Surgical staplers top ECRI’s list of top medtech hazards
ECRI Institute said today that surgical stapler misuse is the top health technology hazard, beating out the likes of point-of-care ultrasounds and sterile processing errors.
The ECRI Institute said it intends to help surgical stapler users avoid many of the common errors that can lead to patient harm by publishing the 13th edition of its Top 10 Health Technology Hazards. The selections are made based on a review of ECRI’s incident investigations, medical device testing and public and private incident reporting databases.
Earlier this year, the FDA published an analysis of nearly 110,000 stapler incidents that have occurred since 2011. Among the incidents were 412 deaths, 11,181 serious injuries and 98,404 malfunctions.
ECRI Institute said it has investigated 75 stapler incidents, including numerous fatalities, and published 42 safety alerts.
“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” ECRI Institute president & CEO Dr. Marcus Schabacker said in prepared remarks. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”
The rapid adoption of point-of-care ultrasounds was selected as the second-largest health technology hazard, as the safeguards for ensuring that users have the required training, experience and skill has not kept up with the speed at which the facilities are adopting the ultrasounds.
Rounding out the top three was the risk of infection that comes with sterile processing errors in medical and dental offices. ECRI Institute said not all healthcare settings have similar resources for core infection prevention and control practices, with many lacking the means to properly process devices.
“What used to be hospital problems are now concerns in ambulatory and home care settings,” added Schabacker. “As healthcare shifts outside the hospital, ECRI remains committed to building awareness about technology hazards to keep patients safe.”
ECRI Institute’s Top 10 Health Technology Hazards
- Surgical stapler misuse
- Point-of-care ultrasound
- Sterile processing errors in medical/dental offices
- Central venous catheter (CVC) risk in at-home hemodialysis
- Unproven surgical robotic procedures
- Alarm, alert, and notification overload
- Connected home healthcare security risks
- Missing implant data and MRIs
- Medication timing errors in EHRs
- Loose nuts and bolts in devices