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6th International Forum "Medical Device Processing": Instrument Management
Conference Report

25 February 2005
Estrel Hotel, Berlin, Germany

Conference Report
by Ronald Graeber

The 6th international forum "Medical Device Processing" organised by Chirurgie-Instrumenten AG (CIA) Berlin was held on 25 February in Berlin. Users, manufacturers, researchers and representatives of the competent authorities came together to learn about the latest trends and the state of the art, exchange experiences and discuss a broad variety of topics relating to work practices in the CSSD. The lectures were supplemented by an industrial exhibition which was organised by the sponsors and presented innovative products. Once again, the main sponsor was the Berlin-based services' firm Zehnacker-Cleanical.

In his welcoming speech M. Held, on behalf of the German Society of Sterile Supply (DGSV), paid homage to the Forum's contribution towards the continuing education of CSSD staff. This contribution was all the more important in the light of the increasingly more complex tasks and requirements faced by users on a daily basis.

Dr. Fengler, honorary secretary of CIA-Berlin, gave an introductory speech, stating that there was a growing interest in the topic of processing. This was due to some fundamental changes taking place in this field: new directives and standards, more inspections of premises by the competent authorities, the more important role played by information technology in a field where hitherto manual tasks tended to hold sway. A further factor was the introduction of the flat-rate case fees whose implications could scarcely be predicted so far. These and similar considerations meant that users and experts had a greater need for information. Therefore since its foundation in 1999 the Forum was experiencing a rising demand, reflected in a growing number of attendees, higher circulation figures for the reference volume - now available as a bilingual version - and more workshops. Participation in at least five international conferences is planned for 2005.

In his talk about regulatory affairs and the activities of the competent authorities, Dr. Attenberger from the Ministry for Health of Lower Saxony gave the first of a series of lectures. He advocated that these supervisory bodies should be viewed as partners who could bring pressure to bear on responsible parties so that long-overdue investments could be made and shortcomings eliminated within a short period of time. Indeed, the reality was that staff eagerly awaited inspections because, faced with a situation of helplessness, they provided them with clear-cut advice and with ideas on which to base their arguments. The investments needed here were not only for procurement of new equipment but often also for personnel qualification. The onus was on the responsible parties to ensure that their staff were in possession of the requisite knowledge or were given the opportunity to gain this knowledge in the medium term. Hence one condition frequently stipulated by his department was to compile a list of minimum requirements and a schedule for ongoing training.

Cleaning - as the most important substep in processing - and monitoring of the cleaning results were the focus of an entire series of talks. Mr. Kamer outlined prescribed processes for quantification of the cleaning results with a view towards optimisation of cleaning. He stressed that it was of paramount importance to use process challenge devices, test soils, loads, detergents and test methods that reflected everyday practice. K. Roth reported on an investigation conducted by the firm SMP into various detergents with the Oxivario programme based on the specifications of prEN/ISO 15883-1. The tests compared the radionuclide and the OPA method using a standardised test soil. It was revealed that oxidative additives (hydrogen peroxide) essentially enhanced performance, thus contributing to a more uniform and more thorough cleaning action. Furthermore, there were the following findings: first, more attention should be paid to the cold precleaning step as this was a chief determinant of the cleaning result obtained. Second, the arrangement of the instruments in the washer-disinfectors played an important role because these machines did not provide for a homogeneous cleaning action; the lower rack proved to be the more effective. The results of a multicentre trial which took place in 18 German hospitals for checking washer-disinfectors (WDs) in situ are published in this edition of Central Service; it is expected that the standard test procedure will be commercially available already in the course of 2005.

Validation with process challenge devices (PCDs) and test soils was not fully devoid of controversy. In his talk, Dr. Michels expressed the opinion that the use of such methods, notwithstanding their valuable role in a WD type test (or for comparison of detergent performances), merely served to promote an alibi mentality when used for the operational qualification. This was because the main focus of all efforts was not to find out the truth, with its possible unacceptable implications, but rather to obtain a positive result. Since evidence of the WD's basic cleaning performance should already have been obtained at the time of installation, validation on site should check suitability under the locally prevailing conditions. This included not only the water quality and the choice of detergents, but also the specific design of the instruments and the specific degree of contamination, etc. Therefore the real test was to successfully run an everyday load, something that would also be taken account of in the forthcoming standard EN ISO 15883-1.

Mr. Mohr elaborated on how the water quality affected the cleaning performance. Impressive photos of hospital pipelines almost completely blocked with biological sludge or lime sent out a clear message: the water that reaches the CSSD should by no means be regarded as the "drinking water" supplied by the waterworks company. Rather, it is "tap water" whose quality must be checked. Investigations attest to how water hardness, in particular, affects the cleaning results. Water softening or demineralisation by means of an ion exchanger or reverse osmosis was therefore definitely to be recommended.

