Module 5 & 6: Regulation & Standards (MOD 5.pdf)

Managing the environment to prevent the spread of bacteria Environmental concerns in central service Module 5 Regulation and standards Introduction Statutes ,regulation and voluntary standards impact every healthcare professional including those working in central service these laws and guideline e...

Managing the environment to prevent the spread of bacteria Environmental concerns in central service Module 5 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 quality and safety Statute/ written law adopted by a legislative body that governs a city country state or country Regulation / rules issued by administrative agencies that have the force of law 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 REGULATORY AGENCIES The us food and drug administration (FDA) is the federal agency responsible for ensuring that food cosmetic human and veterinary drugs biological 137 products medical devices and electronic products that emit radiation are safe and effective for public use Medical device classification The level of regulation placed on any device depends upon how the FDA classifies that device : Class 1 devices these include low risk device Class 2 devices these are devices considered to pose potential risks great enough warrant a higher level of regulation Class 3 these are the most stringently regulated devices and include heart valves Center 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 U.S department of Transportation The US Department of Transportation (DOT) is federal government agency dedicated to ensuring a fast safe and efficient transportation system laws relating to healthcare include those concerning the transportation of minimally processed instrumentation for repair reprocessing and the 138 transportation of hazardous and radioactive wastes the DOT inspects and cites organizations for statute violation U.S Environmental Protection Agency 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 Its primary role and responsibility is to protect workers from occupational caused illnesses and injuries PROFESSIONAL ASSOCIATION Develop and promote voluntary standards that provide a foundation for processes and practices performed in the cssd functions Association for the advancement of medical instrumentation (AAMI) 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 International standards organization The joint commission National Fire protection association United states pharmacopoeia national formulary Society of gastroenterology nurses and Associates Canadian standards association European committee for standardization Module 6 Surgical Instruments Chapter II Introduction The CDC mandates that instrument end-users “comply with all steps as directed by the device manufacturer”. The International Association of Healthcare Central Service Materiel Management (IAHCSMM) recommends that processes such as care and cleaning; and the 139