For this year’s 28th National Sterilisation Days relating to the healthcare services, CEFH (French Centre for Hospital Studies and Training) had chosen the scenic city of Tours, which is situated in the Loire and big enough to accommodate the well over 1600 delegates in attendance. For some 30 years now CEFH has been responsible for continuing education and advanced training in the healthcare sector, no mean feat as this entails coordinating the continuing professional development needs of very diverse professional groups with accordingly very different backgrounds. Participating in the congress were engineers, pharmacists as well as doctors, nurses and CSSD workers.
A number of company-sponsored satellite symposia were held in advance of the actual congress on 11th April. These focused on all conceivable subjects ranging from validation of cleaning and disinfection processes through marking instruments for tracking to packaging. The principle topics of the congress, "Tracking - why, how, to what extent?" "Surgical instruments and sterilisation" (focusing primarily on the issue of corrosion) as well as "The air and ambient conditions in the clean zone" dealt with topical issues in the field of sterilisation.
The congress was opened by Christine Chopard from the leading health authority, Hubert Garrigue, hospital director of the Tours University Hospital Centre (CHU Tours) as well as A. Dayan, deputy mayor of Tours.
Tracking - why and how?
This topic was immediately addressed by Claude Evin, President of the French Hospital Federation (FHF), in his opening talk: What is tracking; what rights do patients and personnel have? He explained that tracking was to be equated with localisation of the medical device in terms of time and place. Already back in 1998 French legislation made provision for assuring this standard of safety. Accordingly, guaranteed quality was something to which the patient had a right and those responsible for assuring this had to ensure that a quality management system was in place.
Luc Rozenbaum, hospital pharmacist from Nanterre, took a closer look at this topic by elaborating on the provisions set out by the standard XP 594-467:2006, which stipulates that each instrument must bear an unequivocal and unique identification code. Automatic recording was needed for qualitative and quantitative tracking of instruments in terms of time and place, thus providing for information flow showing the physical movements of the instruments, including identification of the instrument and respective staff member. Rozenbaum emphasised that all other related conditions had to be assured: care of instruments and their delivery to the CSSD as well as implementation of standards. Rozenbaum described the different types of coding systems used, e.g. Barcode and DataMatrix Code, and finished off his talk by explaining why this was needed: a tracking system enabled one to detect malfunctions at an early stage. Staff members could be held to account since whoever was discharging a particular task could be identified. Repairs could be made early on to ensure smooth running of operations.
Aude Coquard, hospital pharmacist from Rouen, showed a short film to demonstrate how her hospital was using a tracking system with Infodot marking (DataMatrix-Code). Her department had more than 5000 instruments in circulation each day. Each instrument was scanned on entering and exiting the packing table, as were the entire trays once again when placed in the steriliser. Overall, the insights gained from such activities were very positive.
Damien Talon, hospital pharmacist from Paris, summarised once again the benefits to be derived from tracking, stating that this enabled one to optimise the composition of the trays and instruments could be made available more quickly. Moreover, all the activities carried out in the CSSD could be recorded: working hours, provision of instruments, which staff members were doing what, where and for how long as well as the circulation time of instruments spanning the entire period elapsing from the time of use until they were reused. This provided not least for optimal scheduling of surgical procedures and warehousing.
Talon gave an analysis of the utilisation frequency of certain instruments. On this basis, instruments that were not being used could be withdrawn, while those that were rarely used could possibly be replaced by single-use devices. Conversely, in the case of those medical devices that were frequently used, such as orthopaedic motors, it might be advisable to purchase extra supplies to minimise the instances where devices had to be decontaminated in short turnaround times. This would also reduce the number of repairs needed, while ultimately enhancing warehousing and decontamination.
François Gougeon, orthopaedic medical director at the Lille University Hospital Centre (CRHU Lille), spoke about various aspects of tracking from the surgeon’s point of view, i.e. that of the "final consumer" of instruments. In his view tracking played a preventive and a curative role. Preventive measures ensured that unsuitable devices were not put to use (contaminated or malfunctioning instruments), while the curative element resided in the fact that a potentially contaminated device could be located and assigned to a particular procedure or patient.
One of the user’s main concerns was being assured of finding an optimally assembled tray, as well as the assurance that decontamination had been carried out in accordance with the manufacturer’s instructions and guidelines. Moreover, being able to relocate an instrument and assign it to a particular patient was a plus point. Looking ahead to the future, Gougeon stated that the use of paper-based documentation would continue to decline, while conversely the trend towards single-use devices and outsourcing was becoming more pronounced. An advantage accruing to the CSSD management was that tracking helped to keep a record of the milestones in an instrument’s service life. Episodes of use and repairs were clearly documented. But a change of mindset was needed before such benefits could be reaped.
