Medical devices aren’t just any old pieces of technology. Lives depend upon them. For that reason, the government outlined a process decades ago by which manufacturers and importers were supposed to report malfunctions. But there was one problem: When malfunctions occurred, the manufacturers and importers did not admit it. According to the Food and Drug Administration, “A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported.”
That all changed in 1990 with the passage of the Safe Medical Devices act, which required healthcare facilities such as hospitals and nursing homes to report medical device problems. While the law has been tweaked in various ways over the last couple of decades, the basic requirement remains.
The FDA has extensive Web resources for reporting these issues and has made sure that it can be reached in a variety of ways. Addresses, phone numbers, and additional notification requirements can be found at fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm. For information on the codes that need to be submitted along with the reports, visit fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm.
No one wants to go through the trauma of a device malfunction. Our health and our very lives can be affected. For that reason, it is critical that reports be made.