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Medical Product Safety Network

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The Medical Product Safety Network (MedSun) is an adverse event reporting program within the U.S. Food and Drug Administration's Center for Devices and Radiological Health (FDA, 2018). MedSun's goal is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.

The Safe Medical Devices Act requires hospitals and other health care organizations to report medical device problems that result in serious illness, injury, or death. Once a problem is identified, MedSun clarifies the problem and shares information with the clinical community and the public, without facility and patient identification, so that other clinicians can take preventive actions. MedSun participants are also highly encouraged to voluntarily report problems with devices that resulted in actual or potential harm. By monitoring reports about problems and concerns before a more serious event occurs, the FDA, manufacturers, and clinicians can work together to prevent serious injuries and death. Sometimes, this results in a product redesign.Current Educator, Clinical Educator, Novasyte Health representing Hill‐Rom Figure 4.10

FIGURE 4.10 Nancy Withers, BSN, RN, displaying her MedSun recognition certificate.

Source: Nancy Withers.

Kelly Vana's Nursing Leadership and Management

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