London welcomed delegates to this year's Decontamination Sciences Congress with a cold drizzle. Spirits were high, nonetheless, because on opening the conference Gillian Sills, Chairman of the International Federation of Sterile Supply (IFSS), was able to welcome almost 500 delegates from 44 countries. On this occasion, the congress was jointly organised by three institutions: in addition to the IFSS, the Institute of Decontamination Sciences IDSc (formerly known as ISSM) and the European Forum for Hospital Sterile Supply (EFHSS). A key note address, "Where are we now; where are we going", was given by Dr Geoffrey L Ridgway, President of the IDSc and Chairman of the Central Sterilising Club (UK). Having given an overview of the early stages of invasive medical procedures, e.g. trepanning which was practised already in Neolithic times, he outlined developments in sterilisation, ranging from the use of heat through the introduction of steam around 1890 right up to present-day technologies.
Little progress was made in the field of sterilisation until the 1960s; at that time, high-vacuum autoclaves were developed, followed by other sterilisation techniques such as irradiation, ethylene oxide and gas-plasma sterilisation.
The emergence of variant Creutzfeldt-Jakob disease (vCJD) led to a greater recognition of sterile supply processing as a specific discipline; moreover, the importance of cleaning was recognised because prions, the causative agents of CJD cannot be destroyed by sterilisation.
Increasingly more complex instruments, especially flexible endoscopes, are posing new challenges for sterilisation. Ridgway stated that this meant that manufacturers, clinicians and decontaminators had to get together at an early stage when developing instruments. At a scientific level, too, sterilisation had to deal with more and more new fields. Hence the term "Decontamination Science" is by all means apt.
Valerie O'Brien and Fiona Kennedy gave an overview of the situation of decontamination in the United Kingdom. A survey conducted in 1999 recorded the prevailing status on the basis of spot checks in different categories of healthcare establishments (from primary to maximum care). O'Brien outlined how data was collected and which parameters were used.
Unfortunately, deficiencies, some serious, were noted in many respects. In the meantime, recommendations for improvements have been implemented in some cases.
Kennedy described the strategies aimed at improvements in decontamination in the long term. These included greater centralisation of processing using "Super Centres", which should contribute to acceptable, uniform standards at a national level. However, greater centralisation entails a number of special problems, e.g. as regards throughput and delivery times, legal business forms e.g. joint venture, and economic problems.
In her talk Nancy Chobin, USA, dealt with a further important topic: training and continuing education. She described how competencies for different jobs in sterile supply processing, from sterile supply technicians to department heads, were measured using job analyses. These were now being taken account of in courses and training modules at national level. The accredited Certification Board for Sterile Processing and Distribution (CBSPD; formerly NICHSPDP) thus looks after certified training of sterile supply staff regardless of their workplace. Chobin also showed the examination results for different training levels and federal states. She briefly alluded to the factors that could have a bearing on the failure rate. She then pointed out that since 2004 New Jersey, as the first US federal state, had made certified training mandatory for sterile processing personnel.
Cornelia Hugo, Switzerland, reported on validating training for sterile supply personnel. She described the valid laws and regulations in Germany and Europe which stipulate the use of appropriate, validated processing procedures to rule out endangerment of patients, users and third parties. However, Hugo stated that only in around 20% of cases were processes correctly validated. Therefore, appropriate staff training should be recommended so that the binding, stringent requirements could be met. A 1-week course was already being offered to that effect at Tübingen University, Germany. While, according to Hugo, participants should not necessarily have to conduct validation themselves, they should be able to interpret the results of the validation process carried out by specialist validation firms and be able to make any necessary changes to ensure continuous improvement in the quality of patient care.
Richard Bancroft, United Kingdom, spoke about the global requirements for processing, stating that the microorganisms to be conquered were essentially the same worldwide and that standardisation committees were also working towards uniform standards worldwide. However, there was considerable variance between the different countries as regards the methods used to investigate sterility. Bancroft described the advantages and disadvantages of the different monitoring approaches taken. In the case of biological indicators, the results depended e.g. on the respective load; the same reactions did not always take place.
Conversely, as far as chemical indicators were concerned one had no real guarantee that they would react in the same way as microorganisms. Both methods, to cite Bancroft, had their uses and complemented each, together with parametric measurements, for quality control in sterilisation.
Frank Schuurmans, head of a CSSD department that employs 35 staff members in the Netherlands reported on reorganisation of his department. In general, when carrying out reorganisational measures the originally designated goals are not reached in 70% of cases. But one goal that was reached in this case was the reduction in the sickness rate from 20 to 12%, although there was no negligible change in staff satisfaction with working conditions during the study period.
