2024-04-18T20:03:01+03:00[Europe/Moscow] en true <p>regulation</p>, <p>standards</p>, <p>best practice</p>, <p>FDA</p>, <p>FDA Medical Device Classification Class I</p>, <p>FDA Medical Device Classification Class II</p>, <p>FDA Medical Device Classification Class III</p>, <p>FDA Medical Device Recall Class I</p>, <p>FDA Medical Device Recall Class II</p>, <p>FDA Medical Device Recall Class IIII</p>, <p>MedWatch</p>, <p>CDC</p>, <p>DOT</p>, <p>EPA</p>, <p>OSHA</p>, <p>CMS</p>, <p>AAMI</p>, <p>TIR</p>, <p>ANSI</p>, <p>AORN</p>, <p>TJC</p>, <p>APIC</p>, <p>NFPA</p>, <p>USP-NF</p>, <p>WHO</p>, <p>SGNA</p> flashcards

SP CH6

Terms and Agencies

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  • regulation

    rules from administrative agencies that have the force of law

  • standards

    a uniform method of defining basic parameters, products, services, and measurements 

  • best practice

    method or technique with superior results

  • FDA

    Food and Drug Administration: regulates manufacturing of medical devices, sterilants, and disinfectants

  • FDA Medical Device Classification Class I

    low-risk devices has general controls for FDA approval, ex: hand held surgical instruments

  • FDA Medical Device Classification Class II

    potential risk and needs a premarket notification for FDA approval, ex: sterilization equipment, chemical indicators and biological indicators

  • FDA Medical Device Classification Class III

    Stringently regulated requiring pre-market approvals and post market requirements, ex: heart valves and pacemakers

  • FDA Medical Device Recall Class I

    can cause serious health problems or death, requires a press release

  • FDA Medical Device Recall Class II

    can cause temporary or reversible health problems

  • FDA Medical Device Recall Class IIII

    malfunction not likely to cause health problems

  • MedWatch

    FDA's voluntary reporting of device related problems

  • CDC

    Centers for Disease Control: made first recommendations for isolation techniques, makes recommendations for public health measures

  • DOT

    Department of Transportation: makes laws regarding transport and labeling of biohazardous or radioactive material

  • EPA

    Environmental Protection Agency: regulates gases, toxic chemicals, air pollution and other toxins used and created in healthcare

  • OSHA

    Occupational Safety and Health Administration: protects workers, maintains the Bloodborne Pathogen Standard

  • CMS

    Centers for Medicare and Medicaid Services: in charge of Medicare, Medicaid and HIPAA

  • AAMI

    Association for the Advancement of Medical Instrumentation: responsible for the development, management, and use of safe and effective medical technology, develop TIRs

  • TIR

    Technology Information Reports: supplemental information on devices

  • ANSI

    American National Standard Institute: promotes standards for healthcare

  • AORN

    Association for peri-Operative Nurses: developed Best Practices for cleaning, disinfecting, packaging, sterilization, and instrument processing 

  • TJC

    The Joint Commission: develops standards for healthcare facilities and conducts site surveys

  • APIC

    Association for Professionals in Infection Control and Epidemology: prevents disease and infection

  • NFPA

    National Fire Protection Association: develops codes and standards for fire safety

  • USP-NF

    US Pharmacopoeia-National Formulary: develops standards for purity of medicine, drug standards and dietary supplements 

  • WHO

    World Health Organization: Part of United Nations:   coordinates international efforts to monitor outbreaks and promotes general health

  • SGNA

    Society of Gastroenterology Nurses and Associates: develops safe and effective practice of gastroenterology and endoscopy