In the last 11 years over 600 medical devices have been approved for use in humans by a procedure referred to as 501(k). The 501(k) is a process whereby devices used in cardiovascular care, neurology, obstetrics and gynecology, and most areas of medical device production can be approved with very little oversight.
The benefit of this easier and less demanding approval process is that incremental improvements of previously approved medical devices can be brought to market quicker and for less money. However, it can also act as a shield protecting manufacturers from liability when they produce defective products that are inserted into patient’s bodies.
The FDA safety-surveillance strategy has been to rely on hospitals and physicians to report medical device failures. This reporting system fails to identify medical product defects until there have been extensive reports of failures. Also, it requires that an extensive analytic review be done as reports of failure are made.
To properly identify and track medical device failures it has been proposed that all medical devices implanted to the human body be followed with regular reporting of the devices status. This could be done by the patient or the primary care physician.
The quick and easy approval process known as 501(k) should not allow faulty and defective products to harm the public and then give the manufacturer limited or no liability by claiming the product was “approved” when the approval lacked full investigation at the request of the manufacturer. A method to track the results of all medical devices is needed as well as a method to hold the manufacturer liable if there product harms the public.