15 September 2007 to 18 September 2007
MEMBER_US_ASHCSP ASHCSP 2007: Gateway to Success St Louis, United States
01 September 2007 / 11:00 - 14:00
IDI - Irish Decontamination Institute General IASSM Meeting 1 September 2007 Dublin Dental School and Hospital, Dublin, Ireland
27 May 2007 to 30 May 2007
Czech and Slovak Societies for Nosocomial Infections Prevention III. International Congress on Nosocomial Infection Prevention Lednice, Czech Republic
Organised by the Czech and Slovak Societies for Nosocomial Infections Prevention under the Auspices of the Ministers of Health of the Czech and Slovak Republics
[ Conference Info (PDF File) ]
27 January 2007 / 11:00 - 14:00
IDI - Irish Decontamination Institute General IASSM Meeting 27 January 2007 Dublin Dental Hospital, Dublin
(All full IASSM members requested to attend)
Joint OEGSV/WFHSS Congress Baden/Vienna, 3 - 5 May 2007 Conference Report
After its foundation, or rather its evolution from the European Forum EFHSS, the World Forum for Hospital Sterile Supply joined forces with the Austrian Society of Sterile Supply (OEGSV) this year in organising the annual congress on medical device decontamination. This was a fitting occasion because, after all, the OEGSV is celebrating the 10th anniversary of its foundation this year.
And it was in that spirit of international collaboration that Tillo Miorini, OEGSV chairman, and Viola Buchrieser, on behalf of the organising team, opened the congress with a simultaneously translated German-English welcoming speech, announcing with justified pride that delegates from more than 50 countries had travelled to Baden, close to Vienna.
Top priority accorded to exchange of information
Wim Renders, president of the WFHSS, congratulated the OEGSV on the 10th anniversary of its foundation, stressing the pivotal role played by the congress in disseminating information and promoting exchange of ideas between experts.
Reflecting this spirit, Yaffa Raz from Israel presented a study that focused on visitors to the WFHSS website. The Questions and Answers section of this page was opened in 1999. In the course of the next years the number of questions posed increased continuously, reaching the figure of 367 in 2005. Concrete analysis of the questions raised had shown that people often had difficultly in understanding normative regulations and standards and there were problems with the implementation of such standards as well as ethical dilemmas because of conflicting requirements. An in-depth analysis of these topics could serve as a basis for designing training programmes to meet the need for information in this multinational forum.
Medical device decontamination worldwide
The next stop in the "Journey around the world of medical device decontamination" was in Malaysia. W. Wan Ngah, chairman of the Malaysian Sterile Supply Association (MSSA), reported on reprocessing in Malaysia. She described the trends seen since the 1950s when boiling was used as the sterilisation method through centralisation of reprocessing activities in the 1970s to the present-day modern sterile supply facilities with corresponding training and continuing professional development programmes. The MSSA had made a significant contribution to that effect. Since its foundation with 38 members in 1996, membership had in the meantime grown to more than 1200. In 2006 the association was able to move into premises of its own, thus making it considerably easier to organise events, e.g. training seminars.
The next lecture meant a return to Europe: Reinhard Berger from the Austrian Agency for Health and Food Safety (AGES) reported on medical device safety in Europe. Devices that met the essential requirements during conformity assessment could be marketed without restriction throughout the entire European Economic Area. Following their placement on the market, they became the focus of market monitoring and medical device vigilance systems. In that context, reports of incidences and almost incidences relating to medical devices were recorded. Berger stated that the majority of such reports were initiated by manufacturers; at present some 1400 reports were submitted each year.
Tillo Miorini delivered a talk on behalf of Dr. Ecker for the Austrian Ministry of Health on hygiene management for medical devices in healthcare establishments. He stated that all EU member states had to transpose EU medical devices directives into national legislation. In 1996 the Austrian Medical Devices Act stipulated that cleaning, disinfection and sterilisation of medical devices in healthcare institutions be conducted with suitable validated processes so that they did not pose any danger to the safety or health of patients, users or third parties. A subsequent amendment to this Medical Devices Act took account of the increasing trend in outsourcing processes, while including all Central Sterile Supply Departments (CSSDs). Detailed regulations were to follow in a directive that was being currently drafted, e.g. risk analysis relating to the medical devices to be reprocessed, based on the algorithms of the German Robert Koch Institute. Some parts of these would have a legal character.
Standards and legal aspects
In the afternoon on opening the "Legal aspects" block of topics, T. Miorini asked the audience whether EN ISO 15883 was to be seen as a milestone. Despite dedicated work over many years the working group WG 8 had not been able, at least as far as Europe was concerned, to formulate uniform test methods to investigate the cleaning performance. This gave rise to a situation whereby was a number of (highly divergent) test methods from the member states had been incorporated into an international standard (or Technical Specification).
Some parts of the standard also described requirements that had to be met at the time of the type and factory tests or during validation (operational and performance qualifications). In Annex 3 to the "Guideline for testing, validation and monitoring automated cleaning and disinfection processes for medical devices", based on the Austrian standard OENORM EN ISO 15883 Part 1, 2 and CEN ISO/TS 15883-5, the OEGSV had defined the contents of a type test report that had to be available before commencing operational testing. What was planned was to compile and publish a list of those washer-disinfector types that met these requirements. Unfortunately, to date very few manufacturers had responded to that call to make the corresponding documentation available.
