Mod 5.txt

Regulation and standards Introduction Statutes ,regulation and voluntary standards impact every healthcare professional including those working in central service these laws and guideline establish minimum levels of quali- ty and safety Statute/ written law adopted by a legislative body that governs...

Regulation and standards Introduction Statutes ,regulation and voluntary standards impact every healthcare professional including those working in central service these laws and guideline establish minimum levels of quali- ty and safety Statute/ written law adopted by a legislative body that governs a city country state or country Regulation / rules issued by administrative agencies hat have the force ofa | Standard / a uniform method of defining basic parameters for processes products services and measurements Regulatory standards / a comparison benchmark that is mandated by a governing agency noncompliance with regulatory standards may lead to citations and legal penalties Voluntary standards / guidelines or recommendations for best practices to provide better patient care industry nonprofit organization trade association and other develop Best practice / a method or technique that has consistently shown results superior to those achieved by other means Qo he us food and drug administration (FDA) is the QUEENIE eoonsible for ensuring that food cosmetic human and veterinary drugs biologi edical devices and electronic products that emit radiation ar se / public YS@ e level of regulation placed on any device depends upon how the FDA classifies _ that device: eta evices these include low risk device —_—— S evices these are devices considered to pose potential risks great enough warrant a higher level of regulation aaa are the most stringently regulated devices and include heart valves enter for disease control and prevention The centers for disease control and prevention CDC is a federal agency organized with the us department of health and human services it works to promote health and quality of life by preventing and by responding to health emergencies Kise RIIK U.S department of Transportation 1%. 2y sar . . nisi yt 2 i rae ~ AW NN we WN SN a) ‘okey oD s ‘oo Sst } sil ‘ a Ri Ws a) Le CI L zu x federal government agency dedicated to ensur- ing a fast safe and efficient transportation system laws relating to healthcare include those concerning the transportation of minimally processed instrumentation for repair reprocess=) ‘ing and the transportation of hazardous and radioactive wastes the DOT inspects and cites organizations for statute violation A regulatory agency the purpose of protecting human health and the environment by writing and enforcing EPA responsible for minimizing greenhouse gases and toxic ‘Occupational safety and health administration 0,5 tl > Its primary role and responsibility is to protect workers from occupational caused illnesses Develop and promote voluntary standards that provide a foundation for processes and prac- tices performed in the cssd functions ‘Voluntary guidelines representing a consensus of AAMI members that are intended for use by healthcare facilities and manufacturers to help ensure that medical instrumentation is Safe for patient use American national standards institute Association of perioperative registered nurses — The association for professionals in infection control and epidemiology

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