The Food and Drug Administration's most serious medical device recalls are Class III, which involve failures that could cause serious harm or death to patients. A recent study of Class III recalls found that nearly 70 percent of the devices had been cleared for use by the FDA without any evaluation of their safety. Allowing these devices to reach the market constitute a violation of federal law and of the FDA's own policies and procedures.
All new medical devices are reviewed through one of the FDA's two processes, Prior Market Approval (PMA) and the 510k process. Class III devices, the FDA's designation for devices which support or sustain human life, or are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury are subject to Prior Market Approval. PMA review includes many of the same procedures and standards the agency applies to new drugs. Clinical trials with human subjects to confirm that the device is both safe and effective are usually a part of the process. HIV diagnostic tests, surgically implanted heart valves, defibrillators, and cardiac stents are representative of the kinds of devices subject to PMA.
The 510k review is a much less demanding process. New devices must only be shown to be equivalent to another device already on the market. Devices which meet this standard are not described as approved, simply as 'cleared for market.'
The FDA does not require post-market testing, relying instead on health care professionals and patients to report failures and problems in medical devices. The FDA uses these post market reports to evaluate the degree of risk to patients and to decide whether a device should be recalled. In 2006 the FDA received over 116,000 reports of device-related injuries, and more than 200,000 adverse event reports concerning medical devices. The reports included 2,830 deaths related to device failures.
Published in the Archives of Internal Medicine, the study of Class III recalls examined all 113 FDA Class III recalls between 2005 to 2009. Seventy-one percent, 80 of the recalls, were devices which had been cleared for market by 510k review, and not held to the higher PMA standard. Many of these devices, such as hip and knee replacements and external defibrillation devices, although they are designated as Class II, meet the Class III standard in that they are of substantial importance in preventing impairment of human health. They should have been subject to the more rigorous PMA review. Had these flawed devices been reviewed to PMA standards, it is likely that many of them would not have made it to market.
These recommendations came out of the study:
The FDA's definition of a Class III device take into account the potential risks if the device fails;
The FDA comply with current law and review all Class III devices under the PMA process;
The FDA inspect the manufacturing processes of 510(k) devices just as they do for devices approved through the PMA process; and
The FDA use special controls for 510(k) devices as they do for PMA devices, including post market surveillance, performance standards, and product-specific and general guidance documents.
Putting these recommendations into practice would make the use of medical devices less of a gamble for patients and their physicians, and increase the likelihood that patients would get the care they need and deserve.