Over time, an increasing number of patients use medical devices at home—hospitals want patients quickly removed from beds and manufacturers are developing sophisticated equipment for people with chronic conditions. FDA is launching an initiative to increase safety for these home users. Some devices, such as kidney dialysis machines, are specifically FDA approved for home use. But many other devices, such as infusion pumps, may be more difficult to use in environments where many factors can limit their effectiveness. For example, cat fur in a patient's kidney dialysis tubing can enter the patient's body and cause peritonitis (a dangerous membrane infection).

Ideally, the agency's new initiative will facilitate the development of home-use medical devices, according to CDRH director Jeffrey Shuren. "What we are seeing is an explosion in home care," he says. Other plans for FDA include developing guidelines to help OEMs design simplified versions of hospital devices for the home and establishing a library of labels and instruction manuals written for nonmedical caregivers.

(Oh, and in case you need statistics, FDA received more than 19,000 reports of adverse events involving medical devices used at home from 1997 to 2009.)