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