Soluscope® 3 Automated Disinfection

Just to keep you up to date with Endoscopic Reprocessors, Soluscope® 3 is available for use with peracetic acid in New Zealand and has been approved by TGA for providing both HLD and STERILE processing for flexible endoscopes. I have prepared this document specifically to outline the multiple benefits this machine has to offer and to give you the facts to enable you to make an informed decision for purchase of equipment for future placements.

Apart from being the fastest processor available in Australia/New Zealand, it is currently the only machine meeting the latest European reprocessing Standards. Its main features, advantages and therefore benefits over other Reprocessors on the market are as follows:

1. Leak Test is active and continuously monitored during the entire cycle. If a leak occurs during any part of the cycle, the operator is informed by an audible alarm as well as displayed information on the screen and the validation printer. The significance of the leak test facility is poorly appreciated, particularly by those who have no experience with equipment offering this function. There are three distinct and significant advantages of this permanent function:

a. It minimises repair costs if 'scope leakage' is detected early and not allowed to continue. Small leakages are associated with water and chemical vapours traversing across to the electronic and optical components and causing corrosion and eventually failure. The longer the leakage remains undetected, the larger the repair costs.

b. It protects the patient from cross-contamination. Small leaks are insidious and basically, if water vapour / fluid can leak into the endoscope, bacteria will also move passively across. If bacteria move across into the endoscope, then it can also move back into the next patient during the next procedure and therefore cross-contaminate.

c. Cross-contamination if preventable therefore minimises the risk of potential litigation to the hospital, the endoscopist and associated staff.

d. Soluscope can also detect if the valve on the endoscope has not opened. This is difficult to detect manually and in most instances escapes the notice of users during the manual cleaning procedure i.e. it gives the user the impression that there are no leaks in the endoscope and usually results in a major repair costs. It also contributes to the cross-contamination potential if it goes undetected. Of the equipment available in Australia and New Zealand, only Soluscope® has had this feature available in its range of equipment and has had for the past 10 years. As an example of significant savings associated with repair costs, the Medical Physics Department at Royal Perth Hospital can be contacted for verification as to the potential cost savings related directly to this function. The TSSU / CSSD and the Endoscopy Department at Royal Perth Hospital have standardised and used Soluscope® since 1998 and estimated repair costs has been measurably demonstrated to run into tens of thousands of dollars each year.

2. Channel Irrigation Control is the machine's capability of detecting both blockages and misconnections at each stage of the process, (i.e. washing, disinfecting and rinsing) of the endoscope during reprocessing. Additionally, Soluscope® 3 can also detect if the various channels have ruptured or become disconnected on the 'end rubber' further protecting the patient from damaged equipment and the endoscope from further damage. This minimizes "down-time" and allows for speedier reprocessing cycles if the faults are detected before completion of the cycle.

3. Soluscope® 3 incorporates a distinct Washing Procedure as part of the complete reprocessing cycle. This is part of the European Standard prEN ISO 15888-4 and it is now mandatory for all European manufacturers to provide a distinct washing cycle as part of the overall process. This washing cycle also conforms to the new French regulation on Prion Risk associated with medical devices. A machine washing cycle is considered an adjunct to the manual brushing procedure and is therefore a positive reinforcement to that procedure. Essentially, machines provide a consistent and reproducible process and are not subject to the same inconsistencies that people may be associated with. The most important function of Soluscope's detergent is its ability to disrupt the biofilm formation, disolve it and to wash it off. Chemical cleaning used in Soluscope® 3 provides proven action against biofilm and decreases bacterial contamination of species such as pseudomonas aeruginosa and staphylococcus aureus by a 5 log factor. Additionally, once the endoscope has been brushed, the Soluscope® 3 will flush the channels saving the operator time and effort. Only the small additional channel which cannot be brushed requires manual flushing before being placed into Soluscope® 3. This function is currently only available to users of Soluscope® 3 with channel irrigation control.

