The Principles of Medical Device Decontamination

Some medical device manufacturers’ instructions state that pre cleaning needs to be carried out immediately after use in theatres, prior to sending to the SSD. An example of this are handpieces for phacoemulsification used in eye surgery. 6,7

The USER

Health Technical Memorandum (HTM) 01-01 series Part A 8 defines the roles and responsibilities of key personnel involved in the management of medical devices within an organisation. The term USER has many definitions including the practitioner using a medical device, but also in terms of the HTM, cover the individual who is responsible for the day-to-day management of the decontamination of reusable surgical instruments, and for seeing that the decontamination process is operated safely and efficiently. In the case of the SSD this would be the manager, however at ward and department level could be the senior ward manager. The USER is also responsible for the operators of any decontamination equipment and for the equipment being fit for purpose. Large organisations often struggle to ensure that everyone involved in decontamination understand their roles and responsibilities. A report by the Health Services Safety Investigation Body (HSSIB) 9 in 2022 highlighted the need for improvement to governance arrangements in large healthcare organisations.

Medical device labelling and symbols

The international standard for medical device labelling which employs symbols is ISO 15223-1 and aims to provide a visual and a universal means by which device information can be imparted to users. There is always a risk of misinterpretation when any language translation is undertaken. Hence the use of symbols. A few of the most commonly used symbols are reproduced below, together with their meaning:-

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