MedSun
Patton-Fuller Community Hospital
The need for reporting on adverse events related to medical device usage has never before been more salient. Medical technology has certainly been responsible for improving the quality of care, the quality of life, as well as health outcomes. However, at the same time, medical devices are being developed and released at a much faster rate than ever before. To monitor the progress and the safety of these devices, it requires a centralized monitoring system to evaluate outcomes; especially the adverse outcomes. This can allow the monitoring of devices that have issues associated with them in an efficient and effective manner and would give regulators a better opportunity to stop the usage of devices with questionable track records.
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH); the primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices (FDA, N.d.). This paper will provide an analysis of why this is an important step in improving the quality of care that hospitals can provide and why the Patton-Fuller Community Hospital should work diligently to register and maintain a clinical reporting system with MedSun as a mediator for the FDA.
Background
The U.S. Food and Drug Administration (FDA) has made it a priority to identify medical device-associated risks as fast as possible through the Medical Product Safety Network (commonly known as MedSun) (Engleman, Rish, Powell, & Flack, 2008). MedSun has expanded nationally to include a variety of hospitals, but...
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