Safety, BME Style [From the Editor]

Abstract

Safety is a topic about which we are all concerned: we undergo safety training before entering the workplace, and we are aware of it at home and in every other aspect of our lives as well. Safety is also important in the clinical and research application of biomedical devices that we develop, and many courses in biomedical instrumentation and device design have sections concerned with safety issues. For example, the textbook that I use in the my course on biomedical instrumentation has an entire chapter devoted to electrical safety. This is certainly very important, but there is much more to biomedical device safety than minimizing electrical leakage currents. To illustrate this, let me tell you of an experience I had several years ago.Back in the early 1990s, I was an investigator in a major multicenter clinical trial that involved monitoring physiologic variables of newborn infants in their homes for up to six months. My role was to manage the Clinical Trial Operations Center, which ultimately involved four engineers and a technician. Our job was to work with the clinical investigators in specifying and developing the monitoring equipment for the study, work with a selected vendor to design and build the equipment, and work with the investigators and their staffs who interfaced with the research subjects who used the equipment. When I took on this task, I had no idea how large it would be. The specification and design phases went well, and aside from some difficult negotiations with the vendor, everything fell into