Instrument Sterilization

For the sterilization of medical instruments

Prevention
Prevention
  • PREVENTION
  • DIAGNOSTIC
  • TREATMENT
  • OVERVIEW
  • TECHNOLOGY Characteristics
  • Instrument Sterilization
    Representative Product

    GLOBAL ANNUAL DEATHS ASSOCIATED WITH SEPSIS*

    PERCENT (%)
    NUMBER

    Maternal

    13%
    33,000

    Neonatal

    20%
    615,000

    Stillbirth

    1-2%
    30,000 - 65,000
    *Deaths associated from non sterile instruments are a subset of sepsis-related deaths.

    Condition
    Microorganisms on instruments and drapes that come into contact with body fluids pose a risk of infection to both mothers and neonates. These instruments must be sterilized before use. Neonatal tetanus is just one common example of a disease that is often transmitted on instruments, but others include HIV and hepatitis.

    Mechanism of Action
    Several sterilization techniques are used, including ethylene oxide gas, hydrogen peroxide gas plasma, peracetic acid immersion, and ozone, but, globally, steam sterilization remains the most common method for the resterilization of hospital instruments. 

     

    Steam sterilization is commonly performed inside a heated pressure vessel known as an autoclave. In most cases, 30 minutes at 121°C is sufficient, but high performance “flash” autoclaves can reach higher temperatures and pressures, reducing sterilization times. A variety of power sources are used on steam autoclaves to heat the water to boiling against the pressure provided by the sterilization vessel. The simplest are electrically powered, but others are heated by natural gas, propane or even a wood burning stove.


    Current Use in High-Resource Settings
    Disposable products are increasingly common and typically come in sterile packaging, obviating the need for the caregiver to sterilize prior to use. For re-usable instruments, freestanding autoclaves with integrated (electrical or gas) heat sources are the most common sterilization technique in high-resource settings. A survey performed in the UK found that 82% of physicians used autoclaves for sterilization, 91% of which had been serviced within a year. High volume, front loading units are most common.

    Application in Low-Resource Settings
    “Stovetop” autoclaves are common in the developing world, even in clinics without electricity or water service. Typical heat sources include small, dedicated gas stoves and/or wood fires commonly used for cooking. Some 'disposable' plastic parts such as those which interact with a patient in ventilators may be chemically sterilized in some hospitals.
     

    REPRESENTATIVE DEVICES

    MAKE
    MODEL
    PRICE*
    TECH
    STATUS
    NOTES

    Priorclave

    APS/Q63/EH320
    $25,000
    Electric, 320L
    Marketed
    Front loading, fully automated

    Ritter

    M9 UltraClave
    $4,700
    Electric, 13L
    Marketed
    Fully automated, digital readout

    Tuttnauer

    Valueklave 1730
    $2,000
    Electric, 7.5L
    Marketed
    1350W electric heater

    All American

    25X
    $600
    Electric, 24L
    Marketed
    1050W electric heater

    All American

    1915X
    $300
    Stove Top, 15L
    Marketed
    Popular device, made since 1930

    * Prices are approximated. Actual pricing can, and will vary by marketplace and market conditions.

  • CHARACTERISTICS OF REPRESENTATIVE PRODUCT

    TECHNOLOGY CHARACTERISTICS

    OPERATIONAL PARAMETERS

    POTENTIAL OPPORTUNITIES FOR IMPROVEMENT

    SKILLS

    REQUIRED

    Intended end user
    Training required
    Time required per use
    Physician, nurse, assistant
    Hours
    Approx 30-45 minutes

    This technology is mature and widely available, even in rural clinics. Training may be helpful in increasing frequency of use, safety, and effectiveness of use.

    ENVIRONMENT/ INFRASTRUCTURE

    Power required
    Waste collection
    Complementary technologies required
    Temperature and storage
    Maintenance
    Gas or wood stove most common, electric hotplate also possible
    N/A
    Stove, hotplate, or fireplace and fuel
    N/A
    Annual check recommended

    COST

    Device Cost (Approx)
    Cost/course (Approx)
    $200-$400
    ~$1

    For a steel stovetop unit.

    OTHER

    Portability
    Regulatory
    Efficacy
    Not easily portable at 20 lbs (9kg)
    Sterility assurance level (SAL) in excess of 10-6 for stainless steel instruments

    Additional devices required for impact: Instrument capable of remaining intact in autoclave conditions.

Sources: White, RR and J.M.P Smith. Infection control in general practice: results of a questionnaire survey. J Public Health.1995; 17: 146-149. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Centers for Disease Control and Prevention. 29 Dec 2009