Conference Report
For the first time ever the Turkish sterilisation association
Central Sterilization Units Society of Turkey (MSÜD) organised this year’s
EFHSS conference together with its national congress - no mean feat for a society that is still in its infancy, particularly in view of the constantly increasing number of delegates. On opening the conference, Hülya Erbil,
MSÜD chairperson, and Wim Renders for
EFHSS were able to welcome more than 450 delegates from some 30 countries. And equally international were the speakers. The first talk, given by Benedicte Benoit, France, focused on the issue of "What’s new in sterilisation since ...Louis Pasteur?" Benoit gave an overview of the history and development of sterilisation and concentrated then on current issues, such as e.g. quality assurance. In France, where the CSSD is inspected by the health authorities, around 10% of departments were refused approval in 2003, mainly because of shortcomings related to their premises.
Benoit then went on to elaborate in greater detail on the French system. She stated that sterilisation departments were managed in principle by a pharmacist, which had the advantage that s/he was on the same hierarchical level as the head of hospital infection control. For a long time now there has been a university degree course for training sterilisation specialists, and this has essentially served to upgrade training.
Despite the fast pace of developments, steam sterilisation continues to be the standard process. Benoit concluded by stating that new developments were expected more for materials and verification of cleaning than for sterilisation.
The talk given by Arzu Sayiner, Turkey, dealt with the role of the CSSD in infection prevention. She described cases of nosocomial infections and outbreaks cited in the literature, such as infections with Serratia marcencens attributable to inadequately sterilised draping materials. Minimally invasive surgery and endoscopy were posing special problems for sterilisation departments. Sayiner stated that based on an American study 24% of processed endoscopes were not clean and that microbial loads of = 106 cfu could still be detected in the channels.
Reprocessing of single-use devices, which was still practised in many places, even though it was not recommended or was even prohibited in some cases, also often caused problems, not only because of nosocomial infections but also because of material changes adversely affecting the functional capabilities. New pathogens, e.g. prions, were constantly giving rise to new and increasingly more exacting requirements. The CSSD was playing a leading role in infection prevention. Successes could be scored already at the time of making a purchase by buying medical devices that completely lent themselves to cleaning and sterilisation. The MIS instruments and endoscopes described would continue to cause problems in this respect in the long term. Sayiner concluded by stating that well-qualified personnel as well as standardised working procedures also contributed to success.
Rosemary Simpson, United Kingdom, described an online course for training sterilisation personnel. This represented one option of decentralised learning, similar to training courses offered by radio transmissions or television/video-based programmes.
However, practical training in the workplace was indispensable in the field of sterilisation. So far it had not been possible to devise any virtual techniques to simulate this. Another important factor was communication with tutors, giving the students the opportunity to interact with experienced trainers.
Low-Temperature Sterilisation in the Spotlight
The session focusing on low-temperature sterilisation, under the chairmanship of David Hurrell, United Kingdom, was opened with a talk by Murray Nicholson, United Kingdom, who dealt with the use of H2O2 (Steris). Nicholson described the myriad potential applications of this technology which, for example, could also be used for decontamination of buildings or electronic equipment.
A.A. van Sorge, Netherlands, spoke about validation of the H2O2 plasma system (Sterrad). He described a practical approach for installation of equipment-independent measuring facilities that made it possible to conduct installation, operation and performance tests and thus provided for parametric release of the Sterrad process.
Linda Ashurst, Norway, described formaldehyde as a broad-spectrum biocide, however, because of its properties a certain level of knowledge was needed to use it. As a result of its toxicity, an explosion could endanger personnel and patients, especially in view of the fact that residues continued to be found on implements. For safety reasons constant vigilance was thus necessary.
Formaldehyde was not suitable for certain areas, in particular in view of the problems relating to prions, since it resulted in protein fixation.
Ashurst described the various steps of the low-temperature steam-formaldehyde (LTSF) sterilisation process and then elaborated on the requirements enshrined in EN 14180 for LTSF sterilisers. The main advantage of this new standard was that it led to conformity of sterilisers, making it possible to check older models on the basis of this standard for weak points. Even if this meant that older sterilisers might have to be taken out of service, an improvement in quality and safety was expected.
The session on low-temperature sterilisation was concluded with a talk by Louis Laurin, Canada, on the topic of ozone sterilisation. He stated that ozone had been recognised for ages as an agent for, for example, water disinfection. However, only recently had its use for sterilisation acquired market maturity (TSO3 Inc.) and it had been licensed in Canada and the USA. Lorin described how the efficacy of this process had been checked against vegetative bacteria, fungi, mycobacteria and bacterial spores. An additional test series conducted with the 236K strain against prions had demonstrated inactivation of these agents in the region of 4 log levels. As a novel low-temperature sterilisation process the ozone process could thus confer certain important advantages when processing heat-sensitive medical devices.
Egil Lingaas, Norway, opened the second day with an interesting talk about the bioburden. He described various origins of the bioburden and stated that the quantity found after using the device was in most cases less than 10 cfu; in fewer than 10% of cases could a bioburden, i.e. viable microorganisms, in the region of >1000 cfu be expected. The method for measuring the bioburden and for interpretation of the results were described in the standard ISO 11737, which was now being revised. Lingaas stated that while determining the bioburden should be part of the quality requirements to be addressed to the manufacture of sterile medical devices, this was often not carried out in hospitals.
Lingaas described a few methods for determining the bioburden and for validation, pointing out that not only viable microorganisms but also their components, e.g. endotoxins could lead to serious problems if they managed to penetrate into the tissues or sterile body cavities of a patient. To be borne in mind also was that the bioburden was higher in some cases after cleaning than prior to it, as revealed by a study recently published. This was particularly interesting in the light of the problems relating to prions.
