Guidance Spells out Human Factors to Consider When Developing Devices

The FDA has shed some light on what factors it wants companies to consider when developing devices to eliminate or reduce design-related problems that contribute to or cause unsafe or ineffective use.

According to final guidance issued earlier this month, risk management should focus on use-related hazards involving situations such as:

• Use of the device is inconsistent with the user’s expectations or intuition about device operation;
• The use environment impairs the physical, perceptual and cognitive abilities that exceed the abilities of the user;
• Devices are used in ways that the manufacturer could have anticipated but did not consider; and
• Devices are used in ways that were anticipated but inappropriate, and for which risk elimination or reduction could have been applied but was not.

“By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device and avoiding potential device recalls,” the final guidance says.

The guidance on Applying Human Factors and Usability Engineering to Medical Devices was released in draft form on June 22, 2011, drawing more than 600 comments. They were generally supportive, but requested clarification in a number of areas, the agency says.

The FDA clarified points including risk mitigation and human factors testing methods, user populations for testing, determining the appropriate sample size, reporting of testing results in premarket submissions and collecting human factors data as part of a clinical study.

The final guidance was issued Feb. 3, along with draft guidance on the List of Highest Priority Devices for Human Factors Review, explaining which device types should have human factors data in premarket submissions because they have clear potential for serious harm resulting from use error.

The list includes devices such as anesthesia machines, artificial pancreas systems, automated external defibrillators, duodenoscopes with elevator channels, infusion pumps, insulin delivery systems, robotic surgery devices and ventilators.

The final guidance on applying human factors and usability engineering supersedes Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management issued on July 18, 2000. Read it here: www.fdanews.com/02-16-FDAHumanFactors.pdf. Comments on the draft guidance on the list of highest priority device are due by May 3. Read it here: www.fdanews.com/02-16-FDAHumanList.pdf. — Jonathon Shacat