The Olympus PAA Process. Relax, we care about your reprocessing.

Transcription

1 The Olympus PAA Process Relax, we care about your reprocessing.

2 Endoscope reprocessing a lasting challenge Since the first appearance of flexible endoscopes, the number of endoscopies and the complexity of the interventions have increased continually. In Europe, over 12,000,000 gastrointestinal procedures are performed every year. During the procedure, the endoscopes are routinely contaminated with a variety of germs colonising the human body. Transmission of these micro-organisms in subsequent procedures must be avoided by thorough reprocessing of the contaminated endoscope before the next use. Although endoscopic procedures are nowadays part of the daily routine in hospitals, the reprocessing of these highly sensitive and technically elaborate devices remains a challenge. Over the last decades, protocols and procedures have developed and changed significantly. Nevertheless, there is no worldwide uniform guideline on endoscope reprocessing to date. 2 What should always be kept in mind, though, is the universal right of the patient to be examined with a properly reprocessed endoscope, no matter where or when!

3 Endoscope reprocessing a historical review...4 Peracetic Acid the rediscovery of a wellknown molecule...5 Traditional standards in endoscope reprocessing...6 Peracetic Acid a challenge for product development...7 Flexible endoscopes represent a substantial investment for hospitals. The choice of the ideal reprocessing equipment and procedure consequently not only serves to protect patients and staff, but also to keep these highly sensitive medical devices in good condition and working order. We at Olympus have committed ourselves to develop an ideally adapted system of endoscopes, machines and reprocessing chemistry. The year-long cooperation with our highly renowned partners Miele and Ecolab has enabled us to constantly optimise and facilitate endoscope reprocessing, to adapt the latest scientific findings and to set state-of-the-art standards. EndoDis and EndoAct the Olympus solution...8 Product charasteristics and user benefit...9 Comprehensive testing and assessment the guarantee you need...10 Optimised processes the key to increase efficiency in endoscopy...12 Olympus ETD ready for EN The key to our success: User benefit and patient safety always come first. 3

4 Endoscope reprocessing a historical review Endoscopes are instruments that allow us to look inside the human body. They already made their first appearance in ancient Greek and Roman times: an early prototype of an endoscope was discovered in the ruins of Pompeii. The 18th century, also called the Age of Enlightenment, brought about a decisive step for endoscopy. For the first time, the purpose shifted from pure investigative interest to diagnosis and treatment of living human beings. However, endoscopic procedures still caused significant discomfort for the investigated patient: endoscope tubes were rigid and the light source at the tip of the tube heated up quickly, eventually causing burns. It took another century before efficient solutions were found: 1964 First flexible endoscope by Olympus The combination of gastro camera and real time visualisation finally allows for the necessary patient comfort, effective lighting of dark body cavities and easy bending and handling of the scope, delivering various examination perspectives s Endoscopy becomes an acknowledged diagnostic intervention. At the same time, the increasing awareness of hygiene and the prevention of germ transmission makes endoscope reprocessing a largely discussed topic. Reprocessing, consisting of cleaning and disinfection is carried out manually. As endoscopes are not waterproof, only the parts inserted into the human body are disinfected. Reprocessing trays are equipped with an extra holder for the non-immerseable parts First fully immerseable endoscope 1986 In joint cooperation with Henkel/Ecolab and Miele, Olympus develops the first generation of ETD machines. It significantly relieves the work load while optimising and standardising reprocessing results The 3 rd generation of ETD machines comes with highly innovative reprocessing chemistry: peracetic acid used effectively for the first time in fully automated endoscope reprocessing (AER). 4

