What is a Defective Medical Device?
Between 2007 and 2011, the incidence of defective medical device recalls more than doubled with more than 1,200 moderate to high-risk medical devices recalled and 50 high-risk device being removed from the market. In 2007, only 26 high risk and 540 moderate risk devices were recalled by the FDA. Yet, the organization has updated approval guidelines that will allow medical device manufacturers to get new devices on the market more quickly, which many patient safety advocates say will lead to more injuries from devices in California and other states.
In February 2011, Congress heard testimony from both medical device manufacturers and patient safety advocates regarding the FDA approval process. Both sides provided conflicting information, with medical device manufacturers claiming that the United States was falling behind other countries when it came to releasing new medical devices. Yet patient safety advocates claimed that, although Europe does allow products to reach the market more quickly, more defective medical devices are recalled in other countries than in the United States. They claim that this is due to FDA guidelines that require additional steps to reach approval.
Patient safety advocates say that defective medical devices are still released to the public even with the current strict guidelines and that this indicates a need for even stronger guidelines, not a relaxation of requirements for approvals. In fact, statistics show that 70 percent of recalls over the past few years have been products that have been approved through the FDA’s 510(k) program, which is less stringent than the pre-market review program.
510(k) Program
The FDA uses two programs for approving medical devices used in California and other states. The pre-market approval program is used for high-risk devices and requires human testing before approval. However, 90 percent of all medical device approvals are done through the 510(k) program, which does not require extensive pre-testing. Manufacturers often use this process if the device is similar to another device on the market, even if the first device is used for something completely different. In fact, one device approved for testing tumors was initially approved for testing for illegal drugs.
Do You Have a Defective Medical Device Lawsuit in California?
There are many who are concerned that injuries and deaths from defective medical devices will rise in California and throughout the world if guidelines are not strengthened, yet the decision was made to keep a more relaxed view on approval guidelines. If you or a loved one has been injured by a defective medical device or if a loved one has died, contact Attorney Group for California for a free, no-obligation consultation to determine if you may have a personal injury or wrongful death case.
