thesia provider, which was off-label and dangerous." The fear of cost-
ly lawsuits may also have tempered interest. "The amount of
liability imposed on the facility with this device was more than most
wanted to deal with, I suspect," says Mr. Landess. "It's safer and
smarter to have an anesthesia provider."
The FDA also restricted the patients on whom you could use
Sedasys, says Carl Noback, MD, medical director of Innovative
Practice Strategies, an anesthesia services provider in Alpharetta, Ga.
"I'm not criticizing the device itself, but what you have is a device
that is supposed to monitor and administer sedation in a restricted set
of circumstances: EGDs and colonoscopies of ASA 1 and 2 patients,"
says Dr. Noback. "Very few patients in general are considered ASA 1.
So most often, the patients undergoing colonoscopies are ASA 2 or 3.
Everyone undergoing an EGD is at least an ASA 2, since they're not
healthy and that's why they're there in the first place. The utilization
parameters were just very, very restrictive."
Higher prices and a bundled fee
In an interview before Ethicon decided to shut Sedasys down,
Michael L. Volk, MD, head of gastroenterology at Loma Linda (Calif.)
University Medical Center, said that the hospital initially used the
device for all colonoscopy patients who met the strict guidelines. But,
after seeing an added cost-per-case for the machine's disposables and
a longer case set-up time, the hospital moved to using it only for
select patients considered hard to sedate with traditional methods. "It
improves safety and satisfaction for a select group of patients," says
Dr. Volk. "But it doesn't necessarily add efficiency. It also doesn't
come with additional reimbursement. If Medicare unbundles the anes-
thesia fee from the procedure fee, others may start using it."
That's where the system really suffered, says Dr. Noback. While
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