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

ncluding the presence of pets, sanitation issues and electromagnetic interference from home wireless networks or even video games that can disrupt the function of a medical device," Shuren explained.

The agency has already received reports of medical device-linked adverse events that have occurred in the home. "And due to widespread underreporting, it is likely just the tip of the iceberg," Shuren said.

For example, a dialysis machine became blocked by cat dander and would not function, he said. In another case, a ventilator whose alarm could not be heard in the home caused the ventilator to fail, resulting in injury and death. "We do have such examples," he said.

To deal with these problems the agency plans to:

  • Develop recommendations for approval of these devices, including testing with home caregivers and patients.
  • Develop FDA's authority to require that certain devices are labeled as cleared for home use.
  • Develop post-market procedures to track and address adverse events in the home.

In addition, the agency is launching a 10-month pilot program this summer to get manufacturers to voluntarily submit their labeling to the agency for posting on a central Web site, Shuren noted.

This could help patients and caregivers to quickly find important safety information about their devices, he added.

The FDA is already citing manufacturers on potential trouble from at-home devices. On Monday, the agency sent letters to makers of negative-pressure wound therapy devices indicating that they will have to start including testing their devices specifically for home use and labeling them accordingly or stating that the device is not for home use, Shuren said.

"By providing greater assurance of the safety and safe use of medical devices in the home, FDA hopes to support the tremendous promise of home health care to provide patients with more comfort, convenience and
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