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FDA Tightens Oversight of Home Medical Devices
Date:4/20/2010

As more patients use portable ventilators, dialysis machines, agency says safety an issue,,

TUESDAY, April 20 (HealthDay News) -- As the population ages and medical technology improves, more people are using complex medical devices such as dialysis machines and ventilators at home, adding to the need for better-educated patients.

To meet this growing need, the U.S. Food and Drug Administration announced Tuesday that it has started a new program to ensure that patients and their caregivers use these devices safely and effectively.

"Medical device home use is becoming an increasingly important public health issue," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said during an afternoon news conference.

The U.S. population is aging, and more people are living longer with chronic diseases that require home care, he added. "In addition, more patients of all ages are being discharged from the hospital to continue their care at home," Shuren noted.

Meanwhile, medical devices have become more portable and sophisticated, making it possible to treat and monitor chronic conditions outside the hospital. "A significant number of devices including infusion pumps, ventilators and wound care therapies are now being used for home care," he said.

Given the growing number of home medical devices, the agency plans on developing procedures for makers of home-care equipment. Procedures will include post-marketing follow-up, and other things that will encourage the safe use of these devices.

The FDA is also developing educational materials on the safe use of these devices, the agency said.

According to Shuren, there are no clear regulations for complex medical devices used in the home.

Devices not made specifically for the home can pose a safety problem, he noted. "There may be environmental or safety hazards that can affect a device's performance, i
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