Schuurmans gave examples of the dilemmas and pitfalls faced during the reorganisation phase which lasted around one year. Bowie and Dick did not have the chance to enrol in suitable courses, e.g. an MBA, but Schuurmans emphasised that at present CSSD managers could and should take advantage of the existing knowledge in this domain.
To round off the first day of the conference, the firm ASP/Johnson & Johnson conducted a symposium on new developments in sterilisation and disinfection. M. Favero gave an overview of new and re-emerging infections, pointing out that infectious diseases continued to be the leading cause of death worldwide. He drew attention in particular to some of these diseases, such as AIDS and CJD, elaborating on the significance of various sterilisation processes.
E. Hoxey focused on how ISO influences international sterilisation practices. He described working practices in the standardisation organisations and the role of standards in general. He named some of the working groups that are important in the field of sterilisation, and summarised the standards compiled hitherto by these groups.
M. Lavery reported on the setting up of a new central sterilisation department in Glasgow, which is to replace the obsolete departments of 6 hospitals. He described the various planning and implementation steps involved, while highlighting the problems to be expected in each case. In such cases, he stated, the needs and also the ideas of all clients regarding the best sterilisation practices had to be borne in mind.
M. Eyles reported on practical experiences gained with the Sterrad system used in her department to process rigid endoscopes, among other things. There has been a considerable reduction in the number of instances of damage to endoscopes compared with those seen when using earlier techniques.
C. Roberts elaborated on the problems associated with processing flexible endoscopes and described new disinfection and automated processing methods. Of particular importance is to ensure that all endoscope channels are connected; this can be greatly facilitated by using, for example, colour-coded connections. Single-use disinfectants have different advantages compared with reusable solutions, e.g. the same disinfectant concentration in every cycle, which can be kept lower, thus reducing staff exposure.
Finally, K. Roth reported on investigations conducted by his working group on processing activities in the presence of prion diseases. He described effective, and partially effective as well as ineffective processing procedures and the different phases involved in testing detergents and disinfectants for efficacy against prions. A combination of alkaline cleaning in the Sterrad system had proved effective in animal experiments.
Day 2 began with a further company symposium; L. Sondergaard, Getinge Lunatronic, reported on the latest developments in tracking instruments and presented various tracking systems. Before choosing a system, one should find out exactly what requirements have to be met. Beginning with the choice of marking system - which can be anything from imprints to adhesive labels, each with its own strengths and weaknesses - the specific circumstances of the department concerned must be taken into consideration as far as possible. Of paramount importance is to think about the future too. It should also be possible to upgrade the system at a later date.
Gerald McDonnell, United Kingdom, outlined new perspectives in the decontamination of prions. He stated that the pronounced lipophilia of brain tissue was one explanation for the particularly good adhesive properties of prion-containing material. He described various studies for efficacy testing of cleaners, emphasising that each and every product had to be tested. An investigation of different enzymatic cleaners had shown that in some cases poorer results had been obtained with these than when using sterilisation alone.
One alkaline cleaner and a phenolic derivative had proved effective; they achieved a reduction of > 5 log levels. Furthermore, there was evidence that H2O2 steam was more effective than H2O2 plasma sterilisation. But no explanation could be given for this.
K. Roth, Germany, kept to the same topic, speaking about parametric control of cleaning processes in the age of vCJD. He stated that while disinfection and sterilisation steps were well documented and release was based on parametric criteria, the cleaning outcome continued to be subjected to only visual inspection in most cases. Roth reported on his own studies of MIS instruments, conducted under laboratory conditions. Using the radionuclide method it was possible to detect considerable shortcomings as regards their suitability for cleaning. This ultimately resulted in the modifications being made to the design of the instruments and washer-disinfector. Roth emphasised that validation had to be conducted for each instrument in order to obtain valid results.
Peter Hooper, United Kingdom, portrayed product release as a modern mythology. He posed the question as to whether release, as practised worldwide in different ways, was really based on adequate process monitoring or whether it was based on "imaginary and supernatural" assumptions - hence was more a mythology.
He described various methods of process monitoring ranging from parametric release through chemical and biological indicators to process challenge devices; it became clear that 100% safety could not be achieved in reality. But processes could, and should, be monitored to such an extent that an appropriate level of safety was assured for the medical devices.
Mariette Jungbluth, Netherlands, reported on investigations into various test soils to be used pursuant to prEN 15883 for verification of the cleaning outcome. Various failures were simulated, e.g. too high a pre-cleaning temperature, immobilised spray arms or no dosage of the detergent. The time and temperature were also recorded with dataloggers. The aim of these studies was to devise a standard test that would lend itself to daily routine checks: it should be easy to handle and of low cost. Furthermore, there should be no residues on the instruments and reading errors should be ruled out.
