November 17 - 20, Geneva, Switzerland and online
The World Sterilisation Congress, organized by the World Federation of Hospital Sterilsation Sciences (WFHSS) and the Swiss Society of Sterile Supply (SGSV), was held in Geneva this year. In spite of to the ongoing Corona pandemic, many delegates had travelled to Geneva, and another 200 followed the event on screen at home.
What's new? MDR and standardization
What's new? This was the heading of the first two sessions.
Richard Bancroft from the UK spoke about harmonized standards in the era of MDR and Brexit. With new regulatory requirements, standards need to be revised not only to stay current with the latest technology, but also to align with the new requirements of MDR and IVDR.
WFHSS President Christine Denis gave a presentation on process challenge devices (PCDs), focusing primarily on sterilization. She explained that PCDs are intended to help users ensure that the process has proceeded according to specifications, thus providing a high-quality product. However, a more precise definition of PCD would be useful. A working group within the WFHSS is to deal with this in the near future.
Lionel Pineau addressed the topic of high-level disinfection (HLD) with liquid sterilant. He first reviewed the Spaulding classification, which assigns medical devices to their intended use and application according to the level of reprocessing required for safe reuse. Using flexible gastrointestinal endoscopes as an example, he explained the approach. Does sterilisation really make endoscopes safer? First of all, it is crucial that cleaning has been carried out correctly and that all surfaces have been reached during disinfection.
What is the benefit of additional pre-cleaning?
In the second session, Tiziano Balmelli from Switzerland reported on the use of a new pre-cleaning process for medical devices with sodium bicarbonate under pressure (Safe Clean Box STK 103-113 from Bicarjet). In fact, reprocessing with STK 103-113 took twice as long. However, the results were much better: the MD were absolutely clean, and even the first signs of corrosion were removed by the sodium bicarbonate treatment.
Medical products from the printer
Mélanie Albert from Lyon, France, reported on ways to manufacture MD using 3D printing. Various printing techniques are available on the market. Fields of application are customized implants or prostheses, but also anatomical models for surgery preparation. Overall, this can reduce surgery time, and the tailored implants fit better.
Meeting the increasing workload
The presentation by Ingrid Jullian Desayes from Chambéry in France dealt with the increasing workload in sterile processing. Her presentation aimed at solutions to improve workflow and process quality. A consulting company analysed the situation and implemented "lean management" methods, i.e., optimization of processes and procedures. The speaker reported that the measures have increased the satisfaction of the employees.
Management of loan sets
Sigurd Vandendriessche, head of the Central Sterilization Department of a private hospital group in Belgium, reported on management of loan sets. In collaboration with a MD manufacturer, a modern "management of loan material sets" has been implemented. The third-party supplier delivers the sets sterilized just-in-time and picks them up again after use. This would result in a number of advantages. For example, Vandendriessche sees the issue of traceability as a major plus of the system.
To simplify the complex process of managing surgical loan instruments and make it safer, Laura Delassus introduced a digital platform at the University Hospitals in Strasbourg, France. She reported on the initial results in her presentation. The process, she said, is laborious and error-prone. The project aims to explore and evaluate the benefits of a digital platform. Although 41 percent of the medical devices treated were not included in the query, a better overview of material lending has emerged, she said. The flow of information between the various players as well as the entire cycle for loan instruments has been optimized.
Transport and storage - which conditions are ideal?
In his presentation, Gerhard Kirmse from Tuttlingen, Germany, dealt with the ideal transport conditions between the OR and the CSSD. All guidelines worldwide require cleaning at the point of use. Nevertheless, in reality, transport often takes place in a contaminated state. In laboratory studies, stainless steel plates and test specimens were contaminated with different test soils to obtain indications of what maximum time between use and the start of reprocessing is acceptable. For longer waiting times, cleaning results can be improved with moist storage, but any chemicals used during transport can interfere with the subsequent cleaning process and must be removed.
Karin Bundgaard from Denmark also spoke about storage conditions prior to reprocessing and the impact on instrument longevity. For this purpose, contaminated irrigation syringes and forceps that had been stored for a longer period were examined for protein residues. One half was stored dry, the other half in a humid environment. The results showed no correlation between storage environment and corrosion. Thus, it appears that cleanliness and longevity are influenced by use and the number of reprocessing cycles, but not by storage conditions prior to reprocessing, Bundgaard explained.
