The Principles of Medical Device Decontamination

Best Practice Guidance

• Every sterilization cycle of any type should be monitored using appropriate physical indicators where available and a record of the parameters made for evaluation before load release. For steam sterilization this would include the measurement and recording of temperature, time and pressure. For LTS time, temperature and pressure is possible. The measurement of sterilant concentration is desirable but will depend on the process and model of sterilizer. • BIs are rarely used in the UK healthcare sector for monitoring steam sterilization processes but are nevertheless an option to be considered. For the common Low Temperature Sterilization (LTS) processes such as Ethylene Oxide, Low Temperature Steam & Formaldehyde, and Vapourised Hydrogen Peroxide (VH 2 O 2 ) it is advisable to use biological indicators to monitor every sterilization cycle. Some guidance recommends that if parametric monitoring is possible then BIs need not be used (SHTM 01-01 E 9 ). However, practitioners should ensure that sterilizer monitoring systems are capable of monitoring all of the process variables. • CIs are used extensively in healthcare practice. For every sterilization process, every pack, pouch or container should have a process indicator present so that SSD staff can carry out an appropriate batch release process and clinical practitioners 10 can check packs for evidence of processing before use. The inclusion of internal pack indicators is an option and should be considered and discussed with clinical practitioners. Type 4, 5 or 6 CIs should be considered. • A daily BDT should be carried out on every steam sterilizer in use. This can be in the form of a CI based test pack but electronic alternatives can be considered. If other LTS processes are in use appropriate equipment function tests using CIs should be carried out in accordance with manufacturers and standards recommendations.

126

@ 2025 Central Sterilising Club. All rights reserved. Do Not duplicate