Workshop Sponsored by JSMI Sterilization - Technician Approval Committee: Panel Discussion : The Role of Sterilization in Implementing Infection Prevention Chair: Hiroyoshi Kobayashi (Tokyo Healthcare University and Postgraduate School, Professor, JPN)
Opening Session Moderators: Carlos Carreiras, Portugal - Mayor of Cascais
Elaine Pina, Portugal - PNCI Coordinator
Wim Renders, Belgium - WFHSS President
Luisa Nogueira, Portugal - Chair of the Local Organizing Committee (ANES)
The quality and safety of the disinfection and sterilization processes varies a lot, despite the wide Access to scientific information and the opportunities for Professional improvement. Even when we just consider one country, the different hospitals of the different geographical regions are under unequal conditions, which means that it is difficult to follow the national and international recommendations on this topic. The human resources training, the incorporation of sterilization and disinfection technology and the cost of processes play a critical role in the maintenance or in the correction of such inequalities. This presentation's objective is to discuss the reasons for the safety differences and the effectiveness of sterilization and disinfection practices, its consequences and the challenges to overcome them.
Panel 1: Cleaning (I) Moderator: Luísa Nogueira (Portugal) President - ANES - Portuguese Association of Sterilization
Guideline for the standardized manual cleaning and chemical disinfection of medical devices- In August 2008 a working group comprising representatives of the German Society for Sterile Supply (DGSV), the German Society for Hospital Hygiene (DGKH ), and the instrument preparation working group (AKI) was founded to develop a guideline for the standardized manual cleaning and chemical disinfection (hereafter "Manual cleaning and disinfection") of medical devices. Based on the experience and results in the development of the "Guideline of DGKH, DGSV and AKI for the validation and routine control of the mechanical cleaning and thermal disinfection process for medical devices and principles of equipment selection" the following objectives were set:
Provision of study materials for the creation of operator-specific work instructions for manual reprocessing of medical devices depending on the design and the classification of medical devices.
Provision of methods and acceptance criteria to verify the operator-specific work instructions with regard to the results of the cleaning and disinfection as well as to detect chemical residues after the manual cleaning and chemical disinfection.
At the start the performance and the success of previous working practices in Central Sterile Supply Departments (CSSD) for manual cleaning were verified in laboratory studies. In a practical field test, ten “Crile forceps” soiled as for use in the performance qualification (PQ) as part of the validation of automated cleaning and disinfection processes, were cleaned manually in nine CSSDs in accordance with the respective present work regulations in those departments. The performances differ in their implementation as well as using different cleaning agents and methods. With the insertion into an ultrasonic bath very good cleaning results with protein levels below 100 mg / specimen could be achieved by all trial participants. Without ultrasound a number of specimens of several panelists showed residual protein levels greater than 100 mg / specimen, with the highest value at 200 mg / test (W. Michels and K. Roth, Zentr Steril 2010; 18 (36-39).
At the same time tests were carried out in the laboratory of the Institute for Hygiene and Public Health at the University of Bonn and in the test laboratory by Miele&Cie for the manual cleaning and disinfection of dissecting forceps and Crile forceps. Crile forceps were used to obtain comparability to the mechanical cleaning and thermal disinfection. The results of the various tests are presented in the lecture. It became clear that the current approach in clinical practice for manual cleaning and disinfection is often not sufficiently effective.
The laboratory experiments were carried out using different approaches. Based on the results mentioned above first standardized steps to improve the cleaning and disinfection were developed. These steps were summarized in a standard operating procedure (SOP) and a second field test was conducted in various CSSD. Unlike in the first practical test, the same operating procedure was used in all departments. Variable parameters, such as the duration of individual process steps, brushes and cleaning agents used were documented by the operators. The expectation to improve the results significantly through standardization of individual steps without the use of ultrasound could not be fulfilled. The results were only slightly better than those in the first practice field test. The conclusion was that probably not all possible influencing factors for cleaning and disinfection had been considered even though the steps described in SOP were followed. The instructions have to be more precise.
