Recent media reports—including last fall’s International Consortium of Investigative Journalists/Associated Press series “The Implant Files” and Netflix’s “The Bleeding Edge” documentary—have brought unexpected-but-much-needed scrutiny to both the device industry and the regulatory approval process.
Device manufacturers and the U.S. Food & Drug Administration (FDA) have been quick to respond but, as stories of patients gravely injured or inadvertently killed by medical devices capture public attention, these responses fall short of improving patient safety in any meaningful way.
The device industry has assumed a defensive position in response to these concerns. One spokesperson noted that less than 1 percent of all devices are recalled by the manufacturer, suggesting that safety concerns are exaggerated. A compelling soundbite, sure, but keep in mind that companies are much more likely to discontinue a product (and perhaps replace it with a costlier model) than initiate an embarrassing recall.
Drug-eluting cardiac stents, frequently used in the surgical treatment of coronary artery disease, provide a compelling example. Analysis conducted by Lumere of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) safety database shows that among the five stents with the highest incidence of serious adverse patient events (including increased risk of thrombosis and myocardial infarction), only one was recalled while the remaining four were quietly discontinued and replaced with new products.
On the regulatory side, the FDA already had plans underway to modify its 510(k) process (the most commonly used approval pathway for medical devices) even before recent concerns emerged. The agency has reason to exercise caution, given the public hearings that inevitably water down the impact of any proposed changes, but even by those standards, their recommendations fall frustratingly short.
Take for example the FDA’s proposed strategy to disallow manufacturers from referencing an old technology when seeking new product approvals. By eliminating references to older devices, it seems likely that medical device manufacturers will simply increase how quickly they bring new products to market.
This maneuvering introduces new problems – while new healthcare technology is nearly always more expensive, it is frequently no better at improving patient outcomes. As the FDA itself suggested in the press release announcing these proposed changes, “old” certainly does not always equate to “harmful.” In fact, a 2017 study published in The BMJ made clear that newer hip implants are no more effective than older-generation products. We observed a similar phenomenon with newer knee implants.
Even the proposed name of the FDA’s new “Safety and Performance-Based Pathway” is worrisome. Many physicians and hospital administrators mistakenly interpret 510(k) clearance as unequivocal FDA sign-off, and it’s not a stretch to believe that manufacturers will tout their products’ approval under this new name as absolute proof of safety and efficacy.
While device “approval” and “clearance” both mean that a device can be legally marketed and commercially distributed in the U.S., an FDA-approved device has provided valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for its intended use via clinical investigation and non-clinical testing. FDA “clearance,” on the other hand, means a device has been determined to be substantially equivalent to another legally marketed device via the 510(k) pathway.
What steps should the FDA take to improve the safety of medical devices entering the market? One powerful strategy would be to increase the number of products governed under the more rigorous Premarket Approval Application (PMA) process—also known as “up-classifying”—which is used for devices “that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
Today, only about 10 percent of products require PMA approval. If the FDA were to require implants used in joint replacement (the most common surgical procedure performed on Medicare patients) to undergo the PMA process, this would mean up-classifying nearly 400 additional devices in just this one category. This more rigorous review would inevitably lead to a reduction in safety issues. Concerns that this would slow down innovation are exaggerated because manufacturer margins are incredibly attractive, often comparable to those seen by manufacturers of luxury goods.
The truth, however, is we cannot rely on manufacturers or regulators to lead the patient safety charge. Ultimately, hospitals and physicians must serve as the strongest line of defense for assessing the safety of implants. Our analysis of data from over 500 hospitals shows that organizations have historically approved 83 percent of requests to introduce new devices, often with limited analysis.
By developing staff proficient in understanding scientific research and safety data, implementing procedures to monitor safety incidences specifically related to devices, and paying physicians for time spent reviewing devices, hospitals can counterbalance the deep pockets of manufacturers that spend billions of dollars on sales and marketing to influence physicians.
We as a society frequently stand in awe of the devices, implants and instruments that physicians use to treat and cure us. Many indeed are marvels of innovation. However, all of us in the healthcare industry need to take a critical look at the way we separate life-saving devices from those that may do more harm than good. The public scrutiny is long overdue.
Hani Elias, JD, MPH, is CEO and Co-founder of Lumere, a healthcare technology and services company that leverages data science and advanced analytics to empower evidence-based decision making on drugs and medical devices.
