10 Ways to Design Error-Resistant Medical Devices

Medical devices should be designed to provide the best possible user experience, while reducing the risk of errors that can result in harm, injury, or compromised medical care. To do this, 21 CFR 820:30 states that “…when designing a device, the manufacturer should conduct appropriate human factors studies, analyses, and tests from the early stages of the design process until that point in development at which the interfaces with the medical professional and the patient are fixed…” However, in an interview with MD+DI, Gia Rozells, director of user experience design at Becton, Dickinson, and Co. (BD) said “many medical devices in use today were developed prior to these human factors guidelines and other regulations. Some of those devices may still exhibit human factors deficiencies that would be eliminated in products designed using current standards and requirements. Advances in medical technology, improvements in human factors engineering guidance, and more stringent requirements all serve to reduce the potential for use errors.” Rozells will be speaking in the MD&M West 2020 session, "10 Ways to Design Error-Resistant Medical Devices," on Wednesday, February 12, from 2:05 to 3:00 p.m. in Room 210A/B. Additionally, Rozells said, “Although some devices may have human factors deficiencies, the consequences of use errors can be benign...
Source: MDDI - Category: Medical Devices Authors: Tags: Design Source Type: news