FDA has addressed a new initiative to ensure that caregivers and patients safely use complex medical devices in the home, as part of an initiative to improve safety of the increasingly popular medical devices.
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 medical devices used in home. In addition, the FDA is developing educational materials on home use of medical devices.
The FDA said that the Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among the medical devices that have migrated to the home in recent years. As per the FDA, more hospital patients of all ages are being discharged to continue their medical treatment at home.
Currently, the FDA does not have a clear regulatory pathway for medical 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 action manufacturers should take to support premarket approval or clearance of the devices, including device testing with at-home caregivers and patients in a non-clinical setting.
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 the 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 collecting similar information on the use of some wound therapy devices.
Jeffrey Shuren, director of the Center for Devices and Radiological Health, said: “Using 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.
“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.”