Despite the fact that work had been completed a long time ago on Part 4 of the standard, which dealt with the requirements addressed to the washer-disinfectors used for flexible endoscopes, it had not been published to date. Based on prEN, the following points should be borne in mind when purchasing an endoscope WD:
Interposition of a rinse step between the cleaning and disinfection cycle
Single-channel cleaning (no pressurised-chamber machines)
Single-channel monitoring?
Tracking facilities
Leak test.
Klaus Roth from Tübingen reported on the compilation of a decontamination guide based on ISO 17664. As per ISO 17664 the manufacturer was required to provide a detailed description of a decontamination process for his instruments. Here, it was possible to group together instruments of a similar design and carry out validation in each case for the most difficult instrument. Roth reported on the classification of instruments into 7 groups in accordance with the cleaning requirements. Despite the fact that automated decontamination was recommended for virtually all groups, Roth reported on studies he himself had carried out and that had demonstrated that, depending on the design, more or less intensive precleaning was needed since otherwise residual contamination was a problem, especially in areas that were not amenable to visual inspection.
To finish off, Roth pointed out that it was incumbent on the user to use the process recommended by the manufacturer. Therefore already at the time of purchasing instruments one had to ensure that the specified cleaning process could also be implemented in the given situation.
Hydrogen peroxide plasma sterilisation
Walter Koller spoke about the role played by hydrogen peroxide plasma sterilisation. The first machines placed on the market were not approved by the Austrian authorities since certain criteria had not been met and reliability did not appear to have been assured.
However, recent investigations had attested to adequate sporicidal efficacy of this system, admittedly within narrow limits: for example, one prerequisite was the absence of any form of organic or crystalline substance on surfaces as well as of cotton or other organic carrier or packaging materials. Nor was the procedure suitable for reprocessing long narrow lumens, in particular those of metal-coated instruments. Koller pointed out that the new generation of Sterrad products were fitted with facilities for process control, thus providing for validation - this was one aspect that had been criticised in the first generation of this type of equipment.
He went on to say that since October 2006 this process had been granted approval also in Austria, admittedly with severe restrictions: the process was not to be viewed as an alternative to other low-temperature processes such as ethylene oxide (EO) or formaldehyde (FA) and was recommended only for those medical devices that had not been designed for minimally invasive use. In any case, the special instrument packaging (Tyvek) and associated foil heat sealer recommended by the manufacturer had to be used.
Procurement procedures and how to deal with loaned instruments
The afternoon was devoted to the topic of loaned instruments. Renate Zierler from Graz described the various types of procurement, explaining the features of a clearly defined procurement process in the context of quality management. Increasingly more importance was being ascribed to the actual wording of the tender when purchasing equipment since this had to conform to myriad standards and regulations.
Andrea Percht, Linz, described the procurement process for washer-disinfectors. In a "WD dialogue", organised by the firm MicroMed Mittermayer in 2006 it was concluded that the CSSD management was often not sufficiently conversant with the current requirements and as such failed to take account of important issues. For that reason a working group was set up which compiled Annex 3 dealing with the following:
Procurement of washer-disinfectors
Information from the type test that was needed for commissioning/validation
ÖGSV recommendations as regards WD fittings
This draft was revised and released by the ÖGSV Expert Committee for Testing and could be downloaded from the ÖGSV homepage (www.oegsv.com).
Diana Bijl from Nijmegen University Hospital reported on how loaned instruments were being dealt with in Holland. Using a few photos, she showed the problem areas: unsuitable trays were as commonly encountered as contaminated instruments. The Dutch standard "Loaned instruments" and the position paper published by ASHCSP/IAHCSMM on loaned instruments, dealing with topics such as placement of orders, delivery, inspection of incoming goods, preparation before use for surgical procedures, decontamination after surgery, final inspection and rejects, was useful as was the standard EN ISO 17664 specifying information requirements to be observed by the manufacturers of medical devices. Nijmegen University had compiled a list of requirements for manufacturers and suppliers based on these standards. This list was discussed with all suppliers of loaned instruments. This approach had given rise to very positive experiences, with the result that all university medical centres had already adopted this requirements’ list.
In his afternoon lecture Adrie de Bruijn from the Dutch Institute for Public Health (RIVM) gave an overview of the difficulties encountered when purchasing instruments. Despite the fact that the European Medical Devices Directive mandated that the manufacturer gave clear instructions for reprocessing, this had not been done in the majority of cases. De Bruijn reported on a study carried out by means of a questionnaire to assess the quality of decontamination instructions. He stated that the checklist compiled on the basis of the findings could be consulted before purchasing instruments, thus ensuring prudent decisions were made. A detailed report on this study as well as the checklist were published in Central Service 2006; 14: 30-36.
