Who's pushing the propofol?
Sedasys was touted as a technology so disruptive that it would one day
put anesthesia providers out of work. A GI doc or endo nurse could
operate the computerized sedation system, which delivered IV 1%
propofol and monitored the patient's oxygen, heart rate, respiration
rate, blood pressure and responsiveness. Sedasys featured several
alarms and safety locks designed to prevent complications. Instead of
using the traditional combination of midazolam and fentanyl for GI pro-
cedures, Sedasys let GI docs administer propofol themselves,
which shortened patient recovery times and increased effi-
ciency.
Ethicon's decision to kill Sedasys is odd given the uphill bat-
tle the device faced for regulatory approval. Sedasys was first
submitted for FDA approval in 2010, when it was rejected due
to safety concerns. The device finally won approval in 2013,
but only under a set of strict restrictions, including a require-
ment that an anesthesia provider be on-call for emergencies.
What exactly did on-call mean, though?
"The company indicated that it meant a provider be avail-
able within the institution, but the FDA's language was a bit
fuzzy," says Jeffrey L. Apfelbaum, MD, former American
Society of Anesthesiologists president and chair of the ASA
committee that reviewed Sedasys. "Did that mean the
provider was available within a few minutes, or did that
mean right there in the room or in the institution? It wasn't
clear."
William Landess, CRNA, MS, JD, corporate
director of anesthesia services at Palmetto Health
in Columbia, S.C., says that "some of the GI places
that wanted to use it wanted to use it in lieu of an anes-
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