The FDA wants to reclassify surgical staplers as class 2 medical devices rather than class 1, a decision that would subject them to additional controls, Medscape reports.
What you should know:
1. If the reclassification is approved, surgical stapler manufacturers will have to submit their devices for premarket review and meet several special controls including performance testing, usability testing and labeling requirements.
2. The FDA received more than 41,000 individual medical device reports for surgical staplers and staples from Jan. 1, 2011, to March 31, 2018. Among those MDRs, there were 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions.
3. Despite concerns, the panel issued a favorable risk-benefit ratio. "The risk-benefit ratio is strongly in favor of using the device," said Michael J. Miller, MD, founding chair of the Department of Plastic and Reconstructive Surgery at Columbus-based Ohio State University.
4. The panel also recommended simplifying the device's label, cutting away some overly detailed facts to present only the most relevant information.
5. Committee chair Frank R. Lewis Jr., MD, said that the reclassification would provide adequate oversight.