4. Bar Code Entry is "error proofing" in its simplest form. Endoscope recognition is integrated into Soluscope® 3 via bar-code reader and is identified at the start of every cycle. Once the operator selects the reprocessing cycle required, bar-coding automatically selects the correct endoscope monitoring parameters. The machine requires no further operator intervention. If required, the operator and endoscopist performing the procedure can also be entered into the system via code to complete the documentation as well as for privacy.

5. Endoscope Validation is performed each and every cycle. It is not dependant upon a factory validation procedure which may be significantly different to the process carried out by dedicated and well trained staff in a factory or "artificial" environment. This is simply because each channel is channel irrigation controlled and each endoscope is automatically identified by Soluscope® 3 via bar-coded input.

6. The specific BB Soluscope® 3 machine accommodates the large Ultrasound endoscopes and the Fujinon double balloon enteroscopes which are currently gaining popularity and acceptance across Australia and New Zealand. This makes the system less prone to obsolescence when new techniques or endoscopes come into the
market

7. Turn-Around Times show that Soluscope® 3 is the fastest reprocessor on the market. A cycle offering leak testing, detergent cleaning, rinsing, HLD or STERILE, rinsing, channel irrigation control and air drying is completed in 20 - 21 minutes. A "decontamination only" cycle without a cleaning process (which is what most competitor machines in Australia and New Zealand offer), takes 16 minutes. The advantage with Soluscope® 3 is that it automatically offers a distinct cleaning cycle as a part of the decontamination process and additionally leak tests, performs channel irrigation control and validates each process within 21 minutes.

8. Air & Alcohol Dry as required. Soluscope® 3 has an inbuilt filter air compressor which dries the internal channels of the 'scope during each procedure. At the end of the day, the operator can select a complete washing, decontamination, air and alcohol dry cycle for endoscope storage as required by GENCA further eliminating operator intervention. Additionally, the operator can select an air & alcohol dry regime on an endoscope for storage purposes if a previously processed scope has not been used and is no longer required for the examination list.

9. Low Concentration, Low Biocide Contact Time and Low Temperature all add to the effectiveness and protection of the endoscope. The concentration, temperature and contact time of peracetic acid (compare these to other machines) used in Soluscope® 3 is as follows:

10. Operator Selectable HLD or STERILE Cycles are available in the one machine further enhancing flexibility and reduces running costs for the selected cycles i.e. HLD for gastroscopes and colonoscopes and STERILE for cystoscopes, bronchoscopes and duodenoscopes (according to statutory regulations). As with all liquid sterilants, the STERILE cycle, is a "wet" cycle and the endoscopes sterilised with this process must be processed on a strictly "just before use" regime. On completion of the cycle, scopes must be removed from Soluscope® 3 and handled in a aseptic manner.

11. Other Operator Selectable Running Cycles are available and includes Rinsing only and alcohol drying only. These enhance the flexibility of the system to reflect the functions required or may be useful to the operator at some future date.

12. Machine Decontamination Cycle using a second biocide (Chlorine) is available and as per GENCA is recommended to be run at the end of each day. This cycle decontaminates all parts of the hydraulic circuit including the Soluscope's® 3 capsule filter eliminating the risk of biofilm formation and machine colonisation.

13. Retro-Contamination is effectively banished from Soluscope® 3 because of the use of the daily decontamination of the capsule filter using chlorine and treatment with peracetic acid each cycle.

14. Microbiological Sampling as required by GENCA to ensure "sterile" water used to prevent retro-contamination during the rinsing process is easily, rapidly and automatically collected using a specific cycle on the machine. The operator only needs to insert the collection device, run the process and then send the concentrated "sample" to the laboratory for analysis. Typically, the result using the technique outlined is 700 times more sensitive than those currently performed on ìwetî water samples sent to the laboratory where 1mL of sample only is used to determine contamination.