Protein detection/inspection of cleaning results
The Friday morning’s series of lectures was opened with a talk by Helmut Faber from Graz who presented comparative studies relating to various protein detection tests. These tests had compared the Protect-M, BCA Protein Assay Kit and the Test Kit for protein measurement (Miele), all of which were based on the modified biuret reaction. Furthermore, HemoCheck S, a test for detection of blood, was evaluated. All protein detection tests had their pros and cons. For example, Protect-M had proved to be particularly easy to use; the test kit was very rapid, and thanks the combination of a portable reflectometer it provided for quantitative reading. Faber stated that being able to furnish rapid results was definitely important since in some cases the values were liable to rapid change. The investigations carried out with a standardised soil - as was highlighted in the discussion - did not provide any conclusive information on the reactions when used in conjunction with the proteins encountered in a real-life situation.
Horst Taferner and Jasmin Hribar from Klagenfurt reported on the formulation of a routine policy for checking minimally invasive surgery (MIS) instruments for residual protein. Attention was paid to choosing items for testing to select instruments with intricate, narrow, and in come cases angled design as well as materials that were difficult to clean. The protein detection methods compared were the Pro-tect M, made by VWR (semi-quantitative), BCATM Protein Assay Kit, manufactured by Pierce (semi-quantitative) and the quantitative OPA method manufactured by Miele (semi-quantitative and quantitative photometric measurement). In this study the BCA method scored best since it was simple to use (wipe test) and inexpensive. Furthermore, in duplicate testing by various investigators it showed the highest concordance (>96%). To finish off, Taferner gave the audience a few recommendations for routine operations: protein residues should be measured regularly once a week. Critical MIS instruments should also be subjected to pre-decontamination measures. Thorough cleaning was also recommended on a regular basis.
Tomozo Yamamoto from Japan reported on studies on the effectiveness of cleaning carried out at Japanese hospitals. A working group was to formulate a guideline for quantification of cleanliness. This working group had carried out tests to measure residual protein content following routine cleaning of surgical instruments with clinical soils at four university hospitals and three foundation hospitals. The residual protein content on the surgical instruments from seven hospitals was between 20 and 174 µg bovine serum albumin per instrument. On that basis, stated Yamamoto, it should be possible to formulate acceptance criteria for residual protein on reprocessed instruments.
Prions - current state of research
Walter Schulz-Schaeffer from Göttingen reported on novel insights into prion diseases in relation to decontamination of medical devices. He described the various types of Creutzfeldt-Jakob disease (CJD), citing their distribution and incidence.
In the case of invasive procedures in patients with a high risk of CJD transmission, the following cleaning and disinfection process could be used for steam-sterilisable instruments after use on high-risk tissue:
1-2 M NaOH for 24 hours or
2.5-5% NaOCl for 24 hours or
GdnSCN (3 M for 24 hours; 4 M for 1 hour; 6 M for 15 minutes).
Following this, steam sterilisation at 134 °C 3 bar pressure for 1 hour was needed. Instruments that did not lend themselves to steam sterilisation were to be incinerated.
Schulz-Schaeffer once again stressed the importance of cleaning to remove prion proteins. A combination of several decontamination steps using an alkaline cleaning cycle was advisable.
Validation of sterilisation and WD processes
The validation block of topics was opened by Theresia Enko who described how validation of sterilisation processes was conducted in practice. An analysis of the current state was needed before defining the procedure to be adopted. Enko stressed the importance of documentation. A well-functioning error management policy was also important so as to be able to take appropriate remedial measures.
Michael Gehrer, Graz, described implementation of the ÖGSV guideline for validation of WDs. The Austrian method used as a test soil heparinised sheep blood that had been reactivated with protamine sulphate since compared with other test soils, this best reflected the everyday conditions. It was also served to detect less obvious shortcomings and was relatively easy to use. The test soil was applied in situ and results could be evaluated by means of visual inspection without any major investment.
Tillo Miorini reported on the experiences gleaned over a 10-year period by the Institute for Applied Hygiene with testing WDs for medical devices. Using revealing photos he described the drawbacks detected, elaborating in particular on MIS instruments and endoscopes. In the case of MIS instruments, protein detection tests revealed, in some cases, serious shortcomings in cleaning performances, often related to old residual contaminants. In the case of flexible endoscope WDs, cleaning problems were detected as regards the cleaning of channels, chamber and external surface, in particular in the case of "short programmes" without an intermediate rinse step. For that reason as from December 2006 all endosocope WD programmes had to interpose a rinse step between the cleaning and disinfection phase.
Endoscope decontamination
Ulrike Prüfert-Freese spoke about testing and validation of WD processes for flexible endoscopes. She reported on tests carried out with Teflon tubes contaminated with an MNE test soil composed of wheat flour, nigrosin and hen’s egg. The PCDs used to test the disinfection performance, within the framework of the standard method, were Teflon tubes (length: 1.500 mm + 2000 mm; internal diameter: 2 mm und 1 mm) and germ carriers that had been inoculated with a defined microbial suspension (Enterococcus faecium ATCC 6057, 1010). The results demonstrated that following the cleaning phase the test organism had been reduced by between 4 and 7 log levels and that in general the reduction factor obtained for 1 mm tube was one level lower than that achieved for the 2 mm tube. The results for the entire cycle revealed that it was not possible to recover the test organism from any of the germ carriers, thus attesting to the fact that a reduction by > 9 log levels had been achieved. On the basis of those tests, this test method could be interpreted as being a clear-cut method, which was easy to use in situ, for investigating the cleaning and disinfection performance as stipulated y international standards.