A further topic of paramount importance for instrument management is the use of software in the CSSD. Mr. Liekfeld (Karl Storz) demonstrated the performance spectrum of the Kenus system. This is a multifunctional, Windows-based SQL databank solution for efficient management of the entire arsenal of instruments. Dr. Fengler reported on the initial findings of a pilot study conducted in a clinical setting with this system at the Martin Luther Hospital in Berlin. He recounted the numerous setbacks faced when installing electronic data processing facilities in such (in some cases wet) workplaces and how to find solutions. One other type of similar software, the BarCon system, was presented by A. Schorer (Asanus). This, too, holds out good prospects for cost transparency, continuous tracking of instruments and making life easier for the CSSD staff, especially for inventory management, documentation and packing trays. At present it is not clear whether individual marking of all instruments is clinically warranted. It is possible that soon transponder technology will replace all other forms of marking.

These two competing products are based on different technologies and hardware and have different strengths. Deciding in favour of one of these systems means a long term commitment and should not be done without due reflection, but ultimately this decision has to be made. Without such performance software, it will be scarcely possible in the future to meet the increasingly more stringent demands addressed to economic efficiency, quality control and documentation. Accordingly, the expectations that operators and users have for these programs are equally great. In particular during the introductory phase, cooperation between manufacturers and clients is important, together with continual product modification in order to meet the specific requirements at the respective site.

Software, in the form of dataloggers, is also facilitating routine monitoring and validation of automated cleaning, disinfection and sterilisation processes. I. Kruse presented Winlog.Med validation from ebro Electronic. This is a program that automatically evaluates the process parameters, compiles a detailed protocol and releases (or fails to release) as validated equipment the respective WD, showing its conformance to a selected standard or directive. What Winlog.Med cannot do is to select the valid standard in each individual case. It is essential that one staff member should be conversant with the applicable regulations.

A further software solution was presented by the CSSD Personnel/Cost Management Working Group of the DGSV, represented by Mrs. S. Premer and Mr. Weiss. This is intended for CSSD managers and enables them to elucidate the optimal personnel key for each department of every hospital. The first task is to identify the entire spectrum of tasks carried out in the department, ranging from cleaning the ultrasonic bath to processing an MIS tray. The program then calculates the average personnel requirement and the staff costs incurred right down to the individual set. Benchmarking with other hospitals is possible, something that could not be assured by the hitherto comparative methods used, e.g. number of beds, sterilisation units (StUs) or the number of operations. The software is straightforward, but suitable and non-commercial - it can be downloaded free of charge from the DGSV homepage (www.dgsv-ev.de).

Mr. Lindmarck from University Hospital Trondheim in Norway reported on the findings of a study of measures aimed at reducing damage to rigid endoscopes which was conducted between 1995 und 2000. In view of the exponential growth in surgical endoscopic techniques, avoidance of damage to these delicate instruments has important economic savings potential. A large number of instances of (mechanical) damage were related to handling during the operation itself, prior to it or afterwards. But an equally large number related to processing: thermal damage to the lenses accounted for well over a third of overall damage before changing over in Trondheim from steam autoclaves to low-temperature sterilisation with hydrogen-peroxide gas plasma. This measure alone served to reduce the rate of thermal damage by 80% - success that deserves to be emulated!

A relatively new standard could prove to be very helpful for CSSD personnel if finally complied with: EN/ISO 17664 "Information to be provided by the manufacturer for the reprocessing of resterilisable medical devices", which was published in 2003. A. Van Drongelen from the Dutch Ministry of Health (RIVM) outlined the difficulties encountered when implementing this standard. A survey conducted by him among users in Holland revealed that the quality of the information supplied by the majority of manufacturers, if indeed at all given, was completely inadequate. But the buyers also have a role to play here in determining whether matters will change in this respect. Inadequate information on suitability for reprocessing should, on the one hand, be reported to the competent authorities (who, as attested to by Dr. Attenberger, are facing a backlog of demands to clarify such transgressions). On the other hand, buyers should boycott such suppliers.

Finally, in his characteristic humorous manner H. Pahlke from CIA-Berlin reported on "unconventional" strategies used for cleaning and sterilisation (which often violated regulations or were simply meaningless): "What do we really find in a sterilisation unit?" denotes both the StU volumetric mass (60x30x30 cm) as well as the CSSD department itself. Suboptimal results obtained for instrument processing were accordingly often due to poorly conceived cleaning techniques or to a lack of experience of modern materials or instrument designs on the part of staff. The photo documentation of German CSSDs put together by H. Pahlke over the last year served as an amusing closure to the conference. But, on a more serious note, it highlighted at the same time the need for excellent staff qualifications coupled to practical experience.

As revealed by a survey among delegates, Forum 2005 was a success. The delegates applauded the organisers for having provided for a relevant selection of topics and competent speakers, among others. As regards the talks, some criticism was expressed about the poor dividing line between papers presented by firms and pure research contributions.

The reference volumes for all Forum conferences can be downloaded at www.cleanical.de; information on the Forum workshops can also be obtained here.