Central Service - Issue 2/2004
Safety Culture - A Mere Congress Topic or Something Urgently Needed?
- What's New in Standardisation: EN 13060 adopted
- Special Issue of Central Service
- Focus on the Liability Risks Faced when Processing Medical Devices. Fourth Hospitec Steri Meeting
- Anton J. Schmidt New Chairman of the BVMed Board
- Central Sterilising Club Meeting
Classification of Medical Devices as per Annex 7 of the Guideline of the Robert Koch Institute (RKI) and Practical Consequences
(Zentr Steril 2004; 12 (2): 81-95)
Developments in the healthcare sector are making the service providers, such as the doctors and hospitals as well as the industrial companies providing healthcare services, face never-ending sets of new requirements. For example, all those working in this field are obliged to provide and ensure high quality in all respects. This includes, inter alia, implementation and compliance with all laws and directives as required by legislation and the state of the art. These include the Recommendation of the Robert Koch Institute (RKI) governing hygiene requirements when processing medical devices. The recommendation published in 2001 is the prime focus of this present report. After a brief overview of the legal situation, the existing issues and problems will be dealt with, while explaining how this recommendation can be implemented. This report is also intended as a means of highlighting the importance of the RKI recommendation in the hospital setting, while at the same time serving as a guide when carrying out risk assessment and risk classification for medical devices as set out in the RKI recommendation.
Legal Aspects of Medical Device Reprocessing Based on Swiss Law
J. Morgenstern, M. Bühler:
The Much-Discussed Multi-Functional Use of Bedpan Washer-Disinfectors
W. Michels, H. Frister:
The Modified OPA Method with an Alternative Thiol Component
(Zentr Steril 2004; 12 (2): 115-118)
The modified OPA method for measuring the degree of proteinaceous contamination has become a standard method employed for verification of cleaning following automated processing of instruments and has now also been included in prEN ISO 15883-1. The reagent N,N-dimethyl-2-mercaptoethyl ammonium chloride, which is used as a thiol component, is difficult to source. An alternative to this is 2-mercaptoethane sulfonic acid, readily available as sodium salt, which in the same manner yields reaction products photometrically detectable at 340 nm and with the same extinction values.
RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)
Mesh Trays and their Implications for Successful Cleaning in the Washer-Disinfector