Location: Houston Texas, University of Houston Hilton Hotel and Conference Center

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) is mandated to regulate medical devices; however, the regulatory authority alone is inadequate to assure that devices are safe and effective when used in the home environment. CDRH also receives reports of adverse events that happen with medical devices and more of these reports are coming from the home environment. This is due in part to more device use in the home which in turn is associated with improvements in technology, changes in the practice of medicine, shifting reimbursement patterns, and patients’ desire to receive care in the home. Because the devices are not usually cleared or approved for home use, user problems are becoming more prevalent. This can be from poor device design, defective components, an inappropriate environment for device use, and inadequate information for proper device use.

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