Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex technologies like pacemakers and infusion pumps. Given the wide range of risks and benefits, Congress tasked the Food and Drug Administration in 1976 with determining whether new medical devices should be authorized for use based on their potential to help or harm patients.
Public health experts have long voiced concerns about this balancing act. In 2011, for example, the Institute of Medicine (IOM) issued a landmark report calling for reforms to improve the regulation of medical devices. While some of the recommendations have made their way into policy, others, like reform of the 510(k) pathway, have not. This pathway allows devices to be made available for use with limited to no clinical evidence if manufacturers can demonstrate their product is “substantially equivalent” to an existing, approved device.
We and our colleagues Adam Beckman and Joseph Ross recently published an analysis of a device designed to treat stroke patients that was recalled just one year after the FDA cleared it for use in 2019. This case illustrates some of the problems with the 510(k) pathway.
The device, the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, was designed to break down and remove clots that block blood vessels in people experiencing ischemic strokes. It was one of more than 3,000 devices the FDA authorizes annually under the 510(k) pathway.
This pathway is a well-intentioned program for advancing innovation. After all, it doesn’t make sense for manufacturers to do multi-year studies every time they make a change to a device. The problem with this approach is that it assumes the original device used for comparison was authorized based on high-quality evidence demonstrating that its clinical benefits outweighed its potential risks, and that new features in the next generation of the device do not introduce new problems.
The JET 7 device reflects many of the IOM’s concerns about the 510(k) program. Even though devices like JET 7 can save lives, major modifications of a device compared with the original can transform the balance of risks and benefits and cause more harm than good. Consider the following: JET 7 was cleared by the FDA without any new clinical evidence because the product was deemed similar to previous versions of it. The original Penumbra device in this family tree was cleared in 2007 under 510(k) based on non-randomized clinical studies with small numbers of patients. The FDA later cleared nine modifications of the Penumbra device before authorizing JET 7 in 2019. Of these nine next-generation devices, only six reported new animal data and only one reported new clinical data.
Historically, the Penumbra devices have not had issues apart from a manufacturing-related recall in 2010. Yet clearing present-day medical devices based on evidence generated many years earlier — a phenomenon known as predicate creep — can lead to risks slipping through the cracks. In the case of JET 7, the consequences became apparent only after the FDA cleared the device for use, with physicians filing more than 200 adverse event reports about the device — including 14 deaths — within its first year of use. Issues including breakage, dislocation of the device, and other malfunctions that threatened patient safety by hindering clot removal and creating the risk of rupturing the artery through which the device was inserted. These numbers, which led to more than 22,000 JET 7 devices being recalled, are likely an underestimate given that reporting of device malfunctions is voluntary and only a fraction of incidents are ever reported.
The FDA has sensible policies that try to align the burden of evidence with the risk a device might pose. A tongue depressor, for example, does not have the same risks as a device like JET 7 used for stroke surgery. The methods used to classify risk, however, are not foolproof and are overdue for an update. For example, JET 7 is currently placed in the same risk category as some surgical face masks. To safely advance innovation, the FDA needs to develop clearer standards for risk profiles and evidence requirements.
When medical devices have been cleared and are being sold and used, the FDA and others need to be able to learn from what happens in the real world, when use of the device expands to large numbers of patients across diverse health sites. But the FDA does not have a system to collect real-time data on devices. Instead, it relies on self-reports by clinicians and patients, which are frequently filed late and may lack or misclassify key information the FDA evaluates when deciding whether to intervene. The fact that alarm bells about the JET 7 were first rung by hedge fund managers instead of FDA scientists is a testament to the need for reform.
While medical device approvals have increased in the decade since the IOM report, so too has the rate of recalls and the associated costs to the health care system. JET 7 is the latest reminder about the continued salience of the issues the IOM identified in 2011.
The JET 7 recall arrives as lawmakers are in the process of drafting the Cures 2.0 bill and negotiating the reauthorization of the Medical Device User Fee Amendments. Policymakers can use these bills to implement overdue improvements to medical device regulation, from clarifying the standards for premarket evidence needed for 510(k) authorization to adequately funding active surveillance systems and advancing the implementation of unique device identifiers (akin to a tracking number for medical devices).
Medical device innovation is an important avenue for advancing public health in the 21st century. Realizing the full promise of these devices, however, requires a regulatory system that is appropriately calibrated to the risks these products can pose to patients. Policymakers should mark the 10th anniversary of the IOM report by seizing the moment and implementing long-overdue reforms to advance device safety while preserving innovation for the benefits of patients everywhere.
Kushal T. Kadakia is a student at Harvard Medical School. Harlan M. Krumholz is a professor of medicine and director of the Center for Outcomes Research and Evaluation at Yale School of Medicine. He reports having received expenses and/or personal fees in the past three years from UnitedHealth, Element Science, Aetna, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing; and grants and/or contracts from the Centers for Medicare & Medicaid Services, Medtronic, the FDA, and Johnson & Johnson.
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