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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.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
Causal factors are analyzed, focusing on systems and processes, not individual performance. Potential improvements, called an "action plan", are identified and implemented to decrease the likelihood of such events in the future. Each accredited organization is encouraged, but not required, to report any sentinel event to The Joint Commission.
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 provides a database for reporting of adverse medical device events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.
The idea for AHCA came to him in 2009 after a choking incident involving an infant, which highlighted the need for accessible CPR training. AHCA was launched as an online training platform in Texas [1] [3] and expanded to Vietnam in July 2019, the Philippines in May 2018, and later to Mexico, Latvia, India, and Pakistan. [4]
The American Health Care Association (AHCA) is a non-profit federation of affiliated state health organizations that represents more than 14,000 non-profit and for-profit nursing homes, assisted living communities, [1] and facilities for individuals with disabilities. Clifton J. Porter, II became CEO on 14 October 2024.
The Florida Agency for Health Care Administration (AHCA) is the chief health policy and planning entity for the U.S. state of Florida. The agency was created by the Florida Legislature as part of the Health Care Reform Act of 1992. [ 1 ]