does the future hold for FDA regulation?
    As we have shown in this feature, the confusion over the various stages of FDA "approval" and "clearance" is not limited to patients. These examples show that FDA classifications and processes can also - naively or wilfully - be misinterpreted by manufacturers and medical professionals.


    The concerns from doctors, patients and consumer advocacy groups on the lack of regulation of medical products and the conflicts of interest within those regulatory processes remain.


    Dr. Carome recommends that the IOM's 2012 guidelines be implemented and suggests that more of the Class 2 products sped through to market under 510(k) need to be reclassified as Class 3, for which the PMA process is much more stringent.


    "Manufacturers do heavily promote their devices as being new and innovative, and many health care providers and patients believe that a 'newer' or 'innovative' device must be better," reasons Carome. "However, in most cases, there is no evidence that the newer medical devices are any better than older devices or other less-invasive treatments that don't involve a medical device."


    "It is a real safety problem," agrees Dr. Rajamannan, who adds: "If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered."


    "The patients in the US are at major risk and the FDA is doing nothing to help the patients.""


    Written by David McNamee



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