5. Regulations & Standards

Overview:  

Tell the difference between regulations and voluntary and regulatory standards.

Provide basic information about the U.S. Food and Drug Administration (FDA), and review its regulations applicable to:

• Medical device classification
• Pre- and post-market requirements
• Medical device reporting requirements   
• Medical device recalls
• FDA labeling document
• Re-use of single-use medical devices

Explain the roles and responsibilities of other federal government agencies that impact Central Service, and discuss important aspects of the regulations and standards they administer:

• Centers for Disease Control (CDC)
• Department of Transportation (DOT)
• Environmental Protection Agency (EPA)
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• Occupational Safety and Health Administration (OSHA

Discuss the assistance provided by professional associations that develop regulations and standards affecting Central Service:

• Association for the Advancement of Medical Instrumentation (AAMI)
• American National Standards Institute (ANSI)
• Association of Operating Room Nurses (AORN)
• Association for Professionals in Infection Central and Epidemiology (APIC)
• International Standards Organization (ISO)
• The Joint Commission
• National Fire Protection Association (NFPA)
• United States Pharmacopoeia – National Formulary (USP-UF)
• World Health Organization (WHO)
• Society of Gastroenterology Nurses and Associates (SGNA)