Food and Drug Administration (FDA) Center for Devices and Radiological Health Director Jeffrey Shuren, M.D., J.D., announced three new actions the agency is taking in an effort to curtail the number of malfunctions, injuries and deaths associated with surgical staplers and staples for internal use.
First, the agency is proposing to increase the regulatory requirements of the staplers for internal use by reclassifying them into a higher-risk category so that they require the review before they are cleared for marketing.
Second, the agency issued a draft guidance to help manufacturers ensure the labeling on their staplers provide adequate information for use, including relevant hazards and contraindications.
Third, the FDA will hold a public meeting of the agency’s General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee on May 30, to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate, as well as to receive expert input on the proposed reclassification of the devices and the draft guidance.
Surgical staplers for external uses will not be included in the premarket review, the FDA clarified.
The announcement comes just weeks after the FDA issued a warning that the staplers and staples for internal use had been linked to more than 41,000 medical device reports from Jan. 1, 2011 and March 31, 2018, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 device malfunctions.
The FDA said in its initial warning that many of the problems reported with the staplers and staples can be attributed to the stapler malfunctioning or being used improperly. The most common problems reported include opening of the staple line or malformation of staples; misfiring; difficulty firing; failure of the stapler to fire the staple; and misapplied staples, such as the user applying the staples to the wrong tissue or applying the wrong sized staple to the tissue. These issues often resulted in prolonged surgical procedures or unplanned, additional surgical interventions with complications such as bleeding, sepsis, fistula formation, tearing of internal tissue and organs, cancer recurrence, and death.
Surgical staplers and staples for internal use are used in a wide range of surgical applications including gastrointestinal, gynecologic and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures.