• Cleaning and disinfecting is critical to the sterilisation process. Soil cannot be sterilised, so the presence of soil or organic material on instruments reduces the effectiveness of disinfection or sterilisation. Failure to thoroughly clean and disinfect items for sterilisation, however, can jeopardise the entire process.

Need for Proper Cleaning of Medical Devices Before Sterilisation

  • Cleaning is critical because residual organic material (e.g. blood, bone, proteinaceous material) can in-activate disinfectants. If a device is not cleaned thoroughly, sterility may not be achieved. Surface cleaning is a crucial aspect of any central sterile service department's cleaning process. Effective cleaning of any surgical instrument is important regardless of the complexity of the instrument. There is no thing as "sterile dirt".

    Improper cleaning leads to surgical site infection, tissue damage, and other complications impacting patient safety on one hand and also leads to corrosion of instruments leading to reducing their life, thus increasing replacement costs.


  • To achieve greatest cleaning efficacy, 3M considers using Multi-Enzyme Cleaners and Neutral pH Solutions to be a best practice.

    Multi-enzyme cleaners are recommended because enzymes have single specific function. e.g. Lipase works at breaking down only lipids. Any instrument used on a patient, will have a combination of human secretion left on the instrument - a mixture of blood, tissue, fats, and mucus. Thus, it is important to have a multi-enzyme cleaner that is effective against proteins, carbohydrates, lipids and mucopolysaccharides.

    Neutral pH detergent solutions are recommended as they are non- corrosive and compatible with metals and other materials used in medical instruments.

    • AS/NZS 4187:2003 standards recognize the need to digest all the human secretions and specify the use of an enzymatic cleaning solution effective against various types of organic soils when processing flexible and rigid endoscopes.
    • APIC Guidelines recognize the need for enzymatic detergents solutions and neutral pH solutions.

Need for Multi-Enzyme Cleaner

  • Enzymes help break down or digest large organic molecules like proteins, fats and start into smaller ones. In all aspects of infection control, it is essential that no micro-organisms are afforded the protection of built-up matter. This can occur with both cold sterilising and autoclaving when insufficient attention is paid to instrument pre-cleaning.

    By adopting the multi-enzyme approach there is complete assurance that all instruments are optimally pre-cleaned.

Need for Cleaning Verification

  • Is Validation of cleaning process recommended?

    Yes, CDC, FDA and AAMI and other regulatory bodies recommend verification of cleaning process. Studies have demonstrated that dirty/improperly cleaned instruments cannot be effectively disinfected.

    According to ASTM D7225, "The cleaning efficiency is based on the removal of standardised test soil as a result of mechanical action of ultrasonicator/washer disinfector or detergents, or both.

    How to validate the cleaning process?

    Visual Inspection: CDC 2008 / AAMI TIRI2 2010
    Direct Test (Performance Qualification): AAMI TIRI2 / ISO 15883
    Surrogate Device (Operational Qualification): FDA / ISO 15883

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3M Sterilisation - Assurance at Every Step

3M is a trusted leader for sterilisation assurance for load, pack, exposure and equipment monitoring for steam, hydrogen peroxide and ethylene oxide sterilisation. Our commitment to education, service and product innovation ensures patients receive a high standard of care.

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