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Iahcsmm chapter 5

regulations and standards

QuestionAnswer
agency which may intervene in a matter of worker protection even if there is no specific regulations covering the situation Occupational Safety and Health Administration (OSHA)
regulations under the Clean Air Act are administered by the Environmental Protection Agency (EPA)
agency which imposes very strict labeling requirements on manufacturers of disinfectants used by central service departments Environmental Protection Agency (EPA)
healthcare regulations and standards establish minimal levels of quality and safety
chemical indicators are classified as FDA Class II medical devices
heart valves and pacemakers are examples of FDA Class IIIfalse medical devices
under current regulations, who is required to report suspected medica device-related deaths to the FDA all of the above
standards and regulations help set levels of quality,safety and efficiency
medical device reporting is regulated by FDA
the department of transportation enforce statutes relating to the transportation of clean and soiled instruments between facilites
sometimes state or local regulations differ from federal regulations. when that happens the most stringent regulations apply true
it is optional to follow OSHA regulation for wearing PPE in decomtam. false
third party reprocessors are regulated by the FDA true
recommendations regarding sterilization practices are provided by the association for the advancement of medical instruments (AAMI) true
OSHA is a voluntary association dedicated to infection control and prevention false
failure to receive accreditation from the joint commission can result in the loss of Medicare/Medicaid payments true
the society of gastroenterology nurses and associates is a source of information about the proper processing of flexible endoscopes true
class III medical devices are identified as high risk true
reuse of single use medical devices is less regulated than it was in the 1990's false
the FDA recalls may be either mandatory or voluntary true
Created by: clmcnees
 

 



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