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Presentation

Panel: Rigorously Applying HFE in Medical Product Development – Does it Actually Save Lives and Prevent Injuries?
Event Type
Track Keynote
TimeTuesday, April 1312:30pm - 1:30pm EDT
LocationMedical and Drug Delivery Devices
DescriptionPanelists will answer the fundamental question, “When it comes to making healthcare safer, are human factors engineering professionals making a difference?” More specifically:

• Is there evidence that products reflecting good HFE are less frequently associated with adverse events?
• Are there cases in which products reflecting good HFE prevented an accident?
• If an epidemic of use error remains, would it be any worse if HFE has not been applied more rigorously since 1996?
• Can we expect a dramatic reduction in device-related adverse events as older products are retired and the beneficiaries of those developed with good/better HFE take their place?

The moderator and panelists were all practicing in 1996. This is the year when the US changed the Quality System Regulation (QSR), ostensibly requiring medical device manufacturers to apply HFE during medical products development. Subsequent to the QSR change, they each have contributed substantially to ensuing HFE movement in the medical device industry. With this perspective, they will address the questions listed above and engage in related debate. They will do so with the sobering knowledge that it is difficult to count non-events; the accidents that did not happen.

In preparation of the panel discussion/debate, the panelists will have completed a search for evidence, such as patterns involving certain types of medical products over time, that HFE has made a meaningful contribution to healthcare safety or not, and share their findings with the audience.