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Medical Device Safety Standards Questioned

The May edition of Consumer Reports magazine offers a helpful investigation of the safety (or lack of safety) in the medical device approval process. The advance of medical technology has opened up many new doors for creating and using medical devices inside patient bodies. From defibrillators and mesh to artificial joints, more and more patients are having operations where various devices are inserted into their body.

Our Illinois medical malpractice attorneys work with many local patients who have had these devices implanted only to have something go terribly wrong. In some instances the problems are entirely unavoidable. However, in many others, the malfunctioning of the device is rooted in some sort of negligence. The trouble may be caused by the medical professional who inserted the device (in which case it would be medical malpractice). In other cases, the problem is caused by the safety of the device itself and nothing done by the surgeon.

The latter harm-malfunctioning devices-are hardest for medical patients to understand, because there is a fair assumption that the devices being used in these delicate operations are properly tested for their safety and effectiveness.

That is not always true.

In fact, according to the CR article, most new medical devices are not tested for safety at all. Amazingly, in many cases some paperwork is filed, a fee is paid, and then the new device is sent to market. Many manufacturers of these devices make millions of dollars in revenue and were only required to pay a $4,000 filing fee to receive FDA approval. A smaller number of “high-risk” devices require more advanced safety testing. However, even then, the testing requirements are generally far less rigorous than those used in other contexts-including prescription drugs.

For many of those reasons, last year the Institute of Medicine suggested that the FDA completely re-work its device regulatory system. Amazingly, Congress is actually debating a law that will do the exact opposite, and work around the system to get devices on the market even faster. These conflicting proposals indicate that there is a sharp disconnect between those looking out for patient safety and those with deep-pockets and Congressional influence who stand to make significant sums of money by rushing new products to the market.

Our Chicago medical malpractice lawyers appreciate that patient safety far too often takes a backseat to the financial interests of big businesses. That should not be allowed to happen here. As one expert explained, the only “testing” that is done is on patients who unsuspectingly receive the devices in the hospital. He noted of some manufacturers, “What they’re doing is conducting clinical trials on the American public.”

Making matters even worse, there is often little that outside observers can do to learn about potential device problems. Patients, researchers, and even government regulators do not have access to databases that track the use of these devices. That means that it takes a long time to identify potential problems before steps are taken to pull the product from the market. Sadly, in the end there is not too much that individual patients can do. Most medical devices are implanted in emergency situations and patients have no way to investigate the safety of each device beforehand. That means proper oversight is paramount with these products..

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