FDA Zeroes In On Human Factors Engineering For Home-Use Devices

Article preview from "The Silver Sheet"- May, 2010

A heightened FDA focus on medical devices used in the home is giving a boost to human factors efforts at the agency.

FDA announced its new Medical Device Home Use Initiative on April 20, with the goal of strengthening pre- and post-market oversight of complex devices that could be used at home, including infusion pumps, ventilators, hemodialysis equipment and wound therapy devices.

FDA Zeroes In On Human Factors Engineering For Home-Use Devices

Article preview from "The Silver Sheet"- May, 2010

A heightened FDA focus on medical devices used in the home is giving a boost to human factors efforts at the agency.

FDA announced its new Medical Device Home Use Initiative on April 20, with the goal of strengthening pre- and post-market oversight of complex devices that could be used at home, including infusion pumps, ventilators, hemodialysis equipment and wound therapy devices.

"Much of the new initiative centers on this issue of human factors," CDRH Director Jeffrey Shuren told "The Silver Sheet" during a recent Food and Drug Law Institute meeting in Washington, D.C.

"I may have a device that was designed for a hospital setting, and it works just fine in that setting with experienced users, but if I take that same technology and I move it to the home, now I may run into problems," he said. "And the manufacturer may never have intended for that device to be used in the home setting."

The initiative springs in part from the agency's alarm over a large number of adverse event reports involving medical devices used outside the clinical setting. From 1997 through 2009, FDA received more than 19,000 reports of adverse events that took place at home.

The reports of injuries come as more people are using complex devices in their homes as the population ages, hospitals discharge patients earlier and patients manage chronic diseases at home.

When devices are used in the home, "you don't have the same level of care that you may have in a hospital setting," Shuren said.

Manufacturers "need to think about designing those devices differently," he said. "We're going to lay out a much more clear, predictable pathway to market, and one of the issues will be, if you intend to use it in the home, then you need to test it in a nonclinical setting - preferably in a home."

The cornerstone of FDA's initiative will be a new guidance for manufacturers. It will more concretely explain what firms should do to gain FDA approval or clearance of a device intended for home use, including recommendations such as usability testing with lay users in a nonclinical setting.

The guidance also will "recommend post-market surveillance that manufacturers should undertake to identify and address adverse events that occur in the home," according to an FDA white paper released April 20.

FDA plans a public meeting May 24 to discuss steps manufacturers can take to design and test devices for use in the home and develop user-friendly instructions for home caregivers and patients.

The meeting will help shape the guidance document, which is expected out within the coming year.

Shuren Cites Need For More Human Factors Experts

The success of FDA's home-use device initiative will depend in part on involvement from the agency's human factors experts. Shuren acknowledged that current staffing in this area is inadequate.

"We are looking to beef up staff in human factors. We're looking to add warm bodies," Shuren said.

- Shawn M. Schmitt

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