The FDA has produced an informative video titled Designing the User Into the Device: Human Factors Tips for Investigators. The 17-minute video is designed to help the FDA’s field investigators understand the role that human factors engineering plays in ensuring product safety. However, the video also holds value for companies seeking to develop a deeper understanding of the FDA’s intentions to enforce their human factors-related regulations.

Fortunately for health care providers and consumers alike, the FDA views human factors as an imperative in medical device design. A handout that comes with the video points out that even expert clinicians make errors that may be induced by poor design; that good instructions and warnings are insufficient remedies to user interface inadequacies; and that a comprehensive human factors program that involves end-users in the design process is a good way to produce safer and more usable medical devices.

We’re pleased to see that Dr. Matthew Weinger, a prominent anesthesiologist involved in patient safety research and a Wiklund Research & Design affiliate, has a major role in the video. He effectively advocates human factors engineering as a means to reduce the incidence of patient injury and death due to medical error involving devices. (Note: Dr. Weinger wrote the foreword to Designing Usability Into Medical Products.)

The FDA didn’t produce the video for industry per se. But, you might be able to get a copy by contacting the FDA’s human factors group at HFSO@CDRH.FDA.GOV, or by calling 301.443.2436. Learn more about the FDA’s human factors video by visiting http://www.fda.gov/cdrh/humfac/hufacimp.html.