On a daily basis, doctors across the country rely on disclosures from medical device manufacturers to assess the risks and benefits of medical devices they recommend for their patients. To do so, they routinely rely on the U.S. Food and Drug Administration’s (FDA) public online database known as the manufacturer and user device facility experience (MAUDE) for objective reports of adverse events associated with those devices. Now imagine that millions of adverse events were systematically hidden from the public database over the course of two decades—and the FDA was complicit in that deception. Hard to imagine but true.

A Back-Door Program for Device Manufacturers

Earlier this year, the FDA acknowledged dozens of medical device manufacturers had been granted a little-known exemption from regulations requiring the submission of adverse events for publication in MAUDE. In June, the FDA released roughly six million previously undisclosed reports it received from various manufacturers between 1999 and April 2019 through a back-door program known as alternative summary reporting (ASR). Though ASR, manufacturers of critical devices such as surgical staplers and pediatric breathing machines satisfied their obligation to notify the FDA of certain reports of intraoperative device failure or post-surgical complication without also disclosing those reports to the general public. Pursuant to 21 CFR Part 803, a manufacturer is required to inform the FDA within 30 days if it learns from any source that its device may have caused or contributed to a patient death or serious injury. A duty to report is also triggered when a manufacturer learns of a device malfunction that would be likely to cause or contribute to death or serious injury if it were to recur. The FDA voluntarily created the ASR program through a regulatory loophole, allowing some of the largest device manufacturers, including Medtronic and Zimmer, to bypass the more transparent reporting process and discreetly submit summary reports of device failures, often on a quarterly basis.

The FDA’s Explanation

While easy to understand why some device manufacturers might favor this approach, the FDA’s decision to allow ASR raises more questions than there are answers. In a June 21 “statement on the agency’s efforts to increase transparency in medical device reporting,” director of the FDA Center for Devices and Radiological Health, Jeffrey E. Shuren, said the agency “recognized the public interest in this information” and began taking steps to limit ASR in 2017 by requiring that exempted manufacturers file companion reports on the public database. While announcing the formal end of ASR, the FDA explained the program allowed manufacturers to request an exemption from normal reporting avenues only for “certain events that were well-known and well-established risks associated with a particular device.” Over the past two decades, 108 such exemptions were granted. According to the FDA, ASR submissions were not made publicly available because they were not required to be provided to the agency in a format compatible with the public database. Ultimately, the FDA said the program let it “more efficiently review reports of well-known, well-understood adverse events, so it could focus on identifying and taking action on new safety signals and less understood risks.” In a separate statement on the agency’s website, the FDA said ASR exemptions excluded events where a device may have caused or contributed to a patient death except for those involving sudden cardiac arrest more than five years following implantation of certain heart valves the agency determined did not pose an unreasonable risk of harm to the public health.

The FDA’s explanation leaves many questions unanswered. For one, it stops short of confirming that all six million ASR submissions were duplicative of similar publicly filed MAUDE reports. Further ambiguity exists as to the FDA’s threshold for concluding the risks of an exempted product were already “well-known” and “well-established.” The FDA’s June 21 statement offered only that the risks of exempted devices were “often already described in the product labeling available to health care professionals and patients.” But how was the general public expected to learn of risks that were not included in product labeling?

Unintended Consequences

On a fundamental level, the ASR program disregarded the fact that without a device recall or comprehensive “dear customer” letter, the sheer volume of similar adverse events is itself the general public’s only way to identify device failure trends. While not the intended goal of the program, ASR undoubtedly had an immeasurable negative impact on the FDA’s mission to protect and preserve the public health. MAUDE is routinely searched by interested parties such as doctors, researchers, patients, FDA watchdogs and attorneys. With millions of reports submitted for the FDA’s eyes only, countless doctors may have been left unable to identify trends in medical device failures so they could make informed decisions about treatment courses, and in turn, give their patients informed consent about the risks of a given medical procedure. Patients who did their own research may have unknowingly been kept in the dark about how many others experienced similar problems with the same device. Attorneys seeking to represent patients who believe they were harmed by exempted devices may have been hampered from completing thorough pre-suit investigations. Without disclosure through the FDA, the public was left without a critical objective tool to identify health hazards.

A Transparency Overhaul

The FDA’s decision to end the ASR program comes as it prepares for major changes to modernize the agency’s 42-year-old framework for evaluating new medical devices and updates to the way the agency discloses device data to the public. In April 2018, the agency announced the implementation of a “Medical Device Safety Action Plan.” Among other things, the plan fosters technological advances by scrutinizing the age of predicate devices used as a comparison point for assessing the safety and efficacy of new devices. To improve transparency, the FDA created a program designed to capture the total life cycle of a device by integrating its pre-market and post-market data in one searchable database. Together with a host of other measures, the agency said it hopes to establish a “medical device patient safety net.”

While the FDA’s recent efforts toward transparency are significant and certainly worthy of praise, they show more can be done to make sure there is full disclosure about the medical devices they approve. At the very least, the medical community and general public should know what the device manufacturers already know.