Medical Devices Help and Harm Millions: The FDA Needs a Better Regulatory Process

As of the publication of this article, 2019 has already seen recalls of twelve medical devices. Most recently, Two Medical Technologies, Inc. recalled automatic transport ventilators due to a potential risk of fire. But these are likely not all of the devices that should be recalled. The Food and Drug Administration (FDA) hid reports about harm caused by medical devices. In its article discussing these reports, Kaiser, a healthcare delivery system, profiled a surgeon who was using a surgical stapler to seal tissue around someone’s appendix, but the stapler locked up. Over two-thirds of surgeons he talked to about this issue experienced a similar malfunction. The FDA apparently had granted the makers of these staplers a special exemption “allowing them to file reports of malfunctions in a database hidden from doctors and from public view.” This database, MAUDE, includes serious injury and malfunction reports for about 100 medical devices. More than one million reports of malfunctions or harm spanning about fifteen years remain in the database. The FDA has been notified of 5.4 million adverse events between 2008 and 2018. While some malfunctions are openly reported, thousands more are hidden.

The FDA’s Center for Devices and Radiological Health is tasked with regulating medical devices. There are three risk categories that essentially determine the level of scrutiny they receive during the regulation process. Class I devices are not at all highly regulated, and do not actually have to do what they claim to do as long as they are adequately packaged and properly labeled. Class II devices—which are considered medium risk and could hurt patients if misused—also do not receive a high level of oversight, especially if it is a device that is substantially equivalent to a device already allowed on the market. Class III devices must go through a premarket authorization scientific review process before approval. However, there are several loopholes in the regulatory process. First, medical devices often are not tested in humans before they are released on the market. Second, there is not systemic way for the government, researchers, or patients to spot problems in the process. Third, there are not many protections for patients who are harmed by medical devices.

Class III devices are still not being regulated enough. The FDA needs to re-evaluate its regulation process, particularly for Class II and Class III devices. It does not seem that the “substantially equivalent” test and the premarket authorization process are working. These sorts of loopholes are creating problems in the medical field. For instance, if the FDA was actually regulating medical devices, 80,000 deaths due to malfunctions could have been prevented. People would potentially not be permanently paralyzed, burned, and otherwise permanently damaged otherwise. Even when devices cause problems, they are rarely pulled from the market.

The FDA may not always know the extent of risk before the medical device reaches the market. But there are ways to mitigate these problems before recalling the devices. One surgeon has called for mandatory registration of all implantable devices. The FDA has also called for human testing and, for at least one type of medical device, has required companies to submit a report on devices already on the market. The FDA recently said that it will start actively watching how devices perform once on the market, rather than relying only on patients to report problems. Hopefully in the coming years, the FDA will no longer see huge medical device recalls.