Sometimes it’s a simple question of knob placement. Other times it’s consideration of the environment where a device is being used. In any case, when more than one-third of Medical Device Reports to the FDA mention errors and approximately 44 percent of product recalls involve design problems, the human/machine interface ranks as a prominent concern for BMETs and clinical engineering departments. Some industries call it “ergonomics”; the medical device industry knows it as “human factors engineering.
Does your car seat require you to stop frequently on long drives to “stretch your legs”? Does your home computer workstation contribute to eyestrain and muscle fatigue? Do you understand those jokes about people’s frustrating attempts to program their videocassette recorders because you’ve “been there, struggled with that”?
If you’ve answered “yes,” to any or all of those questions, you’ve experienced poor product design — a casualty of the manufacturing process that ignores the human needs and capabilities which come into play when people interact with products. That car seat, that workstation, that VCR all came off the assembly line without any nod to ergonomics.
But while poorly designed products in the everyday world may cause irritation and inconvenience, deficient medical device design raises the stakes. Complex medical devices, often used in stressful, life-and-death situations, can’t afford to ignore the role they play in patient safety. Human factors engineering — the science devoted to the interaction of people and equipment — is the medical device industry’s version of ergonomics, so to speak.
With more than one-third of Medical Device Reports (MDRs) to the FDA mentioning errors and approximately 44 percent of product recalls involving design problems, the human/machine interface ranks as a prominent concern for BMETs and clinical engineering departments everywhere.
As soon as the Joint Commission on the Accreditation of Health Organizations (JCAHO) implemented National Patient Safety Goals in January of this year — including emphasis on proper maintenance of infusion pumps and improved effective use of clinical alarms — attention to the human aspect of device use ratcheted up a notch in importance.
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