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#1. Which agency regulates disinfectants used in healthcare facilities?
Correct Answer: EPA
Explanation: The EPA regulates disinfectants to ensure they are effective and safe for their intended use.
#2. Chemical indicators (CIs) are classified as which type of medical device?
Correct Answer: Class II
Explanation: Chemical indicators are FDA Class II medical devices because they help verify sterilization processes.
#3. Which organization is responsible for protecting workers by enforcing workplace safety regulations?
Correct Answer: OSHA
Explanation: OSHA creates and enforces workplace safety rules to help protect employees from job-related hazards.
#4. Heart valves and pacemakers are examples of which FDA device class?
Correct Answer: Class III
Explanation: Class III devices are high-risk medical devices that require the highest level of regulatory review.
#5. Who is responsible for reporting certain medical device problems to the FDA?
Correct Answer: Healthcare facilities
Explanation: Healthcare facilities must report certain device-related events to help improve patient safety.
#6. Which government agency regulates chemicals and environmental protection?
Correct Answer: EPA
Explanation: The EPA develops regulations that protect the environment and oversees the safe use of certain chemicals.
#7. Regulations and standards help Sterile Processing departments improve:
Correct Answer: Quality and safety
Explanation: Following standards helps ensure safe practices while maintaining consistent quality throughout the department.
#8. The Department of Transportation (DOT) establishes rules for transporting what between healthcare facilities?
Correct Answer: Clean and contaminated instruments
Explanation: DOT regulations help ensure medical items are transported safely to reduce the risk of contamination.
#9. Which agency regulates medical device reporting in the United States?
Correct Answer: FDA
Explanation: The FDA oversees medical device reporting to monitor safety issues and protect patients.
#10. Why are healthcare regulations and standards important?
Correct Answer: They improve quality and patient safety.
Explanation: Regulations and standards help healthcare facilities deliver safe, consistent, and high-quality patient care.