FDA Takes Action to Reduce Risks Associated with Surgical Staplers

In response to “an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries,” the U.S. Food and Drug Administration (FDA) announced it will take steps to help reduce risks associated with these devices. As a first step, it issued a letter to physicians and other healthcare providers with an update about adverse events and recommendations for improving patient safety.

The letter – which defined the scope of the problem: “366 deaths, over 9,000 serious injuries and over 32,000 malfunctions – outlined commonly reported problems and complications and provided recommendations designed to reduce these risks. The FDA recommendations include:

• following stapler manufacturer instructions;
• selecting the appropriate size staple;
• understanding when to avoid using staples;
• ensuring nearby structures aren’t in the staple line; and
• knowing how to handle stapler malfunctions.

As it continues to address and monitor the issue, the FDA asks all providers to report adverse events promptly. Later this year, as announced in the letter, “to further promote the safe and effective use of surgical staplers and staples for internal use, the FDA intends to issue a draft guidance for public comment in 2019, which will describe proposed recommendations to manufacturers of surgical staplers and staples for internal use about information to include in their product labeling.”