The Principles of Medical Device Decontamination

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by the OR practitioners, and it is vital that they are appropriately trained in the interpretation of the CIs and have appropriate reference material available.

Special Test CIs of type 2 are used in specific performance tests described in standards and guidance documents to ensure that the sterilizer is performing according to specification. An example of such a CI would be the Bowie and Dick Test (BDTs) which employs a CI placed within a stack of textile material. When used within the sterilizer, the test is designed to assess the capability of the process to remove air and enable steam penetration. The test is described in many standards and guidance documents and involves placement of a CI A4 sheet in the centre of a stack of towels. There are many alternative, commercially produced test packs available which have equivalent performance but are more consistent and convenient to use. Electronic versions of BDT packs are also available. The manufacturers of sterilizers have also started introducing technologies into their equipment claiming to be ‘built- in’ BDTs, thus removing the need for a separate test product. Users should exercise caution when using such technologies and make sure that the devices fitted are indeed offering an independent measure of air removal and steam penetration rather than an air detector type technology.

Process Challenge Devices (PCDs)

PCDs are devices which challenge a particular aspect of the sterilization process. Examples would include the BDT which is a specific form of PCD designed to assess air removal and steam penetration in an empty chamber. Other PCD’s may be designed to monitor a particular aspect of a production process and would be included in with the load. The Air Detector is a specific form of PCD which not only monitors the amount of residual air present in a sterilization process but also would abort the process if excess was detected thereby providing a control function as well.

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