Essential for consistently high quality cleaning and disinfection is a sufficient contact between the cleaning and / or disinfectant solution to the pollution and the medical device. In case of instruments with a box joint, such as the Crile forceps, a "mechanical" support, such as opening and closing of the forceps during cleaning, using an ultrasonic bath and/or brushing is required. Other technical factors that influence the outcome of manual cleaning and disinfection are:
- water quality
- cleaning agents: the type and concentration
- disinfectant: type, concentration and reaction time
- design of instruments / medical devices
- type, quantity, dryness of the contamination on the instruments
- type of aids used for the procedure, for example
- water and compressed air
Since these factors are not the same in each CSSD there won’t be any "finished" work instructions for manual cleaning and disinfection in the guideline. Instead flow charts will be provided, which can be used in CSSDs to develop specific SOPs for their instruments.
The guideline is also dealing with Medical Devices of the category "critical B". The German RKI / BfArM recommendation states that in principle, instruments in this category must be cleaned mechanically and thermally disinfected in a washer/disinfector. Only in justified exceptions, and having undertaken a risk analysis and assessment, manual cleaning and disinfection of an instrument classified into the group “critical B” is an option.
Three examples of flow charts for manual cleaning and disinfection of different instrument groups according to their risk classification following the RKI / BfArM recommendation have been created. These are sample charts for:
- a critical instrument of group A > (Volkmann) sharp spoon
- a critical instrument of group B with joint, but without the hollow tube > Crile forceps
- a critical instrument of group B with joint and hollow tube > arthroscopy trocar
Currently, these flow charts are presented as a draft and tests have been carried out in the laboratory. The results will be provided in the lecture.
If instruments are cleaned and disinfected manually using a standardized procedure, all steps carried out have to be documented. The success of the procedures has to be verified. Methods for verification are currently being developed within the group. This work will take some time; therefore, the publication of the guideline is currently not useful. The working group plans to publish the guideline at the earliest next year (2012). Current state of work is as follows:
- legal and normative foundations are extensively worked out (nearly finished)
- requirements for standardization are extensively worked out (nearly finished)
- Three flow charts depending on the design and the classification of medical devices are finished. Work on verification has been started
- Recommendations for Checking in view of the flow charts
- cleaning - in preparation
- disinfection - in preparation
- residual chemicals-determination - in preparation
The development of the guideline could not be done without the support of the staff in CSSDs and laboratories who performed all practical and/or laboratory tests. Therefore, the members of the working group would like to thank all those very much who have supported the work over the past three years.
The cleaning agents in ultrasonic cleaners are actually bubbles that emerge at sufficiently high ultrasonic intensity (acoustic cavitation). In the presentation, fundamentals of acoustic cavitation are proposed (e.g. ultrasonic fields, cavitation bubble dynamics, sonoluminescence), and applications are highlighted (e.g. sonochemistry and cleaning).
Panel 2: Cleaning (II) Moderator: Isabel Malta (Portugal) Director of the Central Sterile Supply Department - Portuguese Oncology Institute, Porto
Diana Bijl (The Netherlands) Expert Sterile Medical Devices - Diana Bijl Consultancy: New insights in cleaning of highly complex minimal invasive surgery [in English]
Twenty 20 years ago minimal invasive surgery (MIS) was widely introduced as a new operating technique in the operating theatre. Less operative trauma, reduced post-operative pain, less incidence of wound infections and shorter hospital stay, thus resulting in earlier return to normal life and productive work are the advantages. For these reasons, minimally invasive surgery has emerged as a highly competitive new sub-specialty within various fields of surgery. Special medical equipment may be used, such as fiber optic cables, miniature video cameras and special surgical instruments handled via tubes inserted into the body through small openings in its surface. The process of minimally invasive surgery has augmented the development of highly complex instruments with lumens, joints, cables and bending tips. The restricted vision, the difficulty in handling of the instruments (new hand-eye coordination skills are needed), the lack of tactile perception and the limited working area are factors which add to the technical complexity of this surgical approach. The comfort of the surgeon is a big issue in designing the instruments but less attention is paid to the fact that after the operation the instruments has to be cleaned and sterilized in a proper way.
