Share Chapter 5 - Regulations and Standards
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The U.S. Food and Drug Administration is responsible for what? Maintaining all manufacturer records? Ensuring items can be properly cleaned and sterilized? Ensuring food, drugs and cosmetics are safe for use?
Ensuring food,drugs and cosmetics are safe for use.
TRUE OR FALSE: Center for Disease Control guidelines are considered regulatory guidelines.
False
The federal program designed for the voluntary reporting of device related problems is called what? Safe Medical Device Act? FDA reporting requirements? MedWatch? The Medical Device Recall Act?
MedWatch
The Association of periOperative Registered Nurses is what? A professional organization that writes guidelines for the OR? Responsible for writing Infection Prevention guidelines? A voluntary agency that oversees professional standards?
A professional organization that writes guidelines for the OR.
Which organization conducts onsite survey of healthcare facilities? SGNA? APIC? TJC? ANSI?
The Joint Commission.
Which agency intervenes in a matter of worker protection even if there are no specific regulations covering the situation? EPA? FDA? OSHA? AORN? None of the above?
Occupational Safety and Health Administration.
Healthcare regulations and standards provide consistency of departmental activities by outlining what? Minimal levels of quality and safety? Equal pay practices? Productivity time lines? All of the above?
Minimal levels of quality and safety.
Chemical indicators are what class of devices? FDA Class I? FDA Class II? FDA Class III? Unregulated?
FDA Class II.
TRUE OR FALSE: Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.
True
Under current regulations, who is required to report suspected medical device-related deaths to the FDA? Device manufacturer? Hospitals? All of the above? None of the above?
All of the above.
Regulations under the Clean Air Act are administered by whom? OSHA? FDA? EPA? AORN?
Environmental Protection Agency.
Standards and regulations help set what? Equal pay practices? Productivity time lines? Minimal levels of quality & safety? All of the above?
Minimal levels of quality and safety.
TRUE OR FALS: Following OSHA regulations for wearing PPE's in the decontamination area is optional.
False
Regulations and standards provide information to help ensure what? Standard guidelines for legal protection? Quality and safety? Goals for patient safety? All of the above?
Quality and safety.
OSHA is responsible for what? EtO guidelines, worker safety & blood borne pathogen standard? Bio hazard material transport safety, PPE & product labeling? Prion guidelines, Safe Medical Device Act & MedWatch?
Ethylene oxide guidelines, worker safety, and the blood borne pathogen standard.
TRUE OR FALSE: In order to reprocess single-use devices, a hospital must be able to prove the device will act the same as it did when it was first manufactured.
True
