Automation and Anesthesia

After years of research, debate, and Food and Drug Administration review, the federal agency will allow nonanesthesia professionals to use a device that administers sedation during colonoscopy and esophagogastroduodenoscopy procedures, provided that certain requirements are met.

This article first appeared in the March 2015 issue of HealthLeaders magazine.

Increasingly, a colonoscopy team includes not just a gastroenterologist, but also an anesthesiologist. Not content with conscious sedation achieved through a combination of intravenous drugs, more patients and gastroenterologists are opting for deep sedation that only an anesthesia professional can deliver.

That scenario is about to change. After years of research, debate, and Food and Drug Administration review, the SEDASYS system is now available. The device, the federal agency states, will allow nonanesthesia professionals to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures "provided they have training that meets the requirements and in settings having immediate availability of an anesthesia professional as defined in the labeling."

The emergence of the SEDASYS system and other devices may herald the age of automation in anesthesia. Systems that aid humans in monitoring and responding to vital signs are already routinely used by anesthesiology professionals in Europe. Recent studies suggest the benefits of automated intubation and IV fluid systems. And researchers at McGill University in Canada are also working on the McSleepy, an automated monitoring and drug delivery device.

John Pawlowski, MD, PhD, is director of thoracic anesthesia at Beth Israel Deaconess Medical Center in Boston, a 649-licensed-bed facility with more than 800 full-time staff physicians. While his organization does not currently use SEDASYS, he says the approach is the "wave of the future" because not only are the automated systems more efficient, they are safer. "We never react as well in the third hour of a procedure as we do in the first hour of a procedure."

Not everyone in the anesthesiology community is sold on the SEDASYS system. . Concerns about safety led the FDA to reject the device the first time it came up for approval in 2010. A requirement for an intensive training program and postapproval clinical trials led to an FDA nod in 2013.

The American Society of Anesthesiologists issued guidelines for the use of the device in 2014, but did not endorse the system.

Under consideration
The question for healthcare leaders will be: Should we get one? Anesthesiologist Sonya Pease, MD, is the chief medical officer for TeamHealth Anesthesia, a national provider of hospital-based clinical outsourcing. She says the use of automated systems, such as SEDASYS, is a topic of much discussion in the C-suites she visits. One driver: patient satisfaction.

"There has been a huge trend of patients wanting to have anesthesia and sedation for procedures and a lot of these procedures are being done outside the operating room," she says.

Expanding sedation services through automation will require the support of anesthesiology programs, Pease says. The key to those using a system like this is to choose patients properly and have an emergency response team ready to react if things go wrong, she says. "We will work with the hospital to implement a patient safety response team if complications arise from use of the device," she says.

Karen S. Sibert, MD, an associate professor of anesthesiology at Cedars-Sinai Medical Center in Los Angeles, has written about SEDASYS on the KevinMD blog. She says the device will work fine for routine procedures. But she cautions about situations if there is no one in the room to handle complications. And those complications can come on very quickly. Propofol, Sibert says, can be a "very treacherous medicine" and anesthesiologists have nightmares about being called in to handle a complex breathing problem.

"Sedation can be scary," Sibert says. "There's a fine line between breathing and not breathing." Cedars-Sinai Medical Center has no plans to use the device, she says.

Still, GI patients often want propofol and doctors are accommodating them. In addition to offering deeper sedation, the drug wears off much more quickly than the drugs used for conscious sedation. The percentage of colonoscopy procedures making use of an anesthesiologist is expected to rise from 23.9% 2007 to 53.4% in 2015, according to a 2010 study in the journal Gastrointestinal Endoscopy.

Another study found slightly lower numbers, but a similar trend. Between 2003 and 2009, the use of anesthesia in gastroenterology procedures increased "substantially," according to a 2012 report in the Journal of the American Medical Association. Conducted by researchers at the Rand Corporation, the study found a 50% increase in the number of gastroenterology procedures performed on commercially insured patients in that period.

For both Medicare and commercially insured patients, the proportion of procedures using anesthesia increased from approximately 14% to 30%, according to the study, which was financially supported by Ethicon Endo-Surgery Inc. Ethicon, the maker of SEDASYS, is a subsidiary of Johnson & Johnson.

Soeren Mattke, MD, DSc, MPH, a Rand Corporation researcher and one of the authors of the study, says that the standard of care limits anesthesia services to high-risk patients during routine endoscopies. His team's research found that more than two-thirds of anesthesia services were delivered to low-risk patients. The fees paid to anesthesiologists for those procedures added up to $1 billion a year in charges for services "that are not consistent with current, evidence-based standards," he says.

The GI community has attempted to get FDA permission to use propofol, but a large clinical trial would be required to convince the FDA the drug can be used safely by a non-anesthesiology professional, he says. The SEDASYS is what Mattke calls "a patch" around that labeling restriction in that it allows nonanesthesiologists to use propofol without an FDA-approved change of the drug's label. Or as the device's website notes, the system can "help address the challenges in the current healthcare environment."

