Surgical Staplers Top List of Most Dangerous Medical Technologies

Published on October 15, 2019 by Sandy Liebhard

The ECRI Institute has published its annual rundown of the most dangerous medical technologies, placing surgical staplers  at the top of this year’s list.

“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” said Marcus Schabacker, MD, PhD, president and CEO of the Pennsylvania-based Institute. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”

Surgical Staplers: Risks and Complications

THe ECRI has investigated 75 surgical stapler accidents, including several fatalities, over the past two decades,  and issued 42 safety alerts.

Earlier this year, the U.S. Food & Drug Administration (FDA) published an analysis of 109,997 surgical stapler incidents since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. According to the agency, surgical stapler malfunctions can prolong procedures or result in the need for additional interventions, increasing the potential for serious and life-threatening complications, including:

• Bleeding
• Sepsis
• Fistula formation
• Tearing of internal tissues and organs
• Increased risk of cancer recurrence
• Death

Surgical staplers were initially categorized as Class I (Low Risk) medical devices. However, the FDA recently finalized new rules that would move surgical staplers to Class II (Moderate-to-High Risk) and subjected the devices to special controls.

Other Medical Technologies on the Hazards Lists

The ECRI Institute is an independent, nonprofit organization dedicated to improving the safety, quality, and cost effectiveness of care across all healthcare settings.

The annual Top 10 Health Technology Hazards report is now in its 13^th year, and identifies top concerns that warrant attention by healthcare leaders.  The ECRI selections are based on a rigorous review of the Institute’s incident investigations, medical device testing, and public and private incident reporting database.

Other health care technologies making this year’s list include.

• Point-of-Care Ultrasound
• Sterile Processing Errors in Medical/Dental Offices
• Central Venous Catheters in In-Home Dialysis
• Unproven Surgical Robots
• Connected Home Healthcare Security Risks
• Missing Implant Data and MRIs
• Medication Timing Errors in EHRs
• Lost Nuts and Bolts in Medical Devices

“What used to be hospital problems are now concerns in ambulatory and home care settings,” Schabacker noted. “As healthcare shifts outside the hospital, ECRI remains committed to building awareness about technology hazards to keep patients safe.