"Sterile with a Smile" - EFHSS Congress in Lillehammer, Norway, 18 - 20 May 2006
Conference Report
by Dr. Gudrun Westermann
Anyone who was lucky enough to travel to the congress already on 17 May had an opportunity to experience Lillehammer festively adorned for Norway’s National Holiday, and above all resplendent in the bright sunshine. As the congress began, so did the rain, but this was confined to the exterior of the conference hotel. Inside, the mood continued to be sunny and thanks to the international composition of the delegates, the Olympian spirit of 1994 was rekindled.
The morning of the first conference day was devoted to various workshops. The firm B. Braun Aesculap organised a seminar on the topic of quality assurance in the CSSD. This dealt with proper management of instruments during decontamination, in particular as regards visual inspection after cleaning, instrument care and functional checks. Various types of residues and functional impairments were demonstrated and the critical aspects of different instrument groups were explained.
The firm ASP Johnson & Johnson sponsored a seminar on low-temperature sterilisation, showing how the costs of instrument repairs could be reduced, especially for rigid optics, by using H2O2 gas plasma sterilisation. In addition, Dr. Clayette, Paris, outlined the current guidelines for prion decontamination. Other lectures dealt with validation and evaluation of the Sterrad technology.
The firm Getinge ran a seminar on the topic of "T-Doc", showing the facilities currently available for instrument management. Special attention was paid to organisational procedures using a case carts. While this is not a precondition for using the T Doc system, it is optimally supported by it. This type of organisational measure has considerable advantages for planning surgical procedures; depending on the size and organisational structures of the hospital, the number of instruments needed could be reduced since a more efficient system of instrument provision is in place.
The congress was officially opened in the afternoon. S.B. Klemetrud, Mayor of Lillehammer, presented the touristic highlight of the region, which since the Olympic Games is having twice as many visitors each year as before.
Wim Renders, EFHSS Chairman, in his opening speech spoke about growing globalisation, something that was now reflected in the new name of this European forum: World Forum for Hospital Sterile Supply (WFHSS) (see p. 184 for extracts of this speech).
Ann M. Berg reported on university studies for CSSD management in Norway. This discipline was planned and implemented in 1994/95 by the Norwegian public health office. The Norwegian Society of Sterile Supply has in the meantime devised and introduced an upgraded curriculum for CSSD managers. The first students had completed this course in 2003, while a further 20 had begun the course in 2006. Berg described how this course was structured, stressing the pivotal role played by training in assuring an efficient quality management system.
Maria Tuulse described the training courses available for CSSD technical assistants and managers in Sweden. In a total of six courses focusing on different topics it was possible to collect points which together with practical work experience determined the total number of points, and as such the qualifying grades.
The first lecture on the next day was given by Marie Banck, likewise from Sweden, who spoke about experiences relating to certification. She began her talk with a few facts about Sweden, where there are a total of 89 CSSDs. Since 1996 quality assurance has been enshrined in legislation. Banck outlined the advantages accruing from a QM system, e.g. greater customer satisfaction and the financial aspect that good quality served to save money since hardly any remedial action had to be taken anymore.
She described the current situation in Sweden, which she had surveyed with the help of a questionnaire. This showed that some departments had initiated the certification process already before 1994, but this was done in the majority of cases at the same time as the corresponding regulations were introduced. This initiative was mainly launched by the CSSD management, and on average it took three years until certification was complete. So far, 7% of CSSDs in Sweden had been certified, but all were aiming in that direction. To finish off, Banck described the positive and negative experiences gleaned from certification. Of course, time and money had to be invested to achieve a corresponding standard; on the plus side this gave rise to better organised working procedures and to enhanced occupational safety. Relationships with customers had also benefited.
Torben A. Pederson described the current situation as regards standards in Denmark. He stated that the Danish standardisation committee had published standard DS 2450 on infection control and infection prevention, which was also valid for the CSSD. Accordingly, in organisational terms the CSSD was also part of a hospital’s infection control system. Pederson described how to address risk factors and define critical control points within the system. Critical limits had to be specified for certain domains. What was important was scrupulous observance of risk factors, also relating to sterilisation within the hospital; continuous improvement should always be the target.
