FDA to Address Challenges of Using Complex Medical Devices in the Home

Agency's Home Use Initiative to provide guidance, other measures to help caregivers, patients

SILVER SPRING, Md., April 20 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

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Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among the medical products that have migrated to the home in recent years. And more hospital patients of all ages are being discharged to continue their medical treatment at home.

"Using complex medical devices at home carries unique challenges," said Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health. "Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product's functioning."

According to an FDA white paper, the initiative will develop guidance for manufacturers who intend to market a device for home use, provide for postmarket surveillance, and put in place other measures to encourage safe use of these products. In addition, the FDA is developing educational materials on home use of medical devices.

"The FDA's Home Use Initiative will help address the potential challenges, providing greater protection and awareness for patients who are being cared for in the home," Shuren said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products. The new home use guidance document that FDA intends to develop will:

• make recommendations for actions manufacturers should take to support premarket approval or clearance of these devices, including device testing with at-home caregivers and patients in a non-clinical setting,
• define circumstances under which the FDA may exercise its authority to require that certain devices cleared for marketing carry a statement in the labeling that the device has not been cleared for use in the home,
• recommend postmarket surveillance to identify and address adverse events that may occur in the home.

In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.

The Home Use Initiative also contains measures for enhanced postmarket surveillance through HomeNet, a subnetwork of the FDA's Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.

Understanding issues experienced by home users will help the FDA develop appropriate actions to address those issues in the future. It may also identify cases in which devices intended solely for use in a health care facility are being used at home. The FDA already has collected information on safety concerns related to home hemodialysis and is now collecting similar information on the use of some wound therapy devices.

The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.

For more information

FDA's Medical Device Home Use Initiative

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/default.htm

SOURCE U.S. Food and Drug Administration