Heike Martiny from Berlin outlined the parameters that affect cleaning of flexible endoscopes. Since visual inspection of the cleaning results was not possible for flexible endoscopes, a standardised validated decontamination method was urgently needed. The cleaning outcome itself was dependent on various parameters, including complete wetting/cleaning of all internal and external surfaces, the effectiveness of the detergent, the cleaning temperature and the cleaning time. The cleaning outcome could also be influenced by the water quality.
Visual inspection was used to assess the cleaning results for the external surfaces. More in-depths control methods included the use of a test soil and its successful removal with or without microorganisms and/or removal / measurement of chemical parameters such as proteins.
Martiny cited data from various studies to attest to the crucial role played by the various parameters in assuring good cleaning results, stressing once again that failure to assure the latter jeopardised the success of the other decontamination steps.
In the evening delegates had the opportunity to sample typical new Austrian wine with local specialities in a congenial atmosphere. Nonetheless, a surprisingly large number of people managed to appear early in the congress centre the next morning.
Certification and structured training
The morning of the last conference day was opened by Robyn Williams from Australia who spoke about continuing professional development in Queensland. The training courses in Australia consisted of some 300 hours and by now more than 95% of sterilisation personnel had successfully completed certified courses. But the question was how was this acquired knowledge to be retained and further expanded. The present approach was a structured continuing professional development system based on an American model where participants could voluntarily enrol in different advanced training courses, for which they were given corresponding credits. The idea here was that course attendees should also pass on their expertise and could gain further credits by giving talks to colleagues. The aim was to initiate a long-long, voluntary learning process so that staff were always conversant with the state of the art as far as quality assurance was concerned.
Monika Semler reported on the certification of her department at Vienna General Hospital. Each year around 80,000 StUs were reprocessed in the CSSD. Since June 2006 it had been certified as per ISO 9001:2000 and ISO 13485:2003, as the first CSSD in Austria. Semmler outlined the requirements for staff training, technical equipment, validation and documentation, and went on to describe the approach taken to achieving certification. An important aspect was the concept of "The quality management system as implemented", which ultimately meant continuous further development and improvement of the QS system with the help of all CSSD personnel.
Thomas Kießling and Mr. Breder from the Rheinland Technical Inspectorate reported on their experiences of certification in line with the guideline that was jointly formulated by the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM).
In virtually all cases the descriptions provided for the decontamination processes were in line with the requirements. For almost all certification audits the required risk classification as per the RKI/BfArM had been carried out and the training concept devised by the German Society of Sterile Supply (DGSV) had been taken into account when defining the level of personnel qualifications needed. Only rarely were serious flaws in hygiene detected.
Shortcomings were found in validation of sterilisation processes (apart from steam sterilisation). There was also a need to improve the availability and evaluation of the manufacturers’ instructions. Another problematic area was the IT systems used. In some cases these were not at all suitable, thus leading to gaps in documentation.
Wood fibres in medical devices
Kaj Henricson from Finland reported on the use of wood fibres in medical devices. Single-use medical devices were composed of a lot of non-recyclable materials and therefore there was a need for devices that could be easily recycled or could be used for heat generation. Wood fibres were eminently suitable to that effect because in general cellulose materials could be recycled. In the course of that study it had come to light that many types of packaging were made of other materials that could easily be replaced by wood fibres. These included, for example, packaging. That study was to be continued and was to soon enter phase II where concrete proposals for new products and solutions could be put forward.
Outsourcing - what must be borne in mind?
And just as in real life, the statutory authorities had the last word here too. Robert Kellner from Healthcare Department of the Lower Austrian State Government spoke about the various aspects of outsourcing to be borne in mind before taking a decision. These related to technical aspects (e.g. shelf life, pretreatment in-house, need for special instruments, etc.), as well as the organisational aspects of such collaboration. Kellner described medical device decontamination as one of a hospital’s core competences which would be relinquished if one were to fully hand over this decontamination service to an external supplier. In such a case, one could not fall back on one’s own resources even in an emergency. Therefore a termination clause should always be agreed so that the contract could be cancelled e.g. in the event of inadequate quality or other disagreements. Kellner compared the role of the statutory authorities with that of a marriage councillor: they could proffer valuable advice, thus contributing to long-term harmonious partnership.
To finish off: prizes, prizes ...
The congress was brought to a close with the award of a number of prizes. Wim Renders awarded this year’s WFHSS Prize, the "Sparkling Egg Award", to Josy Holdener from Switzerland (see p. 184).
The 3M Poster Prize went to Wan from Malaysia as well as to Vlatka Bojic-Turcic from Croatia.
...and fast forward to the future
Showing spectacular photographs the Monza racecourse, Flavia Bossi, chairman of the Italian Sterile Supply Association (AIOS) gave delegates a preview of what to expect next year when the WFHSS Congress was to be jointly organised by AIOS. We hope that many of this year’s as well as new delegates will attend this event so as to maintain this vital exchange of information.
WFHSS Conference 2007 Lectures and Presentations Introduction
by Wim Renders
3 May 2007 to 5 May 2007 Baden/Vienna, Austria
In the name of the WFHSS we warmly welcome you to our first congress. 7 years after the European Forum was launched, it was time to broaden our horizons and to approach sterilization no longer from an exclusively European perspective.
