MedSun Network Could Increase Event Reports for Home Devices

The Center for Devices and Radiological Health (CDRH) is in the planning stages for a network that will focus on problems with medical devices used in the home.

The agency is hoping for an increase in adverse event reports, particularly an increase in reports pointing to issues the agency may be unaware of because the end users for homecare devices are so diverse, project leader Diana Kaufman said.

The Home Health Network (HomeNet) will be run under the Medical Product Safety Network, an FDA-funded surveillance project targeting 350 U.S. hospitals.

HomeNet participants will collect and share information about adverse events occurring with home devices in three ways:

• Through the online reporting of adverse events or potential-for-harm events;
• Through discussion groups with CDRH and healthcare providers to encourage information sharing about home-use devices; and
• Through CDRH and HomeNet community members posting “reports of interest” and asking participants for their assessments and suggestions to address these events.