So these instruments are a real challenge not only for the Central Sterile Supply Department (CSSD) but also for the manufacturers of washer disinfectors and detergents. Because by the urgent request of the CSSD's, manufacturers of washer disinfectors but also suppliers of detergents did a lot of investigations to the cleaning efficiency of the processes on the CSSD and modified the machines and processes, sometimes in cooperation with the manufacturer of the instruments.
In this lecture I will show the attendees the results of the studies and investigations and I will talk about new insights in the cleaning of these highly instruments like the relevance of the flow in the tubes, the choice of the detergent and the relevance of a manual pre-cleaning.
In washer disinfectors we use a large range of detergents, disinfectants and final rinse aids/lubricants. A case of depolymerisation of polyoxymethyl (component of a lot of instruments in loan orthopaedic trays) brought about by cleaners led us to a lot of questions:
Are these cleaners safe for medical devices?
Are they laboratory-tested on all types of medical devices before launching?
At the opposite, do medical devices’ providers test their instruments in all kinds of cleaning situations?
Do they produce precise enough instructions about recommended cleaners?
All the questions have to be asked and the answers are not so patent….
Panel 3: Traceability Moderator: Duygu Percin (Turkey) Associate Professor - Department of Microbiology - University Faculty of Medicine Kayseri
With the advent of the computer and today´s tracking technologies, there are some possibilities to solve the issues of the management of a CSSD. There are systems capable of monitoring the instruments, the processing cycle including the provision of cleaning and assembly instructions as well as the sterilization and biological monitoring systems. Instrument sets can be tracked through the entire cycle, and the information can be tied to specific instruments sets to keep everyone informed regarding the instruments or set status. Instruments orders and repairs can be entered into the overall system and tracked through the procurement cycle. This information obtained through this system will allow materials management to standardize products and vendors. This is one of the most important portions of the instrument tracking system. The sterile processing management should have the ability to utilize the system for training and quality control purposes. Sets and individual instruments can be traced to an individual employee. This will provide sterile processing management with the ability to take corrective action and to review the productivity of the CSSD as well as individual employees.
Christophe Lambert (France) President - French Association of Sterilisation: Individual traceability of surgical instruments: guide of application [in Portuguese]
Within the framework of the sterilisation of the sterile medical devices, the requirement of traceability is inseparable of the system of quality assurance. However this traceability of products and processes applies only to the packaging and ever to the instrument. And nevertheless, it is well this last one who is used in the contact with the patient!
In an internal study, the author and his co-workers showed that during the reprocessing of one caesarian composition, about 15 % of instruments were replaced at each reorganization.
Different French experimental sites investigated these solutions and grouped together at the initiative of the French association of Sterilisation to share their experiences. The coordinator of the group presents the various solutions applicable in establishments of health. The guidelines for the implementation of an individual traceability of surgical instruments is available on www. afs.asso.fr
Panel 4: International practices Moderator: Amália Espada (Portugal) Responsible for CSSD - Hospital do Espírito Santo de Évora, E.P.E.
Ana Paula Coutinho (Denmark) Technical Officer - Infection Prevention and Control, Alert and Response Operations, Division of Communicable Diseases, Health Security & Environment - World Health Organization - Regional Office for Europe: Sterilization with limited resources, what is essential? [in Portuguese; PDF File; ]
Infection Control Specialist with 10 years of experience in outbreak response and disaster management in Europe, Africa and Middle East. Solid background on communicable diseases and hospital epidemiology. Assisting countries facing public health events of national or international concern by ensuring rapid appropriate technical support on site or remotely. Assisting national outbreak preparedness initiatives by advising on the implementation of control and preventive measures for containment of epidemic threats.
This presentation will give an overview of the international situation in relation to the current concerns of practitioners employed in decontamination scientific services. It will highlight the differences in standards and practices and offer some potential solutions to the world's pressing need for patient safety and positive outcomes.
