By Dennis McMahon, Dennis McMahon Consulting
A Fluke Biomedical e-Learning Series White Paper
Introduction:
Durable medical equipment is depended on for support of patient diagnosis and therapy, so it must be safe, effective, and reliable. It is also represents a huge capital investment, and therefore must be supported for maximized life.
The challenge for those responsible for the upkeep of this equipment is both the spectrum and quantity of devices, depending on the size and specialization of your institution.
In the earliest days of medical equipment maintenance, there were no standards or even conventions for verification of equipment safety and function. Clinical Engineering personnel (or their predecessors) were dependent on manufacturers’ procedures or recommendations. Without as much as a schematic diagram or block diagram, all that remained was technical intuition. Manufacturer support in this regard varied from complete to non-existent; and the trend today is toward less information from the manufacturers.
Earlier scheduled maintenance was driven primarily by fear of patient injury liabilities. The typical biomedical department met informal industry conventions mainly by documenting completion of preventative maintenance procedures (PMs), with little or no documentation of safety checks or failure rates to justify the depth and frequency of those PM’s.
After very public, if distorted, attention was given to the electrical safety of medical equipment in the early 1970’s, standards-setting organizations like AAMI and ECRI set standards for electrical safety, and the Joint Commission began to sharpen the focus on medical equipment maintenance. ECRI first used the term “preventive maintenance inspection” in 1972, which included more than electrical safety verification and a superficial examination. In the mid- to late 1980’s, several different models were offered as a means to assign medical devices to different inspection frequencies based on risk level, function (therapeutic, diagnostic, or monitoring), and maintenance intensity. By 1996, the American Society for Healthcare Engineering proposed a method to classify a risk level to any clinical device, using a formula of five factors: function, clinical application, preventive maintenance requirement, likelihood of failure, and environment of use. “Likelihood of failure” depended on determining the Mean-Time-Between-Failure (MTBF). In 2006, an improvement on previous models was offered which addresses weaknesses in earlier systems by factoring-in cost-effectiveness and (most importantly) a continuous review of outcomes.
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About The Author:
Dennis J McMahon, CBET-R, is a biomedical equipment technician with over 40 years’ experience with medical technology. Dennis has been an instructor at North Seattle Community College since 2002, and is a member of the Washington State Biomedical Association (WSBA). The WSBA named him Biomed of the Year in 2006. Dennis has written or co-authored ten articles in technical publications, one of which won an AAMI award, and contributed three chapters to a text on anesthesia technology. He retired from full-time employment in 2010, and is now a consultant while continuing to instruct in biomedical technology.
Posted by Ohio Clinical Engineering Association 
