IAHCSMM Chapter 5 Practice Test Flashcards
25 Questions
100 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

Which agency may intervene in a matter of worker protection even if there are no specific regulations covering the situation?

  • U.S. Food and Drug Administration
  • Association of periOperative Registered Nurses
  • Occupational Safety and Health Administration (correct)
  • Environmental Protection Agency
  • Regulations under the Clean Air Act are administered by which agency?

  • U.S. Food and Drug Administration
  • Occupational Safety and Health Administration
  • Association of periOperative Registered Nurses
  • Environmental Protection Agency (correct)
  • Chemical Indicators are classified as which type of medical devices?

  • FDA Class III medical devices
  • FDA Class I medical devices
  • None, not regulated by FDA
  • FDA Class II medical devices (correct)
  • Under current regulations, who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?

    <p>All of the above</p> Signup and view all the answers

    Standards and regulations help set levels of _______ in our departments.

    <p>All of the above</p> Signup and view all the answers

    The agency which imposes very strict labeling requirements on manufacturers of disinfectants used by Central Service departments is?

    <p>Environmental Protection Agency</p> Signup and view all the answers

    Heart valves and pacemakers are examples of which type of medical devices?

    <p>FDA Class III medical devices</p> Signup and view all the answers

    Medical device reporting is regulated by which agency?

    <p>U.S. Food and Drug Administration</p> Signup and view all the answers

    The Department of Transportation enforces statutes relating to the?

    <p>Transportation of clean and soiled instruments between facilities</p> Signup and view all the answers

    Sometimes state or local regulations differ from Federal regulations and when that happens, the most stringent regulations apply.

    <p>True</p> Signup and view all the answers

    It is optional to allow the Occupational Safety and Health Administration's regulation for wearing PPE in the Central Service decontamination.

    <p>False</p> Signup and view all the answers

    Third party reprocessors are regulated by the U.S. Food and Drug Administration.

    <p>True</p> Signup and view all the answers

    Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.

    <p>True</p> Signup and view all the answers

    The Occupational Safety and Health Administration is a voluntary association dedicated to infection control and prevention.

    <p>False</p> Signup and view all the answers

    Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.

    <p>True</p> Signup and view all the answers

    Established national emissions standards for EO used by hospitals are regulated.

    <p>False</p> Signup and view all the answers

    The FDA regulates the manufacture of all medical devices and requires the pre-market clearance of new medical devices. It also regulates sterilants and high level disinfectants.

    <p>True</p> Signup and view all the answers

    What is The Joint Commission?

    <p>A private, independent not-for-profit organization that develops standards for health care facilities</p> Signup and view all the answers

    The agency responsible for the MedWatch program is?

    <p>The FDA</p> Signup and view all the answers

    Medical device reporting is regulated by the?

    <p>FDA</p> Signup and view all the answers

    Healthcare regulations and standards provide consistency of departmental activities by outlining:

    <p>Minimal performance standards</p> Signup and view all the answers

    The SGNA (Society of Gastroenterology Nurses and Associates) is a good source for information about the proper processing of flexible endoscopes.

    <p>True</p> Signup and view all the answers

    Which agency imposes very strict labeling requirements on manufacturers of chemicals used by Central Service departments?

    <p>EPA</p> Signup and view all the answers

    A voluntary international organization dedicated to the prevention and control of infections and related outcomes is?

    <p>APIC</p> Signup and view all the answers

    Each year, approximately _______ patients develop a healthcare-associated infection.

    <p>2 million</p> Signup and view all the answers

    Study Notes

    Regulatory Agencies

    • Occupational Safety and Health Administration (OSHA): May intervene to protect workers even without specific regulations.
    • Environmental Protection Agency (EPA): Administers regulations under the Clean Air Act and imposes strict labeling on disinfectants.
    • U.S. Food and Drug Administration (FDA): Regulates the manufacture of medical devices, including pre-market clearance and medical device reporting.

    Medical Device Classifications

    • Chemical Indicators: Classified as FDA Class II medical devices.
    • Heart Valves and Pacemakers: Classified as FDA Class III medical devices.

    Reporting Requirements

    • All stakeholders, including device manufacturers and hospitals, must report suspected medical device-related deaths to the FDA.

    Standards and Safety

    • Standards and regulations help ensure quality, safety, and efficiency in healthcare departments.
    • Healthcare regulations standardize departmental activities with minimal performance standards.

    Jurisdiction and Compliance

    • When state or local regulations differ from federal regulations, the stricter ones apply.
    • Compliance with OSHA regulations regarding Personal Protective Equipment (PPE) is mandatory in Central Service decontamination.

    Accreditation and Third-Party Oversight

    • Failure to attain accreditation from The Joint Commission can result in loss of Medicare and Medicaid payments.
    • Third-party reprocessors are regulated by the FDA.

    Recommendations and Resources

    • The Association for the Advancement of Medical Instrumentation (AAMI) and the Society of Gastroenterology Nurses and Associates (SGNA) provide guidance on proper sterilization and processing practices.

    Infections and Health Statistics

    • Approximately 2 million patients develop healthcare-associated infections each year.
    • The Association for Professionals in Infection Control and Epidemiology (APIC) focuses on infection prevention and control.

    Miscellaneous Facts

    • Established national emissions standards for ethylene oxide (EO) used by hospitals do not exist.
    • The FDA oversees the MedWatch program for medical device safety reporting.

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Description

    Test your knowledge of key concepts from Chapter 5 of the IAHCSMM textbook. This practice test includes essential terminology and definitions related to occupational safety and health regulations. Perfect for students preparing for their certification exams.

    More Like This

    FDA Medical Device Classification Quiz
    17 questions
    Medical Device Reporting SOP
    10 questions

    Medical Device Reporting SOP

    WorkableSteelDrums5546 avatar
    WorkableSteelDrums5546
    Use Quizgecko on...
    Browser
    Browser