5 Peracetic acid the rediscovery of a well-known molecule Although it has only recently been used for automated reprocessing of flexible endoscopes, peracetic acid (PAA) can look back on more than 100 years of history > Freer and Novy publish an article in the American Chemical Journal on the germicidal and sporicidal efficacy of PAA > Confirmation of its anti-microbial superiority: in a comparison with more than 23 active substances, PAA displays the highest level of efficacy s > PAA is principally applied as an anti-microbial substance in the food industry, breweries and dairies. The efficacy, stability and corrosiveness can now be managed s > First application of PAA in the manual disinfection of medical devices such as surgical instruments > First efficient and safe use of PAA in fully automated reprocessing of flexible endoscopes in Europe. PAA profile Colour: Bright, colourless liquid Odour: Strong, almost piercing ph value: Approx. 3 (strongly acidic) Characteristics: Oxidising substance Highly reactive and instable Corrosive No toxic residues Environmentally friendly, not harmful to aquatic organisms No allergic or mutagenous potential Spectrum of activity: Compared with other commonly used active ingredients in endoscope reprocessing, PAA has by far the most comprehensive spectrum of activity, including enveloped and non-enveloped viruses as well as bacterial spores Efficacy against Active substances Bacteria Fungi Mycobacteria Viruses with envelope Viruses without envelope lipophilic slightly lipophilic hydrophilic Spores Aldehydes Glutaral(di)aldehyde (Glutaral) Active-Oxygen Peracetic acid Amines Quartenary Ammonium Compunds (QAC) e.g. Benzalkoniumchloride 5

6 Traditional standards in endoscope reprocessing For decades, aldehydes, and in particular glutaraldehyde (GA), have been the gold standard for the reprocessing of flexible endoscopes, combining a large spectrum of activity with high material compatibility. So why change? Glutaraldehyde-based disinfectants have a number of disadvantages that can have a major negative impact on instruments and users: Odour and sensitisation During reprocessing with GA-based disinfectants, users frequently complain about a number of health impacts, such as respiratory irritations or even asthma, eye irritations and skin rashes, ranging from mild to severe. The installation of appropriate ventilation as well as the use of suitable protective equipment (e.g. gloves, gowns and masks) can reduce and even prevent an occurrence of these symptoms. Despite all possible and effective countermeasures, stress, a heavy workload and non-ideal working conditions can still make the use of GA problematic. Protein fixation One of the most important disadvantages of GA is the fixing property with regard to proteins. Glutaraldehyde, as other reactive substances, chemically interacts with proteins and does not destroy them but forms molecular crosslinks. These may then deposit on the surface of the endoscope and can hardly if at all be removed. This is also the reason why in the past, so much emphasis was put on thorough cleaning prior to GA based disinfection. Build-up of biofilms Biofilms represent a major problem in endoscopy. Building up especially on the inner surfaces of the endoscope, they provide optimum grounds for pathogen growth and transmission. Investigative studies have shown that biofilm build-up can mainly be attributed to insufficient pre-cleaning and the afore - mentioned fixing properties of GA. 6 Protective equipment Fixed blood on metal plate Biofilm in endocsope channel

7 Peracetic Acid: a challenge for product development Peracetic acid (PAA) as an active ingredient offers a number of advantageous characteristics for the reprocessing of instruments, e.g. the large spectrum of activitiy or the toxicological safety. However, looking at the pure substance, the corrosiveness as well as the instability of PAA can also bring about negative consequences. For a long time, PAA has for example been criticised as not being material-compatible, even leading to damage of the endoscopes. Furthermore, it has repeatedly been stipulated that PAA, as well as GA, does not have any cleaning effect, but rather fixes proteins to the surface while bleaching them. The answer to these allegations lies in the product development an essential difference to glutaraldehyde! While current reprocessing guidelines only refer to GA as an active ingredient in defined dosing concentrations (e.g. immerse the endoscope in 2% glutaraldehyde ), such generalisation is not possible for PAA. The product characteristics of PAA-based disinfectants depend on a number of factors such as the ph value of the solution, the process temperature, the concentration of PAA or the hardness of the process water. The challenge of PAA product development can be very well illustrated with the example of the ph value and the influence on: Material compatibility As with all acids, the ph value strongly influences the compatibility with different metals and plastics. Whereas aluminium or chrome-nickel steel are not influenced by the ph value of the PAA solution, a significant negative effect can be observed with copper or galvanised iron. Some plastics can change with oxidation and become brittle. The more neutral the ph value, the better the material compatibility. Spectrum of activity PAA is mostly effective in acidic solutions of ph <3. The more neutral the ph value, the less effective is the product e.g. against bacterial spores. A compensation of this effect can be achieved by adjusting other parameters such as the concentration or process temperature. The lower the ph value, the larger the spectrum of activity. Cleaning result As PAA is a reactive substance, its reaction with proteins differs with the ph value. Whereas PAA at acidic ph values of <4 leads to the formation of higher molecular compounds and thus to the fixation of residues, products with a ph value of >5 destroy the protein molecules in an oxidation reaction. The higher the ph value, the better the cleaning result. Product benefits or disadvantages cannot simply be generalised for all PAA products of the same concentration. PAA product development hence aims at finding the ideal balance for all influential factors. Extensive testing and evaluation is necessary to assure optimum efficacy and safety while preserving the material. 7

