9 Questions
What is the impact on healthcare professionals and CSSD workers if regulations and standards are not followed?
Possible legal consequences and poor patient outcomes
What is the role of the Saudi Food and Drug Administration (SFDA) and U.S Food and Drug Administration in terms of medical device regulations?
They oversee medical device classification, reporting requirements, and recalls
What is the main objective of the Saudi Food and Drug Administration (SFDA)?
To control and supervise licenses procedures for food, drugs, and medical devices factories
What is the classification of Class II medical devices according to the FDA?
Intermediate risk devices subjected to FDA's general and special controls
Which agency is responsible for controlling indoor air pollution and reinforcing pesticide regulations in the USA?
Environmental Protection Agency (EPA)
Which organization was established with the mission to enhance both the global competitiveness of U.S. business and the U.S. quality of life?
The American National Standards Institute (ANSI)
What is the main aim of the Association for the Advancement of Medical Instrumentation (AAMI)?
To develop, manage and the utilization of safe and effective reusable medical devices
Which organization provides guidelines related to infection prevention and control to prevent Hospital Acquired Infection (HAI) in healthcare organizations?
Association for Professionals in Infection Central and Epidemiology (APIC)
Which organization develops and reviews guidelines related to reprocessing flexible endoscopes and high level disinfectants?
Society of Gastroenterology Nurses and Associates (SGNA)
Test your knowledge on healthcare regulations, national and international guidelines, and voluntary standards that impact healthcare professionals and CSSD workers. Learn about the importance of following regulations for maintaining safety and quality assurance in healthcare organizations.
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