Statute - ✔✔a written law passed by a legislative body
Regulation - ✔✔Rules or orders issued by an administrative agency of government that
usually 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 organizations, trade associations and others develop
these.
Best Practice - ✔✔A method or technique that has consistently shown results superior to
those achieved by other means.
Class I, II, III devices - ✔✔From least stringent to most stringent devices used in surgical
procedures
I: low risk, hand held surgical instruments, ultrasonic cleaners
II: sterilization equipment, bio and chem indicators
III: heart valves, pacemakers, life sustaining items
, Medwatch - ✔✔A safety information and adverse event reporting system that serves
healthcare professionals and the public by reporting serious problems suspected to be
associated with the drugs and medical devices they prescribe, dispense, or use.
FDA Recall Device classification - ✔✔Class 1-3, from highest risk to lowest risk
ODOT - ✔✔Ohio Department of Transportation, for SPD they regulate the transportation of
surgical instrumentation etc throughout the hospital.
DOT regulations must be followed when transporting soiled goods.
EPA - ✔✔Environmental Protection Agency
Regulates SPD detergents and CFC emissions from EtO sterilization methods.
Medicare - ✔✔A federal program of health insurance for persons 65 years of age and older
Medicaid - ✔✔A federal and state assistance program that pays for health care services for
people who cannot afford them.
HIPPA (Health Insurance Portability and Accountability Act) - ✔✔federal protections for
individually identifiable health information held by covered entities and their business
associates. Gives patients many rights with respects to their information.
DHS - ✔✔Department of Health Services
OSHA - ✔✔Occupational Safety and Health Administration, a government agency in the
Department of Labor to maintain a safe and healthy work environment
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