8 EndoDis and EndoAct the Olympus solution Since the early 1980s, Olympus closely cooperates with Ecolab and Miele, two highly renowned experts in the field of industrial cleaning and reprocessing. The first result of this cooperation was the ETD System. It has been constantly improved since its first launch and is today available in its 3rd generation. PerOxyBalance Concept In the middle of the 1990s, Olympus and Ecolab started research for a new, aldehyde-free alternative for the automated reprocessing of endoscopes in ETD. During this extensive project, a variety of active principles among which were Quaternary Ammonium Compounds (QAC) were closely investigated and compared. The main problem with QAC lies in the rather restricted spectrum of activity, with a lack of effect when it comes to mycobacteria and non-enveloped viruses (see also page 5). A combination of QAC and alcohol could compensate for this lack, but it leads to significant material impairment, especially in higher concentrations and in connection with temperature. Material compatibility Anti-microbial efficacy Safe handling Odour Cleaning power ph 1 ph neutral ph 14 It soon became clear that there is only one alternative which cannot only compete with glutaraldehyde, but even surpasses the established standard: Peracetic acid (PAA). The development challenges for PAA based disinfectants are considerable: While the anti-microbial efficacy generally decreases with the shift from acidity to alkalinity, the material compatibility and cleaning efficacy of PAA-based products improves. The solution to this apparent contradiction can be found with the PerOxyBalance concept, a synonym for the ideal balance of anti-microbial activity, cleaning efficacy and material compatibility. It defines the ideal ph value of the used solution almost at neutrality of ph 6 8, respecting efficacy and compatibility aspects as well as user safety. The Olympus PAA process the ideally balanced formulation gives patient and user safety first priority! 8

9 Product characteristics and user benefit With EndoDet, EndoDis and EndoAct, Olympus has created a product system that efficiently manages the challenges of PAA based reprocessing: Patient Safety The large spectrum of activity guarantees fast and efficient inactivation of all relevant germs. The reproducibility of the reprocessing results was reviewed and assessed in accordance with the latest European standards. Material Preservation Before the actual market launch, the material compatibility of the Olympus PAA process was assessed and proven in more than 5000 subsequent reprocessing cycles. This test clearly reconfirmed that the comprehensive anti-microbial efficacy is not achieved to the detriment of material compatibility. Staff Protection An integrated suction lance in the EndoDis container prevents any direct user contact with concentrated PAA. Furthermore, the Olympus PAA process is classified as neither corrosive nor irritant. This significant hazard reduction renders process handling much safer and provides additional staff protection. A report on practical user experience: France In France, the use of PAA in endoscope reprocessing had already become a recommended standard in In view of the discussions on Creutzfeld Jacob Disease (CJD), the French authorities defined PAA as the safest and most efficient reprocessing chemical for heatsensitive instruments which cannot be sterilised. Although the change from GA to PAA is not a voluntary decision but based on the official reprocessing recommendation, users in France noted on the particular advantages of the Olympus PAA process. Reprocessing with glutaraldehyde Working with GA, hospital staff was wearing masks against the almost piercing odour. Even though automated reprocessing already reduced the nuisance to the possible minimum, the odour of GA was still largely noticeable. Irritated eyes and throats were regular symptoms when working in the reprocessing rooms, sometimes even accompanied by headaches. The transition to the Olympus PAA process The improvements were immediately noticeable: the strong GA odour disappeared and made the use of face masks against odour obsolete. There is only a slight odour of vinegar when opening the ETD machine after the completion of the reprocessing programme. The running eyes or itching throats have disappeared as well as the headaches, although the reprocessing environment has not changed in itself. The user benefit of the Olympus PAA process The canister of EndoDis is greatly appreciated, as the protective membrane in the spout prevents all direct contact with the concentrated chemical. The integrated suction lance guarantees the complete emptying of the canister: no more spilling when trying to refill, no more waste of chemicals. 9