Implements that were used as medical devices and were also sent for sterilisation, when in fact they were not medical devices, e.g. spools of string, laundry clips, etc. were also problem. A piece of string could for example could carry a bioburden of > 50 x 103 cfu/cm and would thus, of course, be fully unsuitable for use as a medical device.
To finish off, Lingaas mentioned a few figures relating to endoscope processing, showing a broad range of bioburden levels. Even if the median load was 0, values of approx. 600 were possible; because of the broad range it was questionable whether conventional quality control methods were suitable for such items.
Toni Zanette, Germany, spoke about validation and routine monitoring of cleaning processes for washer-disinfectors. The relevant specifications are summarised in prEN 15883. Zanette emphasised that the entire processing cycle should be validated, something that was difficult especially since the majority of steps were still carried out manually.
A working group was thus set up at Tübingen University composed of members from science, the field and industry in order to devise a practical guide to validation of cleaning and disinfection processes, while taking account of the valid standards, guidelines and recommendations. This guide has been published in the meantime in English and German (publisher: mhp-Verlag, Wiesbaden).
The poster prizes were awarded during the break. The awards went to "In-Service Training and Assessment in CSSD" by Faize Yafay and colleagues from Turkey and to "Instrumentation Used in Odontology and Required Processing Levels" by J.P. Daniel and colleagues from France. Wim Renders expressed his hope that the poster awards will be an incentive to initiate more research work from the CSSD practice.
The chairman of the
British Institute for Sterile Services Managers (ISSM) Paul Holland reviewed decontamination of reusable medical devices in terms of risk management. He summarised the reasons which made risk management indispensable. Apart from legal arguments and the protection of personnel and patients, there were also organisational reasons; it contributes to upholding a department’s reputation and helped not least in reducing costs. Risks had always to be balanced against the benefits. By way of example he referred to the re-introduction of reusable medical devices for tonsillectomies in the United Kingdom. Since the risk of postoperative bleeding and other complications had risen sharply following the, in some cases, obligatory use of disposable devices, the potential risk of contracting vCJD receded into the background compared with the in reality increased surgical risk.
Being able to trace both the trays and the individual instruments within a tray was also of paramount importance in the context of vCJD.
Holland clearly expressed his opposition to reuse of single-use devices. The risks emanating from material faults were increased even when reprocessing was conducted by certified industrial reprocessors.
Oonagh Ryan, Ireland, gave a talk about "The validation challenge", which she introduced with a few photos in remembrance of Jack van Asten. She stressed the importance of reproducibility of the sterilisation cycle; temperature and pressure measurements reflected only a momentary recording. After a brief overview of the validation steps and methods she presented the results of studies on validation. The results obtained for flexible endoscope accessories were particularly poor; biopsy forceps were not sufficiently clean, hence the subsequent sterilisation process was in all probability adversely affected. Ryan advocated that certain types of instruments that were very difficult to clean (e.g. those with narrow lumens) be replaced as far as possible by single-use devices. To finish off, she pointed out that the increase in invasive techniques as well as the high susceptibility to infection, e.g. immunocomprised patients, promoted the spread of infection. In this respect, being able to monitor all processing steps was of paramount importance.
Peter Newson’s talk outlined the various methods of sterilisation control, ranging from release with biological indicators to parametric release. The methods for batch control carried out in the CSSD and the indicators placed in the individual packaging for visual inspection by the final user complemented each other; what was important in all cases was documentary evidence that the parameters met the performance verification requirements and that the sterilisation process was thus properly executed. Newson also spoke about the imminent harmonisation of standards EN 554, ISO 11134 and ISO 13683. In EN ISO 17665 (sterilisation of medical devices, requirements for development, validation and routine monitoring of a sterilisation process for medical devices - moist heat) the key standards for validation and routine monitoring were to be brought together.
Tim Galekop, Belgium, described how to deal with residual moisture in sterilised loads. In moist loads the barrier function was not intact, he stated; hence such loads had to be viewed as being unsterile. Often, to cite Galekop, the problem was imputed to the packaging, but a combination of factors was generally responsible. This also meant that the solution was not always obvious. Galekop outlined a few potential sources for this problem, e.g. premature energy loss in the steam supply due to leaks or too high a container weight. Troubleshooting could be narrowed down using a checklist.
Nonetheless, Galekop stressed that the packaging was one of the most important aspects of the processing cycle after cleaning, as it was supposed to be the guarantor of sterility. Hence false economies should not be attempted here.
In the last talk René Vis, Netherlands, took a look at how sterile supply will be organised in the future. He viewed the ‘threat’ posed by outsourcing and showed how this could be countered. Today, a CSSD should be run on the principles of business management, as was the case for external suppliers. The costs had to be calculated exactly in order, for example, to work out the price per tray. It was also recommended that an annual report be compiled rendering the activities of the CSSD transparent to the hospital management. Collaboration could be essentially enhanced and costs reduced by aiming for good communication with the OR and management.
To round off, Vis stated that as a result of outsourcing a greater number of instruments was needed because of the prolonged processing and transportation times. This could amount to several million euros for a large hospital - an important argument for retaining the in-house CSSD.
Toni Zanette and Hülya Erbil gave the closing speeches at this congress, which bore witness to the Turkish society
MSÜD's successful debut as conference organiser and produced for all delegates not only interesting talks but also the chance to foster existing links and make new contacts - beyond the European frontiers. Next year's
EFHSS congress will be held together with the annual meeting of the
British ISSM and the international sterilisation association
IFSS at the beginning of April in London.
Dr. Gudrun Westermann
mhp-Verlag GmbH
Wiesbaden, Germany
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