Diana Bijl, Netherlands, also focused on the topic of cleaning. She stated that it was no longer enough to merely check the temperature and cleaning time; validable processes, validation methods, routine checks and revalidation are specified in prEN 15883. Bijl outlined the problems encountered in everyday practice, stating that the "human factor" could not be eliminated in verification of cleaning if one continued to depend on visual inspection. Moreover, the manuals provided by the manufacturers were often incomplete or even incurrent. The instrument design presented a major problem, in particular in the case of MIS and lumened instruments.
The afternoon began with a trip to South America. Helga Sager de Agostini reported on processing in Argentina. Using photos of her department she described how problems relating to processing of endoscopes, surgical instruments and respiratory equipment had been solved. She stated that by carrying out reconstructional measures, it had been possible to create separate cleaning areas for different types of instruments. A colour-coded system and cleaning indicators were also used to enhance quality.
Adrie de Bruijn, Netherlands, described investigations conducted with the European helix test. He pointed out that the Bowie & Dick test which, inter alia, was used by hospitals as a reference load for operational qualification and requalification and as a daily steam penetration test, no longer necessarily met the daily requirements, since only rarely were textile packs sterilised in a hospital setting. Rather, intricate laparoscopic instruments were posing a new challenge to the sterilisation cycle. The Dutch National Institute for Public Health and the Environment (RIVM) had conducted a study in 20 hospitals to establish whether the sterilisers would pass the helix test defined in standard EN 867-5. All sterilisers passed the Bowie & Dick test, but 41% of them failed the 476 helix test cycles. These investigations had demonstrated that whether or not the sterilisers passed the helix test depended on the test conditions and on the method of air removal used. An air removal phase in the sterilisation cycle that is suitable for removing air from a textile pack does not necessarily lend itself to air removal from hollow devices.
Cynthia Spry, USA, reported on a quality assurance programme for processing rigid endoscopes. She pointed out that because of the exponential growth in endoscopic procedures hospitals were obliged to invest more money each year for purchasing new scopes. But in some cases even higher costs were being incurred for necessary repairs of existing scopes. Often, these did not function properly after repairs or they failed again after a short time.
Spry advocated that both new and repaired scopes should be subjected to a number of tests that were very easy to conduct, so as to check the resolution and the field of vision. This would allow a baseline value to be recorded for every scope, and any deviation from this could be noted subsequently. Faulty repairs could thus be identified at an early stage.
This was followed by a talk by Mike Pointer, United Kingdom, who drew attention to the advantages conferred by Statistical Process Control (SPC), which in the United Kingdom is being discussed as one of the innovations seen in the context of changing over to a super centre for decontamination. Quality assurance and servicing represented the most important contributory factors. Pointer compared the potential improvements with the expected efforts and costs. These would ultimately have to be weighed up against each other.
Simon Robitaille, Canada, explained the newly introduced ozone sterilisation, stating that for example ozone was very effective in killing microorganisms, but also resulted in oxidisation of materials. However, in-depth studies had shown that the resultant optical changes did not detract from the functionality of the medical devices tested.
In parallel to the main lectures two Free Paper sessions were conducted. The subjects covered here varied greatly, ranging from validation of a H2O2 gas-plasma sterilisation process through sterilisation in Papua New Guinea to reprocessing of single-use devises.
A further company symposium was conducted by Getinge on the new standard for low-temperature steam-formaldehyde (LTSF) sterilisers, EN 14180.
The evening was reserved for a gala banquet at the luxurious Savoy Hotel during which the EFHSS "Sparkling Egg Award" was handed out for the first time (see box).
The third day, too, began early - too early for some of the banquet attendees, who probably still had to order their "sparkling eggs".
First of all, the firm Miele and the German Surgical Instruments Working Group Berlin reported on new trends in instrument processing. Here too the prime focus was on cleaning problems. W. Michels highlighted the advantages of the Oxivario process and demonstrated its efficacy by giving what amounted to a "chemistry lesson for beginners".
David Hurrell, United Kingdom, at the start of the first session gave a talk in commemoration of Jack van Asten, while elaborating on the basic prerequisites for infection control. In this respect, sterilisation had the task of preventing transmission of infectious agents to other patients. In his customary entertaining manner, Hurrell referred to various shortcomings in the healthcare sector and in the processing domain. A change of nomenclature from "sterile supply" to "decontamination science" was not enough to eliminate these, he stated. He then went on to formulate a few scientific laws for decontamination (which should not be taken too seriously) and asked listeners to identify other characteristics of this new scientific discipline and let him know about the corresponding laws.