Various aspects of this topic were further discussed in a panel discussion, with the views of other European participants also being expressed.
Annette Cubertafond, Limoges, outlined developments over the past decade, stating that already 10 years ago the topic of tracking had been broached - and now it had become reality to a large extent.
Hervé Ney, Geneva, gave an overview of Swiss regulations, stating that the basic issues involved were the same as those in France.
This was also the case for Germany, as portrayed by Andrea Fischer, former German minister of health who explained the regulations in force in Germany. Since 2001 the guideline formulated by the Robert Koch Institute (RKI) has been in force in Germany. This regulation clearly stipulates the hygienic requirements to be met for decontamination. She stated that it was particularly important to document each individual step, something that ultimately had to give rise to a corresponding tracking system. The involvement of the manufacturers was also needed as they were responsible for prescribing decontamination measures for each medical device.
Loic Geffroy from the Association of Private Healthcare Institutes emphasised that it was no longer possible to operate without tracking systems since otherwise it would be impossible to assure an appropriate quality management system. While admittedly costs were incurred for such systems, they were an indispensable prerequisite for meeting present-day requirements.
Marie-Christine Burnier from the French Hospital Association described how such considerations were given prime importance in various branches of industry ranging from the foodstuffs sector to medical device decontamination. The overriding concern was to avoid damage to the client, i.e. the patient, something that called for implementation of the best quality management system possible.
Christine Crespon, SNITEM Paris, outlined the requirements from the manufacturer’s perspective. Once the legal regulations were in place, the manufacturers had to come up with appropriate solutions, while one had to bear in mind that the requirements set by the international market differed in some respects. A higher degree of harmonisation was desirable here.
André Ochmann, vice president of Agence Régionale ARH Centre (entrusted with tasks on a par with those of a regional council) reported how ARH was also involved in decontamination processes, whether in planning and managing departments or outsourcing. ARH approval had to be sought in all cases. He emphasised once again that quality had a price that had to be paid, but pointed out that even at present a price had to be paid, that is to say for "Non-Quality". What was ultimately important was that the patient received the best possible care with a minimal risk.
Brigitte Louvel cited a further advantage conferred by tracking systems: they provided for archival of data together with the patient’s file - this was a tremendous benefit in the light of the increasing importance of documentation.
After this comprehensive portrayal of all aspects, the delegates broke up for lunch and then went on to attend various workshops.
Decontamination of Dental Equipment
Marie-Dominique Lecolier, Reims, Bénédicte Gourieux and Véronique Dasnoy, Strasbourg as well as Stéphane Corvaisier and Aurélie Bonvin, Lyon, dealt with decontamination of dental equipment. One problem encountered here was the manifold nature of the instruments and the applications that often called for a combination of devices. For example the size and design of drilling equipment entailed their own specific requirements, just as did the rotational components and complex design of handpieces and turbines. There was also a plethora of different boxes and containers for accommodating small components, likewise made from the most diverse materials and thus making more exacting demands on cleaning and on other processing steps. In summary it could be concluded that decontamination of dental equipment called for several procedural steps as well as for intensive control measures. In addition, staff had to be given special training.
Corvaisier and Bonvin then went on to elaborate on the special features of dynamic instruments, e.g. rotating handpieces, of which there were also many different types. For example, rotational speeds between < 200 and approx. 180.000 rpm were observed. These devices could be processed in special washer-disinfectors (WDs) or in a WD with special inserts. A further point was that these instruments had also to be lubricated, and various systems were available to that effect. These had been compared in Lyon, permitting the conclusion that the preferred solution was decontamination in a WD in tandem with an automatic lubrication facility.
Gourieux and Dasnoy reported on the setting up of a new dental clinic in Strasbourg, and this had provided an opportunity for reorganisation of the documentation system and sterilisation. In future decontamination would be carried out from a central department in the new clinic. Certain devices were being replaced by single-use instruments; nonetheless, the instrument inventory was to be expanded (inter alia, due to the fact that there were plans to increase the clinic to accommodate 90 dentists’ workstations compared with the present 67). Continuing staff training was essential for documentation and decontamination.
