Injuries and deaths caused by surgical staplers are “substantial and preventable” and are the No. 1 health technology hazard hospitals face in 2020, according to the ECRI Institute’s Top 10 Health Technology Hazards. The ERCI Institute is an independent nonprofit organization authority on medical practices and products.
“We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm,” said Marcus Schabacker, MD, PhD, president and CEO of ECRI Institute.
Surgical staplers were called out last year by the Food and Drug Administration (FDA), which announced that from Jan. 1, 2011, to March 31, 2018, more than 41,000 individual medical device issues were reported to the agency involving surgical staplers and staples for internal use. Among them were 366 reports of death, more than 9,000 cases of serious injuries, and more than 32,000 malfunctions involving the devices.
In June, the FDA’s General and Plastic Surgery Devices Panel issued recommendations that included reclassifying surgical staplers from Class I to Class II devices, which subjects them to general as well as special controls.
This is the 13th year that the ERCI Institute has released its Top 10 Health Technology Hazards, which identifies what it believes are the biggest health technology concerns deserving of special attention by health care leaders. The hazards are selected based on a review of public and private incident reports, device tests, and investigations. The institute also provides practical strategies with each top hazard that hospitals can adopt to reduce risks.