MedSun Seeks to Work with Physician Practices to Improve Patient Safety
MedSun: Newsletter #49, June 2010

The Medical Product Safety Network (MedSun) is pleased to announce that HeartNet is expanding to include cardiac catheterization labs and independent physician practices. As a subnetwork of MedSun, HeartNet was originally developed because FDA was interested to learn about user experience and other issues with the medical devices used in cardiac electrophysiology (EP) labs.

With this expansion, FDA hopes to detect and evaluate emerging device signals even earlier. To help ensure comprehensive device surveillance, reported information may include device problems detected during ongoing cardiac care, such as during outpatient device interrogation, as well as other signs and symptoms of possible device-related problems noted during patient follow-up. FDA believes this proactive approach gives the clinical community, FDA and the manufacturers the ability to efficiently recognize and address issues to help mitigate risk to patients.

Participation in HeartNet also allows reporters to contribute to special studies, share their knowledge, and receive information from their colleagues on device issues. If you are already a part of MedSun it’s easy to join HeartNet. FDA is also eager to include other hospitals and independent physician practices who want to join this important patient safety program.

For more information on this initiative or to participate in HeartNet, contact us toll free at 1-800-859-9821 or via email at medsun@s-3.com.


MedSun Newsletters are available at www.fda.gov/cdrh/medsun