Sterile Processing University Seventh Edition Study Guide

THE ROLES AND RESPONSIBILITIES OF STERILE PROCESSING

• Introduction to SPD Functions: To be effective, technicians must be competent in performing multidimensional tasks. These include:

  • Decontamination, packaging, and sterilization of surgical instrumentation.

  • Processing and reprocessing of reusable medical devices.

  • Cleaning, testing, assembly, and distribution of movable patient care equipment.

  • Adhering to facility purchasing procedures.

  • Storage, handling, and distribution of sterile surgical instrumentation, including inventory control and cost recovery systems.

  • The nature of this work prioritizes patient and personnel safety above all else, and practices are highly regulated.

• Definition of the Sterile Processing Department (SPD): The SPD is the area/department that receives, cleans, decontaminates, assembles, disinfects, and/or sterilizes reusable medical and surgical devices for safe and effective care. It is often referred to as the "heart of the hospital" because a facility cannot function for more than a few hours without it.

FUNCTIONAL AREAS AND WORKFLOW OF THE SPD

• Specific Areas within the SPD:

  • Decontamination Area: Where soiled items are received and cleaned. It features various transport systems for used items.

  • Preparation and Packaging Area: Where cleaned items are inspected, assembled, and packaged; sometimes called the "clean work room."

  • High-Level Disinfection (HLD) Room: Where cleaned items undergo HLD before transfer to prep and pack or storage.

  • Sterilization Area: Where terminal sterilization occurs. It may include a separate room for Ethylene Oxide ($EO$) sterilization.

  • Sterile Storage Area: Stores sterile items from outside vendors or those processed on-site.

  • Sterile Stores: A dedicated area for patient care items from outside manufacturers.

  • Case Cart Area: Where sterile supplies and trays are kept and picked for specific surgical cases.

  • Dispatch: Where clean and sterile items are dispensed.

  • Loaned Area: For the receipt and return of loaned instruments.

  • Patient Care Equipment Clean-Up Area: Dedicated to cleaning and disinfecting patient care equipment.

• Workflow Principles:

  • Standard Workflow: Work must always progress from DIRTY to CLEAN. The sequence is: Decontamination → Clean Prep/Packaging → Sterilization → Sterile Storage → Distribution.

  • People Flow: Movement is CLEAN to DIRTY. When leaving Decontamination, Personal Protective Equipment ($PPE$) must be removed and hands washed. When entering Decontamination, $PPE$ must be donned. Visitors should start in clean areas and finish in decontamination.

  • Traffic Control: Access is restricted to staff and authorized personnel. Technicians must ensure visitors abide by dress codes, including head and shoe covers.

• Disaster Preparedness: The Joint Commission ($JC$) requires facilities to prepare for internal (e.g., sewer back-up) and external (e.g., mass casualty accidents) disasters. Technicians must know their roles, maintain inventory readiness, and participate in routine plan reviews.

PROFESSIONAL STANDARDS, ETHICS, AND ORGANIZATIONAL STRUCTURE

• Training and Certification:

  • Most training is on-the-job, supplemented by online programs and hands-on experience.

  • CBSPD (The Certification Board for Sterile Processing & Distribution, Inc.): Offers certifications for Technicians, Management, Flexible Endoscope specialists, and Ambulatory Surgery Technicians.

  • IAHCSMM (International Association of Healthcare Central Service Material Management): Offers Technician, Surgical Instrument Specialist, and Healthcare Leadership certifications.

• Organizational Structures: Detailed by "Organizational Charts." The departmental chart shows reporting lines within the unit; the facility chart shows accountability to administration (e.g., Chief Operating Officer or V.P. of Nursing).

• Foundational Ethics Definitions:

  • Ethics: The discipline dealing with good and bad, moral duty, and obligation.

  • Ethical Actions: Actions conforming to accepted professional standards of conduct.

  • Morals: Principles of right and wrong behavior.

  • Unethical Conduct: Failure to conform to moral standards or policies.

  • Professional Ethics: Principles governing an individual or group.

• SPD Code of Ethics (Suggested):

  • Act in the best interest of the profession, applying professional judgment.

  • Compliance with regulations regarding safety and processing.

  • Excellence: Reprocess every device as if it would be used on a family member.

  • Ownership: Own up to mistakes immediately to allow corrective action.

  • Confidentiality: Strictly follow the Health Insurance Portability & Accountability Act ($HIPAA$) guidelines.

• Ethical Challenges in SPD:

  • Work Ethic: Navigating misunderstandings in a diverse cultural workplace.

  • Patient Confidentiality: Protecting information found in OR schedules and electronic records.

  • Hospital Property: Reporting theft or damage of facility assets.

  • Employee Safety: Reporting non-compliance with $PPE$ or decontamination protocols.