Klaus Roth focused on new cleaning processes in his talk, e.g. the Oxivario system and other multi-step processes. Validation of the Oxivario process had revealed that the addition of H2O2 had potentiated the cleaning performance of certain detergents. The cleaning performance was verified with the OPA as well as the radionuclide method, with the latter proving to be the more sensitive.
Problems were encountered on using the Oxivario process for different materials. For example, titanium screws showed discolorations that receded only after processing them again on 10 further occasions. Admittedly, stated Roth, decontamination of titanium implants was generally not recommended.
The surface of coloured anodised aluminium also underwent a change, but this could be avoided on using the newly developed Orthovario process, which did not adversely affect the colour. What was decisive in all cases was also the water quality; very hard water could cause a sharp decline in the pH value.
Th. Fengler highlighted the role of ultrasound in cleaning. He also outlined the fundamental principles of cleaning, e.g. its important role for preservation of the functional capabilities and inherent value of instruments. Being able to dismantle instruments was vital. Manual cleaning had to be avoided.
The parameters underpinning effective ultrasonic cleaning were the detergent, volume of solution, transducer position and energy distribution within the basin. On the basis of a few interesting graphs, Fengler demonstrated that energy distribution differed greatly within the ultrasound basin. Other important aspects were the tray composition and the water quality. Silicone mats were not suitable as they absorbed the ultrasonic waves. Energy was also lost when trays were overloaded.
Conclusion: While ultrasound cleaning does play a role in cleaning, it is difficult to standardise. Therefore it should be used mainly as an additional measure for precleaning of certain types of instruments.
Anne Jacolot reported on the experiences with various test soils in France. Tests had been carried out with different hollow devices (e.g. endoscopes, hollow dental instruments) which had been cleaned using different methods: once in an ultrasonic basin using sonic irrigation, once in a special cleaning trolley for endoscope accessories, once by flushing and once in an endoscope washer-disinfector. The dental instruments were cleaned in a special stomatology trolley.
Tests conducted with different process challenge devices (PCDs) and test soils (Tosi Lumcheck or Flexicheck) revealed that cleaning endoscope accessories first with ultrasound and in a special trolley produced the best results. Likewise, the best cleaning results for dental instruments were achieved in a trolley specially designed for that purpose. Cleaning once in the endoscope washer-disinfector did not produce satisfactory results for endoscopes; the instruments came out clean only after cleaning once without a detergent followed by cleaning once again with an enzymatic detergent.
Damien Talon continued this topic by elaborating on verification of the cleaning performance of three novel detergents whose performance had also been compared using commercially available test soils, i.e. PCDs incorporating test soils (Tosi) as well as with the Soil Test described in EN ISO 15883, including a microbial contamination (B. subtilis).
To investigate the cleaning performance, the parameters temperature, concentration and cleaning duration were varied such that 20 different combinations were obtained for each detergent. In this way it was possible to define optimal parameters for each detergent, thus in turn assuring an optimal cleaning performance while, at the same time, providing for economical use of the respective detergents.
Heid Garberg Gule spoke about validation of combi loads at Rikshospitalet University Hospital in Oslo. The continuing upsurge in surgical procedures presented a major challenge to the CSSD, which could be countered only by making certain changes to work flow patterns. Improvements had been made in various domains, e.g. ISO certification of the quality management system, checklists for enhanced staff training and the introduction of combi loads. To cite Gule, these conferred various benefits:
- There was greater transparency for staff as demonstrated by photos from the CSSD, which soon helped to coin the motto of this congress: "Sterilisation with a smile"
- Only one programme had to be run
- Fewer mistakes in decontamination and load assembly
- More economical
- Quicker instrument turnaround times and more rapid instrument delivery to the OR
Validation of these loads was effected using reference loads, reflecting in all cases both worst-case and optimal scenarios. Gule stated that all loads should be revalidated after a period of one year, and any necessary changes made.
Anne Mette Koch reported on experiences with reusable surgical drapes (textiles) at Bergen University Hospital. She briefly outlined the requirements to be met by surgical drapes and stressed that cotton drapes and gowns did not comply with the standards and their use, wherever this was still the case, should be discontinued.
