Analyzing planned maintenance (PM) inspection data by failure mode and effect analysis methodology

There is no question that medical devices are becoming more reliable. However, we have had some difficulty finding a satisfactory method for providing persuasive documentary evidence that this improved reliability will allow us to relax our traditional planned maintenance (PM) practices without compromising patient safety. The acceptance and increasing use of Failure Mode and Effect Analysis (FMEA) by several of the oversight agencies, including the Joint Commission on Accreditation of Healthcare Organizations, provides us with an important opportunity to take another shot at this vexing problem. Using this proven FMEA methodology and some relatively simple rules to quantify the results of the routine PM inspections that all healthcare providers are still performing in considerable abundance, we have developed a method that allows us to reduce the test results to a simple, single measure (the Risk Score) that can be used to characterize the effectiveness and levels of safety of our current PM regimens. When tested on theoretical data and a sample of real PM inspection results, the method provides answers that seem reasonable. Although it will probably require some modification as we begin the standardized data gathering and gain working experience, it is our hope that this new approach will become generally accepted within the industry. This kind of positive response should enable us to persuade the various accrediting and licensing agencies to similarly accept the concept.