REGULATORY AGENCIES, STANDARDS, AND GUIDELINES

• Definitions of Oversight:

  • Regulation: A principle, rule, or law designed to control behavior; compliance is mandatory (e.g., $OSHA$, $EPA$, $FDA$).

  • Standard: An established norm determined by authority or research; not always law but represent good practice (e.g., $AAMI$).

  • Recommended Practices: Guidelines based on scientific data/expert opinion; not legally required but reflect accepted practices (e.g., $AORN$).

• Key Agencies:

  • EPA (Environmental Protection Agency): Regulates environmental disinfectants, controls air/water emissions (Clean Air/Water Acts), and regulates the sale and emissions of $EO$ gas.

  • FDA (Food and Drug Administration): Regulates medical devices from simple (tongue depressors) to complex (pacemakers). It requires Medical Device Reporting ($MDR$) for user-related deaths or injuries.

  • OSHA (Occupational Safety & Health Administration): Regulates exposure to airborne contaminants ($TB$), bloodborne pathogens, and workplace hazard communication ("Right to Know").

  • CDC (Centers for Disease Control): Not regulatory, but publishes critical guidelines on hand hygiene, isolation, and sterilization ($2008$, updated $2017$).

• FDA Instructions for Use (IFUs):

  • Manufacturers must provide specific instructions for cleaning/sterilizing products.

  • SPD must maintain current IFUs in binders (one for Decontamination, one for Prep/Pack).

  • IFUs should be obtained before a device is purchased to ensure compatibility with facility equipment.

  • Manufacturers should be contacted for updates at least every $2$ years; orthopedic/loaner sets should be checked annually.

• Validation vs. Verification:

  • Validation: Performed by MANUFACTURERS to prove a process yields a product meeting specifications.

  • User Verification: Documented procedures performed by FACILITY PERSONNEL to establish that specifications are met in the user environment.

OCCUPATIONAL SAFETY AND HAZARD COMMUNICATION

• Safety Data Sheets (SDS):

  • Mandated by OSHA’s Hazard Communication Standard. They contain $16$ specific sections.

  • Sections $1–8$: General identification, hazards, and emergency measures.

  • Sections $9–11$ and $16$: Technical/scientific properties and stability data.

  • Sections $12–15$: Alignment with the UN Globally Harmonized System ($GHS$).

  • SDSs must be accessible without leaving the work area, with backups for power outages.

• Emergency Eyewash Stations:

  • ANSI Z358.1 Standards: Must provide at least $0.4$ gallons of water per minute for $15$ minutes.

  • Operation: Hands-free, stay-open feature, must flush both eyes simultaneously.

  • Temperature: Water must be tepid ($60^\circ\text{F}$ to $100^\circ\text{F}$ [$15.5^\circ\text{C}$ to $37.7^\circ\text{C}$]).

  • Location: Within $10$ seconds travel time (approx. $55$ feet) of chemicals. A door is an obstruction unless the chemical is non-corrosive and the door opens with the direction of travel.

  • Maintenance: Weekly testing (documented) including temperature checks.

• Fire Safety Regulations:

  • Fire Triangle: Fire requires an ignition source, fuel source, and oxygen source.

  • RACE: Rescue/Remove, Alarm, Contain, Extinguish.

  • PASS: Pull pin, Aim nozzle, Squeeze handle, Sweep base.

  • Extinguisher Classifications:

    • Class A: Ordinary combustibles (wood, paper).

    • Class B: Flammable liquids/gases.

    • Class C: Energized electrical equipment.

    • Class D: Combustible metals.

    • Class K: Commercial kitchen oils/fats.

  • NFPA Diamond: Blue (Health), Red (Flammability), Yellow (Instability), White (Special). Ratings range from $0$ (no hazard) to $4$ (severe hazard).

INSTRUMENTATION MANAGEMENT AND DRESS CODE

• Loaned Instrumentation:

  • One case can require $10–30$ trays, each with $25–100$ instruments.

  • Maximum weight per set: $25\,lbs$ (including container) per $AAMI$ recommendations.

  • All incoming loaned items are considered contaminated and must be reprocessed according to the IFU.

  • Inventory and count sheets are required upon receipt and after use before return.

• Dress Code and Hygiene:

  • Scrubs: Provided and laundered by the hospital; no home laundering. Change daily or if wet/soiled.

  • Head Coverings: Required to contain hair; should not be removed when leaving the area to avoid shedding microbes onto scrubs.

  • Shoes: Non-skid soles, sturdy/enclosed. No clog-style with openings allowed.

  • Nails: No artificial nails; natural nails must be piano-length ($\frac{1}{4}\,inch$ or less from tip).

  • Jewelry: Generally not recommended; can puncture gloves or harbor bacteria.