The worldwide interest in the WFHSS - OGSV congress,
demonstrates that we have made the right decision.
Indeed, standing still inevitably means that progress
is no longer made. The world of sterilization too is affected by changes. In our area of expertise the goalposts are continually shifting. This has not only meant, generally speaking, a broadening of the international framework in which we are working but especially a changing of the way in which sterilization departments carry out their tasks. It is becoming apparent that not so much new technologies but rather new trends will impact the most on the way the CSSD will function in the near future. I can for example refer to the increased attention to cleaning and disinfecting, to outsourcing or the centralisation of departments and to the introduction of quality management and traceability systems.
These approaches make it possible to guarantee the all important reproducible quality.
Indeed it is expected of the CSSD that it provides a medical device which meets the same standards as an industrially prepared one. That is the reason why in the CSSD the principles, which are applied in industrial production are more and more introduced.
The big advantage is that in this way the traditional, individual interpretation of the procedures, a situation, which still frequently occurs in the CSSD, is replaced by an industrial homogenous approach of the production processes by all members of staff.
The previous paragraph dealt with the striving for homogeneity within a sterilization department,
in my opinion however there is a much more urgent problem we have to deal with: namely the differences in quality between the different sterilization departments in one country.
Even today we have to conclude that the differences between these departments are often too big, that the quality levels are very different and that uniformisation and harmonisation leave much to be desired.
It is quite unacceptable that a patient who has to undergo medical treatment runs a greater risk in one hospital than in another one, depending on the quality of the sterilization department. But this is indeed
"an inconvenient truth". And this in spite of the efforts made by the members of staff in the sterilization departments. These efforts have been too
non-committal, very often, as a result of a lack of local guidelines and follow-up by the authorities.
But Sterilization Departments should be able to guarantee at least a minimum quality level.
Realizing this is a difficult but an important task for the national and regional societies. They can draft recommendations and provide information.
But first and foremost they should sensitise the authorities for this problem. Indeed only the government can ensure that guidelines and norms are followed, can impose the necessary measures and provide the funds to renovate departments.
In this debate too the CSSD should put itself in the position of the protector of the interests of the patient by striving for the harmonisation of the departments and by actively promoting and supporting the adequate treatment of instruments.
The interests of the patients bring us to the interface between the CSSD and Infection Prevention. The link CSSD - Infection Prevention is more and more made these days. And rightly so.
By providing a medical device of a high quality the CSSD can undoubtedly make a substantial contribution to safeguarding the health and the safety of the patient.
But due to the technicity and advanced skills reprocessing requires, it is my opinion that the CSSD should take a separate place in the organigram of the hospital and certainly in infection prevention.
This will allow the department to independently make its own decisions. This of the utmost importance especially when the interests of the same patient have to be protected e.g. in the framework of the irresponsible re-use of single use medical devices.
The backing by infection prevention is in this case of course more than welcome.
Decontamination is a rational, industrial process
of which the outcome can be perfectly predicted if
the essential requirements of process control are met.
To create the conditions to make this possible is
the primordial task of the CSSD. Reprocessing then becomes measurable and hence an objective process.
The essence for the CSSD remains the delivery of a medical device of a high quality. This inevitably means that there is no more room for amateurs.
Our members of staff have to be highly motivated professionals. Only in this way will the CSSD get the recognition and respect it deserves. Indeed all too often the importance of the sterilization department is still underestimated. In any case this is the perception of a large number of members of staff in the CSSDs all over the world.
But respects starts with self-respect and recognition can only be gained after a CSSD has met its own quality standards.
As I have mentioned earlier the quality of the end product the CSSD puts at the disposal of the patient and of the medical staff is our ultimate touchstone. Quality is the conditio sine qua non for our recognition by third parties. If this condition is met the department will, supported by a cooperative, pro-active attitude, radiate a positive image and will get the recognition it deserves.
Adaptation to the changing circumstances is not only a challenge to the CSSD but it has become a priority.
If the CSSD wants to have a future in the hospital, if it does not want to suffer the fate of the dinosaurs, it will have to evolve and progress.
We trust that the world congress can contribute to this and can stimulate the development of the departments. The diversity of the programme is proof of these objectives.
To disseminate information has always been the prime task of a congress. However, it is also our ambition to make Baden into a meeting place of the sterilization world. This congress offers an unique opportunity to get to know each other better, to exchange views and to discuss crucial issues. We will undoubtedly experience that the problems we have always thought to be unique to our department are in actual fact universal bottlenecks. It creates the opportunity of looking for solutions in collaboration with others and of joining others on the road to - or is it a quest for? - an ever better sterilization practice.
We would also like to congratulate the OGSV on its tenth anniversary and to express our thanks for organizing this congress.
We are convinced that the dynamism of the OGSV will remain the driving force behind an excellent national sterilization practice and a benchmark for all of us.
We wish you a very successful congress.
Wim Renders WFHSS President Baden/Vienna, 03/05/2007
We are honored to invite you to take a part in this conference, organized by the Israel Sterilization Association and the Israel Infection Control Nurses Association with cooperation of World Forum for Hospital Sterile Supply.