15. Liquid Chemical Concentrates are used in Soluscope® 3 to provide "single-shot" (i.e. non-reuse) chemistry systems. Liquid chemistries specifically manufactured for use on Soluscope® 3 offer several advantages over dry chemical powders and were chosen for reasons as follows:

a. They are more stable and have an expiry date of 1 year from date of manufacture and typically 6 months from date of delivery. They are not subject to humidity effects, clumping and poor dissolution which typically give variable peracetic acid or buffering effects.

b. Being liquid, the chemical components are already in solution and there is no risk to the operator removing non-dissolved chemical components should the system fail to operate as designed. There is no unnecessary risk to the operator from exposure to chemicals which have failed to dissolve in the reprocessing cycle. Operator safety is further enhanced by the system which automatically initiates a rinsing programme should an error be detected during any part of the reprocessing cycle. This ensures the endoscope and the bowl is completely rinsed prior to allowing the operator access to the system / endoscope for inspection or removal. The rinsing period is automatically initiated as selected according to a set protocol as follows; No rinsing is initiated if a leak has occurred during the initial start-up "dry" period, 3 rinses during the chemical washing cycle and 6 rinses during the decontamination cycle.

c. The peracetic acid concentrate in the container is only 5% (compare this to other manufacturers) making it comparatively safer to handle than competitor products.

d. The Liquid chemicals for Soluscope® 3 come in 5L containers ensuring the operator spends less time installing and removing containers when reprocessing is carried out. Each detergent container provides sufficient chemical for 91 cycles and each peracetic acid and buffering reagent provides chemicals for 38 HLD or 19 STERILE cycles. Thus, less labour time is required for the operator for this function.

e. Soluscope® 3 automatically counts each chemical dosage and warns the operator on impending change-over via a virtual counter. Each dosage is also independently monitored for correct volume / concentration leading to constant chemical concentration each cycle and 'error-free' operation.

f. Liquid concentrates also have the advantage that each chemical is added in a unique manner into the system. In Soluscope® 3, the bowl is first filled with water and the concentrate is added to the water giving an instantaneous low useable chemical dose. If dry chemicals were to be used, the system must operate in reverse manner to that just described such that the incoming water is directly added to the concentrate thereby forming an instantaneously high peracetic acid solution which is injected directly onto the endoscope and then subsequently diluted to the useable concentration. It is preferable to have the concentration of peracetic acid at as low a concentration as possible to achieve HLD or STERILITY without the potential for causing damage to the endoscope. Oxidising agents, temperature, contact time and concentration all have an effect on plastics and in particular, plasticisers which allow plastics to remain pliable without rupturing or becoming brittle. Specific liquid chemicals manufactured for use in Soluscope® 3 ensure that the lowest concentration, the lowest contact time and the lowest temperature are needed to achieve HLD or STERILITY without compromising endoscope integrity or longevity.

16. Contact Infection Control Consultants and actively discuss operational aspects of available equipment. Every institution has access to these groups and they should be used to obtain non-biased and valuable information on the advantages each machine has to offer. Ramsay Health also employ the services of an external consultancy service across Australia for their expertise in this important area. HICMAR should also be approached for their input. Although they may be unwilling or unable to directly influence a decision, they should be able to verify each machine's processes and functions and should be able to suggest which functions may be of value and the reasons for accepting or negating a particular function as of value or concern.

17. Contact End Users who are using the new Soluscope® 3 reprocessor with Peracetic acid for their critical and informative comments.

18. Finally, Soluscope® 3 is TGA approved for HLD and STERILE reprocessing of flexible endoscopes in Australia and New Zealand:

• TGA Certification for HLD (118778) and STERILIZATION (22580)

It is also approved to comply with:

• The European Standard on washer disinfectors (draft prEN ISO 15888-4)

Approved to comply with:

• The English Health Technical Memorandum HTM 2030

Approved to comply with:

• The new French regulation on Prion Risk associated with medical devices
   

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