Difference Between Regulations and Standards

- Regulation: Rules set by administrative agencies that are enforced by law.

- Standard: An established norm of the basics for processes, products, and services.

U.S. Food and Drug Administration (FDA)

  • Ensures medical devices are safe and effective.

  • Regulates medical device manufacture, sterilants, disinfectants, packaging, sterilizers, biological indicators, and single-use devices.

FDA Medical Device Classification 1-3:

  1. Class I: Low-risk devices (general controls) 

    e.g. hand-held surgical instruments, hospital beds, and ultrasonic cleaners.

  2. Class II: Moderate-risk devices (performance standards & specific guidelines)

    e.g. most sterilization equipment, Bls, chemical indicators CIs, wraps, etc.

  3. Class III: High-risk devices (requiring premarket approval)

    e.g. heart valves, pacemakers, and other life-sustaining devices.

- FDA Has Emergency Use Authorization (EUA): Facilitates the use of medical countermeasures during emergencies, e.g. decontaminating N95 masks during COVID-19.

Centers for Disease Control and Prevention (CDC)

The federal agency promotes health by preventing diseases, injuries, and disabilities by responding to health emergencies.

Centers for Medicare and Medicaid Services (CMS)

  • Operates Medicare, Medicaid, and the State Children's Health Insurance Program.

  • Administers and upholds HIPAA standards to safeguard patients' medical records and personal health information.

U.S. Department of Transportation (DOT)

  • Ensures efficient transportation systems.

  • Regulates transportation of specific healthcare items and hazardous wastes.

U.S. Environmental Protection Agency (EPA)

  • Regulates environmental aspects, including emissions, waste reuse, and chemical regulations.

  • Products must have specific label information, including EPA registration.

  • Sets emission standards for ethylene oxide (EO) sterilization.

Occupational Safety and Health Administration (OSHA)

Protects workers from occupational hazards.

Association for the Advancement of Medical Instrumentation (AAMI)

  • Nonprofit organization developing healthcare technology standards and technical information reports (TIRs) many of address functions that affect the SPD, including cleaning, sterilization, packaging, and equipment testing.

  • Publishes standards affecting SPD, e.g. ANSI/AAMI ST79:2017 (steam sterilization and sterility assurance).

Association of periOperative Registered Nurses (AORN)

  • Professional organization providing guidelines for perioperative care, with several sections devoted to topics directly affecting the SPD, including cleaning, disinfection, packaging, endoscope processing, and sterilization.

  • Is not a regulatory body, but its guidelines are referenced by officials and surveyors during SP area reviews.

Association for Professionals in Infection Control and Epidemiology (APIC)

Works on preventing hospital-acquired infections and disease prevention.

The Joint Commission (TJC)

  • Evaluates healthcare organizations in the U.S. (spends 2-5 days).

  • Come unannounced and conduct onsite surveys at least once every 3 years.

  • Non-compliance can lead to loss of accreditation and funding

    (millions of dollars).

United States Pharmacopoeia-National Formulary (USP-NF)

Sets standards for medicine purity.

World Health Organization (WHO)

Promotes international health and combats diseases.

American Society of Heating Refrigerating and Air-Conditioning Engineers (ASHRAE)

  • Sets standards for healthcare heating, ventilation, and air conditioning (HVAC) Systems.

  • Such as the ASHRAE/ASHE Standard 170.