CAii/CMII cheat sheet
CAii/CMII · Keep the key ideas within reach.
Infection Prevention and Control Principles
Chain of infection: infectious agent, reservoir, portal of exit, mode of transmission, portal of entry, susceptible host; breaking any link prevents transmission.
Spaulding classification: critical items (enter sterile tissue or vascular system) require sterilization; semicritical items (contact mucous membranes or nonintact skin) require high-level disinfection; noncritical items (contact intact skin) require low-level disinfection.
Standard precautions apply to all patients regardless of diagnosis: hand hygiene, gloves, gown, mask, eye protection, and safe injection practices.
Hand hygiene moments per WHO: before touching a patient, before clean/aseptic procedure, after body fluid exposure risk, after touching a patient, after touching patient surroundings.
Transmission-based precautions: contact (MRSA, C. difficile, scabies), droplet (influenza, pertussis, meningococcus), airborne (TB, measles, varicella); airborne requires N95 or PAPR and negative-pressure room.
Alcohol-based hand rub is preferred for routine hand hygiene when hands are not visibly soiled; wash with soap and water for at least 20 seconds when visibly soiled or after C. difficile exposure.
Sterile field rules: sterile items contact sterile items only; 1-inch border of sterile drape is nonsterile; never turn away from or reach over a sterile field.
Bloodborne pathogen exposure: immediately wash needlestick site with soap and water, report, and initiate post-exposure prophylaxis evaluation; source patient testing requires consent or state law.
Reprocessing area design follows one-way workflow: dirty-to-clean flow, with decontamination, preparation/packaging, sterilization, and sterile storage physically separated.
Medical Device Reprocessing and Sterilization
Steam sterilization standard cycle: gravity displacement at 121–123°C (250–252°F) for 15–30 min or 132–134°C (270°F) for 3–4 min; pre-vacuum cycles at 132–134°C for 3–4 min with 20–30 min dry time.
EO sterilization: 37–63°C, 40–80% relative humidity, EO concentration 450–1200 mg/L, exposure 1–6 hours; aeration required to remove toxic residues.
Low-temperature sterilization alternatives: hydrogen peroxide gas plasma (45–55°C), vaporized hydrogen peroxide, and peracetic acid; choose based on device manufacturer instructions.
High-level disinfectants: glutaraldehyde (≥2% for 20 min at 20°C for semi-critical items), ortho-phthalaldehyde (0.55%, 12 min), hydrogen peroxide (7.5%, 30 min), peracetic acid.
Biological indicators: Geobacillus stearothermophilus for steam and hydrogen peroxide; Bacillus atrophaeus for EO and dry heat; Bacillus subtilis for radiation.
Chemical indicators: Class 1 process indicator (tape), Class 2 Bowie-Dick test for pre-vacuum steam, Class 3 single-parameter, Class 4 multi-parameter, Class 5 integrating, Class 6 emulating indicator.
Bowie-Dick test: run daily in an empty pre-vacuum sterilizer at 132–134°C for 3.5–4 min; uniform color change confirms air removal and steam penetration.
Packaging: use FDA-cleared sterilization wrap or pouches; label with sterilizer ID, cycle/load number, date, and expiration; internal chemical indicator inside every pack.
Sterile storage: shelves at least 20 cm (8 in) above floor, 45 cm (18 in) below ceiling, 5 cm (2 in) from walls; temperature 20–24°C (68–75°F), humidity 30–60%.
Immediate-use steam sterilization (IUSS): only for urgent items, not as a routine substitute for planned reprocessing; transport in a covered container and use promptly.
Instrumentation Inspection, Testing, and Maintenance
Inspection steps: disassemble to smallest component, inspect for soil, corrosion, cracks, pitting, and alignment; use magnification and borescopes for lumens.
Lumened instruments: flush with enzymatic cleaner, brush with appropriate-diameter brush, rinse, and verify patency; use lumen gauge or borescope when available.
Scissors: test by cutting a single layer of tissue-equivalent material (e.g., suture or test paper) along the full length; sharp scissors cut cleanly to the tip.
Needle holders and forceps: check jaw alignment and serrations; a slip or misalignment indicates need for repair or replacement.
Powered equipment: inspect cords for fraying, test insulation, verify battery function, and follow manufacturer's preventive maintenance schedule.
Flexible endoscopes: leak test before and after each procedure; perform channel obstruction test; store vertically in a ventilated cabinet.
