FDA to Increase Oversight of Home Use Medical Devices

By Nisha P. Shah –

FDA recently issued a white paper revealing that the Agency intends to strengthen its review of medical devices for home use, such as hemodialysis equipment, wound therapy care, intravenous therapy devices, and ventilators, as more hospital patients are being discharged to continue treatment at home.

FDA claims that about “7.6 million individuals in the United States currently receive home healthcare from roughly 17,000 paid providers” with annual U.S. expenditures for home care estimated as high as $57.6 billion in 2007.  Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health, stated that “[u]sing complex medical devices at home carries unique challenges … 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.”

Currently, there is no clear regulatory pathway for devices intended for home use that describes what manufacturers should consider when designing, testing, and labeling such products.  FDA’s Medical Device Home Use Initiative attempts to fill this gap.  Under the Initiative, the Agency will develop guidance for home medical device manufacturers on the premarket approval or 510(k) clearance of these devices, including device testing with at-home caregivers and patients, identify instances under which FDA may exercise its authority to require that certain devices contain a statement in its label that it has not been cleared for home use, and develop educational materials on home use of devices.

The Initiative also contains measures for enhanced post-market oversight through HomeNet, a “subnetwork of the FDA’s Medical Device Surveillance Network” which is an adverse event reporting program that includes more than 350 health care facilities nationwide.  Additionally, beginning this summer, FDA plans to launch a 10-month pilot program in which home medical device manufacturers may voluntarily submit labeling to the Agency for posting on a central website repository to help patients and caregivers access important information about the safe use of the devices. The pilot program will support FDA’s goal of eventually creating an online labeling repository for devices cleared or approved for home use.

A public workshop on May 24, 2010 has been scheduled to discuss measures manufacturers can take to design and test medical devices used at home, and to develop instructions for home care patients and caregivers.