Abstract
Unlike user facilities, manufacturers are directly under the jurisdiction of FDA and rely on device users to report adverse events in a timely manner to help them comply with their strict regulatory requirements. Therefore, an effective postmarket surveillance program is directly dependent on the active participation of health care professionals. However, the limitations of the spontaneous reporting system challenge the agency’s and manufacturers’ efforts to promptly identify, quantitate, and understand new risks associated with marketed products. Underreporting and lack of quality of information make it extremely difficult for FDA and manufacturers to determine the magnitude of the problem as well as recognize safety trends. The MedSun pilot program was developed in response to the recognition that FDA needed to augment the reporting of device-related adverse events by health care facilities. MedSun has been favorably received by participating user facilities as well as being an extremely valuable resource in helping to promote patient safety
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Ostuni, M. Issues with Medical Device Spontaneous Reporting and Improvements through MedSun. Ther Innov Regul Sci 44, 87–95 (2010). https://doi.org/10.1177/009286151004400110
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DOI: https://doi.org/10.1177/009286151004400110