Movie buffs and science fiction fans certainly remember HAL, the computer in 1968’s hit movie “2001: A Space Odyssey”. Considered one of the greatest villains in film history, HAL was capable of reasoning and language processing to assist the astronauts on their space mission. Ultimately, however, HAL decided that its best course of action was to kill all the astronauts. “I am putting myself to the fullest possible use,” said HAL, “which is all I think that any conscious entity can ever hope to do.”
Forty-five years later, the FDA in its wisdom has given premarket approval to the Sedasys® Computer-Assisted Personalized Sedation System, developed by Ethicon Endo-Surgery Inc. The device has the potential to “redefine sedation delivery”, according to Ethicon’s press release, with propofol sedation “personalized to the needs of each patient, by precisely integrating drug delivery and comprehensive patient monitoring.” The Sedasys device is designed for “healthy” adult patients who undergo colonoscopy and esophagogastroduodenoscopy (EGD) procedures electively.
Ethicon expects to introduce the system into clinical practice on a limited basis in 2014 to address “the growing preference for propofol sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases.”
According to the FDA’s overview, the Sedasys is a “first-of-a-kind device that will allow non-anesthesia practitioners to administer propofol during colonoscopy and EGD procedures.” It links clinical monitors to an IV infusion pump, and will automatically modify or stop the infusion if it detects “signs associated with oversedation” such as oxygen desaturation.
You don’t have to read much between the lines to conclude that the goal here is to make colonoscopies and EGDs cheaper by allowing people other than qualified anesthesia practitioners to administer propofol.
The FDA has given everyone its blessing to ignore the propofol package insert’s warning that propofol “should be administered only by persons trained in the administration of general anesthesia.” The FDA appears to think it will be enough for GI teams to take part in a “simulation-based moderate sedation training program” that will provide “expert instruction in the pharmacology of propofol and airway management.”
The New York Times must have made Ethicon very happy, in a front-page article on June 2, by claiming that colonoscopy costs are causing the U.S. to lead the world in health expenditures. While facility fees are the biggest targets for criticism, anesthesiologists are in the cross hairs too. The Times estimated that payments to anesthesiologists for colonoscopy sedation quadrupled between 2003 and 2009, and that eliminating anesthesiologist services could save $1.1 billion a year.
So what’s the problem?
The problem isn’t actually with the Sedasys device or its clever developers. You can’t stop technology. I’ve argued before that anesthesiologists are being extremely shortsighted to think that we need to personally provide all sedation or general anesthesia (see my previous post, “Vinyl records and the future of medicine”). Technology can help us monitor more efficiently, and use our advanced training more effectively. It’s worthy of note that a prominent Stanford anesthesiologist, Dr. Steven Shafer, chaired the “Anesthesia Advisory Panel” that guided the development of Sedasys.
Jonathan Cohn’s recent article in The Atlantic, “The Robot Will See You Now“, looks at the often scary future of technology in medicine. He quotes Dr. David Lee Scher, president of DLS Healthcare Consulting, who thinks physicians won’t be seeing patients as much in the future. “I think they are transitioning into what I see as super-quality-control officers, “ Dr. Scher says, “overseeing physician assistants, nurses, nurse-practitioners, etc., who are really going to be the ones who see the patients.” By this logic, the development of Sedasys is simply another step toward reducing direct physician involvement when a less costly level of care may suffice.
What happens, though, when the lineup of GI patients for colonoscopies and EGDs includes through some scheduling error a patient who isn’t essentially healthy? That could include many patients we commonly see in the GI suite—those with sleep apnea, obesity, heart disease, or other complicating problems. The FDA specifies that Sedasys shouldn’t be used for any patient with a full stomach, but would that include achalasia? Severe reflux? Diabetic gastroparesis? What are the odds that the team using a Sedasys device will actually stop when they should and call for an anesthesiologist to help? Time is money, and delays annoy everyone. There are so many conditions that can make sedation risky, and the push for efficiency can work against the individualization of care for the high-risk patient.
