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Misuse of Surgical Staplers Tops ECRI Institute’s 2020 Technology Hazards List

By ECRI

PLYMOUTH MEETING, PA—ECRI Institute identified surgical stapler misuse as the number one health technology hazard in its Top 10 Health Technology Hazards for 2020 report.

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

Earlier this year, the U.S. Food and Drug Administration (FDA) published an analysis of 109,997 stapler incidents since 2011, including 412 deaths, 11,181 serious injuries, and 98,404 malfunctions. During the past two decades, ECRI Institute has investigated 75 stapler accidents, including several fatalities, and published 42 safety alerts. ECRI’s latest guidance is intended to help stapler users avoid many of the common errors that can lead to patient harm.

ECRI Institute’s Top 10 Health Technology Hazards, now in its 13th year, identifies top health technology concerns that warrant attention by healthcare leaders. The hazards selected are based on a rigorous review of ECRI’s incident investigations, medical device testing, and public and private incident reporting databases.

The full list of 2020 hazards includes:
1. Surgical stapler misuse—malfunctions and misuse can lead to patient harm.
2. Point-of-care ultrasound—speed of adoption has outpaced policies and practices that could prevent misuse or misdiagnosis.
3. Sterile processing errors in medical/dental offices—failure to consistently and effectively sterilize contaminated items can lead to patient infections.
4. Central venous catheter (CVC) risk in at-home hemodialysis—risks associated with CVCs can be particularly dangerous in the home setting, where family members may be ill-equipped to manage the risks.
5. Unproven surgical robotic procedures—surgical robots are being used for an expanding range of procedures, sometimes before the risks have been fully assessed.
6. Alarm, alert, and notification overload—high number of notifications can overwhelm clinicians, creating the potential for a significant event to go unaddressed.
7. Connected home healthcare security risks—interruption in transfer of patient monitoring data from cybersecurity issues can lead to misdiagnosis or delayed care.
8. Missing implant data and MRIs—being unaware of a patient’s implant information can put patients in danger and delay MRI scans.
9. Medication timing errors in EHRs—critical medications can be delayed if the order generated from the EHR does not match the dose administration time intended by the prescriber.
10. Loose nuts and bolts in devices—failure to maintain nuts and bolts on medical equipment can lead to catastrophic accidents, harming patients, clinicians or bystanders.

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

The full Top 10 Health Technology Hazards report, accessible to ECRI Institute members, provides detailed steps that organizations can take proactively to prevent adverse incidents. An executive brief version is available for complimentary download at www.ecri.org/2020hazards. To learn more, visit www.ecri.org, call (610) 825-6000, ext. 5891, or e-mail clientservices@ecri.org.

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