For once, Friday the 13th was a lucky date because in September it marked the first day of the
EFHSS Conference, which this year was held jointly with the conference of the
Irish Association of Sterile Services Managers (IASSM) in Dublin.
In her opening speech, Oonagh Ryan, chairman of the
IASSM, was able to welcome more than 300 delegates from 24 - not only European - countries.
Tim Galekop from Belgium gave the first talk on "Practical aspects of packaging". This was also dedicated to the memory of Jack van Asten who died last spring. Galekop recalled a few episodes from Jack’s life and elaborated on a number of topics for which he had conducted important research and development tasks.
Galekop went on to say that packing materials should be non-linting. He then highlighted some of the key developments in this domain, ranging from the 1930s when textile packing materials had been introduced through the 1960s, which saw the advent of heat-sealable packing materials, to the introduction of nonwoven materials in the 70s. Galekop stated his own preference for double packaging, stating that the different folding of both layers was better able to prevent microbial migration through the fabric than two-layered material, in which the folds were formed at the same locations. In respect of patient safety, this was an important factor in reducing the infection rate. Disposable materials were not more expensive and contributed further to reducing the infection rate.
Eoin Flavin, Ireland, outlined developments in his company, Steri Tex, which supplies OR departments with ready-to-use sets composed of reusable materials. The company had grown from a laundry contractor to become a specialist supplier. Flavin summarised the properties which the reusable materials must posses, such as e.g. a weaving density of 6000 threads/inch. On the basis of studies conducted in cooperation with OR personnel, the sets and procedures had been increasingly standardised - an important quality assurance measure. Furthermore, the assignment of a barcode to each set ensured complete tracking.
Joost van Doornmalen, Netherlands spoke on "Validation and routine checks in the practical setting". He began by defining the terms "clean" and "sterile", while pointing to the problems associated with such definitions. He described the routine checks to be conducted as well as the technical aspects of measurement and calibration. He drew attention to the fact that the measured values obtained in the course of routine checks served as proof of quality, but were not a substitute for validation. He then went on to elaborate in detail on steam penetration in open and closed lumened instruments and described the helix test as a test example for a lumened instrument; but findings for this test procedure had been available only for the past five years.
René Vis, Netherlands, in the afternoon described his experiences with loaned instruments. First, he outlined the basic problems, e.g. on using loaned instruments one often found oneself confronted with an unfamiliar device, for which no processing information was available either. Nor were the containers often suitable for processing. Vis then highlighted the responsibilities of all parties involved. Accordingly, the loaner was responsible for the instruments and associated information, but the hospital was responsible for decontamination, and had to issue a certificate to that effect. When using unfamiliar instruments, Vis recommended that a two-day run-in period be planned. The safest approach was also to always view instruments as non-clean, even if they had already been sterilised by the loaner these should be processed again in all cases because the hospital was ultimately responsible here.
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Peter Newson, England, spoke about "Validation of indicators". First of all, he outlined the fundamentals of the Bowie & Dick test and pointed out that it was very difficult to detect air in an empty steriliser. Prefabricated Bowie & Dick test packs had always to be compared with the original 7kg laundry pack. Newson stated that here standardisation had its limitations, e.g. there was no higher-level control body, but rather the manufacturers themselves conducted certification. To be on the safe side, he recommended that the test packs employed be certified again by an independent body and he then called upon users to take a demanding stance vis-à-vis the manufacturers, and always insist on getting the pertinent documentation for devices.
The last talk of the first day was given by Tony Kerry, England, on the subject of auditing. He stated that, in addition to the OR, the sterile supply department was the most material-intensive department in the hospital, and went on to outline some of the problems encountered. For example, often there was too little control. Too little attention was paid to staff management and training. Moreover, equipment was often old and poorly maintained.
Kerry stressed that an audit did not take place in the office but rather that the auditor had to check the prevailing conditions on site. It was advantageous if hygiene specialists, the head of the sterile supply departments and the entire team could be present. He then went on to give a few examples of what in England had led to a "red alert" rebuke. He described the hospital infection rates as unacceptable and made an appeal - especially at a time when financial resources were scarce - that attention be paid to the improvements which were available free of cost. Useful information on this topic could be consulted at
www.medical-devices.gov.uk or at
The very interesting first day of the conference was rounded off with an equally interesting evening event during which the very load singing made some of the delegates hoarse; but this hardly prevented anyone from appearing on time at the lectures next morning.
