Medical Devices at Home
February 10, 2013
Patients and consumers are using medical devices more often at home—not just in health care facilities. Many medical devices are now portable, and this feature enables patients to live active lives outside of the confines of the hospital room or treatment center.
“(Home use) devices once were designed only to keep you alive. Now they’re designed to keep you as independent as possible,” according to Mary Brady, MSN, RN, a senior policy analyst at FDA’s Center for Devices and Radiological Health (CDRH).
However, the Food and Drug Administration (FDA) has long been concerned that consumers may sometimes be literally left to their own devices—depending upon medical devices they might not know how to operate and for which they might not understand the safety risks.
There have been serious, and even fatal, problems reported to FDA associated with medical devices used at home. For example, a woman with kidney failure got cat hair in her dialysis tubing, resulting in peritonitis, a life-threatening abdominal infection. And a child died when his mother didn’t hear an alarm on his ventilator signaling that the tubing had become disconnected.
FDA is working on ways to help consumers safely operate and maintain home use devices, which include blood glucose monitors, infusion pumps (a device that delivers fluids, including nutrients and medications, into a patient’s body) and respirators. These efforts include issuing a draft guidance document for manufacturers on the design and testing of devices intended for home use, and the development of clearer instructions for use.