Healthcare Regulations and Standards Quiz
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Questions and Answers

What is the impact on healthcare professionals and CSSD workers if regulations and standards are not followed?

  • Improved patient outcomes
  • Possible legal consequences and poor patient outcomes (correct)
  • More flexibility in carrying out responsibilities
  • Increased job satisfaction and performance

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 handle environmental protection for medical devices
  • They oversee medical device classification, reporting requirements, and recalls (correct)
  • They only classify medical devices
  • They have no role in medical device regulations

What is the main objective of the Saudi Food and Drug Administration (SFDA)?

  • To reduce greenhouse gases and toxic emissions
  • To control and supervise licenses procedures for food, drugs, and medical devices factories (correct)
  • To protect all workers from occupation-associated injuries and illnesses
  • To promote the wellbeing and prevent injuries, diseases, and disabilities

What is the classification of Class II medical devices according to the FDA?

<p>Intermediate risk devices subjected to FDA's general and special controls (A)</p> Signup and view all the answers

Which agency is responsible for controlling indoor air pollution and reinforcing pesticide regulations in the USA?

<p>Environmental Protection Agency (EPA) (C)</p> Signup and view all the answers

Which organization was established with the mission to enhance both the global competitiveness of U.S. business and the U.S. quality of life?

<p>The American National Standards Institute (ANSI) (B)</p> Signup and view all the answers

What is the main aim of the Association for the Advancement of Medical Instrumentation (AAMI)?

<p>To develop, manage and the utilization of safe and effective reusable medical devices (C)</p> Signup and view all the answers

Which organization provides guidelines related to infection prevention and control to prevent Hospital Acquired Infection (HAI) in healthcare organizations?

<p>Association for Professionals in Infection Central and Epidemiology (APIC) (A)</p> Signup and view all the answers

Which organization develops and reviews guidelines related to reprocessing flexible endoscopes and high level disinfectants?

<p>Society of Gastroenterology Nurses and Associates (SGNA) (C)</p> Signup and view all the answers

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