Closed-loop systems and automation in the era of patients safety and perioperative medicine

Abstract

In 2013, General Motors, BMW, Mercedes-Benz, and Tesla all announced that they would bring self-driving cars to market for the general population before 2020 [1]. Some expectations suggest that by 2040, 75 % of all cars will be autonomous [2] and that this may reduce traffic accidents by a factor 10 [3]. In looking ahead at this possibility, three US states have already enacted laws addressing autonomous vehicles (California, Florida, and Nevada). We’ve come a long way since the model T first rolled off the assembly line. A moment’s reflection will show that automation has flourished in nearly every part of our daily lives. It has made aviation safer and more fuel efficient, modern life more comfortable with the widespread adoption of air conditioning, and has transformed the food industry with the invention of the refrigerator. The whole concept of life and homeostasis, described by Claude Bernard decades ago, relies essentially on feedback control; mammalian physiology may be the most sophisticated series of closed loop systems to ever exist. In looking at our specialty, it is likely that forms of automated anesthesia are the next major disruptive technological innovation we should expect. However, as with most major innovations in healthcare, it may take longer than expected before it becomes a reality. Given the otherwise wide-spread success of these systems, one may rightfully ask why has it taken so long for automated systems to come to fruition and help improve patient safety and outcomes in the perioperative environment. There are several probable causes, but the main hurdles have and will remain regulatory approval, acceptance by clinicians, and misassumptions by the community of clinical scientists on the development pathways that should be taken to bring this concept to the bedside. Regulatory pathways for developing new technologies have become more difficult during the past 20 years. Some technologies used on a daily basis that were approved 20 years ago would probably not pass the bar of the regulatory agencies today. The European regulatory process has been considered ‘‘easier’’ than the FDA process and this has helped to bring new technologies to the bedside faster in Europe than in the US. However, CE regulations are going to be modified in the next 2 years and it is expected that the new process will be as expensive and as detailed as the FDA process is now. This is good news in some ways, but this is concerning in other ways. For the pessimist, who sees risks and danger in any novel technology, this is good news because it guarantees that new technologies will have to be extensively tested and their benefit will have to be demonstrated before commercial sales begin. For the optimist, who sees the benefits new technologies will ultimately bring, this is bad news because it may delay the implementation of new solutions to old problems [4]. The second significant hurdle to automation is going to be acceptance by clinicians. A priori, when the concept of closed loop is presented to anesthesiologists, the first reaction is to say: ‘‘Wow, you are trying to replace us and to take over our jobs!’’ If we, as anesthesiologists, truly believe that the entirety of our job is to push the plunger on a propofol syringe, turn the sevorflurane canister on and off, or adjust the flow rate of the crystalloid bag during surgery then, yes, closed-loop systems are a threat to our profession. On the other hand, if we believe that our job is M. Cannesson (&) J. Rinehart Department of Anesthesiology and Perioperative Care, School of Medicine, University of California, Irvine, 101 S City Drive, Orange, CA 92868, USA e-mail: mcanness@uci.edu

DOI: 10.1007/s10877-013-9537-3

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@article{Cannesson2013ClosedloopSA, title={Closed-loop systems and automation in the era of patients safety and perioperative medicine}, author={Maxime Cannesson and Joseph B. Rinehart}, journal={Journal of Clinical Monitoring and Computing}, year={2013}, volume={28}, pages={1-3} }