Central Service - Issue 3/04

EDITORIAL

5th EFHSS Conference in Çesme/Turkey

NEWS UPDATE

What's New in Standardisation: Sterile Barrier Systems
Progress in Instrument Processing: ASP Seminar in advance of the EFHSS Congress
Successful Premiere for Turkish Specialist Society MSUD. EFHSS Conference in Çesme/Izmir, May 2004
The New Standard EN ISO 13485 Is Process-Oriented. MedInform event on quality management for medical devices

MAIN ARTICLES

R. Fushimi, R. Hanamura, M. Takashina, S. Noguchi, S. Nakata, M. Monden:
Research on the Usefulness of Pro-tect® in the Verification of Cleanliness of Cleaned Reusable Surgical Instruments
(Zentr Steril 2004; 12 (3): 171-180.)

Abstract
Various instruments used in surgery often have blood and small pieces of tissue adhering to them. In order to prevent infection and maintain smooth operation of the instruments, it is very important to eliminate such adhering matter by cleaning the instruments. In the decontamination area of modern hospital central service departments, washer-disinfectors and ultrasonic washers are utilized. For the determination of the level of cleanliness after cleaning using these washers, various methods are used, including a visual inspection to identify remaining matter and a staining technique using a coloring agent that combines with protein. However, the determination by either method depends substantially on the subjective judgment of the individual performing the test, and the stain method requires re-cleaning in order to remove the coloring solution. In addition, in these methods, the remaining matter cannot be quantitatively indicated, i.e. it cannot be expressed in terms of specific numeric values. As we are trying to establish a more effective instrument cleaning method, these limitations have been a substantial source of dissatisfaction.

We recently used Pro-tect, which comprises a swab stick with which to wipe the instrument surface and a protein measuring reagent, in order to measure the correlation between the post-reaction interval and the color intensity of the post-reaction reagent, create a standard curve using diluted protein solutions as samples, and compare the measurement sensitivity of the product against the protein staining method. As a result, we found that Pro-tect is capable of detecting the presence of protein down to approximately 25 µg through the very simple operation of wiping the instrument surface with a swab. Accordingly, we believe that checking the degree of cleanliness of cleaned instruments using Pro-tect is quite useful for control of the cleaning process, as well as for the evaluation of detergent products and washers.

T. Miorini, F. Grangl. V. Buchrieser:
Development and Evaluation of a New Test Method for Verifying the Cleaning Efficacy of Washer-Disinfectors for Surgical Instruments (Part 1: Method Development)
(Zentr Steril 2004; 12 (3): 181-188.)

Abstract
Effective cleaning is a prerequisite for ensuring that processing is conducted in line with the dictates of quality assurance and that the safety of the subsequent disinfection and sterilisation steps is assured. Validated procedures must be used for all steps when processing surgical instruments as per the provisions of the Medical Devices Act (MPG) or the Operator Ordinance. The test methods outlined in Annex B, Part 1 of prEN 15883, which are based on conventional national test soils, have given rise to many discussions. The soil most commonly encountered in practice when processing surgical instruments is undoubtedly blood, with blood coagulation and the ensuing formation of a water-insoluble fibrin matrix making the highest demands on the cleaning method. Of the test soils currently available, heparinised sheep blood that has been reactivated with protamine, as recommended by the German Society for Hospital Hygiene (DGKH) in the guideline "Testing and Evaluation of the Cleaning and Disinfectant Efficacy of Endoscope Washer-Disinfectors" is best placed to meet the requirements to be fulfilled by a test soil used for surgical instruments (of relevance in the practical setting, can be standardised, quantified and reproduced). Part 2 of this publication will outline the evaluation of the methods employed here.

RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)

Packaging Part 3: Summary