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Medical device reporting ( MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report ...
An adverse event ( AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom ...
In the United States, response codes are used to describe a mode of response for an emergency unit responding to a call. They generally vary but often have three basic tiers: Code 3: Respond to the call using lights and sirens. Code 2: Respond to the call with emergency lights, but without sirens. Alternatively, sirens may be used if necessary ...
The FDA Adverse Event Reporting System ( FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
Hospital incident command system (US) In the United States, the hospital incident command system (HICS) is an incident command system (ICS) designed for hospitals and intended for use in both emergency and non-emergency situations. It provides hospitals of all sizes with tools needed to advance their emergency preparedness and response ...
Sentinel event. A sentinel event is "any unanticipated event in a healthcare setting that results in death or serious physical or psychological injury to a patient, not related to the natural course of the patient's illness". [1] Sentinel events can be caused by major mistakes and negligence on the part of a healthcare provider, and are closely ...
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