The Principles of Medical Device Decontamination

staff and reprocessing machinery) and are useful to confirm that a cleaning process is within pre-established control limits. The frequency of this testing and the upper control limits should be established with sufficient data to provide statistical significance and be in alignment with hospital risk management policy. Methods that only measure protein on the accessible or visible surfaces of a device, are insufficient for complex devices for quality control purposes, or to qualify the cleaning efficacy of a device using instructions provided by the manufacturer. This is especially relevant for devices with moving parts with mating surfaces, complex mechanical designs or internal components and lumens.

Hospital policy may require that Performance Qualification (PQ) testing for automated washing is performed:

• When a new device is introduced to the sterile supply department • When changes are made to the decontamination process for an existing device • As part of annual requalification of equipment

Performance qualification testing should be performed to establish the cleaning efficacy of a device in an automated process according to the BS EN ISO 15883 2 series of standards. BS EN ISO 15883-5:2021 3 Washer-disinfectors – Performance requirements and test method criteria for demonstrating cleaning efficacy, describes robust and validated methods to extract residual protein from patient contact surfaces and standardised methods for the quantification of protein.

Residual protein testing should be performed by a suitably qualified testing service provider that have experience with and use validated methods for this work, especially in the evaluation of complex medical devices.

The BS EN ISO 15883 series provide targets for acceptable residual protein developed according to established safe practices for infection control. Hospitals should consider these standardised recommendations and use risk management practices to establish cleaning endpoint targets for each facility.

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