The Principles of Medical Device Decontamination

This is an internationally agreed standard that sets out the requirement for a quality management system specific to the medical devices industry pertinent to healthcare facilities. Centralised processing routinely covers surgical instruments and flexible endoscopes and accessories, however some organisations have been able to incorporate decontamination of ultrasound probes and TOE probes, the latter posing a challenge protecting the electronic components during automated processing. Many intracavity devices, i.e. those inserted via natural orifices of the body, are decontaminated at clinical ward dept level often at the bed side using a manual process involving decontamination with wipes. The disadvantages of this approach is in reproducing a consistent decontamination process, due to the likelihood of human error, allowing variations in the application of best practice 3 . There are a variety of wipes available for device processing with very different instructions for use. The contact time of the chemicals used on these wipes is critical for effective decontamination 4 . Training in the use of these wipes is essential and can be provided by the manufacturers of the wipes to ensure decontamination is achieved. The environment in which decontamination takes place in wards and departments will often not be dedicated for the purpose as opposed to an SSD or Endoscopy unit where decontamination is the only activity taking place. Infection Prevention and Control practices are often compromised, due to the environment, and there is also a greater risk of decontaminated devices becoming contaminated before further use due to inadequate protection and storage. Standard operating procedures describing the step-by-step actions are needed for the various devices, and routinely exist, however audits often show that there is significant variation in the application of the steps described. This is one of the reasons central processing involving automated processing is the preferred method of decontamination. Other advantages include the use of validated ‘processes’ washer disinfectors, chemicals, sterilisers etc. Many decontamination failures have been found to relate to manual medical device decontamination. For example, there have been serious failures in decontamination of Transoesophageal Echo (TOE) and Laryngoscope handles 5 which have caused patient harm. The MHRA alerts describing these failures highlighted manual processing which concentrated on the ‘working element’ that came into direct patient contact and not the whole of the medical device which poses an equal infection risk to the patient if not processed appropriately.

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