FDA Reconsiders Approval of Personalized Sedation System
The Federal Drug Administration has granted an appeal by Ethicon Endo-Surgery to reconsider approval of the Sedasys System, a computer-assisted personalized sedation system, according to a Gastroenterology & Endoscopy News report.
The FDA has granted such an appeal only once before, more than 20 years ago, according to the report.
The system would provide automated, minimal-to-moderate propofol sedation for patients undergoing colonoscopy and upper GI procedures. The device would also allow gastroenterologists and nurses to administer propofol without the supervision of an anesthesiologist.
Some experts have expressed concern about the safety of the device, saying the Sedasys system administers propofol in doses known to produce general anesthesia, not "minimal to moderate sedation" as advertised. Proponents say the device could cut costs associated with colonoscopies and upper GI procedures and that propofol is becoming the anesthesia of choice.
Read the Gastroenterology & Endoscopy News report on the Sedasys System.