The SEDASYS system is an example of type of automated sedation delivery knows as CAPS for Computer Assisted Personalized Sedation. A bed-side monitor gauges a patient's oxygen saturation, blood pressure, respiration, and heart rate. That connects to a drug delivery unit and full-screen monitor that displays a provider interface.

According to the FDA, the system was associated with "deeper-than-intended sedation in approximately 2.5% of patients." However, a simulation-based moderate sedation training program developed by the International Society for Anesthetic Pharmacology was designed to prevent and mitigate problems by training users in "airway management and the pharmacology of propofol."

In addition, the FDA notes that "post-approval studies will be conducted to evaluate the need for immediate availability of a trained anesthesia professional for safe use of the SEDASYS system in clinical practice."

Early adopter
Virginia Mason, a 336-licensed-bed hospital in Seattle that performed a total of 9,468 colonoscopies and 4,876 EGDs in 2013, began using the system in September 2014. Otto S. Lin, MD, director of quality for the hospital's Digestive Disease Institute, had been monitoring development of the SEDASYS and contacted the manufacturer once it was approved by the FDA. He says the system addresses two major issues: cost and access. The GI program was having trouble scheduling anesthesia professionals to meet demand. And, he says, gastroenterologists can deliver the same sedation care at a much lower cost using the SEDASYS system for low-risk patients.

Lin says some providers and freestanding practices use anesthesiologists for every colonoscopy, a practice he describes as "an inefficient use of healthcare resources."

"It's expensive for the healthcare system, it's expensive for the health insurance companies, and sometimes it's expensive for the patients if they have a deductible or copay," he says.

The hospital did not have to buy the three SEDASYS systems now in its endoscopy unit. Ethicon owns the units and receives a fee for each case. So, Lin says, there were no upfront capital costs for Virginia Mason, but the hospital needs to pay the company about $50 per case.

"Not only are patients not billed for anesthesia services, they also are not billed for the use of the SEDASYS system, the cost of which is absorbed by Virginia Mason hospital," he says.

Before the system was in place, the hospital did not have enough anesthesiologists available to meet the demand for services in the GI suite, Lin says. The demand for GI sedation services fluctuates and the hospital's anesthesiology department was unable to add more providers at short notice. The director of the Digestive Disease Institute and the director of GI/endoscopy brought representatives from anesthesiology, information technology, purchasing, and billing into the discussion about whether to adopt the technology.

Lin says that because the hospital's anesthesiologists recognized the access problem, they were not opposed to the SEDASYS system. And the anesthesiologists still have an important role in the GI suite because the hospital continues to use anesthesia professionals for high-risk cases.

"They don't feel threatened by the technology," Lin says. "They've been very supportive. I don't think we could have gotten the technology into our hospital if anesthesiologists were opposed."

One of the results of Virginia Mason's using the system is improved patient satisfaction, Lin says. "The SEDASYS system has improved patient satisfaction because they recover from sedation more quickly and are able to remember discharge instructions better and leave the unit sooner."

Beyond the GI suite—and the U.S. border—some anesthesiologists are embracing automation for their own practices. An approach used in Europe is the closed-loop system, which adjusts sedation, or fluid administration, based on monitoring of measures like brain waves and arterial blood pressure.

Advocates often compare closed-loop system to a cruise control or air conditioning. BIDMC's Pawlowski says such systems are used in about 70% of all sedation procedures in Europe. He's observed them in France and Romania and believes they work as well—or better—than an anesthesiologist.

"You get distracted," he says. "I don't think the devices are going to totally replace us. But when you set them up and start running them in somebody who is fairly stable and has pretty predictable response to medication, they make your job easy."

Concerns
In a written response to questions for this article, FDA spokeswoman Jennifer Haliski says the agency is concerned about the over- and under-delivery of anesthetics. "If a trained healthcare provider is not available to attend to the patient, the patient may experience hypoxemia, hypoventilation, and deeper than intended anesthesia or may experience emergence. All conditions require the presence of a trained clinician."

Pease of TeamHealth says hospitals already have emergency response teams for patients who code—or go into cardiac arrest or suffer a stroke. Hospitals using the system might have to have to put together an additional response specifically for anesthesia emergencies, she says.

Kirk Shelley, MD, PhD, is the chief of the ambulatory division of the Yale University School of Medicine in New Haven, Connecticut. He says one of the concerns about automation in anesthesia is that there is too much going on that the machine cannot manage. But he says it seems clear that the anesthesiologist does not need to be in the room all the time—just nearby.

"They are always going to need a smart guy in the hallway if something goes wrong," he says. "Someone needs to be able step back in and put the wheels back on. Every unit needs a professor. You do need someone who can think way outside the box as the situation is evolving."

Shelley says the SEDASYS system is a positive step toward automation. Despite concerns, providers recognize that the approach is worth studying, he says. Over the next 10 years, he expects to see "an explosion" of automated systems in Europe and in the developing world, where machines will help address provider shortages. However, Yale is not planning to use the system at this time.

"It's still very early," Shelley says. "The pioneers get the arrows. If I were a hospital administrator, I would let the others innovate around me and then step into the game."