Medical devices play a critical role in the health care of older Americans. Items classified as medical devices include a wide array of products ranging from tongue depressors to heart valves. The FDA is responsible for premarket review, clearance and approval, postmarket surveillance, investigation of adverse-event reports, inspections, and enforcement. The FDA requires that “high-risk” medical devices undergo premarket approval, a rigorous process involving clinical trials to determine safety and efficacy. However, low- and moderate-risk devices can receive FDA clearance through administrative review of a paper application, known as the 510(k) process. By and large, this relies on the concept of “substantial equivalence” to determine if new devices are similar enough to comparable devices that were already cleared or were on the market prior to 1976, when the first medical device law was enacted. But reliance on substantial equivalence cannot ensure that devices reaching the market are safe and effective, since the majority of devices used as the basis for comparison were never reviewed for safety and effectiveness. In some cases, devices that the FDA has recalled for safety reasons have been used by manufacturers to gain clearance for similar devices based on substantial equivalence. The FDA has stated that it lacks authority to address this problem.
Manufacturers are permitted to market devices only for specific indications that have been approved by the FDA. But under the “practice of medicine” exception, doctors may use any approved device for other, nonapproved indications. This is referred to as “off-label” use. For example, a surgeon may implant a stent, a device used to prop open clogged arteries that has been approved by FDA only for coronary arteries, to prop open other noncoronary arteries.
Estimates of the frequency of serious injury and deaths associated with medical devices vary. The FDA has required reporting of medical device problems since 1990. However, data collected in this manner have been criticized as incomplete, untimely, and not readily accessible. In addition, the FDA requires manufacturers to track certain medical devices that are implantable, life-supporting, or life-sustaining in order to facilitate patient notification and recall. However, monitoring of new devices is performed by the device manufacturer, and that information is not readily available to the FDA. This monitoring activity rarely extends beyond three years, even though most of these devices are designed to last much longer. In order to improve reporting of postmarket adverse events, facilitate device recalls, and reduce medical errors, many countries require that a unique identifier be assigned to high-risk medical devices and listed in the country’s national device registry.
In 2008, the Supreme Court held that medical-device makers are immune from liability for personal injuries as long as the device has been approved by the FDA using its most rigorous review standard, known as the premarket approval process. Devices cleared through this process are typically higher-risk, such as implantable pacemakers and heart valves. Although devices that are shielded from liability represent only a small proportion of medical devices, about ten million people, most of them older than age 65, could be affected by limitations on manufacturer liability for defective medical devices. In its opinion, the Supreme Court left open the possibility that similar protection from liability could be extended to drug manufacturers.
In 2012, Congress directed the agency to put in place a unique device identification system for high-risk devices and to extend its postmarket risk identification and evaluation system to include medical devices.
Medical Devices: Policy
The FDA should ensure that only safe and effective medical devices are allowed on the market.
The FDA should develop a new regulatory framework. It should replace the 510(k) process to ensure the safety and effectiveness of moderate-risk devices and also to allow medical devices to reach the market in the fastest and least burdensome fashion possible.
Congress should grant the FDA discretionary authority to reject applications for 510(k) clearance based on recalled devices, also referred to as “predicate nullification” authority.
While the FDA focuses most of its energies on the premarket review process for approving devices, it should not neglect the postmarket surveillance system, which brings device problems to the agency’s attention.
The FDA should promptly implement recent legislation to extend its Sentinel postmarket risk identification and evaluation system to include medical devices.
Device companies should be prohibited from promoting a device for uses that have not been approved by the FDA.
National device registry
The FDA should continue to implement legislation to establish a national registry to identify, track, and report defective or malfunctioning high-risk medical devices.
Congress should enact legislation that would provide patients with legal recourse if they are injured by a defective or malfunctioning implanted medical device.
Transparency and Competition
Policy makers should increase transparency and competition in the market for medical devices. Efforts may include supporting price disclosure, improving availability of information on medical device performance and clinical outcomes to health care providers and consumers in an understandable format, imposing restrictions on anti-competitive marketing practices, and encouraging cost containment through payment and delivery reforms.
Policy makers should ensure that FDA’s process for approval and oversight of medical devices to better protect public health and safety is thorough, efficient, and not unduly burdensome.
Actions may include: strengthening premarket approval processes for the riskiest devices; establishing quality controls, such as giving FDA the authority to conduct premarket inspection of facilities that make medical devices and enforce recalls; improving postmarket oversight and reporting of medical devices’ failure; requiring testing of devices that were in use prior to 1976; prohibiting recalled devices from serving as a predicate device.