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FDA
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Medical Product Safety Network
A PATIENT SAFETY PROGRAM OF THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
MEDSUN AND ITS SUBNETWORKS
A network of hospitals, nursing homes, and other health care facilities working in collaboration with the FDA to:
- Identify, understand, solve, and share information about problems with the use of medical devices, as well as tissues and cells.
- Facilitate reporting of medical product problems, including deaths, serious injuries/illnesses, close calls, and potential for harm, through a secure Internet-based data entry system, helping to gather data that can help the FDA, device manufacturers, and clinical facilities address safety concerns before they become widespread problems.
- Provide regular feedback to participating sites through newsletters, conferences, and Webcasts.
- Alert its member health care facilities to major actions by the FDA and medical device manufacturers regarding recalls, changes to instructions, and safety tips.
- Develop and distribute educational programs (a video, slide presentations, audioconferences) to increase awareness of medical product-related events that are observed by clinical staff and to encourage reporting from various parts of the health care facilities.
SINCE ITS INCEPTION IN 2002, MEDSUN HAS PLAYED AN IMPORTANT ROLE IN IMPROVING PATIENT SAFETY NATIONWIDE.
- 350+ health care facilities, primarily hospitals, participate in the Network.
- Trained MedSun Representatives from these sites come from Risk Management, Patient Safety, Quality Improvement, Biomedical/Clinical Engineering, Physicians and Nurses, Materials Management, Surgical Services, and the six specific areas of patient care featured in the MedSun subnetworks shown to the right.
THE SUBNETWORKS
These subnetworks collect and share information about actual and potential adverse events from specific clinical areas.
| SUBNETWORK |
DESCRIPTION |
AREA OF INTEREST |
| LabNet |
Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems, whether actual or potential, to the FDA’s Office of In Vitro Diagnostics |
Hospital laboratories |
| Tissue and Cell |
Focuses on identifying issues related to biological products, specifically cells and tissues, such as bones and ligaments |
Tissue banks, surgical services, and infection control |
| HeartNet |
Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories |
Electrophysiology laboratories |
| KidNet |
Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units |
Pediatric intensive care units and neonatal intensive care units |
| HomeNet |
Focuses on identifying the barriers to reporting problems with medical devices in the home environment; also focuses on issues related to labeling, training, and servicing problematic devices |
Home health services |
| SightNet |
Focuses on adverse events observed with ophthalmic medical devices used in providing all levels of eye care |
Ophthalmologists, optometrists, hospitals, and eye clinics |
Updated July 25, 2007 |
