Towards international standardization of the anesthesia machine

Abstract

THE practice of anesthesia and critical care has become increasingly dependent on medical technology. Almost every day we read articles in journals and newspapers and view on television some aspect of patient safety. It’s a trendy topic. Much is written on the fact that we must improve patient safety, but what is really being done about it? We have evolved from the old anesthesia machine which was a hodge-podge assembly of separate components, a Fluotec Mark II vaporizer, Ventimeter ventilator, Dial-a-Flo mixer, oxygen analyzer, low pressure alarm, one-channel electrocardiogram monitor, a manual mercury blood pressure cuff and stethoscope that was bolted together by a handyman in the basement of the hospital. We now have integrated anesthetic gas delivery and monitoring systems and in the future, the automated anesthesia glass cockpit. The term “standardization” when used in the context of making all equipment similar in design and function is really nowadays a misnomer. It’s just a small part of what medical equipment standards writers consider when writing a “standard”. What we are really trying to do is to write the minimum requirements for the “basic safety and essential performance” or in other words minimum engineering specifications for medical equipment in general; or for a particular device. Why the minimum, you may ask? Published standards must be sufficiently flexible to provide enough latitude to promote innovation. Standards that require the addition of numerous safety features increase the complexity of a device which may render the device unusable or more prone to failure. The law of diminishing returns takes over once again. An overview of standards development process has been published previously.1 There is no longer just one safety standard for the “anesthesia machine”, but a family of safety standards for almost every component of the “anesthesia system.”A In addition to the “particular” anesthesia system standard,B there are also additional standards covering radio frequency interference,C software, usabilityD and alarm systems.E Jeffrey Cooper in his classic article originally published in 1978 and reprinted in 2002 in the journal Quality and Safety in Health Care2 pointed out that only 14% of critical incidents in anesthesia were related to equipment failure, but 84% of preventable incidents were due to human error. Usability refers to the qualities of a device whereby it is easy to learn, easy to remember, and requires as few steps as possible to perform a task. Usability also implies that the system should have a low error rate and if errors are made, they should be easy to recognize and easy to fix. The device should be pleasant to use and should not frustrate or annoy the user. EDITORIAL 613