Home Medical Devices to Get Stricter U.S. FDA Review (Update3)
Published: 2010-07-21 17:48:51By: David Olmos and Catherine Larkin | BusinessWeek | April 20, 2010
April 20 (Bloomberg) -- U.S. regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety of the increasingly popular products, according to information posted today on the Food and Drug Administration’s Web site.
The initiative will set new guidelines for home medical device manufacturers, training programs for patients and family members and labeling and testing standards intended to address use of the devices such as heart monitors and kidney dialysis equipment, according to information posted on the FDA’s Web site today.
About 7.6 million people in the U.S. receive health care at home from an estimated 17,000 home health companies, a figure that doesn’t include family members or other untrained caregivers, the FDA said on its Web site. The U.S. spent about $57.6 billion for home health care in 2007, the agency said.
“Using complex medical devices at home carries unique challenges,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
19,000 Reports
The FDA received more than 19,000 reports of adverse safety events from 1997 to 2009, the agency said. Devices used in the home may be exposed to risks such as pet hair, children and electromagnetic interference from computers, video games and home appliances, the FDA said.