Rising healthcare costs have provoked cost-cutting measures throughout our healthcare system, with few care providers left untouched. Anesthesiologists are among the highest-paid physicians, and other qualified personnel are quite capable of performing selected anesthesia procedures with reduced labor costs, so it is to be expected that anesthesiologists are often a prime cost-reduction target.
Now anesthesiologists face a new challenge – the anesthesia machine.
First proposed in the 1950s, these machines have only recently been put into limited practice as technology needed time to catch up to theory. The first machine, actually named McSleepy, was used in 2008 during a liver tumor removal surgery in Canada. Recent testing in France, India, China, Canada using a variety of systems and the United States has seen closed-loop systems used during simpler screening procedures such as colonoscopies or endoscopies in healthy patients. A newer machine, named Sedasys, initially rejected in 2010, was approved by the FDA in May 2013 for use on healthy adult patients requiring mild or moderate sedation during colon cancer screenings.
To be precise, these systems are infusion devices that deliver narcotics and sedatives triggered by the monitored physical condition of the patient, as opposed to traditional anesthesia machines that deliver oxygen, medical gases, and inhalation agents via a ventilator. Both McSleepy and Sedasys are open-loop systems, in which initial doses of anesthetic are pre-determined based on a patients age and weight. The machine then reduces or stops drug delivery based on the conditions it monitors. Only the attending anesthesiologist can increase the dosage. This gave regulators the comfort level they needed to approve use of the systems.
But the bleeding edge of anesthesia devices is a new system known as iControl-RP. This is a closed-loop system. It monitors a patient’s brain activity along with more traditional health indicators such as blood oxygen levels, and makes its own decisions regarding how much anesthetic to deliver. Mark Ansermino, one of iControl-RP’s co-developers and Director of Pediatric Anesthesia Research at the University of British Columbia, says, “We are convinced the machine can do better than human anesthesiologists.” The machine has been used on 250 thus far, with deep sedation, in more complex procedures involving both adults and children, including liver resections and spinal operations. The machine’s algorithm makes all the medical decisions a physician usually makes, scanning brain waves, blood oxygen levels, and breathing rates to maintain the correct level of sedation.
Ansermino claims that anesthesiologists are not able to maintain the proper level of sedation as well as the machine can. Though any anesthesiologist or CRNA would surely disagree with that assessment, it could potentially be important in procedures involving children, where studies have shown negative long-term cognitive impact of deep sedation on infants and toddlers.
iControl-RP is currently undergoing further tests on adults in Vancouver, Canada. It has not yet received FDA approval, and the development team says it has struggled to find corporate backing, which it feels is due to the amount of perceived risk.
We anticipate that same perception may exist among patients as well. The complexity of anesthesia and surgery dictates that multiple failsafe protocols be in place for even the most routine procedures. The surgeon or endoscopist performing the procedure can’t safely supervise adjustments to the delivery device, and nurses are not prepared, qualified, or by law allowed to do so in the majority of states.
A patient’s level of comfort with the procedure, and the clinicians who provide their care, is an important consideration. One wonders whether patients who have undergone procedures using anesthesia machines would have done so if those procedures were performed outside of testing trials. Would the average patient choose the machine over a human clinician? If the machine were in place at a given facility, would patients be given the option? Consider a similar situation involving a potentially hazardous outcome: the self-driving car. Would you ride in a self-driving car? What level of testing and reliability would give you a comfort level sufficient to trust in the technology?
There are many other questions to ask when considering the use of anesthesia machines:
- Is the device equipped to capture the many clinical signs that a patient can express/present that are signs of discomfort or pain, i.e., tearing, physical posturing (bracing, moving extremities, tapping), ocular movements (especially the size of the pupils), salivation, and skin temperature or color?
- How would the machine recognize and react to an adverse event, such as cardiac arrest?
- What about patients who are not essentially healthy, or have complicating health problems?
- What is the protocol for responding to a machine malfunction? Is there a qualified provider immediately available to intervene should an adverse event occur?
- Is the cost of that stand-by provider factored into the cost of use for the device?
- With regard to cost, will legal expenses incurred to defend one adverse hypoxic event from a case gone wrong exceed the cost of a qualified, human anesthesia provider?
It is clear that anesthesia machines have yet to win full acceptance from government regulators and the medical community. What isn’t clear is whether or not a machine could ever reach a widespread level of acceptance from either group, let alone patients. However, the cost factor may ultimately determine the success or failure of the devices. Anesthesiology fees typically range from $600 to $2,000 for the most common procedure, colonoscopy. In contrast, the cost of anesthesia using the Sedasys system ranges from $150 to $200 per use. This significant reduction will surely please payers. Whether that savings is passed along to insured patients remains to be seen, as does whether or not those patients will even be given a choice. Cost of care has been the leading concern among hospital executives for more than two years running, and is expected to remain so for the foreseeable future. Such a significant cost savings will be difficult to refuse, given an acceptably low level of risk.
There will always be a hypothetical scenario in which anesthesia by machine will be undesirable. As machines are developed and improved, those scenarios may become fewer and more remote possibilities. We may even see a time when machines are supervised by physicians, similar to the anesthesia care teams of the present. For clinicians, now is the time to consider a future in which, at least in part, you can be replaced by a machine. From telephone operators and assembly line workers, to fighter pilots and ship captains, technology gradually performs tasks with greater and greater complexity. How will future skilled professionals create value that cannot be mechanized or pre-programmed?
What do you think…?