Wim Renders opened the second day with a few words of thanks to the exhibitors who had made it possible to hold the conference and he then drew attention to the
www.efhss.com, which features some interesting novelties.
Gerard Colleran, Ireland, in his talk on biodecontamination gave a figure of 5000 deaths each year due to nosocomial infections. This gave rise to costs to the tune of more than 1 billion British pounds per year. Therefore liability issues were of enormous importance. Colleran summarised some essential points that could contribute to preventing infection. He evoked the old strategies already established by Pasteur and stated that the latter’s experiments showed that microbes adhered to particles - this was of paramount importance in infection prevention. Colleran also called to mind that residues on instruments had consequences even if they were not composed of viable microorganisms; likewise, biological residues could by all means replicate. Disinfectants were neutralised to an extent by soils, with the latter affording protection to microbes. Therefore cleaning was the most important single step in processing.
Toni Zanette, Germany, gave a talk about Instrument Tracking. He emphasised the need, not least for reasons dictated by liability legislation, to collect, archive and keep ready for access large quantities of data in the CSSD. Therefore, complete computerisation of all activities had become almost indispensable in the present day. Zanette presented a system that operates with a computerised matrix code and which had been tested, among others, at Tübingen University Hospital. The code is engraved on each instrument and is rendered machine-readable by means of a camera. This thus provides for complete tracking. In turn, this means that an ongoing inventory can be made, which ensures better utilisation of the available instruments and could thus ultimately contribute to cost reductions. During the ensuing discussion, someone asked whether the computerised workstations might not pose a safety risk as far as cleanliness was concerned. Zanette replied that flat screens and disinfectable keyboards, as used in the industrial setting, were suitable.
Under the heading "There’s something in the air", Ronnie Russell went on show what is not visible but is nonetheless present. He, too, briefly spoke about the experiments by Pasteur and Tyndall, and explained what are known as 'bioaerosols' comprising microorganisms, their constituents, and possibly metabolite products, which often adhere to particles. There are certain air currents and in particular turbulences that could contribute to microbial dissemination. Russell demonstrated a few sampling techniques that took account of the spread and deposition patterns of such aerosols. He showed how strong turbulences could be caused for example by persons in a working area, which is why access to critical areas should be kept to a minimum, especially where personnel from other departments were concerned.
Peter Hooper, England, outlined the requirements of the British Health Technical Memorandum HTM 20/30 for washer-disinfectors, while portraying its history and comparing it with the European prEN ISO 15883.
A standardised approach was taken for all instruments - however, there was now the problem of CJD. CJD, to cite Hooper, was not a newly emerged problem because there had always been sporadic cases of disease even before the advent of vCJD. The use of single-use instruments in all areas, which would certainly solve the problem, was doomed to failure, alone because of the costs involved. During processing, sterilisation had its technical limitations because for example the temperature could not be indefinitely increased in a steriliser, which is of course a pressurised container. Hence cleaning in the washer-disinfectors was all the more important, stated Hooper, because what was involved were proteins, and protein removal was also a standard requirement. But in this respect the washer-disinfectors should have certain features. For instance, provision should be made for complete empting and self-cleaning of these machines. Special importance should also be ascribed to checking for protein residues after cleaning.
The second day of the congress ended with a few short lectures. Sheila Sheahan and Patricia Doheny, engaged in training at the Institute of Technology in Tallaght, spoke about validation and quality management as per ISO 9001. Philip de Vries, Netherlands, explained the functional method of the Electronic Test Systems (ETS, manufactured by 3M).
In her closing remarks, Oonagh Ryan thanked all members of the organisational committee and from industry. And like many congresses before, this one had one shortcoming: it was over too quickly. The delegates would certainly have liked to have had more time to engage in discussion with colleagues and, of course, to visit the lovely city of Dublin. The latter will have to wait until a holiday in Ireland sometime; but there will be an opportunity for the former next year in July at the
EFHSS Congress in Winterthur.
Dr. Gudrun Westermann