In his talk Paul Holland, United Kingdom, identified humans as a risk factor, while outlining first of all the reasons for mistakes and how to counter these. The "human factor" had to be borne in mind when planning working activities because, after all, decontamination departments made an important contribution to safe healthcare.
Jennifer Grainger, Australia, reported on risk management in respect of surgical instruments. She described the current requirements arising from the development and deployment of increasingly more intricate instruments and, based on risk management and the classification of medical devices into certain risk groups, she showed how the danger to patients could be minimised.
The next talk was given by Yaffa Raz, Israel, who spoke about the introduction of a quality management system into her department. Following an analysis of the error rate as well as a review of the individual errors, various quality control measures were taken. Of paramount importance here was continuing education of staff; it was also important to inform staff members personally when mistakes were made and explain how they could be avoided. One working group organised by staff contributed to quality enhancement by putting forward their own proposals. After introducing the programme it was possible, to begin with, to reduce the error rate from 1.33 to 0.9%, but this rose again after some time.
In the meantime it had been possible to improve the results again using another quality control programme that also recorded the individual staff member's performance and mistakes.
Bénédicte Gourieux, France, presented a quality control programme that had been in place since 1993 at the University Hospital of Strasburg. A new building and reorganisation of the sterilisation department in 2000 had also facilitated implementation of a new quality assurance programme, HACCP (Hazard Analysis Critical Control Point), which analyses the critical control points encountered in the decontamination process. The critical points defined were cleaning, packing, loading, sterilisation and transport. It was thus possible to take specific precautions for adequate control of these critical points. Gourieux stressed that the respective working group was composed of CSSD staff as well as of personnel from other departments (pharmacist, OR nurses, surgeons), thus making it easier to implement the programme. Toni Zanette, Germany, who acted as moderator for the afternoon sessions, remarked that in view of the requisite quality and of the high-quality products used, it would be appropriate to engage the services of quality management officer on a full-time basis.
The last session before closure of the conference focused first on all on the legal requirements. Philip Naylor, United Kingdom, explained how difficult is was to adhere to all laws, standards, regulations and directives, while explaining how these multifarious requirements could be integrated into the respective organisation using a computer program, thus contributing to continuous improvement in communication and performance within the department.
Michael Martin, United Kingdom, reported on decontamination of dental instruments, of which immense numbers - estimates are in the region of 3500 million instruments each day - are processed. Unfortunately, he stated, this was not done to the normally high standard used in hospitals, but rather under fully uncontrolled conditions in private practices. A recently conducted study had shown considerable shortcomings in this area (Smith et al.; www.scotland.gov.uk/library5/ health/sdgdp.00.asp). For example, single-use instruments were reprocessed in a high percentage of cases, or the complete absence of washer-disinfectors. He pointed out that here one had to bear in mind that in many areas of dentistry it was very difficult, or even impossible, to clean several of the instruments used in the dental setting, but these had to be classified as critical since they came into contact with blood. Martin stressed the need for improvements especially during training, ensuring that decontamination science was also part of the undergraduate dentistry curriculum.
Elizabeth Fradd, United Kingdom, reported on a review of endoscope decontamination in Northern Ireland which was initiated following serious drawbacks in cleaning, with the appearance of blood residues on endoscopes that had already been released for reuse. By interviewing staff and representatives of the suppliers it emerged that despite the conscientious working practices the problems persisted. But it had been possible to eliminate the majority of them by improving training and continuing education, even if all it amounted to was asking simple questions such as, "how many channels does an endoscope have?" Only when a clear answer was given could one be sure that all channels would be decontaminated.
National regulations should also focus on other problem areas, e.g. cramped working conditions or unsuitable premises; these should then be implemented on a local and individual basis. Fradd stated that the findings of the study could also be extrapolated to other areas and other medical devices.
Finally, the 3M Poster Award was given to Edna Rodrigues and Kazuko Uchikawa Graziano from Brazil for their work on "Use and Reuse of Cotton Fabrics as Medical and Hospital Articles Wraps in Steam Sterilization", as Gillian Sills pointed out, to honour the efforts to achieve best practices also in countries with limited resources.
This eventful congress, offering a broad range of interesting talks, was an overall resounding success. The lunch breaks, which were suitably long in some cases, provided an opportunity to engage in the most important congress activity: communication and exchange of experiences with colleagues. Next year we direct our glance towards the north: the EFHSS congress will be hosted jointly with the Norwegian society from 18 - 20 May in Lillehammer.