Standards and regulations help set what? Equal pay practices? Productivity time lines? Minimal levels of quality & safety? All 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: Recommendations regarding sterilization practices are provided by the Association for the Advancement of Medical Instrumentation.

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?

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?

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?

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?

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?

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

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

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?