Performance of Hollow Load Process Challenge Devices (HLPCDs) for the determination of air removal and steam penetration in porous load steam sterilization processes: Part 1 – The evolution of HLPCDs in standards and a review of the current supporting published evidence

Steam sterilization Process Challenge Devices (PCDs) are devices which present a defined challenge to a sterilization process. In part one of a two part series the authors review the published literature covering studies evaluating the removal of air and penetration of steam into hollow tubular devices and then discuss the relevance of the material in support of the current custom and practice of utilising simple tubular PCDs (Hollow Load Process Challenge Devices HLPCDs) as a means of monitoring production loads for adequacy of air removal and steam penetration. This review places such data in the context of the evolution of HLPCDs in the standards for small and large porous load steam sterilizers. With regard to the apparent acceptance of the HLPCD in EN 867-5 into custom and practice for batch monitoring the literature suggests this may be misleading. The literature review concludes that there is an urgent need for an International Standard which describes how a HLPCD can be developed and tested against real medical devices in a range of sterilization processes representing current state of the art in full load conditions