Central Service - Issue 5/2014
- What's New in Standardisation: Application of standards
- Patient safety in the spotlight. 9th Middle East Decontamination & Sterilisation Conference, Dubai, 16 – 18 September 2014
- DGSV 18 years on – a responsible adult. DGSV Congress in Fulda, 8 – 10 October 2014
- New Editorial Board members
E. A. Gordon, V. M. Hitchins, K. E. Kelly, A. D. Lucas*:
Evaluation of washer-disinfector efficacy: New method to apply artificial blood test soil on standard test pieces
Successful cleaning is essential in reprocessing medical devices to ensure that clean devices can be further disinfected or sterilized to protect patient safety. The ISO/Technical Specification (TS) 15883-5 ”Test soils and methods for demonstrating cleaning efficacy“ is being updated to establish the performance criteria for washer-disinfectors. The objective is to establish appropriate test soils and test conditions to validate the cleaning efficacy of washer-disinfectors for reusable medical devices. The U.S. Food and Drug Administration (FDA) participated as a member of an international group that is determining the specifications for a standardized test piece, the appropriate test soil, application of the soil onto the test piece, and quantitative method for measuring residual test soil. Comparison of four commercially available citrated sheep blood samples to artificial blood demonstrated that the artificial blood was much more consistent than citrated sheep blood in application and ability to coagulate. A new gravity dependent ”dip and drip“ method for applying the artificial blood to a standard test piece was developed at the FDA. This application method gave less variable weight and film thickness than other methods which use either a pipette tip or a K-coater rod. The ”dip and drip“ method was a reproducible method of applying test soils on different medical device materials. The development of a simple, reproducible method to apply artificial blood as a test soil to a standard test piece is a critical step to updating ISO/TS 15883-5.
washer-disinfector cleaning ISO/TS 15883-5 test soil
FROM THE FIELD
Facing the standards gap: an autoclave for the rest of us
The international standards for sterile supply are embedded in Western societies; their implementation requires a strong economy. However due to many socio-economic limitations, transferring these standards – and the resulting advanced technology – to low-income countries is bound to fail. Manufacturers are forced to comply with the standards and as a consequence appropriate sterilization equipment and related supplies for this market are hardly available anymore. A major problem is caused by the way the requirements for validation of processes have been defined. The current situation related to autoclaves (sterilizers using steam as sterilizing agent) in target health facilities was analyzed, followed by research and development and resulted in prototypes that eventually should mature to an adequate autoclave for the rest of us.
sterilization standards autoclave manual control developing world
Recommendations by the «Quality Task Group»:
Water for reprocessing medical devices (Part 1)