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FDA Takes Closer Look at In-Home Medical Devices
WASHINGTON -- The FDA is trying to make in-home medical devices safer and easier to use, according to agency officials.
On April 20, the agency announced a multipronged initiative to more closely scrutinize medical devices used at home and to offer guidance to their manufacturers. The FDA said it will:
Establish guidelines for makers of home-use medical devices. There is currently "no clearly defined pathway" for device manufacturers to have equipment approved for home use, Jeffrey Shuren, MD, JD, director of the agency's Center for Devices and Radiological Health, said during a teleconference. "FDA will develop guidance documents for actions that manufacturers should take to get clearance for home use."
Develop a home-use device labeling repository. Through a 10-month pilot program beginning in midsummer, manufacturers of devices labeled for home use may voluntarily submit their labeling electronically to FDA for the agency to post in a central location on its Web site. "Posting medical device labeling in a single online location will make it easier for home care patients and caregivers to find important information about how to safely use their device," according to an agency white paper.
Partner with accrediting organizations to train home healthcare providers in device use. "Assuring that [home health] practitioners are adequately trained in the use of medical devices in the home can be daunting, given the wide variety of technologies that are used, on- or off-label, in the home," the agency noted in the white paper.
"Therefore, FDA is partnering with two major accrediting bodies for home health agencies, the Community Health Accreditation Program and the Joint Commission, to review and strengthen accreditation criteria that relate to medical device safe use practices for the home environment."
Develop guidance for postmarketing surveillance. The agency will continue to promote use of its Medical Product Surveillance Network (MedSun) to report problems with home-use devices. In addition, FDA will work to identify situations in which devices not intended to be used outside of a healthcare facility are being used in the home.
"In such cases, FDA may require that premarket submissions for these devices contain either labeling for home use and use testing specific to the home environment, or a statement in product labeling clearly indicating that the device is not intended for home use," the agency noted.
Increase public awareness. To educate the public about issues related to home device use, the FDA is launching a new Home Use Devices Web site featuring information about using medical devices in the home and strategies to reduce the risks associated with home use.
The agency has already developed three informational brochures about home healthcare -- a home medical device checklist, an infusion therapy checklist, and a blood glucose meter checklist -- which are available on the Web site. "We think home care can provide tremendous benefits to patients and we'd like to encourage its use, but we'd also like to ensure that the devices used in those settings are safe," Shuren said.
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