At her hospital tests had been carried out with innovative microfibre fabrics that could be reprocessed. In close cooperation with the laundry and the OR an infection control policy had been compiled explaining how these textiles could be reprocessed. Ensuring appropriate ongoing training staff of CSSD and laundry personnel was of paramount importance so that the relevant processes could be properly validated.
Sverre Fauske, human resources consultant, dealt with another important topic: staff motivation. How could one ensure that staff would turn up for work again every day? That motivation was not exclusively determined by remuneration was something that had to be obvious to everyone. Fauske impressively explained how in his department other factors, which were equally important, came into play, e.g. the chance to engage in continuing personal development, relationships with colleagues, working organisational practices and the organisation’s culture and hierarchy. With the aid of a questionnaire, the mood prevailing in these areas was ascertained and based on a marking scale assigned the colours of the traffic lights: red, amber and green. If the light was "amber", it was already time to take action to improve the level of job satisfaction.
But Fauske stated that one should not concentrate only on the "red side" of the traffic lights; rather, what was equally important was to acknowledge positive aspects in the "green area" and seek to promote these. It was also important that priorities were set by the heads of department, and here their communication skills were of paramount importance. Moreover, in the hospital setting all too often attention was paid only to the activities of the medical and nursing staff, while the equally important "backup departments", including the CSSD, were forgotten.
To finish off, Fauske revealed how the rate of absence because of illness had markedly declined since the introduction of this system, hence the investment in the system in terms of effort and costs had paid off.
In the evening the delegates attended the gala dinner. In addition to the convivial atmosphere created from the outset by the melodious renditions from the musical band, there were some surprises, e.g. the "Sparkling Egg Award" which went to Toni Zanette (see p 183) and the handover of the remaining funds of the International Federation for Sterile Supply (IFSS) by its chairman Gillian Sills to Wim Renders, thus officially highlighting that in future the WFHSS will be taking charge of international tasks going beyond the European borders.
Saturday morning began with the lecture to commemorate Jack van Asten, which has by now become a traditional fixture in the EFHSS programme. On this occasion, the lecture was given by Joost van Doornmalen, who spoke about current standardisation activities. To begin with, van Doornmalen pointed to some inconsistencies in existing standards, e.g. the fact that EN ISO 15883 featured 10 different test soils for verification of the cleaning performance.
He then made a cursory reference to the physical fundamentals of steam sterilisation, while stressing that 100% saturated steam was necessary for sterilisation regardless of the temperature-time combination selected. Van Doornmalen pointed out that in order to select a suitable sterilisation duration for a particular temperature the values specified by the Medical Research Council had been put to the test and had furnished proof of safety, whereas the values calculated in line with the F-value theory deviated from this in some cases and were not able to assure the same level of safety. Furthermore, on the basis of a number of graphs he demonstrated that problems in the sterilisation phase occurred already during the conditioning phase, for example if the pressure had been built up too quickly, thus giving rise to overheating. A longer conditioning phase was safer. After all, successful sterilisation was possible only within narrowly defined limits; hence the pertinent standards were by no means too rigorous.
After this, van Doornmalen went on to address the problems encountered in sterilisation of narrow lumens. Only with great difficult could 100% saturation be achieved at the end of the lumen; there was clear evidence of problems already for lumens measuring more than 50 cm in length. In this context van Doornmalen described tests conducted on ducklings that had been examined with reprocessed angioscopes (Chaufour et al., J Vasc Surg 1999; 30: 277-282.). Here it was revealed that sterilisation without prior cleaning was virtually pointless, since there were many cases of infection just as seen for unprocessed, contaminated angioscopes. Using filmed material, van Doornmalen presented his own tests on endoscopes, showing for example that in some cases better results had not been achieved by cleaning the channels with a brush. Rather what had happened was that any residual soils were redistributed or transferred deeper into the channels.
To finish off, van Doornmalen warned against a false sense of security derived from the existing standards; further investigations and continuous improvement of standards based on results were vital.
Lawrence Dawson spoke about ultrasonic cleaning including continuous irrigation of instruments. He outlined the earlier research conducted in this field using transparent test instruments that simulated the most important characteristics of, for example, MIS instruments. Using the radionuclide method several investigations had been conducted in the meantime, leading to some instruments being designated for single use only. It was also revealed that optimal pressure and flow parameters had to be defined for ultrasonic equipment with sonic irrigation facilities in order to achieve optimal cleaning results. Accordingly, equipment with parameters for flow control was now available (Parametrically Controlled Flow System, PCF).