10 Comprehensive testing and assessment the guarantee you need Better safe than sorry this is especially applicable for endoscope reprocessing. Not only do endoscopes and reprocessing machines represent significant investments, the fact that patients and staff are involved make safe reprocessing imperative. Extensive testing of efficacy, safety and compatibility are an absolute must as they serve two equally important aims: To substantiate the product claims by providing data and proof to the manufacturer In the past, the requirements and design of these tests were established by local or national authorities and institutions. Today, European standards allow for an internationally valid evaluation and comparison of reprocessing chemicals and processes. To enable the user to assess the product suitability for the intended purpose The European test standards for chemical disinfectants are categorised on a modular basis of subsequent test phases: Phase 1 Phase 2 step Phase 2 step Phase Basic Quantitative Suspension Test Aim: assessment of the general efficacy of an active ingredient, without relation to a specific product or intended use. Quantitative Suspension Test Aim: assessment of the bactericidal, fungicidal, virucidal or sporicidal activity of a product, simulating conditions appropriate to the intended use. Quantitative Laboratory Test Aim: assessment of the product s efficacy simulating practical conditions by using representative test bodies. Field Test Aim: assessement of products and processes under real-life conditions, without simulated bias. Validated methodology for this type of test is not yet available. 10

11 EN : The European standard for automated endoscope reprocessing Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes While the European standards of Phase 2 assess the anti-microbial efficacy of reprocessing chemicals, EN specifies the particular requirements for endoscope washer-disinfectors, including performance. In addition to methods and appropriate instrumentation, it also defines the requirement on the validation of the reprocessing process (installation, operational and performance qualification on first installation), as well as the routine control, monitoring and revalidation. Although EN still remains to be finally released, Olympus reprocessing processes are designed to fulfil these future requirements already today. Overview of selected expert reports on the ETD3 PAA process Anti-microbial activity: Phase 2, Step 1 EN Bacterial activity EN Mycobactericidal activity EN Fungicidal activity against C. albicans EN Sporicidal activity EN Virucidal activity Testing acc. to EN Type testing of ETD3 pursuant to EN Process efficacy ETD3 with PAA Process: DGKH method ETD3 PAA: practical evaluation Hygienic assessment ETD3 PAA Efficacy of self-disinfection and rinse water treatment in ETD3 PAA Efficacy of rinse water treatment Report on non-sensitising effect in rinse water In use test of ETD3 PAA process Safety of use Ecological evaluation of EndoDet, EndoDis and EndoAct Hazard assessment EndoDet, EndoDis and EndoAct Institute Hygiene Institute Gelsenkirchen / Germany Institute Hygiene Institute Gelsenkirchen / Germany Institute of Technical Hygiene Charité Berlin / Germany Institute University of Halle / Germany Hospital Infection Research Laboratory Birmingham / United Kingdom Institute for Hospital Hygiene and Microbiology Graz / Austria Ecolab / Germany Biotech Germande / France Henkel KGaA / Germany T. Slotsbjerg, Hvidovre Hospital / Denmark Institute Ecolab / Germany Ecolab / Germany Please ask for our detailed certificates binder. 11

12 Optimised processes: the key to increase efficiency in endoscopy The importance of endoscopy has continuously increased during recent years. On the one hand, the specialisation of hospitals can be observed. On the other hand, endoscopy is becoming a standard procedure for diagnosis and therapy of the gastrointestinal and pulmonary tract. Pre-Cleaning Cleaning Disinfection Leakage Test Improve the working environment efficiently protect your staff Despite all countermeasures, the lack of time and motivation, inadequate staffing and ignorance of the critical aspects of glutaraldehyde have lead to persistent complaints and health problems with endoscopy staff. Ban these phenomena from your endoscope department by choosing the Olympus PAA process. The dedicated canister design for EndoDis provides tri-fold protection for staff: No irritation from odours thanks to patented canister sealing and integrated suction lance No skin and respiratory contact through self-locking canister No possibility of confusion and faulty connection of canisters due to the lock-and-key system and colour coding of cans. Significantly reduce time and process costs without pressuring the human factor Time is precious, especially when it comes to the working time of staff and down-time of instruments, e.g. due to reprocessing. Every hospital consequently strives to optimise procedures and reduce financially unproductive reprocessing time. Instead, the return on investment for an endoscope should be accelerated by intensifying the throughput in endoscopy. The Olympus PAA process produces ideal reprocessing results already at 35 C. This eliminates the time-consuming heating of water to up to 60 C before the cleaning and disinfection step can commence. Meeting standardised, predefined process parameters such as water pressure, water temperature and electrical power, help to further reduce process time. 12

