Questions and Answers
An agency which 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?
An agency which imposes very strict labeling requirements on manufacturers of chemicals used by Central Service departments?
Healthcare Regulations and Standards provide consistency of departmental activities by outlining?
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Established national emissions standards for EO used by hospitals are regulated?
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Chemical indicators are FDA ________ devices?
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Heart valves and pacemakers are examples of FDA _______ medical devices?
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Under current regulations who is required to report suspected medical device-related deaths to the FDA?
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Standards and regulations help set levels of _______ in our departments?
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Medical Device reporting is regulated by 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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Following OSHA regulations for wearing Personal Protective Equipment in the Central Service Decontamination area is optional.
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Third Party Reprocessors are regulated by the FDA.
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Recommendations regarding sterilization practices are provided by AAMI.
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ANSI is a voluntary association dedicated to infection control and prevention.
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The organization that conducts on-site surveys to evaluate healthcare organizations is the ISO.
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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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The SGNA is a good source for information about the proper processing of flexible endoscopes.
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Class III medical devices are identified as High Risk.
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Reuse of single-use medical devices is less regulated now than it was in the 1990s.
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Study Notes
Worker Protection Agencies
- OSHA can intervene in worker protection matters without specific regulations.
- EPA administers regulations under the Clean Air Act.
Chemical Safety and Labeling
- EPA imposes strict labeling requirements on manufacturers of chemicals used by Central Service departments.
Regulations in Healthcare
- Healthcare Regulations and Standards ensure minimal performance standards in departmental activities.
Emission Standards
- No established national emissions standards for Ethylene Oxide (EO) used by hospitals.
FDA Classifications
- Chemical indicators are classified as FDA Class II devices.
- Heart valves and pacemakers fall under FDA Class III medical devices.
Reporting Requirements
- Device manufacturers and hospitals are required to report suspected medical device-related deaths to the FDA.
Standards Impact
- Standards and regulations enhance quality, safety, and efficiency in departments.
Medical Device Oversight
- Medical Device reporting is regulated by the FDA.
Regulatory Hierarchy
- In cases where state or local regulations differ from federal, the more stringent regulations apply.
Personal Protective Equipment Regulations
- Compliance with OSHA regulations for Personal Protective Equipment in Central Service Decontamination areas is mandatory.
Third Party Regulations
- Third Party Reprocessors are regulated by the FDA.
Sterilization Recommendations
- AAMI provides recommendations regarding sterilization practices.
ANSI Misconception
- ANSI is not a voluntary association dedicated to infection control and prevention.
Accreditation Consequences
- Lack of accreditation from the Joint Commission can lead to loss of Medicare and Medicaid payments.
Endoscope Processing Information
- SGNA is a reliable source for information on proper processing of flexible endoscopes.
Medical Device Risk Classification
- Class III medical devices are classified as high risk.
Single-Use Device Regulations
- Regulations regarding the reuse of single-use medical devices have not become less stringent since the 1990s.
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Description
This quiz covers various regulations and standards that govern healthcare, including OSHA, EPA, and FDA guidelines. It highlights the role of these agencies in ensuring worker protection and chemical safety, as well as the oversight of medical devices. Test your knowledge on how these standards impact quality and safety in healthcare settings.
