WASHINGTON, April 20 (UPI) — The U.S. Food and Drug Administration says it’s starting an initiative to ensure caregivers and patients safely use complex medical devices in their homes.
The FDA said hemodialysis equipment, intravenous therapy devices and ventilators are among medical products that have migrated into homes 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 Dr. Jeffrey Shuren, director of the FDA’s 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.”
The federal agency said its 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 such devices.
The FDA said it’s also working to strengthen home health agency accreditation criteria that relate to medical device safe use practices.
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