Safety Concerns with Medical DevicesMay 3, 2016
Every year, about 3,000 deaths in the United States are attributed to problems with medical devices, as reported by the Brookings Institute. Generally, medical devices and their safety issues are not as accurately documented as drugs, both prescription and over-the-counter. Drugs are subject to stringent tracking requirements and extremely careful monitoring, reports The New York Times.
Hospitals, nurses and medical device manufacturers and importers are required by the U.S. Food and Drug Administration (FDA) to report alleged safety problems of medical devices. Doctors, nurses, and other health care professionals are not required to report alleged adverse effects of medical devices in a so-called “passive system” where notification is voluntary, the Times reports. The FDA calls this method of data collection as potentially “incomplete, inaccurate, untimely, unverified, or biased.”
The FDA has established the Sentinel Initiative, one of the largest distribution networks of medical data projects in the U.S. to detect safety issues with drugs. One documented inquiry confirmed alleged reports of intestinal problems with an antihypertensive drug. In addition, a new blood thinner medication was associated with a higher risk of bleeding than others and was identified, the Times reports.
A Senate report in 2016 accused the manufacturer of duodenoscopes of contamination in the medical device used by doctors in examining the small intestine. The report criticized the FDA for its “lethargic investigation” of the situation and in its examination found that none of the involved hospitals had properly documented the incident, reports the Times. The birth control method Essure was also named as having insufficient data to detect potential serious health risks.