Sharpening and repair: only trained personnel or vendor repair services should sharpen or refurbish; document repair and return-to-service.
Instrument marking: use only approved etching or laser marking; never engrave on working surfaces or hinge areas.
Loaner instruments: inspect and verify function before processing; require manufacturer instructions for use (IFU) and validate cleaning efficacy.
Regulatory Standards and Accreditation Requirements
AAMI ST79 provides comprehensive guidance for steam sterilization in healthcare facilities; AAMI ST91 covers flexible and semi-rigid endoscope processing.
ANSI/AAMI ST58 addresses chemical sterilization and high-level disinfection; ST41 covers ethylene oxide sterilization.
Joint Commission infection control standards require a written infection prevention and control plan, surveillance, and annual evaluation.
OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) requires exposure control plan, hepatitis B vaccination offer, PPE, and post-exposure evaluation.
OSHA Hazard Communication Standard (29 CFR 1910.1200) requires safety data sheets (SDS) and labeling of hazardous chemicals.
CDC Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) provides evidence-based recommendations for reprocessing.
FDA regulates sterilants and high-level disinfectants as medical devices; manufacturers must submit premarket notification (510(k)) or PMA.
Accreditation surveys use tracer methodology to follow a patient's care and verify compliance with infection control and reprocessing standards.
Record retention: sterilization records should be kept per facility policy and accreditation requirements, often at least 3 years or longer for implantables.
Environmental Safety and Occupational Health
Chemical hazards: glutaraldehyde exposure limits (ceiling 0.05 ppm per NIOSH); use closed containers, local exhaust ventilation, and PPE.
Ethylene oxide is a carcinogen and reproductive hazard; exposure monitoring required; aeration area must be separate and ventilated.
Radiation safety: follow ALARA principles; wear dosimeters; lead aprons for fluoroscopy; post warning signs.
Fire safety: know RACE (Rescue, Alarm, Confine, Extinguish/Evacuate) and PASS (Pull, Aim, Squeeze, Sweep); sterilizers require clearance from combustibles.
Electrical safety: inspect cords and plugs; do not use damaged equipment; follow lockout/tagout for maintenance.
Ergonomics: adjust workstations, use lift aids for heavy trays, and rotate tasks to prevent musculoskeletal injuries.
Waste management: red bags for biohazardous waste; sharps in puncture-resistant containers; chemical waste per EPA and local regulations.
Spill response: use spill kits, absorbent material, and appropriate PPE; report and document all spills and exposures.
Ventilation: reprocessing areas require negative pressure relative to adjacent spaces and adequate air exchanges per ASHRAE and facility policy.
Quality Assurance and Documentation
Quality indicators: biological indicator failure rate, chemical indicator compliance, package integrity, turnaround time, and customer satisfaction.
Sterilization load records must include cycle parameters (temperature, pressure, time), biological and chemical indicator results, operator ID, and load contents.
Biological indicator incubation: rapid-read BI results in 1–3 hours; conventional BI requires 24–48 hours; positive BI requires recall of all items from that load.
Recall procedure: identify load, notify users, retrieve items if possible, and document corrective actions.
Documentation must be legible, dated, timed, and signed; corrections use single line, initial, and date; no erasures or white-out.
Audits: conduct regular audits of cleaning efficacy, packaging, sterilization, and storage; use checklists and trend data.
Competency assessment: initial and annual competency for reprocessing staff, including observation and written testing.
Root cause analysis for adverse events and sentinel events; use plan-do-study-act (PDSA) for quality improvement.
Traceability: each instrument set should be traceable to the patient; use unique identifiers and load records.
Professional Practice and Communication
Scope of practice: reprocessing technicians must work within their training and certification; know when to escalate to supervisor or infection preventionist.
Hand-off communication: use SBAR (Situation, Background, Assessment, Recommendation) for clear, structured reports.
Conflict resolution: address issues directly, use 'I' statements, and involve manager when needed; document incidents.
Patient safety culture: encourage reporting of errors and near misses without blame; use just culture principles.
Ethical practice: maintain confidentiality (HIPAA), respect patient rights, and avoid conflicts of interest.
Teamwork: collaborate with OR, infection prevention, and materials management to ensure timely and safe reprocessing.
Professional development: pursue certification (e.g., CRCST, CIS, CHL) and continuing education to maintain competence.
Communication with vendors: request IFUs, validation data, and training; document all communications.
Advocacy: speak up for patient safety and adequate resources; participate in committees and quality improvement initiatives.