ABORTED LAUNCH Less than a year after a limited rollout, Ethicon is pulling its Sedasys automated sedation system off of the market.

Now we'll never know if a machine that administers propofol and monitors vital signs could have pulled off an amazing vanishing act: making anesthesiologists and CRNAs disappear from the endoscopy suite. Less than a year into a limited rollout, Ethicon last month pulled the plug on its Sedasys computerized sedation system with little explanation.

'In line with our strategy to further prioritize our investments in high growth and strategic portfolio opportunities, our Ethicon franchise has made the decision to exit the Sedasys business,' says Kristen Wallace, Ethicon's director of communications.

Ethicon denies safety concerns entered into its decision. Instead, it was likely a confluence of events that doomed Sedasys: poor sales forecasts amid a reimbursement landscape that would have cut into bundled payments for GI procedures on the one hand, and job cuts and a restructuring of Johnson & Johnson's medical device business on the other. While the company wouldn't release sales numbers, one insider told the Wall Street Journal that interest in Sedasys never met expectations.

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 procedures, Sedasys let GI docs administer propofol themselves, which shortened patient recovery times and increased efficiency.

Ethicon's decision to kill Sedasys is odd given the uphill battle 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 requirement 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 available 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 anesthesia provider, which was off-label and dangerous.' The fear of costly 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 anesthesia fee from the procedure fee, others may start using it.'

That's where the system really suffered, says Dr. Noback. While Sedasys cost much less per-case than an anesthesia professional — $150 to $200 versus $600 up to $2,000 for an anesthesia provider — how colonoscopies are reimbursed meant that the facility didn't always see the savings. Dr. Noback says that typically a GI provider and facility receive a bundled payment that covers the procedure, as well as costs associated with any anesthesia equipment, supplies and drugs. If an anesthesia provider is brought in to administer propofol, he receives a separate professional fee. With Sedasys, nobody qualified for the separate professional fee, and its higher disposables cost cut into the facility's bundled reimbursement for the procedure. So in theory, facilities could pay up to $200,000 for a machine with limited use and have higher per-case costs — without receiving any additional reimbursement.

Where do we go from here?
Of the 4 facilities that participated in the initial Sedasys rollout, 2 we talked to say they're disappointed that the technology will no longer be available. A ProMedica Toledo (Ohio) Hospital spokesperson says they hope J&J or another company markets the technology in the future.

Andrew Ross, MD, section head of gastroenterology at Virginia Mason Medical Center in Seattle, Wash., says that in discussions with the company, they learned 'that the decision was driven purely by economics.' He says that the hospital found increased efficiency and patient satisfaction after its use in more than 8,000 procedures. 'In light of these and other significant benefits, it's difficult to believe this technology would have no future in medicine,' he says.

Both Rhode Island Hospital and Loma Linda's Dr. Volk declined to comment further on Ethicon's announcement.

Dr. Apfelbaum says that despite anesthesia's initial hesitance about the machine, he was also disappointed when he heard the news. Though it's unlikely a device will ever come along that can completely replace anesthesia providers, there still may be a place in the future for computerized sedation, as long as it improves patient care while being cost-effective.

'I think it was a bit na??ve for some of these attention-grabbing headlines — Device to Eliminate Need for Anesthesiologists and all that. That's not what this is about,' he says. 'If a device is created to improve or increase patient and physician satisfaction, and most importantly, patient safety, then there's a future that's quite bright for it, and it will be welcomed by the anesthesia community.' OSM