The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.
The plan also makes it clear that the FDA must be open when they become aware of the misuse of medical devices. In the last month, the FDA has been working on making the use of surgical staplers and staples safer for patients. These staplers and staples are used in a variety of surgeries.
“The agency’s analysis showed that from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual adverse event reports (known as medical device reports, or MDRs), which included more than 32,000 malfunctions, more than 9,000 serious injuries and 366 patient deaths” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The most commonly reported problems in these adverse event reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).”
Shuren announced three new objectives to prevent misuse of the staplers and staples. The first is an a reclassification from low risk to moderate risk which would increase the regulatory requirements of surgical staplers for internal use. The second objective is the release of draft guidance of labeling recommendations. Finally, a public meeting will be held of the FDA’s General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee at the end of the month. This will allow for expert input on the first two objectives.
