Questions and Answers
Which agency may intervene in a matter of worker protection even if there are no specific regulations covering the situation?
Regulations under the Clean Air Act are administered by which agency?
Chemical Indicators are classified as which type of medical devices?
Under current regulations, who is required to report suspected medical device-related deaths to the U.S. Food and Drug Administration?
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Standards and regulations help set levels of _______ in our departments.
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The agency which imposes very strict labeling requirements on manufacturers of disinfectants used by Central Service departments is?
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Heart valves and pacemakers are examples of which type of medical devices?
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Medical device reporting is regulated by which agency?
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The Department of Transportation enforces statutes relating to the?
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Sometimes state or local regulations differ from Federal regulations and when that happens, the most stringent regulations apply.
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It is optional to allow the Occupational Safety and Health Administration's regulation for wearing PPE in the Central Service decontamination.
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Third party reprocessors are regulated by the U.S. Food and Drug Administration.
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Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
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The Occupational Safety and Health Administration is a voluntary association dedicated to infection control and prevention.
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Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.
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Established national emissions standards for EO used by hospitals are regulated.
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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.
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What is The Joint Commission?
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The agency responsible for the MedWatch program is?
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Medical device reporting is regulated by the?
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Healthcare regulations and standards provide consistency of departmental activities by outlining:
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The SGNA (Society of Gastroenterology Nurses and Associates) is a good source for information about the proper processing of flexible endoscopes.
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Which agency imposes very strict labeling requirements on manufacturers of chemicals used by Central Service departments?
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A voluntary international organization dedicated to the prevention and control of infections and related outcomes is?
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Each year, approximately _______ patients develop a healthcare-associated infection.
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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.
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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.