13 In this context, hospitals are particularly interested in optimising the reprocessing processes in order to spare the investment of an additional endoscope, while increasing the patient throughput. 1st Rinse Final Rins Drying Low temperature reduces material stress and prolongs the service life of your endoscope A lower process temperature does not only save time during reprocessing. It also represents a reduction of material stress for the endoscope as it is not subjected to the same level of repeated heating and cooling by process and rinse water. Thus, the normal wear and tear of an endoscope can be reduced. Reliable and reproducible results at any time utmost patient safety guaranteed Patient safety can only be guaranteed by optimum hygiene results, every time an endoscope is reprocessed. However, many users are not aware of the fact that endoscope, machine and reprocessing chemistry are to be seen as an integrated system which must be balanced in the best possible way. With decades of experience in automated endoscope reprocessing, Olympus has created a care-free system that produces reliable and validated reprocessing results at any time. An independent expert report to reconfirm the validity and reproducibility of the ETD3 reprocessing success was initiated in April 2007 by Dr Torsten Slotsbjerg (Hvidovre Hospital, Denmark). He is one of the most renowned experts in endoscope reprocessing in Denmark, building his experience on more than 14,000 endoscope samples. The report is based on an investigative sample range of over 400 reprocessing procedures. Perfect results were measured in 99.3% of all cases. This is significantly above the acceptable threshold for good results of 96.6%. With Olympus, you can relax we care about your reprocessing! 13

14 Olympus ETD3 Ready for EN In close cooperation with Miele and Ecolab, Olympus has developed ETD as an ideally adapted system of endoscope, machine and disinfectant chemistry, creating a synonym for reprocessing competence. Further to the PAA process, which in itself combines user benefits and utmost patient safety, the ETD offers a variety of additional features that enhance the ease-of-use. 14

15 EndoID all endoscope data under control An automatic identification of endoscopes by means of RFID-based transponders is the key to uncomplicated data management. It lays the basis for individual and efficient flow control for every endoscope, and also represents a quality assurance system, since reprocessing reports can be printed out. Leakage tester detect the problem before it becomes one Leaks are the most common cause of major endoscope repairs. The integrated leakage tester works with very high sensitivity and detects even the smallest perforation in the endoscopes, thereby identifying potential damage prior to machine reprocessing. Flow Control monitor the correct irrigation of all endoscope channels Reliable reprocessing can only be assured if reprocessing takes place under the required preconditions: all channels must be correctly adapted, free of blockage and fully irrigated. Flow Control helps to monitor whether these requirements are fulfilled by independently measuring the flow in every single channel. In the event of any deviation from the pre-registered standard values, the cycle is interrupted to prevent insufficient reprocessing results. Rinse Water Treatment taking care of inadequate water quality Water quality can significantly contribute to the overall reprocessing success. No matter how efficient the cleaning and disinfection cycle have been, the scope can be recontaminated by waterbourne microorganisms such as Salmonella or Legionella. The combination of an improved UV-light unit and the dosage of a small amount of PAA into the rinse water ensures a hygienically safe water quality and therefore perfect reprocessing results. Endoscope System Integration Linking ETD3 to the hospital data warehouse facilitates the updating and harmonisation of relevant patient data. Patient diagnosis, visual records from the examination and reprocessing documentation of the used endoscope are now easily manageable and accessible, everywhere and at all times. 15

16 Specifications, design and accessories are subject to change without notice or obligation on the part of the manufacturer. E /07 RK Postfach Hamburg, Germany