ANATOMY AND PHYSIOLOGY FOR SPD

• Levels of Organization: Cellular → Tissue → Organ → System.

• Cellular Needs: Water (metabolism/transport), Food (energy/nutrients), Oxygen (release energy), Heat (metabolic byproduct), Pressure (force for breathing).

• Cell Structure:

  • Cell Wall: Protects from injury.

  • Cell Membrane: Boundary that allows passage of nutrients/waste.

  • Nucleus: Cell’s "brain" containing $DNA$ and chromosomes.

  • Cytoplasm: Site of molecule processing and communication.

  • Cilia/Flagella: Appendages for movement.

• Skeletal System: $206$ bones. Includes Axial (Skull, Hyoid, Vertebral column, Thoracic cage) and Appendicular (Pectoral girdle, Upper/Lower limbs) skeletons.

• Muscular System: Three types: Skeletal (voluntary, striated), Smooth (involuntary, organs), and Cardiac (involuntary, heart).

• Circulatory System:

  • Heart Chambers: Atria (upper) receive blood; Ventricles (lower) pump blood out.

  • Valves: Tricuspid, Mitral (Bicuspid), Pulmonic, Aortic.

  • Blood Flow: Right Atrium → Right Ventricle → Lungs → Left Atrium → Left Ventricle → Aorta.

• Respiratory System: Filters, warms, and humidifies air. Lungs have $5$ lobes ($3$ on the right, $2$ on the left).

• Digestive System: $30$ feet of tubing. Includes stomach (protein digestion, chyme production) and Small Intestine (nutrient absorption).

• Nervous System: Central Nerve System ($CNS$ - Brain/Spinal Cord) and Peripheral Nerve System ($PNS$ - Nerves). Protected by meninges.

• Endocrine System: Ductless glands secreting hormones (e.g., Pituitary, Pineal, Thyroid, Adrenals, Pancreas).

• Urinary System: Kidneys (elimination/balance), Ureters, Bladder, Urethra.

• Reproductive System: Male (Testes, Prostate) and Female (Vagina, Uterus, Fallopian tubes).

FUNDAMENTAL MICROBIOLOGY

• Classification of Bacteria:

  • Shapes: Cocci (spherical), Bacilli (rod), Spiral.

  • Gram Stain: Gram-positive (purple/blue), Gram-negative (red/pink).

  • Measurement: Bacteria are measured in microns ($1\,\mu m = \frac{1}{25,000}\,inch$).

  • Environment: Require warmth, food, water, alkaline $pH$, and darkness.

• Bacterial Spores: Highly durable, dehydrated cells with thick shells. Examples include Geobacillus stearothermophilus (sterilization testing) and Clostridium difficile ($C.\,diff$).

• Prions: Abnormal proteins causing Transmissible Spongiform Encephalopathies ($TSEs$), such as Creutzfeldt-Jakob Disease ($CJD$). They are highly resistant and target brain/nerve tissue.

• Multi-Drug Resistant Organisms (MDROs):

  • MRSA: Methicillin-resistant Staphylococcus aureus.

  • VRE: Vancomycin-resistant Enterococci.

  • CRE: Carbapenem-resistant Enterobacteriaceae; often linked to GI endoscopes.

INFECTION PREVENTION AND CONTROL

• Healthcare-Acquired Infections (HAIs): In $2011$, approx. $722,000$ HAIs occurred in U.S. acute care hospitals, leading to $75,000$ deaths. About $1$ in $25$ hospital patients has an HAI on any given day.

• Chain of Infection:

  1. Pathogenic microorganism (Source).

  2. Reservoir (Habitat: human, animal, or environment).

  3. Portal of Exit (How it leaves the body: respiratory, GI, etc.).

  4. Mode of Transmission (Contact, Airborne, Vehicle, Vector).

  5. Portal of Entry (Mucous membranes, skin, parenteral).

  6. Susceptible Host (Immune status).

• Hand Hygiene: Single most effective way to prevent infection. Minimum scrub time: $20\,seconds$.

• Bloodborne Pathogens: Significant risks include Hepatitis B ($HBV$), Hepatitis C ($HCV$), and HIV. $HBV$ vaccines must be offered to employees at no cost.

• Standard Precautions: Treat all blood and body fluids as if they are infectious.

• Transmission-Based Precautions:

  • Contact: For direct/indirect transmission.

  • Droplet: For respiratory secretions (close contact).

  • Airborne: For agents that remain infectious over long distances (e.g., $TB$, Measles, Ebola).

• Medical Waste Management:

  • Regulated Waste: Biohazard bags (red/orange, leak-proof). Punctured bags require second-bagging.

  • Inactivation: Bulk blood must be inactivated or poured down utility drains/toilets.

  • Non-regulated Waste: General trash (paper towels, certain wraps).