Tougher Medical Device Rules On The Way

SAN FRANCISCO — Regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety, according to information posted yesterday on the Food and Drug Administration’s website.


Coming are guidelines for manufacturers, training programs for patients and family members, and labeling and testing standards for devices such as heart monitors and kidney dialysis equipment.

About 7.6 million people receive health care at home from an estimated 17,000 companies, a figure that does not include family members or other untrained caregivers, the FDA said. The United States spent about $57.6 billion for home health care in 2007, the agency said.

“Using complex medical devices at home carries unique challenges,’’ FDA official Jeffrey Shuren said. “Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself’’ may pose hazards.

The FDA received more than 19,000 reports of adverse safety events from 1997 to 2009.

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.

One patient with a device that monitors abnormal heart rhythms was playing an electric guitar when he felt a painful vibration that left his arm immobile until his wife unplugged an amplifier, according to an example the agency cited.

The FDA sent a letter to manufacturers of negative-pressure wound therapy products that warn about the risks of home use, Shuren said. The devices are used to remove fluids and infectious matter from wounds, burns, and ulcers. The FDA received reports of six deaths and 77 injuries with the products during a two-year period.

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.

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