Tillo Miorini (Austria) President - Austrian Society for Sterile Supply: The RUMED concept - a new WFHSS guideline [in English]
In Austria, the Medical Devices Act stipulates in it´s ordinance to come that there are different categories of Reprocessing Units for Medical Devices. Why that? Why not talking of CSSD´s? That’s very easy to explain:
1) Not all of the units, that are reprocessing medical devices are centralized (e.g. departments for endoscopy, anesthesia, ICU, but as well doctor´s offices, rehabilitation centres, or homes for the elderly do not have CSSDs)
2) Not all of the units perform sterilization (e.g. departments for endoscopy, anesthesia)
Because not all of the given requirements are applicable for the different facilities there was a need to classify them in 3 categories dependent on the risk connected with the use of the medical devices as well as the risk involved in reprocessing them. Due to the fact that the ordinance is still in waiting position the Austrian Society for Sterile Supply (ÖGSV) decided to make a guideline out of it (with the authorization of the Ministry of Health). A part of this guideline is the RUMED concept, which was adopted (and adapted) by the education/guideline group of the WFHSS.
The question, which RUMED belongs to which category depends on the risk group, as defined by the Robert-Koch-Institute (RKI).
RUMED Category I is allowed to reprocess MDs of the risk group “non-critical”,” semicritical A” and “critical A”.
RUMED Category II additionally may reprocess “semicritical B” and
RUMED Category III (which is comparable with a CSSD) of course can reprocess all of them.
The three categories have to meet different requirements concerning Quality assurance, Structural requirements, Staff qualifications and Technical equipment. Part of the RUMED concept is as well the “Concept for continuing professional development courses”, which will be introduced during the lecture.
Mag. Dr. Tillo Miorini
President of the Austrian Society for Sterile Supply
Panel 5: Environmental factors Moderator: Judite Neves (Portugal) Director of the Health Products Directorate - INFARMED - National Authority of Medicines and Health Products, I.P.
Manuela Cano (Portugal) Responsible for Air Quality Laboratory at the Air and Occupational Health Unit, Environmental Health Department - National Institute of Health Dr. Ricardo Jorge (INSA): Environmental control [in English; PDF File; ]
Maria Manuela Cano has a MSc in Toxicology by the University of Birmingham, is graduated in Biochemistry by the University of Coimbra, she is a member of the technical staff of the Environmental Health Department of the National Institute of Health Dr. Ricardo Jorge since 1994, being at the moment responsible by the Air Quality Laboratory at the Air and Occupational Health Unit.
Her work experience is related with the monitoring of indoor air quality with the identification of potential sources of contamination and recommendation of better practices in order to correct abnormal situations, being also involved in the monitoring of occupational exposure to biological agents.
She was invited as a lecturer in several post-graduate courses, namely on Occupational Health, Qualified Experts on Indoor Air Quality and Biological Risks in Workplaces. She participates in some technical committees of standardization and working groups on Indoor air Quality and Exposure to Biological Agents. She has published some papers and technical booklets.
The relevance and importance of the packaging and sterilisation activities for the safety of the patient is unquestionable. The sterile packaging systems for medical devices need to ensure the sterility of their contents until opened for use and ensure aseptic presentation. In parallel with sterile packaging system itself, the device characteristics, the type of protective packaging (if applicable), and the transport and storage systems will all play a role in challenging its attributes.
Each facility should evaluate the performance of each sterile barrier system or packaging system in order to ensure that conditions for sterilization, storage, and handling can be met. The ISO 11607-1:2006 sets the requirements for materials, sterile barrier systems, and packaging systems, including the qualification of the packaging system design and evaluation of that design and ISO 1607-2:2006 sets requirements for packaging process validation. The scopes of both of these standards apply to health care facilities and wherever medical devices are packaged and sterilized.
