Sedasys Is Here. Who Will Be Affected The Most?

Sedasys

 

The Food and Drug Administration has finally approved the use of Sedasys in the GI endoscopy suite. Sedasys is a computer operated propofol infusion device that automates patient sedation while he is getting an endoscopy. The device monitors six parameters including heart rate, blood pressure, pulse ox, respiratory rate, end tidal CO2, and patient responsiveness to deliver a sedating dose of anesthetic. It is approved only for ASA 1 or 2 patients undergoing EGD's or colonoscopies.

The battle for the approval of the Sedasys system has been going on for years, with Johnson & Johnson and gastroenterologists pitted against anesthesiologists. The ASA won a small victory last year when the FDA initially rejected Sedasys. However, in an unprecedented move, the FDA reconsidered the rejection and now has given the go ahead for the device.

Do you think that there is no way a computer program could function as well as a human anesthesiologist? You better think again. Before you get too cocky, there are several studies that have shown that computers can administer sedation as well as or even better than an anesthesiologist. They are also less likely to oversedate the patients too.

As with any new disruptive technology, there are bound to be winners and losers once all the dust is settled. Who are the likely losers if this equipment becomes widely available? Could it possibly hurt CRNA's? Since it is approved only for sedating healthy patients, most GI docs probably wouldn't use an anesthesiologist anyway in such situations. However, they might use CRNA's instead. The low cost CRNA's suddenly find themselves squeezed between the even cheaper Sedasys for healthy patients and the more expensive but higher expertise of anesthesiologists for sick patients. Uh oh.

What about gastroenterologists? They may think that they can finally rid themselves of the dead weight of anesthesia providers and keep all the money to themselves. However, FDA approval is contingent on having a trained anesthesia provider available immediately for possible airway emergencies. Even that may not be fast enough if nobody is watching the patient except some computer program which is almost always reactive instead of proactive. GI docs may see their malpractice insurance rise as a result of this increased responsibility.

How does the patient fare through all this? I shudder at the possible short cuts endoscopy units might consider once there is no anesthesiologist around to remind them about proper patient safety. We already know that GI docs have a much lower criteria for monitoring patients than anesthesiologists. I also wonder how reactive Sedasys is. Anybody who has ever administered GI anesthesia knows that patients can be maximally stimulated by the endoscope one second then completely relaxed the next once the scope goes past a particularly difficult passage. As an anesthesiologist I've seen far too many instances where the GI doc is yelling at the anesthesiologist to give more sedation because the patient is moving. By the time the extra bolus of propofol has reached the patient's bloodstream the scope has worked through its loop. Now the patient is relaxed but oversedated and his airway is obstructed. Will Sedasys recognize these temporary events and hold back or will it keep pumping propofol into the patient only to overdose when the crisis passes? If the machine does dribble less anesthetic to the patient to prevent oversedation, will that just create more anxiety for the patient?

Anesthesiologists may not be the winners here but I don't think we'll be too badly hurt either. Our expertise will stand out since we will still be called upon to do the difficult cases. Our mastery of the airway will also be evident when we are inevitably called to the endoscopy unit to provide emergency airway support. While there will be some anesthesiologists who may lose their cushy ambulatory surgery center endoscopy jobs, most anesthesiologists don't give anesthesia only for endoscopies. Most ASC's provide orthopedic, urologic, and other procedures that will still need an anesthesiologist present. So I don't see a huge disruption to anesthesiologists either. With a projected shortage of anesthesiologists in the future, our craft should be better utilized on patients who truly require the full gamut of our training. Technology is inevitable. We better get ourselves used to providing a higher level of medical treatment and let the bottom fall out where they may.