Everyone who gives anesthesia knows how easy it is for a patient on propofol sedation to slip over the dividing line between a patent airway and one that is becoming progressively more obstructed. The delivery of supplemental oxygen can delay the recognition that the airway is obstructed because it delays oxygen desaturation. If airway obstruction is just a function of the propofol dose, then it should be easy to write a recipe for propofol delivery that would prevent airway obstruction from happening. But some patients snore and obstruct their airways during sedation worse than others, and one person’s response to a given propofol dose is very different from another’s.
The key problem with Sedasys is this: If oxygen desaturation occurs, and the device stops delivering propofol, who in the room has the skills to manage the airway while the patient recovers? This is especially problematic during EGD, when airway obstruction may be more severe because a large endoscope takes up much of the territory in the mouth and throat.
The American Society of Anesthesiologists (ASA) is doing what it can to monitor the incursion of Sedasys into clinical practice and its future economic effect on the profession of anesthesiology. It is implementing a “three-prong strategy” to review the FDA’s conditions of approval, meet with Ethicon representatives, and “explore an enhanced role for ASA with the FDA relative to this device and other future devices.” The ASA wasn’t initially successful in its attempts to block FDA approval of Sedasys, so it remains to be seen how effective this approach may be.
At least one anesthesiologist thinks the ASA’s efforts are misdirected. Dr. Marc Koch, the president and CEO of Somnia Anesthesia Services, points out that Sedasys only delivers one medication and it can’t take care of patients before, during, and after surgery. In a recent podcast from Anesthesiology News, Dr. Koch said, “I really don’t see any political or other threat to anesthesiologists on the basis of that and that alone.”
The real threat, in Dr. Koch’s opinion, is the $500 to $750 billion that he anticipates will be pulled out of Medicare funding. “It would be helpful if the ASA was keen on taking a more aggressive and proactive approach here,” he said. “Strategically, they need to take a step back and they need to take a look at changes in health care.”
“Obviously, we’re going to be looking at an environment where there will be a thrust to provide better, more expansive service with less financial resources. Who are going to be the winners and losers? Ultimately the winners are going to be those strategies where they are able to provide more service for less cost,” Dr. Koch said. The Sedasys device is “an example that I think serves as a great illustration for what’s coming down the pike.”
“These technologies are really pushing the envelope. I think that having anesthesiologists be at the forefront is irrelevant,” Dr. Koch continued. “They were at the forefront of chronic pain management, they were at the forefront of ICU management, they were at the forefront of the latest and greatest instrumentation for airway management, they were at the forefront of anesthesia delivered outside of the hospital setting, and being at the forefront does very little, frankly, to maintain the footprint of anesthesia involvement in these efforts,” he said.
At the end of the day, what should we as anesthesiologists conclude about Sedasys and future technologies that may replace personally delivered anesthesia care? Robotic devices may play a role in the future of airway management just as they now do in surgery. Whether we welcome and embrace them or work to prevent their approval may not matter; market forces are more likely to determine their success or failure.
It will take time and larger outcome studies to assess the clinical risk of propofol sedation guided by the Sedasys device. Used as intended, with properly selected patients, severe adverse outcomes may be rare. By actuarial standards, the cost in dollars saved for a large cohort of patients may be quite favorable, even compared against the cost incurred with a single severe adverse outcome. As always, though, the cost vs. benefit ratio looks different if the poor outcome happens to be yours.
The Institute of Medicine famously opined in its report, “The Future of Nursing”, that advanced practice nurses should be able to practice “to the full extent of their education and training.” This report has been the springboard to the Affordable Care Act’s broad encouragement of any and all initiatives to expand scope of practice and reduce the role of physicians. Looked at from this perspective, the development of the Sedasys device simply expands scope of practice in another dimension. Why can’t a machine guide sedation? After all, as HAL would say, it’s just trying to put itself to the fullest possible use.
You are probably aware that HAL is actually a representation of the main computer company of its day (when 2001 was filmed), name the letters following HAL…IBM…clever, eh?
But your comments are right on the money as usual and money it is. That seems to be the only driving force in the government’s intrusion into the practice of medicine. As you know, Karen, our brilliant state legislature here in CA wants to allow nurses, pharmacists, etc to become primary care “physicians”. Developing a machine to give anesthesia is the next “logical” step.
