When Medical Devices Fail

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.

Source:
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm


I have always found this very interesting as an insulin pump user and someone who works in the health policy field. When I got my pump, there was never any explanation of what I should/could do in the event that my pump malfunctioned. I remember the trainer saying something about how I should call Medtronic/Minimed, but I was never told that I had the right to report any malfunction directly to the FDA.

After doing some googling, I did come across this FDA website - http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm. It appears that consumers can make direct reports to the FDA. I also recall that when I received my initial blood glucose meter with my pump and it clearly had an issue, I was told by Lifescan that I might receive a call from an FDA rep asking about the issue (I never received a call).

One thing I'd like to see is more clear instructions (that are included with our pump and explained by the trainer) of what we can do in the event that our device malfunctions. Specifically, that we don't have to call the company directly and can report the issue to the FDA if we choose.

Manufacturers have an obvious incentive to NOT report device issues to the FDA. To some degree, I understand this. But it leaves me wondering whether widespread issues are being properly addressed. For example, a few months ago, I noticed that my pump would not restart upon changing the battery. I finally realized that the battery cap was the issue, and this was confirmed after other people blogged/posted about it. I called Minimed and the rep denied that the battery cap had any issues, but what was posted by users on the web suggested otherwise. They sent me out a new battery cap (express mail) and everything has been fine since. Is this an issue that gets reported? Are patterns like this addressed?