Central Service - Issue 4/2010
- What's New in Standardization: Validation of Small Sterilizers
- Requirements for Medical Device Reprocessing
- New Editorial Board Members
- 21st "Steri-Treff" Meeting in Halle/Saale
H. Biering, W. Fuchs, J. Staffeldt:
Analysis of Stainless Steel and Anodized Aluminium Material Compatibility with Foam Sprays Used for Keeping Used Surgical Instruments Moist
The material compatibility of four ready-to-use enzymatic foam cleaners on anodized aluminium and stainless steel was studied. This type of cleaner is applied in operating theatres to prevent bio-burden from drying on used surgical instruments. Cleaners were applied for one exposure time to test materials alone and in combination with blood. The study shows no or slight changes on the tested materials when contacted with most of the cleaners. Pitting corrosion was detected with one cleaner at extended contact time. This effect could be caused by the high chloride content in the product.
Incorporation of a Further Site for Medical Device Reprocessing
The Central Sterile Supply Department (CSSD) at the hospital Diakonie-Klinikum Schwäbisch Hall has been in operation since 1992 as an independent department. It is responsible for reprocessing and sterilisation of all sterile supplies at the hospital. This CSSD has introduced and certified a quality management (QM) system which complies with the requirements of DIN EN ISO 9001/2000 and DIN EN for medical device reprocessing as well as with the Recommendation jointly formulated by the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM). The Diakonie-Klinikum in which the CSSD is situated belongs to the healthcare holding company Gesundheitsholding Schwäbisch Hall gGmbH. Its hospitals are located in Schwäbisch Hall, Gaildorf and Crailsheim. The business management decided not to make any investments in the Gaildorf site and to, instead, transfer instrument reprocessing to Schwäbisch Hall. Only within the framework of a project was it possible (for the hospital Diakonie-Klinikum Schwäbisch Hall) to incorporate an additional site into its range of reprocessing activities. The CSSD management took responsibility for project management. To begin with, the legal regulations and technical fittings of the CSSD had to be reviewed. All participating persons as well as the requisite measures were recorded in the project contract. The CSSD staff were regularly updated on progress during the monthly meetings.
It was not possible to implement all planned measures without encountering any problems. Therefore midway through the project a number of questions had to be posed, e. g.: Was it necessary to change the project timeframe?
The CSSD operates as per ISO 14971:2009-10 (application of risk management to medical devices). Risk analysis was conducted as per that standard. Outsourced processes such as e. g. transport logistics are organised and assured by the CSSD. After execution of the project, the final project report set out its most salient features. The overall outcome was positive. The experiences gained during the project can be used for further tasks, e.g. reprocessing sterile supplies for surgery centres as well as for medical and dental practices.
Recommendations by the Quality Task Group (AK »Qualität«) General Principles for Using Ultrasound for Cleaning Medical Devices - Part 1