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August 2011 Archives

Recent Study Released on Medical Devices and the FDA Approval Process

Patient safety should be the primary concern when a new medical device is approved for sale.  Medical devices, especially artificial hips, have been in the news quite a bit recently. One of the main reasons for the recent coverage is the recall of the defective DePuy ASR hip replacement system (a product of DePuy Orthopedics, a subsidiary of Johnson & Johnson).  The DePuy ASR device is a metal hip replacement that, in August of 2010, because its unsafe design was causing metal ions to break down and enter the blood stream, leading to metal poisoning in many patients. This massive recall brought to the forefront the issue of FDA approval of devices for sale to patients. Many people were, and still are, unaware that a device such as a hip replacement, can be sold to a patient in the United States without undergoing any real testing by the FDA.  A medical device manufacturer can apply to have a new device approved under something called 510(k) by claiming that the new device is "substantially similar" to a device that the FDA has already approved under its strict pre-market approval process. The Institute of Medicine, www.iom.edu, an independent, nonprofit organization that provides unbiased and authoritative advice, released a study criticizing the FDA approval process (510K). (http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx). Since 510(k) allows a manufacturer to apply to have a device put on the market relatively quickly and without rigorous testing, devices, such as the DePuy ASR hip, are sold to patients without even having been tested in an actual person. The result is that the manufacturers can sell and make profits on their products quicker and without spending money to make them safe - to the great risk and detriment to the public. Patient safety should not take a back seat to quick profits of device manufacturers.  Device manufactures began attacking the report of the Institute of Medicine before it was even released because they knew that the report would be critical of the "fast-track" approval that some devices receive. Fear mongering device manufactures attempt to scare the public by raising baseless concerns about slower access to devices. There is no basis for these fears. As an attorney who has the honor to fight for the rights of victims of the DePuy ASR device, I can tell you that a slight delay that could have helped make this device safer would certainly be worth the trade of having an unsafe device put into a person's body quicker at the expense of their health. It is said that "haste makes waste" but in the medical device world, "haste makes unsafe". Patient safety should be the most important concern when releasing a new device for sale to the public. This is the first of a series of blogs related to Medical Device Study Reports and the FDA approval process.   Jonathan B. Acklen

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