While most people would consider a death to be just that – a death, medical device manufacturers seem to disagree. Thousands of deaths caused by defective medical devices are classified as “injuries” or “malfunctions.”
So what do medical device manufacturers consider a malfunction? In one instance, a patient died after falling out of a hospital safety bed when the bed’s alert system failed. The manufacturer didn’t consider this a death, but rather a malfunction.
In another case, a patient died from a fatal septic infection after receiving an injection in the knee. The manufacturer labeled this death an injury.
The labels manufacturers give to adverse event reports have huge implications for other patients. The FDA prioritizes the investigation of potentially defective or dangerous devices by the severity of adverse event reports. Deaths are considered a top priority, while injuries and malfunctions receive a small amount of FDA attention, if any at all.
If you’re wondering why the FDA allows manufacturers to classify adverse events however they want, there isn’t really a clear answer. The FDA “allows manufacturers the discretion to decide when and if their product is related to the death.” Astonishingly, the FDA doesn’t seem to be concerned about any conflicts of interests in the reporting.
The other issue with adverse event reporting is that it is not mandatory for doctors or other healthcare providers. This completely voluntary system has fallen quite short for devices like power morcellators and Essure contraception, which were on the market for more than ten years before FDA investigations led to black box warnings for both devices.
The FDA’s failures have inspired legislation that would give the agency more authority and help hold manufacturers responsible for selling defective or unsafe products. It will likely take some time before the legislation is voted on, but consumer advocates are unwavering in their desire to change the current system.