Sterilisation & Monitoring

Importance of Sterilisation to Control Surgical Site Infections

  • Prevention of surgical site infection (SSI) is a major component of patient safety and a very high priority. Patients undergoing surgical procedures are at risk of infection and the job of every health care provider is to assist in preventing an infection. A surgical site infection can be minor or it can lead to death. When it occurs the impact is felt by the patient and the patient’s family and or support system. The impact on the healthcare facilities is not only financial but can also adversely impact its reputation of the facility where the surgery was performed. CSSDs play an important role in preventing SSIs.

  • Sterilisation Assurance

    Sterility is defined as being free from all living organisms. Since it is not practical to test every device for the absence of microorganisms, sterilisation procedures should be monitored through a combination of mechanical, chemical, and biological techniques designed to evaluate the sterilising conditions and the procedure's effectiveness. Each of these monitoring tools provides different information or clues about the effectiveness of the sterilisation process. Not all of the tools may detect a failure at the same time, but do not ignore any clue that suggests a problem with the process because the purpose of these tools is to detect failures.


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Critical Variables to be monitored for Steam, EO & VH2O2


Sterilisation Monitoring Tools

    • Physical monitors: Physical (mechanical) monitoring involves observing gauges and computer printouts to verify that sterilisation parameters (cycle time, temperature and pressure) are met.
    • Chemical indicators: Chemical indicators respond to physical and chemical conditions in a chamber. There are six types of chemical indicators defined by AAMI. The classification structure used is solely to denote the characteristics and intended use of each type of indicator when used as defined by the manufacturer. This classification has no hierarchical significance.

      Learn more about the types of Chemical Indicators and their applications
    • Biological indicators: A biological indicator (BI) is a test system containing viable microorganisms providing a defined resistance to a specified sterilisation process. Biological indicators are the only sterilisation process monitoring device that provides a direct measure of the lethality of the process. Given that the number of resistant spores contained in a BI is far greater than the routinely encountered microbial challenge on medical devices, a negative BI result indicates that the process delivered sufficient lethality. This ensures a built-in margin of safety inherent to the BI. No other margin of safety is needed when monitoring hospital steam sterilisers.

Monitoring Critical Variables in the Sterilisation process


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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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Dealing with Sterilisation Failures

Steam sterilisation process failures are the result of a series of unfortunate events. The causes for these failures may be complex and in some cases difficult to determine. Steam sterilisation process failures are identified by observing the available monitoring tools including the physical monitors, chemical indicators and biological indicators. When these tools indicate a steam sterilisation failure, the next steps are to determine the cause for the failure by asking the right questions, correcting the failure, and retesting the steriliser (steriliser efficacy testing).


Policies & Procedures - Sterilsation in a Healthcare Facility

Policies and procedures provide the cornerstone for effective sterilisation of medical devices.


Special Considerations

  • Sterilisation of Surgical Implants

    Implants: The FDA defines an implantable as any device that will be intentionally left in the body at the conclusion of a surgical or diagnostic procedure. Implantable medical devices represent a higher degree of risk of infection for the patient as:

    • Microorganisms on implants will remain in the body as they are left behind at surgery. The infections associated with implants may not be noticeable for up to a year after surgery.
    • The placement of an implant often causes the removal of tissue, with interruption of blood supply and significant manipulation of the tissues immediately adjacent to the implant, creating an area of potential safety for microorganisms to multiply, further increasing the risk of infection.
    • Because there is interrupted blood supply, the antibiotics cannot easily get to the microorganisms if they do multiply enough to cause an infection.
  • Loaner Instruments: Loaner instrumentation is on the rise and is becoming common practice in most hospitals. Healthcare facilities frequently need to borrow surgical instruments or implants for specialty operative procedures for a variety of reasons like changing surgical technology, infrequent procedures and limited budgets. It is the facility’s ethical responsibility to ensure the loaner instrumentation and implant items are safe to use on their patients and that the process is properly documented and fully traceable to the patient.

    Learn more about guidelines for creating a policy on loaner instrumentation and implants

  • As new technologies are introduced in healthcare for providing the highest level of quality outcomes for patient care, sometimes they are in the form of medical devices that are complex and difficult to clean and sterilize or disinfect. Flexible endoscopes are among this category. Based on recent investigations of patient outbreaks related to flexible endoscopes, it is time to look into moving from high-level disinfection to sterilisation. It is also important to evaluate the right methods for a cleaning verification test after cleaning and before disinfection or sterilisation.

    Learn about recommendations for disinfection, sterilisation of flexible endoscopes
    Learn about updated evidence-based guidelines for processing flexible endoscopes


Sterilisation Failure - Issues with Wet Packs

Wet Packs: Visible moisture found inside or outside of a package after sterilisation and the proper cooling period is considered a wet pack. Wet packs discovered in the processing area should not be released and wet packs found in the user area, such as the OR should not be used. These packs should be reprocessed and an investigation should be conducted. Wet packs are a concern because the moisture on or within a package can create a pathway for microorganisms to migrate from the outside to the inside of a package.

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