The presentation will focus and provide guidance on interpreting the ISO 11607 to heath care facilities. A brief overview of the more common test methods and the rationale behind their applicability is described and guidance for conformance to ISO 11607-1 and on conformance to ISO 11607-2 is explored. Moreover, the works also highlights potential materials for use in a given application and focuses on the three common choices and main types of sterile barrier systems, which are (1) sealable pouches and reels, called preformed sterile barrier systems (PSBS), (2) sterilization wrap and (3) rigid reusable container. The validation requirements for forming sealing and assembly processes are detailed and emphasis is given to the design and validation of the packaging process during installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) of the (1) (heat) sealing process for PSBS, (2) wrapping process, (3) container process and through handling, distribution and storage.
Australia is a large country with diverse climactic conditions. Maintenance of the temperature and humidity in sterile storage environments poses particular challenges. Recent episodes of extreme climatic conditions highlighted that some air conditioning systems were unable to maintain specified requirements, with many Sterilising Department Managers facing the dilemma of having to discard single use sterile medical devices and reprocess in-house produced instruments and sets. This presentation will answer the following commonly asked questions:
- Why is maintenance of temperature and humidity conditions important for maintenance of sterility?
- Is there a real risk of contamination of sterile items when storage conditions exceed specified requirements?
- How do I manage in situations where temperature and/or humidity are noted to be outside acceptable limits?
Panel 6: Advanced technologies Moderator: Valeska Stempliuk (USA) Specialist in Infection Prevention and Control - PAHO/WHO
Hervé Ney (Switzerland) Head Manager of the CSSD - University Hospitals of Geneva: Once upon a time in a lumen after washing process [in English]
"Only well cleaned devices can be well sterilized: an old rule taught, professed, repeated in the training course and in sterile supply department! Mr J. Huys wrote on page 81 of the French version of the book "Steam sterilization of medical devices " that cleaning is regarded as the most important step in reprocessing of sterile products. Sterilization has its definition as SAL: Sterility Assurance Level. How to target a CAL: Cleanliness Assurance Level? Of course, many industrial laboratories offer tests for the detection of residual, qualitative or quantitative protein, and equipment are deemed more efficient with the ultrasound to irrigation devices or specific conveyors in the washer-disinfectors. Surgical instrumentation is more complex, and the standardization of procedures and protocols for cleaning in sterilization services leads to repetitive supported, sometimes without taking the time to consider the relevance of such application. Hollow medical devices with lumen are interesting from this point of view: the hollow body is more difficult to clean. Are our procedures effective? We wanted to make a qualitative observation. The STF Test Soil ® stain was used on different needles and instruments to hollow body lengths and different diameters. Manual cleaning with a brush, assistance of a Steamer ® steam cleaner or not, apparatus with irrigation or non-ultrasound, and cleaning in washer-desinfectors with adapters have been observed. We realized that macroscopic and microscopic examinations, with optical assistance to observe the interior of the instruments, allow to account for the level of efficacy of different methods. Many questions appeared:
- Is it possible to ensure the effectiveness of the cleaning for all medical devices?
- Should we not mandate the pre-disinfection at the point of use to ensure effective cleaning for CSSD?
- Each takes into account the peculiarity of medical devices, beyond the approaches of standardization of protocols?
- Is there a variety of medical devices, the same as for patients?
Then, between lights and shadows, about what Dominique Goullet mentions in the magazine of Zentral sterilisation 2/2009, how can we talk about cleaning medical devices without being able to define it in advance?
The aim of this presentation is to show how fluids at a supercritical state, i.e. above their critical temperature and pressure, may be exploited to achieve pasteurization and sterilization of substrates and materials in general, and specifically of biomedical devices. A short introduction will provide essential information about supercritical fluids (SFs) and their relevant properties, their potential in the field of hospital sterile supply, including advantages and disadvantages of SF-based techniques. Secondly, the ability of SF to decrease and/or annul microbiological activity of both vegetative and latent forms will be addressed, and deactivation mechanisms will be briefly discussed. The attention will then be focused to potential applications of SFs for the effective treatment of biomedical devices in view of their reuse, and the case of cardiac interventional catheters will be discussed with details. The presentation will be closed by some concluding and outlook remarks.
