Decontamination
kill microorganisms. Different disinfection levels can be achieved, including low, intermediate, and high-level. Similarly, different sterilisation methods can be used to achieve the desired level of lethality known as “Sterility assurance level” or “SAL”. The extent of the process depends on the classification of the medical device. For reusable instruments, this classification is
governed by the Spaulding classification scheme which categorises medical devices based on the degree of risk for infection involved during use. i) Critical devices contact sterile tissue, ii) semi- critical devices contact mucous membranes or nonintact skin, and iii) non-critical devices contact intact skin. If contaminated with microorganisms during use, critical devices evoke a high risk of infection, semi-critical devices evoke an intermediate risk of infection, and non-critical devices evoke a low risk of infection (see Figure 2, below). All steps in the reprocessing IFU shall be GLP
validated to ensure the effectiveness of the process. Validation of the reprocessing steps is not standardised and is instead governed by a combination of different international standards and guidelines, as well as variable local practices. Often, ensuring the effectiveness of a reprocessing process requires compliance with different criteria depending on several factors including, but not limited to, the geographical location, local requirements, user or regulator experience, availability of cleaning chemistries and equipment. An example of this difference is demonstrated with the acceptance criteria for the cleaning analyte, for protein residuals. In the US, AAMI ST98 accepts residual protein levels of <6.4 μg/cm2
after cleaning. However, in some European countries the criteria are
Figure 3. Example of medical device design which incorporates reprocessing features (robotic surgical instrument).
Figure 4. Example of the reprocessing flow process of a surgical robotic instrument established at 3 μg/cm2 .13,14 Although no global
harmonisation of reprocessing validation practices has been established, certain aspects are commonly accepted. Validation of the IFU is performed at worst-case conditions to ensure that worst practice of the IFU provides a safe reusable medical device. Reprocessing IFU should account for human factors and safety margins, by extending contact times, and
including additional steps in the process. These considerations serve to mitigate the risk of improper decontamination.
SSI and reprocessing Although crucial, the validation of the reprocessing IFU alone is not sufficient for the prevention of SSIs. To ensure that the probability of residual contamination on a reprocessed device is minimised, the reprocessing procedures for medical devices supplied by the manufacturer must be followed. Users play a critical role in the prevention. It is
the responsibility of the manufacturer to provide clear validated IFU and it is the responsibility of the user to follow the validated reprocessing instructions to ensure proper decontamination. Therefore, reducing the risk of infection due to improperly reprocessed medical devices is a shared responsibility among various stakeholders. Advancements in surgical techniques have
Figure 2. Example of a non-critical device (A. Robotic system bedside unit) and critical device (B. robotic surgical instrument and endoscope).
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www.clinicalservicesjournal.com I May 2024
helped to reduce the risk of infection. Moving from open surgery to laparoscopic surgery and, in more recent years, robotic surgery. However, the evolution of surgical techniques has led, at the same time, to the development of more complex reusable medical devices designs that are more difficult to reprocess. The more complex the medical device,
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