Medical device manufacturers are required to report any event that “reasonably suggests a device may have caused or contributed to a death or serious injury.” Madris Tomes, a former FDA consultant, conducted an analysis showing that 4,000 patient deaths were labeled as “injuries” or “malfunctions” between 2011 and 2015. She says these labels are important because they help determine which issues are priorities for public health analysts.
When a death gets categorized as an “injury” or “malfunction”, it delays reviews of that issue. “The way that the FDA reviews the [safety] reports is in order of importance by the classification that is checked on the form,” Tomes said, according to NBC. “So if it is an injury or malfunction, it could take them weeks to months to get to reading them.”
Of course, not every death can be attributed to a medical device. The U.S. Food and Drug Administration (FDA) says there are many cases where there is simply not enough evidence to show a device contributed to a patient’s death. Some lawmakers, however, are critical of the fact that companies themselves determine whether its medical device was responsible for the death of a patient. Critics say that relying on industry’s judgment for these events is a conflict of interest that ultimately risks public health.
NBC News shares the story of one woman who was implanted with the Cyberonics’ Vagus Nerve Stimulator to treat epilepsy in 2010. According to her family, she died less than 48 hours after complaining of unusually painful shocks. Cyberonics has classified dozens of deaths as injuries or malfunctions, a fact that her family learned afterwards.
In 2001 and 2004, the FDA sent warning letters to the company stating that it failed to investigate and report patient deaths in a timely manner. Cyberonics told the agency that those issues have been fixed. After NBC New York and CBNC inquired about more recent deaths labeled as lesser events, however, the company conducted an internal review and found a total of 108 deaths that were mislabeled. A spokesperson for the company said the mislabeling stemmed from a blend of unintentional human and procedural errors. Cyberonics says the cases comprise less than one percent of the 34,728 safety reports filed.
NBC also cited another example involving the Vagus Nerve Stimulator where five separate patients with the device died of pneumonia. The manual warns about the risk of aspirating liquid into patients’ lungs, which can potentially cause pneumonia. Three deaths were labeled as “injuries” or “malfunctions” because medical professionals allegedly determined that the pneumonia was not associated with the device. Human error caused the other two cases to be mislabeled.
There are also questions about how the FDA is managing complaints over Essure, Bayer’s permanent birth control device. NBC reports that more than 300 women have reported getting pregnant, even after implantation, and suffering a miscarriage. The instructions on the FDA safety reports, however, say not to check the “death” box if a fetus is miscarried or aborted due to congenital anomaly. These types of situations are raising questions about whether the FDA guidelines for reporting are sufficient.
Although death reports are prioritized, NBC reports that other criteria are also factored into what gets reviewed. The FDA is improving how it tracks problems with medical devices by upgrading its software. The steps are being taken in response to a 2009 investigation by the Inspector General for the Department of Health finding that most unread safety reports were those labeled as “malfunctions”. Analysts only received about 10 percent of these reports through the FDA software. The new software will incorporate data from several different sources such as clinical registries, electronic health records, medical billing claims and data transmitted from devices.