The U.S. Food and Drug Administration (FDA) has announced a new initiative on safety for using complex medical devices in the home. The type of home equipment concerned includes hemodialysis equipment, wound therapy care, intravenous therapy devices, and ventilators.

"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, in a press release. "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. 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."

The FDA does not have a standard regulatory path for home use devices, but will be developing a home use guidance to:

---Make recommendations for pre-market approval for manufacturers, including device testing with at-home caregivers and patients in a non-clinical setting;

--Define when the FDA may require that some devices carry a statement in the labeling that the device has not been cleared for use in the home;

--Recommend post-market surveillance to identify and address adverse events that may occur in the home.

In addition, the agency plans to launch a 10-month pilot program this summer for manufacturers of home use devices to voluntarily submit their labeling to the agency for posting on a central website repository, which can help consumers obtain information on safe use of devices. The Home Use Initiative also has measures for enhanced post-market surveillance through HomeNet, an adverse event reporting program.

The FDA has a updated its Home Use page, with links to a white paper on the Medical Device Home Use Initiative (with details on the measures above), and information on an upcoming Home Use Device workshop on May 24, in Silver Springs, MD, which will ask for information from primary and secondary health care providers, academia, medical device distributors, manufacturers, professional societies, patient advocate groups, patients and other stakeholders on issues regarding medical device technology in the home. The link has registration information for this workshop.

The FDA Home Use page: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/default.htm

Adapted in part from a FDA press release.

Link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209138.htm

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