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Inadequate Monitoring of Medical Devices by FDA

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

How do prescription drugs get recalled? How do problematic artificial hips get fixed? Many manufacturers imprint a seriel number on their devices – the problem lies however, in the fact that those numbers are never tracked by any standardized system. This leads to countless cases of malfunctioning medical devices in patients that ultimately lead to serious injuries and complications.

Frederic Resnic of Brigham and Women’s Hospital states that “It’s much like a patchwork of streams of information getting to the FDA.” As someone who has worked with the FDA on medical device safety monitoring he knows how the FDA relies on voluntary information from doctors, patients, and hospitals to notify them of the problems with the devices.

How reliable is that you might ask? Well, as you can imagine, not too many doctors will actually contact manufacturers to inform them of defects. This leads to far, and in between reports, that take months before the device even gets recalled. Of course, manufacturers love pointing the blame to others to avoid responsibility, so it sometimes takes longer for the recall to occur. Although manufacturers are legally obligated to investigate an event and report it to the FDA if they get one report from a doctor, this process is not straightforward and not monitored closely. Thus, giving manufacturers of harmful devices and drugs leeway to minimize their own responsibility.

Diana Zuckerman, president of the National Research Center for Women & Families, explains that “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.”

The problem isn’t that the devices aren’t adequately marked. The seriel numbers are clearly printed on each device. The problem is the lack of standardization and data analysis to monitor where each device is, which one is malfunctioning, and why. Although there has been numerous attempts to reform, the government has yet to institute an identifier system that would allow an easy way to track medical devices.

Tracking medical devices is only half the battle. Many doctors are outraged because of how long it might take for the FDA to recall a product that causes so many problems in patients. Although the FDA states that they are trying to improve the system and are constantly trying to find ways to evaluate the medical devices in a more efficient way, it seems that there is a long road ahead. On the upside, many doctors are taking initiative and are not only catching the malfunctioning device before the FDA even notices, but many physicians are conducting their own studies to truly see the harm that certain products have on patients. In 2010, a group of Pennsylvania doctors conducted a study on the IVC filter – a device used to capture blood clots. By taking the matter into their own hands, they found that the filter was breaking off, causing chest pains and building up pressure around the heart. This was also happening in a quarter of all the patients that used it.

Because of their study, the FDA issued a warning. The FDA, however, had been receiving over 900 reports of problems with IVC filters since 2006.

Once a standardized system is instituted by the government – one that takes into account tracking medical devices and reporting malfunctions to the FDA in a timely manner – patient’s will have a better health care service and more reassurance that less complications will occur.

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