Panel 7: Training, psycho-social and other risks Moderator: Maria Glória Aboim (Portugal) Vice-president - ANES - Portuguese Association of Sterilization
Implementation of Quality Management Systems specific to medical devices i.e. ISO 13485:2003 and registration to the Medical Device Directive 93/42 EEC requires application of risk management processes which are compliant to ISO 14971:2009 (Application of Risk Management to Medical Devices). This process ensures safe effective management of decontamination risks to patient safety.
This presentation identifies universal patient safety risks responsible for healthcare adverse events and identifies the impact they have on the patient outcomes. Implementing quality management systems specific to medical devices ensures the Decontamination Unit identifies all risks relating to their processes and minimises the occurrence of adverse events.
The Childrens University Hospitals journey to implementing a QMS which was externally validated by a Notified Body in 2009 presented a steep learning curve to the organisation. The presentation discusses the benefits for the Decontamination Unit and the service users in terms of providing quality assurance and optimizing patient safety. Further benefits include utilising the essential elements of the QMS throughout the organisation with positive risk management results.
The presentation will cover the basic psychosocial risks at work especially related with hospital work and closed environments. First it starts with a definition of job stress and why it happens. Stress is due a misfit between job demands and job and personal resources and then it has consequences such as burnout, anxiety, depression and mobbing among others. High overload and poor social relationships, lack of autonomy, role conflict, poor supervision and role ambiguity among others, are the main stressors at work. Of course, personal and team resources such as efficacy beliefs, optimism, and emotional inteligence are the main "buffers" of job stress as well. Results from recent research concerning psychosocial risks at work are shown. The application of these results to hospital sterilization areas and their implications will be discussed basically how to prevent job stress at work.
João Leite (Portugal) Psychologist: How to improve the training methodologies to be more efficient [in English]
There is no doubt about the value of training!
However, this is one of the activities that is always getting cut down in any service.
Most of them comes from within. From those designing it, from those who give the training, from its own lack of productivity.
In this presentation, we shall highlight the reason why training is given, its engineering and the requirements we should all place in its execution.
Using the andragogy model as the starting point we are going to identify and dismantle some ready made ideas that have contributed for the on-the-job training devaluation...despite the fact that everyone keeps referring that... there is no doubt about the value of training!
Panel 8: Airborne microbial contamination risks Moderator: Birte Oskarsson (Sweden) Vice President - WFHSS - World Forum for Hospital Sterile Supply
Berit Reinmüller (Sweden) Docent of Energy and Environment Building Services Engineering - Chalmers University of Technology; Bengt Ljungqvist (Sweden) Professor of Energy and Environment Building Services Engineering - Chalmers University of Technology: Ventilation and airborne contamination [in Portuguese]
A short introduction to ventilation and airborne contamination is given and some technical terms are explained such as differences between air volume flows and air change rates. The simpliest mathematical model to express the relation between concentration and airborne contaminants and air volume flows is the dilution principle. This relation will be discussed and information given when it is appropriate to use. Comments to some "historical thruths" regarding dispersion of airborne microbial contamination in hospitals will be discussed.
Different types of clothing systems will be discussed, where results from laboratory tests and from ongoing operations will be presented. The laboratory tests have shown that the number of washing cycles affects the filtration efficiency of the clothing system. Results from ongoing surgery show that the filtration efficiency is better for tight polyester materials than those of mixed materials (cotton/polyester).. The role of clothing quality, comfort, microbiological cleanliness and patient safety will be discussed and illustrated. To achieve low concentrations of microbiological contaminants in the air for operating rooms, for central sterile supply departments and for decentralized sterilization facilities.
The presentation will cover the basic properties of dispersion of airborne contaminants such as diffusion, convective transport and gravitation and furthermore accumulation of contaminants in wakes and vortices.. Airborne contaminants can be transported from one room to another due to e.g., temperature differences between rooms. This can occur during door openings and some examples will be given. Furthermore during unloading of autoclaves entrainment of room air can occur and create contamination risks. Results from recent research concerning potential contamination risks in pharmaceutical industry are shown. The application of these results to sterile supply areas and their implications will be discussed.