As technology continues to improve by leaps and bounds, each year medical devices have become more and more complex. Many Houston residents have benefited from medical devices. They have become lifesavers. But, sometimes, there is a defective medical device that instead of helping, causes unexpected injuries. A recent law is further eroding the role of the Food and Drug Administration (FDA) in approving medical devices.
No one would argue that medical devices are not a welcome contribution to the medical community. Millions of people have been helped by a medical device. The problem arises when these devices are not always safe. The FDA has the job to regulate the devices and ensure their safety, but as the devices have become more and more complex, the FDA may be falling behind. Many times, a recall or a warning on a device does not happen until after the device is on the market and has already caused harm to a patient.
A new law passed by the House of Representatives last week, the 21st Century Cures Act, is further weakening the FDA's role. It allows medical device companies to submit safety evidence about their device without using clinical trials, instead, anecdotal evidence, including the experience of an individual patient. This law would help a new "breakthrough technology" device hit the market faster, but it does not mean it will be safe. A "breakthrough technology" device can easily be applied to any device with fancy marketing terms. Meanwhile, the device can cause serious injuries and even death to patients because of its lack of research.
The 21st Century Cures Act is capable of causing harm to patients with defective medical devices. As the Senate now debates the bill, it is hoped that they examine all possible shortcomings.