FDA Investigation Finds Underreporting of Medical Device Problems

Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events.

This reporting helps the FDA identify potentially defective medical devices and prevent additional patients from suffering injuries or death, Consumer Advocacy News reports. But in an inspection of records from 17 hospitals, the FDA found that the hospitals were underreporting the number of adverse events related to medical devices.

Medical devices of all kinds are proliferating and more and more people depend on implantable and external devices for breathing and cardiac support and delivery of nutrition and critical medications. A variety of surgical devices have made many more minimally invasive surgeries possible. But devices may not function as intended or they may be dangerous. Experts worry about hacking of devices that connect to a computer network. Doctors, patients and regulators all want assurance that defective or dangerous devices will be quickly identified and taken out of use.

The FDA began its investigation earlier this year in response to widespread concern about two medical devices, the power morcellator and the duodenoscope, Consumer Advocacy News reports. The power morcellator, a surgical tool used in hysterectomies and uterine fibroid surgery, can spread undetected cancer in a woman’s abdomen. The duodenoscope, a device used to diagnose and treat certain problems in the intestinal tract, has been involved in the spread of serious infections because the device is difficult to thoroughly disinfect between uses.

The FDA selected 17 hospitals that had experienced adverse events with these devices, but without a corresponding report in the FDA’s reporting database. The FDA’s inspections showed these hospitals were not adequately training staff members on FDA regulations and compliance, which contributes to underreporting of adverse events. The agency believes these 17 hospitals are not unique, and that the underreporting extends to hospitals nationwide. FDA officials suspect that many hospitals are not reporting medical device adverse events at all, according to Consumer Advocacy News.

The FDA has pledged to work with hospitals and industry specialists to develop the most efficient and accurate method of reporting device-related injuries or deaths. The agency wants to make sure that dangerous devices like the power morcellator and the duodenoscope come to its attention quickly before they harm more patients.

In Congress, Rep. Mike Fitzpatrick is leading an effort to make device-related adverse event reporting more effective. Fitzpatrick introduced legislation that would require would require doctors, as well as hospitals, to report adverse events associated with medical devices to the FDA. Under current law, hospitals must report adverse events involving medical devices, but reporting by doctors is voluntary. This complicates the task of identifying defective devices. Doctors are concerned about being held liable for device problems that are the manufacturer’s responsibility. Fitzpatrick’s bill would offer protection to doctors who report device-related events.

Device regulation is highly contested because of the sometimes conflicting concerns of the industry and the medical community.  Experts expect that action on Fitzpatrick’s bill will take considerable time.



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