FDA Initiative Targets In-Home Medical Devices

The Food & Drug Administration (FDA) is seeking to increase oversight of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">complex medical devices, such as dialysis machines, ventilators, infusion pumps and IV machines, that are often used in home settings. Because of an explosion in home health care, these complex medical devices are increasingly operated by patients, family members and other minimally trained caregivers.

According to a report in The Wall Street Journal, some devices, including certain kidney dialysis machines, have FDA approval specifically for home use, but others have not. The functioning of medical devices can be adversely impacted by a variety of factors in a home, including humidity, the presence of pet hair and even noise.

Sadly, this has led to tragic consequences for some patients. From 1997 through 2009, the FDA says it has received more than 19,000 reports of adverse events involving medical devices used in homes, including fatalities in children on ventilators where tubing became disconnected at home.

To combat this problem, the FDA today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home. “Using complex medical devices at home carries unique challenges,” Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health, said in a statement announcing the initiative. “Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning.”

According to the FDA, the new initiative will develop guidance for manufacturers who intend to market a device for home use, provide for postmarket surveillance, and put in place other measures to encourage safe use of these products. In addition, the FDA is developing educational materials on home use of medical devices.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products. The new home use guidance document that FDA intends to develop will:

• make recommendations for actions manufacturers should take to support premarket approval or clearance of these devices, including device testing with at-home caregivers and patients in a non-clinical setting

• define circumstances under which the FDA may exercise its authority to require that certain devices cleared for marketing carry a statement in the labeling that the device has not been cleared for use in the home

• recommend postmarket surveillance to identify and address adverse events that may occur in the home.

The FDA also said it will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices, the agency said.

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