Robot Anesthesiologists (partially automated)
SEDASYS® System – a computer-assisted personalized sedations system (CAPS), with a human in the loop enabling administration of propofol sedation to patients undergoing routine colonoscopy or esophagogastroduodenoscopy (EGD) procedures (human assistance required).
First Horizon
The SEDASYS® System is a specific iteration of a CAPS, introduced into the commercial health care market by Ethicon US, LLC (a subsidiary of Johnson & Johnson) for use in hospitals for the purpose of sedating healthy patients undergoing routine procedures, which thus far have been colonoscopy or esophagogastroduodenoscopy (EGD). The American Society of Anesthesiologists opposes the system, which is causing preliminary fears that similar systems may eventually replace the anesthesiology profession (median annual salary of $277,000) altogether. Approved by the FDA in 2013 and 2014 (modifications), the system purports to precisely integrate physiological monitoring and drug delivery for personalized sedation. Currently, the system is used to intravenously deliver 1% propofol for “minimal-to-moderate” sedation for patients above the age of 18 years old for colonoscopy and EGD procedures.
According to Ethicon’s Oct. 13, 2014 press release announcing the SEDASYS® U.S. launch, the system “reduces risks associated with over-sedation[,] . . . demonstrated faster patient recovery – 99 percent of patients recovered from sedation within 10 minutes . . . [because] [t]he system provides continuous monitoring and rapid safety responses if adverse sedation-related physiology is detected . . . enhanc[ing] patient safety through four integrated elements – dosing restrictions, automated oxygen delivery, patient alarms and System status advisories.” While one major risk associated with human anesthesiologists has historically been over-sedation, which leads to oxygen desaturation events, Ethicon’s tests show that physicians are more satisfied with the administration provided by the SEDASYS® System. However, use of the system is currently permitted only in health care institutions with a professional anesthesiologist immediately available for assistance. Additionally, clinicians who employ use of the system must complete the SEDASYS® System training and have all necessary training required regarding management of propofol.
The SEDASYS® System costs $150 to $200 in fees as opposed to $2,000 for a human anesthesiologist, making it competitive financially in the current market. Presently, the SEDASYS® System is undergoing a “controlled launch” in the U.S., and is only used to administer propofol for specific procedures, and only under the watch of a trained human anesthesiologist.
While SEDASYS® is partially automated in the sense that it delivers anesthesia without a human present, it does not decide how much anesthesia to administer. The dosage is predetermined based on the patient’s weight and age, and the dosage can only be increased by a human doctor or nurse. Although this technology is currently undergoing a “controlled launch” in the U.S., it has nevertheless passed clinical trials thus far, received FDA approval, is on the market and people are largely unaware of its existence. Thus, the Sedasys human assisted CAPS is classified as First Horizon.
- Photos or Videos (if available)
SEDASYS® System
SEDASYS® System in practice with a patient
http://www.today.com/video/hospitals-turn-to-computer-assisted-anesthesia-451441731889
The biggest advantages of Sedasys, i.e., efficient dosing and purportedly human-less administration of Propofol, stem from the fact that it is currently only approved for certain, fairly simple procedures where only minimal to moderate sedation is required. In these types of procedures with low dosages of Propofol, patient risk for catastrophic events is generally low, however it is not completely eliminated. Doctors who have investigated the system acknowledge that emergencies can happen during routine procedures, including asphyxiation and respiratory arrest, and “unlike a CAPS device, a physician anesthesiologist can and will intervene to save the patient in these emergency situations.”
While a trained clinician is supposed to be nearby, the very fact that these machines are being used for low-risk routine procedures may cause operators to become overly-confident in them and not adhere strictly to the proximity guidelines. If something should go terribly wrong during a procedure, and there is always a chance of that, an unfortunate patient may have no one to call on except for a partially-automated computer that has no way of helping. Furthermore, the very idea of going to the hospital, let alone being sedated is unsettling for many people. The assurance of the human interaction between a trusted doctor or a nurse is generally a large part of medical care. Whether patients’ uneasiness with a robot delivering anesthesia may contribute to adverse effects could be another cause for concern.
http://www.washingtonpost.com/business/economy/new-machine-could-one-day-replace-anesthesiologists/2015/05/11/92e8a42c-f424-11e4-b2f3-af5479e6bbdd_story.html?tid=pm_pop_b
http://www.sedasys.com/us-launch-sedasys-system-commences
http://www.sedasys.com/training
http://www.today.com/health/digital-anesthesia-robots-deliver-sedation-some-procedures-t22846
http://www.medscape.com/viewarticle/851173
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