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 Tier:

  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 Medical Device RECALLS (Also 1-3 Tier)

A recall is an action taken to address a problem with a medical device when it's found to be defective or poses a health risk. Recalls can be initiated voluntarily by manufacturers or distributors or mandated by the FDA. A recall doesn't necessarily mean the device must be permanently removed; sometimes it only requires inspection or repair. For instance, recalled implants might not need removal, but risks should be discussed with the patient. FDA closely monitors all recalls to ensure public safety.

  • Class I recall – High risk: Use may cause serious harm or death

  • Class II recall – Moderate risk: May cause temporary or reversible harm

  • Class III recall – Low risk: Unlikely to cause harm

Note: Be careful not to confuse FDA medical device classes with FDA recall classes. FDA recall Class I is the strictest recall, whereas medical device Class I is the least strict category.

- 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.