Performance of Hollow Load Process Challenge Devices (HLPCDs) for the determination of air removal and steam penetration in porous load steam sterilization processes: Part 2 - An evaluation of a number commercially produced HLPCDs

Kirk, B., Smith, A. and Winter, S. (2016) Performance of Hollow Load Process Challenge Devices (HLPCDs) for the determination of air removal and steam penetration in porous load steam sterilization processes: Part 2 - An evaluation of a number commercially produced HLPCDs. Zentralsterilisation = Central Services, 24(6), pp. 380-387.

Abstract

Steam sterilization Hollow Load Process Challenge Devices (HLPCDs) are designed to assess the adequacy of air removal and steam penetration in a porous load steam sterilization process including those used in both large and small sterilizers. A PCD should be used in every load to ensure adequacy of air removal and steam penetration. Use of PCDs is also an integral part of the quality assurance systems used to ensure the sterility of each batch of reusable medical devices. There are a number of HLPCDs commercially available which have various design features ranging from simple tubular helical designs compliant to EN 867-5 to more complex electronic measurement systems. The aim of this study was to assess seven commercially produced HLPCDs for their ability to detect residual air in a porous load steam sterilizer employing a range of air removal stages. In addition to testing in processes deemed to be satisfactory, assessment was also carried out in cycles in which increasing amounts of residual air was artificially induced. The performance of each HLPCD was compared to that of a Bowie and Dick (BD) textile test pack into which were inserted temperature sensors. All tests were carried out with a single device in an empty chamber. The BD textile pack was chosen as a reference because it is well established as reference device for both full load and empty chamber tests. Only one of the seven HLPCDs tested exhibited equivalent performance to the BD reference device. One HLPCD was overly sensitive, failing an acceptable process. Four HLPCDs were incapable of detecting large failures in sub/super atmospheric pulsing cycles. One HLPCD was insensitive to residual air introduced into the chamber as a bolus at a specific point in the cycle. The results of this study show an unacceptable variability in performance in HLPCDs claimed to meet EN 867-5. Users should be extremely cautious when selecting an appropriate PCD for use in their own Sterile Service Departments and where possible, evaluation should be carried out before selections are made. Some HLPCDs will lead to a false sense of security and may result in processed goods being released into use, the sterility of which may be compromised due to undetected process failures.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Winter, Ms Sandra and Smith, Professor Andrew
• Authors: Kirk, B., Smith, A., and Winter, S.
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Dental School
• Journal Name: Zentralsterilisation = Central Services
• Publisher: M H P Verlag GmbH
• ISSN: 0942-6086
• Copyright Holders: Copyright © 2016 mhp Verlag
• First Published: First published in Zentralsterilisation = Central Services 24(6):380-387
• Publisher Policy: Reproduced with the permission of the publisher.