The Role of Ultrasound
The role and validation of ultrasound in decontamination were the subject of another workshop. Alain Ragon presented methods for detection of cavitation, e.g. SonoCheck. Ready-to-use test devices, such as SoilTest or TOSI Lumcheck, could also be used in hollow instruments provided that these instruments could be connected to corresponding ports for flushing.
Christine Denis stressed that cleaning always preceded sterilisation. This entailed a combination of mechanical, thermal and chemical action. Ultrasound was particularly suitable for medical devices that could not be cleaned in conventional WDs, e.g. lumened devices. Ultrasound was contraindicated for devices with adhesive joints and for rigid optics as well as for synthetic materials that absorbed the waves, thus rendering them ineffective. She rounded off her talk by outlining a few specifications: the bath had to be changed after each use, something that caused problems or proved impractical in the case of ultrasonic baths integrated into tunnel washers.
It was then pointed out that a suitable cleaning method should be defined for each instrument; efforts should be made to restrict manual cleaning.
Other workshops dealt with the topics of continuing education for sterilisation personnel, organisation of decontamination workstations, liquid waste resulting from sterilisation, requirements for, and maintenance of, ventilation systems, European standards governing surgical drapes as well as concepts relating to low-temperature sterilisation with liquid sterilants. Thanks to the fact that workshops were repeated, all delegates were able to attend two workshops in the course of the afternoon.
The first congress day ended with a reception at the Town Hall, to which delegates were invited by the City of Tours and where they were able to enjoy wine, stimulating conversation and a view of the beautifully designed banqueting hall.
Corrosion - a Problem in Sterilisation?
The second congress day began with talks on the series of topics "Surgical Instruments and Sterilisation". Following an introduction by Jean-Marie Kaiser, Mathieu Giang from the French standardisation organisation AFNOR spoke about various standards that made references to corrosion of instruments resulting from the material properties (NF EN ISO 13402), disinfectants (NF S94-402-1) as well as the water quality (FD S94-468). The materials employed for manufacturing surgical and dental instruments should render these resistant to sterilisation, corrosion and heat. The French standard NF S94-402-1 elaborates on the corrosive effects of detergents and disinfectants on reusable surgical instruments. The manufacturers had to carry out 2 series of tests with stainless steel: an immersion test and electrochemical testing.
FD S94-468 deals with the water quality and is expected to be published in the coming months. It will help the user evaluate the water quality.
Gérard Vasseur from CETIM (French Industrial and Mechanical Technical Centre) began his talk by summarising the studies published on the topic of resistance of steel to corrosion. Stainless steel is composed of iron and carbon, with other elements such as chromium, nickel, molybdenum, etc. included in addition. The content of these materials also determines the properties of the steel. Vasseur presented various types of stainless steel and the relevant applications. On the basis of electron microscopy images, he spectacularly demonstrated how heat affects the structure of steel. At temperatures above 1250 °C the structure disintegrates, with the steel becoming very brittle and hard.
To finish off, Vasseur presented the results of a corrosion test with peracetic-acid-based products, showing macro- and microscopic images of pitted corrosion and of corrosion of instrument joints.
Ophthalmologic Instruments - A Special Problem Situation
Patrice Rat, Paris, presented cleaning studies of ophthalmologic instruments, stating that the majority of such instruments were sensitive to heat and oxidizing agents and as such could not be autoclaved. American manufacturers have often recommended glutaraldehyde, but this did not take into the account the problems relating to prions. Rat and colleagues investigated various ophthalmologic instruments. After cleaning twice with enzymatic detergents and predisinfection with chlorine-releasing agents, the synthetic polymers were damaged. Peracetic-acid-based finished products with a content < 1000 ppm were more compatible. Using these it was possible to subject the instruments to 450 - 500 processing cycles and peracetic acid was less toxic than glutaraldehyde, stated Rat.
Gas plasma processes were a possibility for sterilisation of sensitive instruments. The Sterrad2 process was validated for the products of the majority of manufactures and provided for sterile instruments as needed for retinal surgery.
Stéphane Corvaisier and Catherine Cunat, hospital pharmacists from Lyon, spoke about assembling trays. One problem encountered here was already that of nomenclature: often, there was only one name for at least two instruments, besides each instrument often had several names that were used synonymously. They stated that DataMatrix coding, as prescribed by the latest tracking systems, did not dispense with the need for optical recognition and assignment of instruments.
At the HC Hospital in Lyon, where 1700 different trays were being assembled with 2500 different instruments, in addition to the generic name, the actual name of each instrument plus a description of its characteristics (e.g. number of teeth) as well as size were recorded. There were photos of entire trays, of individual instruments - in particular of the active parts - as well as of instruments in a dismantled state.