The conference will provide an update for infection control, sterile supply, operation theatre and endoscopy healthcare professionals.
On the occasion of its 11th annual congress, the
German Society of Sterile Supply (DGSV) settled for a new venue: this year’s conference was held in the "geographic centre" of Germany, in Fulda, so as to ensure that the journey would not be too long for anyone. The congress also began in the afternoon and finished in the afternoon too, so that arrival and departure was possible at the same time on each day.
This year there was not just one topic on the agenda, but rather a diverse range of topics. Accordingly, the talks were equally varied. The first talk was given by Sigrid Krüger and Martin Held on the subject of "The influence exerted by measurements in the cleaning and disinfection process and their practical relevance". They described loggers as used for various process parameters (temperature, pressure, pH value, conductance). The advantage of loggers, which undergo the cleaning and disinfection process together with the medical devices (MDs) and are able to continually record important variables, resides in the fact that the process need not be interrupted to withdraw the sample. The values obtained are not merely spot checks, such as is the case for the measurements carried out on samples of the cleaning solution using hand-held measuring instruments. As such, these loggers are important tools for control and troubleshooting purposes, providing for process optimisation and, thus, for qualification of the equipment in use.
Some detergents are better than others
Verona Schmidt described "Development trends for enhancement of process safety". She stressed that the cleaning performance played a pivotal role in decontamination. This belief had been reinforced by new challenges such as the discovery of prions, which could not be eliminated by conventional disinfection measures, as well as increasingly more intricate, primarily heat-sensitive medical devices. Hence the positive attributes of alkaline detergents had been eliciting increasingly more interest. Mrs Schmidt presented studies conducted to find out whether and under what circumstances alkaline detergents exhibited antimicrobial efficacy. To that effect the microbicidal properties of six alkaline detergents and two aldehyde-based disinfectants were compared. The results demonstrated that the aldehyde-based disinfectants were endowed with the best microbicidal efficacy. Of the alkaline detergents, only one detergent showed comparable microbicidal efficacy, which excelled thanks to, among other things, its surfactant content. It was possible to demonstrate that under the use conditions prevailing in a chemothermal disinfection process this detergent was also endowed with virucidal efficacy as well as with a prion-destabilising effect. These additional characteristics held out completely novel prospects for designing decontamination processes in the future. Application examples included the use of such a product in modern standard cleaning processes, while conferring the additional benefits of a disinfectant and prion-destabilising action. Mrs Schmidt stressed that these properties were not present in all alkaline detergents; the composition of the individual product was decisive.
New standard for steam sterilisation
Dieter Achterberg outlined the implications of DIN EN ISO 17665 (sterilisation with moist heat) on decontamination practices. He stated that, as from August 2009, DIN EN ISO 17665-1 of November 2006 would serve as the new reference standard, since DIN EN 554 would have to be withdrawn by that date in accordance with the regulations. The new standard was essentially more comprehensive than DIN EN 554 used hitherto. It dealt with all moist-heat processes, whereas DIN EN 554 was confined to processes based on the direct effect of saturated steam on the sterile supplies. Furthermore, DIN EN ISO 17665-1 dealt in detail with the process development and description of processes, something that was particularly important for manufacturers.
The standard also contained new sections on process challenge devices as well as on quality management.
Mr Achterberg pointed out that the efforts to achieve an international compromise had given rise to a very "open standard", that made no reference at all, for example, to numerical requirements for specifications. Hence in practical terms where validation of processes and routine operation were concerned this standard needed to be interpreted and supplemented if it was going to be of any use as a guide to everyday activities. Achterberg finished off by expressing the hope that an appropriate document (e.g. in the form of a recommendation or technical report) would be drafted.
Cooperation sought: workshops’ results
The workshops held in the afternoon and repeated on the second day of the congress dealt on this occasion with the topics of "Managing repairs in a modern CSSD", "Decontamination and value preservation of MIS instruments" as well as "Validation of processes in a washer-disinfector (WD)".
For the first time, a session was devoted at the end of the congress to summarising the workshops, while presenting the various results.
In Workshop 1 Stephan Knoefel from the company Schnorrenberg spoke about management of repairs. In that respect, driver systems and optics as well as increasingly more complex systems used in the MIS and HF area presented a special challenge. Cooperation with specialist workshops, distributors or manufacturers was therefore often needed. In general this meant that the instruments left the hospital and were not available to the users for a certain period of time. Hence it was important to organise a system that guaranteed the fastest turnaround time possible. The quality management system used here called for clear structures and sequences as well as documentation processes which, in the meantime, were largely computerised. Together with the participants describing problem area as well as positive and negative experiences, Knoefel stressed that an appropriate repairs’ management system could also serve as a component for cost control. As such, timely maintenance helped to detect damage on time, thus avoiding expensive long-term effects that could mean that the instrument would have to be replaced.
Workshop 2 focused on value preservation of instruments. Here too close cooperation was needed between reprocessors and manufacturers. Decisive factors related for example to the arrangement of instruments in the loading rack and appropriate adaptor systems. Incompatible cleaning processes, unsuitable reprocessing media or inadequate care could lead to premature wear of highly valuable instruments. Repairs carried out by unqualified persons often resulted in consequential damage to other system components.
