The Principles of Medical Device Decontamination

Sterilizers Formaldehyde sterilizers are supplied as free standing units or fully installed complete with centrally supplied services (steam, compressed air, power etc).

Chamber sizes vary from 150L to 500L. Generally they do not need to be located in specially ventilated rooms but precautions must be taken to avoid exposure of operators to formaldehyde vapour. The formalin liquid must also be handled using appropriate personal protective equipment.

Choice of sterilization process

The vast majority of medical devices decontaminated in a sterile service department will be manufactured from heat tolerant surgical stainless steel and can therefore be sterilized using a high temperature saturated steam sterilization process (see Figure 1 and Table 10.2). Most SSDs will have a bank of porous load saturated steam sterilizers ranging in size from 500 to 1000 litre chamber capacity. It is unlikely that a hospital SSD will become involved in sterilising large quantities of thermally sensitive single use medical devices, this is being carried out by industry. However, it is possible that an SSD may be required to sterilize a re- usable heat sensitive medical device, such as a specialist endoscope, in which case the hospital must make some key decisions about how. The first consideration is what sterilization processes are recommended in the medical device manufacturers instructions. These must be rigorously followed. The second consideration is, will the item or load need to be sterilized frequently. If not, then the use of an external commercial contract sterilization company may be an economically appropriate choice. Alternatively, another SSD which already has the required sterilization technology can be approached. If it is decided to purchase an LTS system then one of the three technologies mentioned above are worthy of consideration since these are the most common in use today. Others are clearly available (see Figure 1) and there is considerable choice, however the suppliers ability to support the installation must be thoroughly investigated.

Of the three choices described above (VH 2 O 2 , EO and LTSF) consideration must be given to the sterilizer characteristics such as maximum loading capacity in terms of

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