To summarise, Corvaisier stated that each tray was assembled for the patient but also for the surgical staff. This tray had to be safe and reproducible, i.e. for example the instruments had to be arranged such that the instrument nurse could access them easily. Correct nomenclature, as mentioned above, made assembly much easier.
The afternoon was rounded off once again with a panel discussion on this topic. Then the CEFH prizes were awarded, for sterilisation (Dominique Gambaud, Paris), quality in care (Olivier Menier, Sarreguemines) and hygiene/infection control (Françoise Ulmann, Aix-en-Provence).
Taking a Look across the Frontiers
The afternoon was opened with a look across the frontiers. The former German health minister Andrea Fischer reported on sterilisation in the German hospital setting. She portrayed the role of medical devices and their decontamination for the patient as well as the economic and political implications. She went on to speak about the problems relating to CJD, and introduced the guideline formulated by the Robert Koch Institute, which in Germany regulates hygiene requirements for decontamination.
The main tenet of legislation was that decontamination or decontaminated devices should not pose any danger to the patient, the user or to a third party. With a view to the future, she also spoke about the subject of single-use devices, stating that there was no uniform European legislation for decontamination of single-use devices. To date, more than 6 million single-use instruments had been processed without any adverse incidents. In the case of cardiac catheters, which could cost more than 100 Euros, it was thus possible to make savings in the range of several 10,000 to millions of Euros in large centres.
The Air and Ambient Conditions in the Clean Zone
Other lectures were devoted to the topic on the agenda that afternoon: the air and ambient conditions in the clean zone.
Jean-Claude Labadie, infection control officer from Bordeaux queried whether the contamination caused by dispersal of particles from humans posed a risk for decontamination. The human being who, depending on the intensity of movements dictated by the tasks performed, dispersed a large quantity of particles into the environment was to be viewed as "Homo contaminatus". In this way, it was possible to transmit microorganisms and pose a real risk to patients. These could also reproduce and grow on inanimate objects. As such, medical devices could by all means be contaminated and pass on this contamination. One problem in this respect was prolonged exposure to the air within the OR theatre.
Standard ISO 14644 focuses on the particle content in clean rooms, while standard ISO 14698 deals with the maximum concentration of living particles and with microbial loads. Labadie stated that at least the ISO Classification 8 should be observed for decontamination departments.
Jean-Claude Guichard, vice president of the French Society for Prevention and Contamination Research (ASPEC), also spoke about the particle count in various environments, which could amount to approx. 10 million /m3 in hardly industrialised regions, and to 400 million/m3 in industrial areas. Pursuant to ISO 5, a count of 3520/m3 must not be exceeded, and of 352.000/m3 as per ISO 8. Even sedentary persons could give rise to emission and transmission of particles as a result of continuous desquamation of the upper layers of the skin and because of rising air currents resulting from the body heat. The air enclosed between clothing and the body generated a "bellows effect", promoting desquamation and transmission. On the other hand, complete surgical clothing served to considerably reduce particle emission.
Efficacy of Various Substances against Prions
The final lecture of the afternoon was given by Cyril Vadrot, hospital pharmacist from Paris, on the subject of peracetic acid for inactivation of prions compared with other products. Based on French Circular 138 of March 2001, glutaraldehyde was no longer recommended for decontamination of medical devices in the context of prions. Other processes deemed ineffective included radiosterilisation and dry heat sterilisation. Glutaraldehyde is one of the subgroups of fixing substances, but has been classified as being partially effective, whereas peracetic acid has been classified as ineffective. Vadrot presented the results of his own efficacy testing of these substances, where efficacy was investigated in vivo (animal experiments) and in vitro (western blot). Residual infectiousness and even a fixing effect were noted for peracetic acid.
The poster prize was awarded on completion of the round of lectures. The prizewinners were Christophe Paumier and colleagues (evaluation of automated cleaning and disinfection using test soils) and P. Janssens and colleagues (an instrument for analysis of workload in a sterilisation department).
The afternoon was rounded off with a summary of the previous day’s workshops, so delegates had the change once again to recall all topics covered. And this brought to a close an impressive congress that was well organised and, thanks to the interesting topics addressed, it made a worthwhile contribution to the delegates’ continuing professional development, and not least provided an opportunity for exchange of views with colleagues, a particularly valuable aspect of such meetings.