Plasma sterilization studies: plasma as the sole sterilant
It combines speed with safety and efficacy, which is why plasma sterilization is receiving a lot of attention. Joao Henrique Campos de Souza from Brazil presented a plasma source developed for sterilization studies at normal atmospheric pressure, in which plasma alone is responsible for the sterilization process. Among the advantages of high-pressure plasma, he cited simplicity of method, low power consumption, and material compatibility.
Reprocessing of flexible endoscopes without working channel in ENT with UV light
Stefan Alexander Rudhart from Marburg, Germany, investigated the UV light disinfection of flexible endoscopes (FE). According to the results, UV-C light technology enables efficient reduction of bacterial contamination of FE and could be useful in daily practice. Also, the method offers substantial financial and practical advantages over standard methods for disinfection of FEs.
Effect of fluid flow on instruments with hollow bodies
Daniel Robertson from the Delft University of Technology in the Netherlands was concerned with the quality assurance of cleaning lumened instruments. The goal was to develop a cleaning device that is safe and cost-effective to improve cleaning processes in low-resource environments. A pilot study was conducted to investigate the relationship between flow rate and mass fraction removed at different soaking times to gain more insight into the effect of fluid flow when cleaning lumened instruments. The results will be used as a benchmark for follow-up studies examining other effects in the cleaning process, such as the influence of instrument geometry and cleaning agents.
Air quality in the AEMP: What to do in case of unexpected results?
Air quality in the AEMP should meet the requirements of ISO Class 8 cleanrooms in Switzerland. In his presentation, Marc Dangel from the University Hospital Basel reported that unexpected results emerged during routine measurements. For example, a high load of bacteria was found in the interior rooms with comparatively few air particles, and this even in the new hospital building. The results show that the bacteria limits set by the Swiss authority (swissmedic) can be exceeded, even if all other air quality requirements are met. UV-C disinfection is considered a good and short-term immediate measure.
Swiss Guideline for the Transport of Contaminated or Sterile MD
What to consider when transporting reusable contaminated and/or sterile medical devices (MD) that are reprocessed by a contracted external or an internal reprocessing unit has been regulated by a guideline in Switzerland. Nicole Berset of the Swiss Society for Sterile Supply (SGSV) presented the paper and sees it primarily as a support for organizations to ensure transport without risk of contamination of the environment or the sterile MD. The main risks during transport arise from mechanical stress, temperature fluctuations, humidity and dust. However, natural events such as heavy snowfall are also included. Therefore, a risk analysis has to performed before the transport.
Chemical indicators for dose determination?
Brian Kirk from the UK asked whether chemical indicators for sterilization with hydrogen peroxide can be used to determine the sterilant dose used for instrument sets. For VH2O2 processes, the area under the exposure curve is defined as the dose by the manufacturer. To address the question of whether CIs can be used as "dosimeters" for VH2O2, some CIs were exposed to VH2O2 to determine their performance. In this way, an extensive collection of data in the form of colour coordinates as a function of exposure dose was obtained. Regression analysis was used to establish the relationship between colour change and exposure dose.
BD or PCD?
How can you guarantee that the saturated steam will penetrate all medical devices? asked Florian Gallais from Rouen, France. Often, hospitals use PCDs for routine control. Gallais presented a study that tested various PCDs on the market under worst-case conditions and compared their detection limits with a BD test. In his conclusion, Gallain said that the PCDs on the market have good sensitivity and a PCD in a container is more sensitive than a standard BD test.
Matías Pilasi from Chile reported on a study of chemical indicator (CI) testing using 9 different PCDs of different lengths with the same inner diameter. In many countries, chemical (CI) and biological indicators (BI) are used to assess sterilization processes. According to ISO 11140-1, Class 5 CIs are designed to be equivalent or outperform BI. Nevertheless, some recommendations do not allow BI to be replaced by CI Class 5. The purpose of this study was to verify in practice whether CI Class 5 are able to detect faults equally well. The results suggest that Class 5 CIs are even more sensitive than BI in the presence of non-condensable gas and consequently may be a safe and cost-effective alternative.
