FDA’s Medical Product Safety Network (MedSun): Shining a Light on Medical Product Safety
http://www.fda.gov/cdrh/medsun/
MedSun provides a representative profile of reports from healthcare facilities, such as hospitals. MedSun improves understanding of medical device problems so FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. Over 350 health care facilities, primarily hospitals, participate in the network. MedSun is unique because it educates health care professionals about the importance of monitoring, being aware of, and reporting device related problems to FDA and the manufacturer.
MedSun also ensures that new safety information is rapidly communicated to the medical community thereby promoting patient safety.
The MedSun Subnetworks
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HeartNet: Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories. |
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HomeNet: Focuses on identifying, understanding, and solving problems with medical devices used in the home environment; also focuses on issues related to labeling, training, and servicing problematic devices. |
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KidNet: Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units. |
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LabNet: Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems to FDA’s Office of In Vitro Diagnostics. |
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SightNet: Focuses on adverse events observed with ophthalmic medical devices used in providing all levels of eye care. |
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Tissue and Cell: Focuses on identifying issues related to biological products, specifically cells and tissues, such as bones and ligaments. This subnetwork is run in conjunction with FDA’s Center for Biologics and Research (CBER). |
These subnetworks are designed to collect and share information about actual and potential adverse events from specific clinical areas of MedSun facilities using high-risk products.
The content that FDA produces is not copyrighted. Stories can be reprinted without permission and copies can be downloaded and displayed free of charge. Editors wishing to use MedSun’s material in publication are asked to please acknowledge MedSun as the source and send copies of stories to medsun@s-3.com.
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For questions contact Tina Powell at 1-800-859-1292 or email at: medsun@s-3.com
