Healthcare Regulations and Standards Introduction
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Questions and Answers

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

  • Regulating the safety of food and drugs for human and animal (correct)
  • Setting up a database for environmental pollutants
  • Providing voluntary guidelines for healthcare facilities
  • Developing infection control guidelines for CDC

    • Which classification of medical devices is subjected to the highest regulations and may require Premarketing Approval (PMA) from the FDA?

  • High Risk Devices (correct)
  • Intermediate Risk Devices
  • Class I Devices
  • Life sustaining devices

    • What is the aim of the Centers for Disease Control (CDC)?

  • Promoting wellbeing and preventing injuries, diseases, and disabilities (correct)
  • Developing pesticide regulations
  • Regulating medical device reporting requirements
  • Protecting workers from occupation-associated injuries

    • Which agency is responsible for reducing greenhouse gases and toxic emissions?

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

    What is the main objective of the Occupational Safety and Health Administration (OSHA)?

    <p>Protecting workers from occupation-associated injuries and illnesses</p> Signup and view all the answers

    What is the impact of not following healthcare regulations and standards in the CSSD?

    <p>Legal consequences and poor patient outcomes</p> Signup and view all the answers

    Which agency is responsible for medical device recalls?

    <p>Saudi Food and Drug Administration (SFDA)</p> Signup and view all the answers

    Which organization develops regulations and standards affecting Central Service?

    <p>Association for the Advancement of Medical Instrumentation (AAMI)</p> Signup and view all the answers

    What is the role of the International Standards Organization (ISO) in healthcare regulations and standards?

    <p>Developing standards for medical devices and processes</p> Signup and view all the answers

    What is the main purpose of regulatory standards in healthcare organizations?

    <p>To maintain the minimum level of safety and quality assurance</p> Signup and view all the answers

    Which organization aims to enhance patient care related to surgery?

    <p>Association of Operating Room Nurses (AORN)</p> Signup and view all the answers

    Which organization is responsible for developing Technical Information Reports (TIR) related to safe and effective reusable medical devices?

    <p>Association for the Advancement of Medical Instrumentation (AAMI)</p> Signup and view all the answers

    Which organization is a non-profit organization that develops guidelines for the safe and effective practice of gastroenterology and endoscopy nursing services?

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

    Which organization is responsible for developing voluntary consensus standards and conformity assessment systems to enhance the global competitiveness of U.S. business?

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

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