7.3 Key Standards, Regulations & Governing Bodies
Key Takeaways
- AAMI (Association for the Advancement of Medical Instrumentation) publishes technical standards including ST79, ST91, and ST108
- AAMI ST79 is the comprehensive guide to steam sterilization and sterility assurance in healthcare facilities
- AAMI ST91 covers flexible and semi-rigid endoscope processing
- AAMI ST108 defines water quality requirements for medical device processing
- AORN (Association of periOperative Registered Nurses) publishes perioperative practice guidelines
- The Joint Commission (TJC) accredits healthcare organizations and surveys for compliance
- OSHA enforces workplace safety including bloodborne pathogens (29 CFR 1910.1030) and chemical safety (GHS)
- The FDA regulates medical devices, manufacturer IFUs, device recalls, and single-use device reprocessing
Last updated: March 2026
Key Standards, Regulations & Governing Bodies
CS technicians operate within a complex framework of standards, regulations, and guidelines. Understanding who sets the rules and what the key standards require is essential for both the CRCST exam and daily practice.
Standards-Setting Organizations
AAMI (Association for the Advancement of Medical Instrumentation)
AAMI develops voluntary consensus standards for medical device processing:
| Standard | Title | Key Content |
|---|---|---|
| ST79 | Comprehensive Guide to Steam Sterilization and Sterility Assurance | Steam sterilization parameters, monitoring, loading, wet packs, quality assurance |
| ST91 | Flexible and Semi-Rigid Endoscope Processing | Endoscope reprocessing steps, AER use, storage, quality monitoring |
| ST108 | Water for the Processing of Medical Devices | Water quality categories (utility, critical), treatment, testing |
| ST77 | Containment Devices for Reusable Medical Device Sterilization | Rigid container standards, filter requirements, testing |
| ST58 | Chemical Sterilization and HLD in Healthcare Facilities | EtO, hydrogen peroxide, HLD processes |
AORN (Association of periOperative Registered Nurses)
- Publishes Guidelines for Perioperative Practice
- Updated annually
- Covers sterilization, cleaning, packaging, sterile technique, and environmental management
- Referenced on the CRCST exam alongside AAMI standards
CDC (Centers for Disease Control and Prevention)
- Publishes the Guideline for Disinfection and Sterilization in Healthcare Facilities
- Defines the Spaulding Classification framework
- Provides evidence-based recommendations for infection prevention
Regulatory/Accrediting Bodies
The Joint Commission (TJC)
- Accredits hospitals, ambulatory surgery centers, and other healthcare organizations
- Conducts unannounced surveys to evaluate compliance
- CS-related survey focus areas:
- Environmental controls (temp, humidity, air exchanges)
- Sterilization monitoring (mechanical, chemical, biological)
- Staff competency and training documentation
- IFU availability and compliance
- Documentation and record-keeping
- Equipment maintenance records
- Non-compliance can result in citations, corrective action requirements, or loss of accreditation
- Accreditation impacts a facility's ability to receive Medicare/Medicaid reimbursement
CMS (Centers for Medicare & Medicaid Services)
- Sets Conditions of Participation (CoPs) that hospitals must meet
- Can conduct independent surveys
- CoPs require effective infection control programs including proper sterilization
- Deemed status: TJC-accredited facilities are "deemed" to meet CMS requirements
OSHA (Occupational Safety and Health Administration)
- Enforces workplace safety standards:
- 29 CFR 1910.1030: Bloodborne Pathogens Standard
- 29 CFR 1910.1200: Hazard Communication (GHS/SDS)
- 29 CFR 1910.132-138: PPE requirements
- 29 CFR 1910.134: Respiratory protection
- CS-specific OSHA concerns: BBP exposure, chemical safety, sharps injuries, ergonomics
FDA (Food and Drug Administration)
- Regulates medical devices — ensures safety and effectiveness
- Requires manufacturers to provide validated Instructions for Use (IFU)
- Manages device recalls (Class I, II, III)
- Regulates single-use device (SUD) reprocessing — only FDA-registered third-party reprocessors may reprocess certain SUDs
- Enforces Medical Device Reporting (MDR) — facilities must report device-related deaths and serious injuries
State Health Departments
- May have additional regulations beyond federal requirements
- Conduct state surveys for licensing
- Some states mandate CRCST certification (NJ, NY, TN)
- May regulate specific practices (e.g., endoscope reprocessing, IUSS usage)
Test Your Knowledge
AAMI ST79 is the standard that specifically addresses:
A
B
C
D
Test Your Knowledge
Which organization is responsible for enforcing workplace safety standards including the Bloodborne Pathogens Standard?
A
B
C
D
Test Your Knowledge
The FDA's role in Central Service primarily involves:
A
B
C
D