Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI September 2005

NEWSTRENDS

Erik Swain

FDA will be placing more emphasis on human factors during premarket reviews, top-ranking FDA officials told conference attendees in June. As a result, the agency is urging device companies to build human factors assessments into risk management plans.

“We are making a renewed commitment to deal with human factors issues. We see public health implications,” said Donna-Bea Tillman, PhD, director of CDRH's Office of Device Evaluation. “We look forward to working with you to meet these challenges. We realize we can't solve every issue at once. But we are looking to identify areas with significant recurring human factors issues, and try to make them more safe, one product at a time.”

CDRH director Daniel Schultz said the increased emphasis is necessary because “devices are becoming much, much more complicated, especially when you have products that can communicate with each other.”

They spoke at an AAMI conference on human factors, ergonomics, and patient safety for medical devices, held in Washington, DC.

Firms should not rely on clinical trial data to prove the usability of devices, Tillman said. “This is typically validated by clinical trial results, but it's not the same thing” as proof of usability, she said. “In clinical trials, the best and brightest are using the device, and they are following strict protocols. But you have to consider who will really be using the product once it is on the market. Instructions for use should not only address use, but also reasonably foresee misuse. A device might be used in less-than-optimal conditions.”

This consideration ties in to the trend of patients wanting more control over their own healthcare, Tillman added. As more devices become available for home use and over the counter, they will have to become easier for nonprofessionals to use and less prone to user error.

Human factors principles played a key role when ODE allowed Philips Medical Systems (North Andover, MA) to sell its HeartStart home defibrillator over the counter, she said. “We had a clear-cut case of what we needed to do,” she said. “The OTC decision was supported by design considerations, usability testing, the labeling program, and the training program. We made sure it could be used easily in a stressful situation.”

“It's a new world,” Schultz said. “More products are being used in different environments, including outside of the healthcare environment, where people are not trained. We need to figure out a way to get these technologies into those environments, but to make them safe.”

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