Which organization writes standards relating to the processing of flexible endoscopes? SGNA? OSHA? ISO? APIC?

Chemical indicators are what class of devices? FDA Class I? FDA Class II? FDA Class III? Unregulated?

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?

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?

TRUE OR FALSE: Center for Disease Control guidelines are considered regulatory guidelines.

Medical device reporting is regulated by who? NFPA? EPA? WHO? FDA?

What do voluntary standards do? Provide a guideline for required levels of service? Provide guidelines for better patient care? Are written enforceable guidelines? Are guidelines followed by the Centers for Disease Control?

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?

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?

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?

TRUE OR FALS: Following OSHA regulations for wearing PPE's in the decontamination area is optional.

TRUE OR FALSE: Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.

TRUE OR FALSE: U.S. Food and Drug Administration recalls may be either mandatory or voluntary.