Spaulding Classification Systems for Medical Devices
The Spaulding Classification categorizes medical devices based on the risk of infection they pose during use, dictating the level of reprocessing required.
Critical Classification
Devices in this category must be sterile as they are intended to enter sterile body tissue or the vascular system. Failure to sterilize these items poses a high risk of infection.
- Examples: Surgical instruments, laparoscopes, arthroscopes, cutting endoscope accessories for biopsy, cardiac catheters, IV catheters, needles, and urinary catheters.
Semi-Critical Classification
These items should be sterile, but at a minimum, they require High-Level Disinfection (HLD). They come into contact with broken skin or mucous membranes. If a manufacturer specifies that an item cannot tolerate sterilization, HLD is an acceptable alternative, though it’s important to note that bacterial spores can survive HLD.
- Examples: Bronchoscopes, gastrointestinal (GI) scopes/endoscopes, respiratory therapy equipment (e.g., laryngoscope blades), and anesthesia equipment.
Non-Critical Classification
These devices only come into contact with intact skin. They require intermediate or low-level disinfection or simple cleaning. Disinfection should be performed using an FDA-approved disinfectant effective against Hepatitis B.
- Examples: Furniture, laundry/linens, operating room (OR) beds, blood pressure cuffs, leads, monitors, stethoscopes, and tourniquets.
Sterile Processing and Decontamination Workflow
Proper sterile processing is crucial to preventing healthcare-associated infections.
Decontamination Area Requirements
A physical barrier or wall must separate the decontamination area from other processing zones, including immediate-use areas. This is because decontamination areas require negative air pressure to prevent airborne contaminants from spreading to clean areas.
Sterile Processing Workflow
The standardized workflow for sterile processing is: Decontamination (always first) → Prep & Pack → Sterilization → Distribute/Store
Most Important Step to Prevent Infection
The most critical step in preventing infection is thorough cleaning and pre-treating with a non-drying enzymatic solution. This prevents the formation of biofilm, which can encapsulate and protect spores from sterilization.
Decontamination Processes
Key practices during decontamination include:
- Complete disassembly of all instruments.
- Brushing lumens and channels under water using brushes that match the manufacturer’s specified diameter and length. This also applies to crevices and joints.
- Automated cleaning methods (e.g., washers, ultrasonic cleaners) are generally more effective than manual cleaning.
Steam Sterilization
Steam sterilization is a common and effective method for reprocessing heat- and moisture-stable medical devices.
Two Types of Steam Sterilization
- Pre-Vacuum Autoclave (Dynamic Air Removal):
- How it works: A vacuum system actively removes air from the chamber before steam is introduced, ensuring thorough steam penetration. Clean drains are essential for proper function.
- Settings:
- Non-porous instruments (regular instruments): 270-276°F for 3 minutes.
- Porous or lumen instruments (e.g., heavy plastic, rubber, wooden handles, Poole suction): 270-276°F for 4 minutes.
- Characteristics: This is the most common and effective method.
- Gravity Displacement Autoclave:
- How it works: Steam enters the chamber and pushes air downwards and out through a drain at the bottom. The drain closes once air is expelled, and the cycle begins.
- Settings:
- Non-porous instruments (regular instruments): 270-276°F for 3 minutes.
- Porous or lumen instruments: 270-276°F for 10 minutes.
- Characteristics: Less commonly used; not ideal for trays or packaged items.
Manufacturer’s Instructions
For specific containers or systems (e.g., One Tray system, containers with lids), always adhere to the manufacturer’s instructions regarding time and temperature, as these may differ from general instrument guidelines.
Avoiding Condensation in Steam Sterilization
To prevent condensation on sterilized items:
- Ensure adequate airflow between trays and packages, allowing air to circulate completely around all items.
- Remove loads immediately after the cycle; do not crack the door to cool items gradually.
- Avoid placing items directly on cooling racks or solid surfaces; use lined surfaces if necessary.
Chemical Integrators for Sterilization Monitoring
Chemical integrators are crucial for verifying that sterilization parameters have been met.
Classes of Chemical Integrators
- Class 1 Chemical Indicator (External Indicator):
- Reacts to heat only, verifying exposure to the sterilization process.
- Examples: Sterilization tape, locks, or filter dots.
- Class 2 Chemical Indicator (Bowie-Dick Test):
- Reacts to pressure and specifically indicates if a proper vacuum was achieved.
- Used only with Pre-Vac/Dynamic Air Removal cycles.
- Class 3 Chemical Indicator (Single Parameter):
- Measures a single sterilization parameter (e.g., steam quality).
- Often made by the manufacturer for specific purposes.
- Class 4 Chemical Indicator (Multi-Parameter):
- Measures multiple sterilization parameters (e.g., time and temperature).
- Also typically manufactured for specific applications.
- Class 5 Chemical Integrator (Most Common, All-Inclusive):
- The most common and comprehensive indicator.
- Covers all critical parameters (time, temperature, pressure, steam quality).
- It is an internal indicator placed on each layer and in the most challenging area of the load.