Traceability with RFID
Hervé Ney from Geneva reported on experiences with RFID tagging of instruments. Geneva already had many years of experience with traceability via a laser data matrix (DM) code on each instrument. Now the technical, functional, organizational and also the financial aspects of an RFID solution were to be investigated. The resistance of the tags was also examined, as well as the ergonomics, the reading time and the opinion of the users.
AEMP employees were enthusiastic about the impressive speed of scanning. However, there were also concerns, according to Ney. What if an IT dysfunction prevents the tags from being read? The system also has its limits with very small instruments.
In summary, Ney did not see a clear advantage of the RFID system at the moment.
Duodenoscopes: contamination rates after reprocessing
Ross Segan, Olympus, USA, spoke about a multicenter study on duodenoscope
contamination rates after reprocessing. There have been several reports of infection outbreaks associated with duodenoscopes in recent years. Segan described the algorithms that were developed for root cause analysis. These were critical to success.
Overall, just over 10% of duodenoscopes examined were contaminated with organisms classified as critical. The majority were due to inadequate reprocessing – mostly by deviation from the reprocessing instructions.
Lionel Pineau continued the presentation by reporting on contamination rates in France. These have decreased over the years, but even in 2021, there were still 6% above the warning level and 10% above the action level. This means that 16% of endoscopes were not safe. Improvements are therefore still needed.
Swiss good practice: risk and quality management
On the last day of the congress, Norma Hermann from Bern, Switzerland, spoke about the requirements of Swiss Good Reprocessing Practice (GRP). She explained the tasks of Swissmedic, the Swiss authority responsible for monitoring MD reprocessing, and described the historical development of the GRP. The third version is due in December, taking into account legislation at the European level. Hermann pointed out that a separate Good Practice exists for medical and dental practices, adapted to the conditions there.
Risk identification in the reprocessing of MPs
Reference is often made to aviation when it comes to safety – how this can be implemented for reprocessing has now been examined. Mélissa Giroux from Canada spoke about an appropriate approach to risk identification. Incidents where adverse events occurred in AEMP were in 90% of cases associated with set assembly or packaging. A project has now been undertaken to try to increase compliance also with regard to the forms to be completed and the reporting requirements. To this end, observations were made during packing. Ergonomic factors obviously play a role in the occurrence of errors. Time of day is also significant – more errors are made after 10 pm.
The approach to improvement included audits, training of OR and AEMP staff, a survey of people involved, updating the reporting procedure (Form AH-223) to create a dynamic tool for dealing with incidents. All of these prevention measures promote a culture of safety and can thus ensure continuous process improvements, Giroux concluded.
Medical device technologists – the long road to becoming a professional
Frédy Cavin began by explaining the Swiss education system and describing the rocky road to becoming a professional. First, a lot of convincing had to be done, for example, so that the relevant authorities would see that reprocessing was indeed complex enough to require a separate profession.
Now there is a dual, competence-oriented training program. Long-serving employees in AEMP can also obtain the diploma, provided they can demonstrate the relevant competencies and hold the Training Certificate Level 1 or 2 as well as at least 3 years of experience.
Improving sterile processing on a global scale
Christina Fast from Canada spoke about improving sterile processing as part of initiatives in the field of surgery. She presented her experiences in low-income countries. A survey of 14 countries revealed a long list of deficiencies – lack of knowledge, lack of equipment, lack of occupational health and safety. For example, inadequately cleaned instruments and careless handling of hazardous chemicals are commonplace.
Fast also showed, however, what can be achieved within a relatively short time, especially through training. Using an example from Cambodia, she showed how simple means can be used to improve the situation on the ground, and this then has an impact on other healthcare facilities in the area by spreading the knowledge thus acquired.
In his closing speech, Harry Oussoren, WFHSS Vice President, emphasized the importance of the international friendships that are forged at these congresses. This time the WFHSS flag could not be handed over directly to the colleagues in Hong Kong, who will host the next congress – due to the pandemic they could not travel to Geneva.SGSV Chairman Hervé Ney concluded by announcing the next Swiss Congress to be held in Biel, Switzerland, 22–23 June 2022, and of course the next World Congress in Hong Kong – save the date: 23-26 November 2022!