Perhaps, in that future day, when someone realizes that the patient is receiving too much medication and tries to adjust it, HAL or Sedasys will say, “I can’t do that, Dave!”
I agree with you that Sedasys sounds like a terrible idea. But I have to disagree about the proposal thing. The ASA has done a good job of lobbying the FDA to limit use of propfol to anesthesia providers. I just don’t think that it takes 4 years of medical school and 4 years of residency to use it. Or even an advanced practice degree. I disagree with the ASA on this one. I know it’s a turf battle and a lot of money is at stake, but in other developed countries propofol is used by nurses for sedation all the time with a high degree of safety.
I also don’t think the ACA is trying to “reduce the role of physicians”. Mid-level providers give doctors the opportunity to expand their role in areas where their expertise really matters, the hard stuff, the research questions, the difficult airway, the mystery diagnosis. That sounds to me like enhancing the role of physicians. I personally would not mind a “reduced role” in colonoscopies, especially if it gave me the chance to practice my hard-earned skills on cases that really needed my expertise.
Dr. Sibert: Please accept another in my growing list of “ATTAPERSONS” sent to you– not only for the sentiments you express, but for their clarity and practical, experienced common sense! “ATTAPERSON” !!!!
The safety of outpatient hospital colonoscopy vs. in office procedures with much lower facility and personnel costs are what is driving up the cost of colonoscopies. This may drive more procedures to ORs making costs even higher. Maybe we will someday get a true head-to-head study of fecal occult blood testing (cheap) vs. colonoscopy (expensive) to see if FOBT is as good too.
It would seem that all this `innovation` alluded to in this blog post,is driven by turf issues & economic/financial considerations.[The idea that a robot,as the technology stands right now is capable of delivering anesthesia/sedation & controlling the multiple factors involved,airway,hemodynamics etc is laughable.Hands up anyone in the know who want HAL to deliver propofol or any other grog on the market to them personally]American anesthesiologists should focus much more on becoming true consultants & not simply & solely be hands on anesthesia providers.The latter arena shall be,in some future time be mostly staffed by technicians nurses etc..call them what you will.The finances will determine such.Anesthesiologists should be supervising these workers,not competing with them directly for menial employment in a race to the bottom.Thus physician anesthesia training should be expanded in depth scope time & rigour.British training is six years at a minimum & Australian training is equally lengthy.Anesthesia training should include fuller lengthier exposure to all areas of relevance with time spent on research resulting in some form of thesis with a masters equivalent produced as well as board certification at the end of it.This may result in there being less doctor ansthetists but with greater credibility.On a more general theme,as a result of the success of anesthesiologists,anesthesia is now so much safer as to be delivered by a caveman as evidenced by who is increasingly giving the stuff in the US & the increasingly paleolithic environment of american medical practice & `health care delivery`,the latter being nothing more than a euphemism for delivery of dollars to insurance consortiums.As in everything in american life,its all about the benjamins.If you are not at the table you are on the menu & it is evident that forces both within their own provenance[lack of foresight,entrenchment,inflexibility etc] & beyond their control[corporate government,insurance companies & the pork barrel nature of american finances ,money allocation & that there is less money`suddenly`etc] now have anesthesiologists,where they stand at present,on the block & destined for the pot.
Thank you so much for writing. I agree with you completely that American anesthesiologists, and American physicians in general, need more rather than less training, and more rather than less specialization. There is no point in competing directly with midlevel practitioners in a race to the bottom, as you put it so well.
It will be very interesting to see how all this plays out.
All the best,
Totally agree with Long on this. Giving propofol for 15 colonoscopies a day is menial labor. Market forces will do exactly what he says. We as physicians should be supervising, consulting, and doing the hard stuff. I’ve said it over and over. The turf wars are about money and must end.
As for training. I agree it must be more rigorous, though not longer. It won’t get more in-depth until ORs stop using residents as labor. Spending days in residency doing cataracts or foot surgery is not a good use of their time or learning capacity.