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RIVERVIEW PSYCHIATRIC CENTERFUNCTIONAL AREA:Ethics, Rights and Responsibilities POLICY No: RI.2.40TOPIC:Informed ConsentAUTHORIZATION: Clinical Director of Nursing Superintendent I. PURPOSE: To delineate
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Quick Safety 21 Informed is a reporting process established by the FDA that allows healthcare professionals to report medical device issues and safety concerns quickly and efficiently.
Healthcare providers, including hospitals, clinics, and individual practitioners, as well as manufacturers and importers of medical devices, are required to file Quick Safety 21 Informed.
To fill out Quick Safety 21 Informed, individuals must complete a standardized reporting form that includes details about the medical device, the issue encountered, and any patient outcomes.
The purpose of Quick Safety 21 Informed is to ensure timely communication of safety information regarding medical devices, thereby enhancing patient safety and helping regulatory authorities take action when necessary.
The report must include device identification, description of the event or issue, patient demographics, and any relevant clinical details pertaining to the incident.
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