Injury and Death from Surgical Staplers Preventable, Product Misuse Tops ECRI’s 2020 Technology Hazards List
After two years in the top spot on ECRI’s annual technology hazards list, cybersecurity was dethroned and replaced by surgical stapler misuse (However, cybersecurity remained an item on this highly anticipated list).
In March, FDA sent a letter to healthcare providers about adverse events involving surgical staplers and staples for internal use, citing more than 41,000 medical device reports between January 1, 2011 and March 31, 2018. In a report that the agency published at the end of May (“Reclassification of Surgical Staplers for Internal Use”), the number of incidents involving the products had climbed. FDA combined MAUDE and ASR (the alternative summary reporting program, which has since been shuttered by the agency) MDR reports, and stated that the number was nearly 110,000—412 of which were deaths, 11,181 were series injuries, and 98,404 were malfunctions.
“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” said Marcus Schabacker, M.D., Ph.D., president and CEO of ECRI Institute in a press release. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”
ECRI’s annual list serves as a warning to healthcare providers and stakeholders about the top technology issues that could present a danger to patients. The following is ECRI’s Top 10 Health Technology Hazards for 2020.
- Surgical stapler misuse
- Adoption of point-of-care ultrasound outpacing safeguards, leading to misuse or misdiagnosis
- Infection risks from sterile processing errors in medical and dental offices
- Central venous catheter use during in-home hemodialysis poses a risk to patients when caregivers/family are not qualified to manage these risks.
- Unproven surgical robotic procedures put patients in danger
- Alarm, alert and notification overload (i.e., alarm fatigue due to clinicians being overwhelmed)
- Cybersecurity risks in the connected home healthcare setting
- Missing implant data delays or adds danger to MRI scans
- Medication dose timing errors in electronic health records
- Loose nuts and bolts in devices, which can lead to “catastrophic accidents” that harm patients and clinicians
The organization’s executive brief can be downloaded from ECRI’s website.
View ECRI’s 2019 Top Technology Hazards List.
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