- Used for implants.
- Class 6 Emulating Integrator:
- An internal, all-inclusive indicator designed for a specific sterilization cycle or tray.
- Made by the manufacturer for precise cycle or tray monitoring.
What “Integrator” Means
The term “integrator” signifies that all critical parameters for sterilization have been met (e.g., Class 5 and Class 6). However, no indicator or integrator guarantees sterility; they only confirm the proper functioning of the sterilization process.
Immediate Use Sterilization (IUS)
IUS is a specialized sterilization method for urgent situations, but it has specific requirements and limitations.
Immediate Use Settings
- Sterilization Cycle: Typically 270°F for 10 minutes, accompanied by a Biological Indicator (BI) and a Class 5 integrator.
- Container: Requires a rigid sterilization container with a lid.
- Decontamination: The same decontamination process must be followed as for other instruments.
- Dry Time: IUS has a shorter dry time, meaning items can be wet, which is acceptable.
- Forbidden Materials: Never use linens, wraps, or packages in immediate-use sterilization.
Daily Requirements for All Steam Sterilizers
- Daily Quality Control (QC) with Biologicals: All steam sterilizers (Pre-Vac/Dynamic, Gravity, IUS) require daily testing with biological indicators to check for spore kill.
- Sterilization Log: A detailed sterilization log must be maintained for all cycles.
Action for a Failed Steam Sterilizer QC Biological
If a steam sterilizer QC BI fails:
- Resterilize all instruments from the failed load.
- Perform three consecutive biological indicator tests. If one or more fails, shut down the sterilizer, contact bioengineering, and run three more BIs once it’s fixed.
- If a BI fails and instruments from the affected period have already been used, contact the surgeon to consider prophylactic antibiotics for the patient.
Flashing Implants
- For the exam: Always select the option to send implants to sterile processing to be returned only when the biological indicator results are ready.
- If an implant is used before the BI results are available, file an occurrence report.
- Never flash an implant unless it is an absolute emergency.
Chemical and Low-Temperature Sterilization/Disinfection
Alternative methods are available for heat- and moisture-sensitive instruments.
Gluteraldehyde (CIDEX) – High-Level Disinfection
- Type: Cold sterilization/High-Level Disinfection (HLD).
- Use: Point-of-care use only.
- Immersion Time: Immersed for 10 hours for sterilization, shorter for disinfection.
- Negatives:
- Can be harsh on instruments, causing pitting.
- Harmful to the environment, requiring 7-15 air exchanges per hour and extensive water flushing down the drain.
- Not user-friendly.
- Important: Always clean the item first, and ensure the container has a tight lid.
Ethylene Oxide (EtO)
- Type: Cold, dry cycle.
- Parameters:
- Cook Time: 2-5 hours.
- Aeration Time: 8-12 hours (due to its carcinogenic nature).
- Temperature: 99-145°F.
- Humidity: 45-75%.
- Perks: Can sterilize almost anything, especially heat- and moisture-sensitive items like lumens, cords, lensed instruments, and flexible endoscopes.
- Negatives:
- Flammable and carcinogenic (maximum exposure of 1 PPM in 8 hours on a dosimeter).
- Personnel must wear an EtO monitor badge and leave the area if the dose exceeds 1 PPM in 8 hours.
Low-Temperature Hydrogen Peroxide Plasma Sterilization (Sterrad/V-Pro)
- Type: Dry and cold.
- Cycle Time: Approximately 75 minutes.
- How it works: Hydrogen peroxide mist combined with an electrical current creates plasma, which sterilizes instruments.
- Characteristics:
- No aeration cycle (dry sterilization).
- Works for heat/moisture-sensitive items (alternative to EtO).
- Lumens require an accessory on the port site to ensure plasma penetration.
Peracetic Acid Processing (e.g., Steris System)
- Type: Low temperature, low pH (effective at killing spores).
- Parameters:
- Temperature: 120-130°F.
- Time: 20-30 minutes.
- Rinse: Uses 4-micron filtered tap water rinses.
- Characteristics:
- Converts to diluted vinegar, which can be safely disposed of down the drain.
- Items must be stored in an endoscope cabinet or used immediately (point-of-care use only).
- Requires sterilization log documentation.
- Common Use: Often used for Automated Endoscope Reprocessors (AERs), especially for GI immersible items.
- Precaution: Perform a leak test BEFORE cleaning, as peracetic acid is corrosive to both instruments and skin (can cause blisters).
Ozone Sterilization
- Type: Low-temperature sterilization.
- Use: FDA-cleared for use on plastic and metal instruments.
- Considerations: Always double-check lumen diameter and length compatibility.
- Characteristics:
- No aeration cycle.
- Considered environmentally friendly.
Dry Heat Sterilization
- Type: High heat, dry.
- Use: Primarily for powders, oils, and items like dental burrs, tattoo needles, and glass.
- Settings:
- Temperature: 360-400°F.
- Time: 50-60 minutes.
- Materials: Requires special packaging designed only for dry heat; no tape should be used.