Mr Haas stated that the most important aim was to ensure that hygiene requirements were assured for the instrument. Hygienic criteria had to take precedence over economic considerations. The workshop participants were unanimous that instruments sent for repair had to be decontaminated before dispatch. Care should be taken when dealing with non-authorised repair centres since they did not have at their disposal the instruments’ original dimensions and spare parts.
In Workshop 3 the team of authors who compiled the WD Guideline were available to answer questions on conductance of validation of WD processes. Robert Eibl reported on additional topics covered since publication of the Guideline in November 2006, such as how to deal with hollow devices and anaesthesia accessories.
He also presented a list of the frequently asked questions (FAQs), which could be answered during the workshop. He gave an overview of the issues that often caused uncertainty among users:
The normal process sequence had to be observed during validation
The processes had to be reproducible and documented by independent measurements
Maintenance comprised inspection, repairs and upkeep; this had to also take account, for example, of the loading trolleys whose connections were often not checked. Malfunctioning connections could lead to loss of pressure.
Calibration of instruments was not to be equated with adjustment where settings were actually carried out on the instrument. Eibl stated that what was important here was that the person carrying out the task had the level of expertise required.
The CSSD as a business enterprise
The second day of the congress began with the economic aspects of the "CSSD Services Enterprise". H.-J. Kleindienst, Munich, reported on the CSSD as a business enterprise and on quality management in an age of increasing cost pressures. The current trends in the healthcare sectors called for a high degree of strategic planning to strike a balance between quality requirements and economic considerations. Mr Kleindienst reported on the organisational form used at Munich Municipal Hospital (StKM) and described frequent weak links in the organisation. The aim was to assure the legal, economic and organisational outline conditions needed for a tray-related calculation system, down to the individual medical device and specific to the investment involved. An important milestone was thus the provision of concrete structures oriented towards the sterile supplies’ circuit, up to the time of delivery to the clients (surgical and other specialist departments, etc.) To that effect, workflow patterns had to be expertly planned, structured, implemented, reviewed and updated. This called for, first of all, thorough knowledge of the actual state: what trays were available, how were they labelled, was this labelling system uniform, how much "dead capital" did the inventory contain etc.? Savings of up to 30% could be made by optimising the loading patterns. Mr Kleindienst described the implementation of organisational measures aimed at optimising the CSSD at Munich Municipal Hospital, and finished off by stressing that quality assurance also ultimately meant a reduction in costs. Here staff represented an important factor; in view of the fact that many people with different backgrounds were involved, it was important that the existing level of knowledge was constantly reviewed and updated.
Barbara Everbeck from Bielefeld described the formulation of a marketing concept for the CSSD. At the Bielefeld Protestant Hospital (EvKB) medical devices belonging to the "Group C" classification were reprocessed at the Johannesstift site. It was thus decided to introduce a quality management system based on DIN EN ISO 13485 for the entire CSSD, and following certification to provide medical device reprocessing services as a professional partner to independent medical practitioners, outpatient surgery departments, medical care centres and smaller hospitals. Frau Everbeck described concepts devised for client acquisition as well as the pros and cons for the external client. For example, it was generally necessary to keep a greater stock of instruments to deal with exchange times. But the service provider hospital had to also make investments, e.g. in hiring and training extra staff. However, Everbeck stated that the provision of comprehensive medical device decontamination services overall produced satisfactory results for the external clients, who through using the service entered into another form of cooperation with the hospital.
Peter Schauerte, from Meschede, described the drafting of a service contract. Many hospitals had to decide whether internal reprocessing of their medical devices paid off in light of the technical, human resources’ and quality-assurance requirements to be met or whether it would be better to outsource medical device reprocessing to other hospitals or specialist firms. If an establishment were to decide in favour of "In-house decontamination also for third parties", the operators of such an establishment would then have to face the issue of what the contract would have to cover. Apart from business management issues, top priority would have to be ascribed to the reprocessing quality, regulated by the legal guidelines and standards governing medical device decontamination. Based on these specifications an outline contract could be drafted. What was important here was to draft a contract tailored to individual needs. While the existing legal regulations must not be transgressed, both parties to the contract could avail of customised and hence structure-related quality assurance. The contract should cover the following points: title, parties to the contract, subject of the contract, scope of services, contractual terms, operational prerequisites, quality management system, expert consultation, liability law and liability queries, pricing and invoicing, date at which the contract would come into force (for example, did this also entail any trial period?) and period of validity as well as pertinent documentation. As such, transparency of the entire decontamination process was absolutely indispensable. Schauerte stated that all issues had to be set out in detail to avoid liability problems, e.g. during transportation, often caused by staff who did not have the required expertise, or relating to storage. Such a contract compelled both parties to observe, in the interest of the wellbeing of the patients entrusted to their care, the provisions of the laws and regulations, and ultimately the targets set by themselves.
Sterilisation of heat-sensitive medical devices
A completely different topic was dealt with by R. Salzbrunn in his talk: sterilisation with ethylene oxide (EO). Increasingly more importance was being given to low-temperature sterilisation processes due to the never-ending stream of new requirements in the field of medicine. Approx. 80% of all heat-sensitive medical devices first placed on the market worldwide were sterilised with EO processes. The most important characteristic of EO was its pronounced permeation facility. Having given an overview of the initial attempts to use EO sterilisation, something that no one should seek to emulate, Mr Salzbrunn went on to describe validation and parametric release of EO processes that also entailed desorption of medical devices as per ISO 10993/7.
