Reclassification of Surgical Staplers
Surgical staplers are complex medical devices, and ECRI Institute has warned of potential risks for nearly a decade in our Top 10 Health Technology Hazard reports and in more than 40 hazard and alert notifications; our Accident and Forensic Investigation team has reviewed cases of staplers jammed on tissue or otherwise involved in patient injury. Despite these concerns, the U.S. Food and Drug Administration (FDA) has classified them as Class I, or low risk, devices. The issue gained public attention in a Kaiser Health Network report, followed by a May 2019 FDA meeting to consider reclassifying the devices as higher risk.
In this episode, we talk to Scott Lucas, Director of ECRI Institute's Accident and Forensic Investigation, who presented at the FDA meeting, and Julie Miller, Senior Project Engineer, who has evaluated surgical staplers for ECRI Institute's Health Devices program.