Home Use of Devices Creates New Challenges for FDA, Manufacturers
MedSun: Newsletter #18, November 2007

Against the backdrop of the September 17-18 Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and University of Houston conference on the safe migration of medical devices into the home, Medical Devices Today reported on the growing concerns of FDA, manufacturers, and other stakeholders as patients and devices move out of the hospital and into the home.

The range of complexity in home care medical equipment runs from canes to laptop-sized ventilators. With home health device use anticipated to double over the next 4 years, in-home product use and regulatory oversight must be addressed by FDA and manufacturers in the interest of safety. In remarks at the conference, CDRH Director Daniel G. Schultz said, "Despite the fact that there is a lot of activity in this area and we've seen a lot of progress, I think we all want more devices that are designed and specifically tested for home use," adding, “We want better and more consistent review criteria.”

Among FDA and manufacturer concerns are the few restrictions governing physicians’ ability to send patients home with devices not labeled for home use and the industry’s obligation to design and market with a close eye to human factors. Susan Morris, vice president for government affairs for Kinetic Concepts, stated that as manufacturers redesign institutional products for home use, they should remove all unnecessary functionality and add features that accommodate patients and caregivers in prescribed protocols. The importance of manufacturer control over product distribution is another concern, and industry and regulatory experts predict that manufacturers will increasingly become suppliers.

Morris believes that legacy devices are particularly worrisome. These are old devices, many from health care institutions and most not produced for home use, that may lack instructions or may have only clinician (versus consumer) instructions. Such devices are and increasingly will be available through unmonitored online markets. Further, recent Medicare legislation requires patients to purchase certain durable medical equipment after having rented it, and this policy will drive the sale of used devices and make maintenance and correct usage of devices in the home even more difficult.

In the near term, FDA will invite manufacturers to participate in a new, voluntary, online labeling repository for home-use devices focusing on infusion pumps and will launch HomeNet, the MedSun subnetwork that will track adverse event reporting related to home-use devices.

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