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Medical Device Standards Severely Lacking

Posted on in Defective Medical Devices

There are tens of millions of patients in the United States living every day with the help of medical devices. Running the gamut from heart defibrillators to surgical mesh and artificial joints, the foundation of all these creations is that they were designed to make a patient's life easier. Sadly, however, a lack of standardization across their design and testing has negative impacts when patients and doctors find out too late that these items are defective. After discovering that their pain or complications are related to a defective medical device, they may be required to go through special treatment or follow up surgery.

Manufacturers of medical devices actually go through a relatively non-rigorous process for getting approved despite the importance of their end product. Manufacturers have to pay a user fee of approximately $4,000 to the Food and Drug Administration and file some paperwork to get started. Many devices, considered on the cutting edge at the time of their development, don't go through extensive long-term testing to determine if there are problems that might appear down the road. For some patients getting these devices shortly after they come out, it's like being a guinea pig for an untested product.

The lack of standardization and clear protocol has gotten the attention of a panel from the Institute of Medicine, who recommended that the FDA completely overhaul the device regulatory system to make it safer for patients. Since then, the FDA has started to take the issue more seriously by requiring that medical devices be outfitted with a tracking code, but that is relatively recent and there are still numerous problems reported by patients with defective devices around the country. Lack of clarity and strict standards means that it's simply too easy for a research and development team to get a product approved by the FDA without fully exploring all the potential impacts for patients. If you are a patient who has been hurt by a defective medical device, you need an Illinois personal injury attorney.

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