CAii/CMII study materials
CAii/CMII study resources

CAii/CMII cheat sheet

CAii/CMII · Keep the key ideas within reach.

Quick reference

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.

Quick reference

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.

Quick reference

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.

Quick reference

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.

Quick reference

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.

Quick reference

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.

Quick reference

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.