Chapter 5 - Regulations and Standards

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?

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

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?

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

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?

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?

Which organization conducts onsite survey of healthcare facilities? SGNA? APIC? TJC? ANSI?

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?

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?

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.

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

TRUE OR FALSE: Failure to receive accreditation from The Joint Commission can result in the loss of Medicare and Medicaid payments.

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?

Which agency imposes very strict labeling requirements on chemicals used by CS departments? OSHA? FDA? EPA? AAMI?

An FDA Medical Device recall means what? Items cannot be used and must be pulled from shelves? Items need to be checked or repaired? A mandatory statute is issued on a defective product? A voluntary statute is issued?

TRUE OR FALSE: Class III medical devices are identified as high risk.

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?

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

Standards and regulations help set what? Equal pay practices? Productivity time lines? Minimal levels of quality & safety? All of the above?

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.

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

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?

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

Regulations under the Clean Air Act are administered by whom? OSHA? FDA? EPA? AORN?