The Food and Drug Administration Friday issued recommendations for health care providers to reduce the risk of adverse events associated with surgical staplers and staples for internal use. Among other recommendations, FDA recommends providers carefully follow the stapler manufacturer’s instructions for use, have a range of staple sizes available and select the appropriate size cartridge for the tissue. Since 2011, the agency has received more than 41,000 medical device reports for surgical staplers and staples for internal use, including 366 deaths. FDA plans this year to issue draft guidance to manufacturers on information to include in their product labeling and to hold a public meeting on whether to reclassify the staplers as Class II devices, which would allow the agency to establish mandatory special controls to mitigate known risks.

Related News Articles

Headline
About 80 percent of new HIV infections in the U.S. in 2016 were transmitted from the nearly 40 percent of people with HIV who either did not know they had HIV…
Headline
Historic flooding in parts of the Midwest caused a number of Nebraska hospitals to be inaccessible by ground transportation, the Nebraska Hospital Association…
Headline
The Senate Appropriations Committee’s Subcommittee on Labor, Health and Human Services, Education and Related Agencies today held a
Insights and Analysis
In this AHA Stat Blog, Institute for Diversity and Health Equity President and CEO Duane Reynolds shares some takeaways from the recent ACHE conference and…
Insights and Analysis
This week, as part of the South by Southwest (SXSW) festival’s Interactive Health and MedTech track, the American Hospital Association and hospital leaders…
Headline
A federal court has ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal…