Legislation proposed concerning FDA approval of medical devices

Patients are at risk of serious personal injuries whenever a defective or otherwise dangerous medical device is used during a procedure. Medical devices that are implanted in the body can be particularly dangerous.

Hip implants, such as those recalled by New Jersey’s Johnson & Johnson, are just one example of a medical devices that have resulted in products liability lawsuits by patients who have been injured.

Generally speaking, these medical devices are ones that have received approval by the Food and Drug Administration (FDA). Doctors and patients rely on this approval and consider the devices safe, even though this is not always the case.

In an effort to prevent injuries from unsafe medical devices, new legislation is being proposed that will allow the FDA to require safety studies on medical devices even after they have been approved. It has also been proposed that FDA approval only be granted on a temporary basis until full testing can thoroughly be completed.

Under current law, pharmaceutical companies need only show that a new medical device is similar to a product already on the market, and not necessarily that it is otherwise safe. In addition, the FDA is limited in its ability to require manufacturers to conduct post-approval reviews. However, these current procedures have failed in ensuring the safety of medical devices.

Hopefully if the proposed legislation is enacted, the FDA will be more aware of dangers with medical devices as soon as they are discovered. Patient safety should be the number one priority and should never take the back seat to putting new technologies on the market.

Source: Bloomberg, “Medical Devices Need Greater Follow Up After U.S. Approval, Senators Say,” Anna Edney and Alex Nussbaum, Dec. 15, 2011