Tip #1 for protecting yourself from harm from a medical device: Ask MAUDE
(This is the first tip for protecting yourselves from the medical device dangers described in our recent animated “Five Dangers” video. The second tip is here.)
The best, most important strategy for protecting yourself from surgical harm is also the most obvious one: Ask the doctor if there are any medical devices that will be used in treatment. Get the brand name and the product (model) number for any devices the doctor plans to use. Ask what they do and why the doctor has chosen that kind of device. Then get online. Whenever something bad happens with a device, the company is required to report it to the FDA. The FDA keeps that information online in a free searchable database called “MAUDE.” (Just google “FDA MAUDE” and you’ll find it.) But beware: only a small percentage of malfunctions that happen are actually reported to the FDA. So if you see any alarming trend in the reports, make sure your doctor is aware of it and ask how he or she will protect you from this problem. If the doctor is dismissive, find another doctor. Be sure to come back for the 2nd strategy for protecting yourself from harm from a medical device.
Pingback : Video: 5 Things to Know About Medical Devices Before Your Surgery - Safe Patient Advocate