Home Medical Devices to Get Stricter U.S. FDA Review

Home Medical Devices to Get Stricter U.S. FDA Review (Update3)

By David Olmos and Catherine Larkin

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.

One patient with a device that monitors abnormal heart rhythms, called an implantable cardioverter defibrillator, was playing an electric guitar when he felt a painful vibration in his arm that left the limb immobile until his wife unplugged an amplifier, according to an example cited by the agency. In other examples, a defibrillator malfunctioned while a patient played a video game and a dialysis patient developed a potentially serious infection when cat fur got into the device’s tubing.

The FDA sent a letter to manufacturers of negative-pressure wound therapy products that warn about the risks of home use of the products, Shuren said in a telephone news briefing. The letter was mailed yesterday to 16 makers of the wound products, said Karen Riley, an agency spokeswoman.

The devices are used to remove fluids and infectious matter in wounds, burns and ulcers, the agency said. The FDA received reports of six deaths and 77 injuries with the products during a two-year period, the agency said in a Nov. 16 Web site posting.

Makers of wound-care products seeking regulatory approval will have to show they have tested the devices in a home-like setting with people who have no medical training, Shuren said. If the products are not intended for home use, the agency may require specific labeling to that effect, he said.

To contact the reporters on this story: David Olmos in San Francisco at dolmos@bloomberg.net; Catherine Larkin in Washington at Clarkin4@bloombergnet.

Last Updated: April 20, 2010 15:20 EDT

via bloomberg.com

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