Frank Hintermaier reported on inspections by the statutory authorities from the perspective of a service provider. In the context of inspections by the statutory authorities no distinction was made in principle between a (external) provider of medical device reprocessing services and a CSSD performing this task in-house for its own needs - after all, what was being inspected here was the actual outcome of decontamination practices. In the meantime the main focus of inspections was on the details of reprocessing. Unfortunately, structural problems relating to medical device decontamination were often ignored, as Herr Hintermaier could demonstrate on the basis of a few current photos. This trend, too, was due to a scarcity of resources. To finish off, Hintermaier advised that a relaxed attitude be adopted to dealings with the authorities. This inspection often served as an important catalyst for change.
The festivities of the evening event were sampled by some people far beyond midnight, hence the wisdom of repeating this congress format was immediately clear: the next day’s programme only lasted till midday.
Apart from summarising the results of the workshops, on the last morning of the congress there was also a talk by Thomas Kießling who spoke about certification of decontamination as per DIN EN ISO 13485 in conjunction with the RKI/BfArM* recommendation. Certification pursuant to DIN EN ISO 13485 in conjunction with the RKI/BfArM recommendation may only be carried out by specially accredited bodies. Mr Kießling reported on the evaluation of some 50 audits of the first accredited certification firms, highlighting the strengths and weaknesses of the QM systems. Kießling stated that in principle decontamination processes in hospitals or reprocessing firms, which had a certified quality management system based on DIN EN ISO 13485 in conjunction with the RKI/BfArM recommendation, were of a high level. But there was room for improvement in particular as regards validation of certain processes (especially for low-temperature sterilisation with H2O2), evaluation of manufacturers’ instructions and risk management. It was important not only to carry out classification as per the RKI/BfArM recommendation but also to document this. Working procedures that were taken for granted had also to be set out in writing.
The most vital component of a well-functioning system was in particular, to cite Kießling, its management: the system had to have the support of the department management in order to be properly implemented. This would become clear during monitoring or repeat audits carried out at annual or 3 to 5 yearly intervals.
And that brought to a close a successful congress by virtue of whose varied agenda each delegate learned something important for their everyday working life. In that spirit there was much praise expressed in the closing session for the organisational setup and choice of venue - so having the courage to embark on a new pathway has already paid off. The next DGSV annual conference will probably take place between 2 and 4 October 2008 in Potsdam.
14th, 15th and 16th November 2007
Napier War Memorial Conference Centre
Marine Parade
Napier
Hawke’s Bay
Theme - "MOVING WITH THE TIMES"
Come and enjoy the 2007 National Conference in our beautiful Art Deco City.
The venue is situated on the ocean edge and in close proximity to the CBD.
Accommodation has been booked at the lovely Te Pania Hotel, situated across the road from the conference venue.
A special conference rate has been negotiated. Be sure to mention this at the time of booking.
Alternative accommodation has also been sourced.
NZSSA Executive Meeting will be held on Tuesday November 13th.
The Managers Forum will be held on Wednesday November 14th.
The Graduation Dinner will be held on Friday evening at the conclusion of the conference.
All entrants must be members of the NZSSA and must be currently employed in a sterilizing unit. Posters may be either an individual or group effort. Posters will be judged by a panel of sterilization experts.The producer/producers of the winning poster will receive a prize of NZD 1000. This money is sponsored by the NZSSA. Interested participants should contact Lorraine Arrowsmith or Jackie Skudder at the contact details below for a registration form and poster criteria.
Lorraine Arrowsmith or Jackie Skudder
Sterile Services Unit
Hawke's Bay Hospital
Hastings
Telephone: +64-(0)6-8788109
Extension: 6590 or 6597
Entrance and Judging Criteria
To design a poster there are a number of steps to be followed.
Identify the key objectives of the presentation.
Analyse the subject that would be of interest to your audience.
Organise the information on your poster keeping the above two points in mind.
The poster must contain the title, name of the author(s), department and hospital/company.
Poster size must be 120cm x 120cm.
Do not use a fancy font. Font must be at least size 16 and black.
Do not justify the text as this will interfere with the legibility of the text.
Line spacing must be inserted with text.
Minimise details to the main ideas you wish to transmit.
State your ideas in clear, simple and jargon free terms.
Explain the process improvement clearly from start to finish.
Pictures may be coloured or back and white.
Information on the poster must be legible at a distance of six feet.
Prepare a scale drawing of your poster to identify the best layout of information.
A wallet size introduction of the poster participant must be included with the material.
Be able to answer questions from delegates viewing your poster.
Be able to answer questions from the Panel Judges.
Include any references regarding the information included in the poster.
Consider handouts for people viewing the poster.
All posters must be mounted using pushpins. Sellotape must be on hand for any tearing mishaps.
1st meeting of the Dutch Association of Experts for Sterile Medical Devices Design of Surgical Instruments - Patient Safety First Lectures and Presentations
22 November 2007 Medical Centre, University Radboud, Nijmegen, The Netherlands