Diana Bijl from Nijmegen University described the use of radioactively marked protein for verifying cleaning of MIS instruments. Instruments that could be fully dismantled were contaminated with radioactively marked protein and cleaned using the standard methods available in the CSSD. It emerged that on average 2.6% of these fully dismantled instruments were still contaminated after cleaning. Further investigations with new instruments had shown that these soils did not accumulate in the course of clinical use. From these results Bijl concluded that the investigation method based on radioactively marked protein was suitable for monitoring surgical instruments. For the MIS instruments used here it was revealed that they were not adequately cleaned with the standard methods.
Ulrich Kaiser, reported on the properties of Class 5 and 6 chemical indicators. These could replace biological indicators and had the advantage that no incubation time was needed before reading the results. But what was important was that the chemical indicators could provide information only on the conditions prevailing at the respective measuring site; but homogeneous conditions were not to be found throughout the chamber. Therefore it was necessary to position several indicators at appropriate locations.
In respect of non-condensable gases (NCGs) Kaiser stated that chemical indicators were only able to detect accumulated NCGs, and this in turn only if the NCGs occurred at exactly the respective measuring site. Hence the process could still be released even if there were up to 10% NCGs in the steam. It was therefore advisable to use indicator systems that could simulate the correspondingly difficult steam-penetration conditions. These "batch control systems" helped to overcome the limitations inherent in Class 5 and 6 indicators. What was always important was to position the indicator system at the site concerning which information was sought.
Terry McAuley elaborated on the Bowie-Dick test and on the issue of whether it still played a role in modern sterilisation departments. She briefly described the fundamentals of the BD test and summarised the myriad standards dealing with this topic. The test was by all means still relevant today. What was important was that there were different air-removal systems. There were also several different commercially available test packs. Certification of these by an independent body, rather than by the manufacturer, should be advocated.
Cornelia Hugo focused on the topic of loaned instruments and described the system used at Tübingen University Hospital. There had been problems with deliveries earlier, with instruments scheduled for use in the OR on the following morning arriving only in the evening, and that without any decontamination instructions. Another aspect was that the instruments were often packed in plastic containers, giving rise to the problem of wet packs when processed. A working group in Tübingen had dealt with these problems and by now responsibilities had been clearly assigned. Forms were compiled and were now available on the intranet. The instruments had to be delivered four days before their intended use. If the instruments remained in the hospital for a long period of time, they were even integrated into the hospital’s own documentation system.
Even if this approach called for certain administrative investments, to cite Hugo, it had to be borne in mind that by now more than 60% of the instruments used in traumatological surgery were loaned instruments. As such, clearly defined practices were indispensable.
Toni Zanette spoke about cost transparency in the CSSD and described how exact invoices could be produced for the various departments on the basis of cost centres and invoicing departments. Of course, investments would have to be made in advance to assure the technical and staffing requirements. But ultimately this system would provide for fair assignment of costs to the various cost centres, right down to the individual instrument. Furthermore, the level of transparency conferred would grant the user more control over costs. A study carried out in a neurology department had for example revealed that there only 48 - 57% of the instruments in a tray were being actually used. There was a savings potential of some 50,000 Euros to be made in that area. Moreover, it was possible to dispense with budgeting by directly making out an invoice; in reality the resources generated from payment of invoices were used to meet everyday running costs. In the event of a surplus, investments could be made in other projects.
And true to the spontaneously coined motto "Sterilisation with a smile" the congress was brought to a close on a humorous note. Kyrre Saether described the important role of humour in creating a pleasant and productive working atmosphere. While the issues involved were of a serious nature, the playful components of humour served to enrich the working climate by introducing positive emotions - and it was precisely a lot of humour that was in evidence at this congress in Lillehammer.
Next year’s WFHSS congress will be held from 3 - 5 May in Baden near Vienna on the occasion of the Austrian Annual Congress. The announcement of the venue by the Austrian delegation gives us hope that there an equally positive congress atmosphere will prevail - so please make a note of this date in your diaries.
