Cassette Washing – Quantem leap forward in fully meeting HTM 2030 / EN 15883 ? or just another Endoscope Washer ?
Author.
Jim Daly MD for Medipure Ltd
Medipure Ltd has carried out many full HTM 2030 validation Checks for Hospitals and for leading washer disinfector makers. It is our opinion that health professionals can be forgiven for buying what they think are HTM compliant machines – manufacturers can be very persuasive.
Manufacturers can also be forgiven in making claims to be compliant.
There is so much subjectivity in interpreting the documents, both the HTM’s and the NHS Model Engineering specifications that some confusion is inevitable.
It is true to say that all the current machines on the market make claims to be 90 to 100 % compliant with the HTM standard.
In fact none of the machines can meet the NHS Model Engineering Specification. This in itself is not a problem in this authors view so long as those responsible for buying take the claim with a pinch of salt.
Purchase decisions should be based on reliability; function; after sales support and lastly cost. Many of the brand leaders are competitively priced. ‘Through the Wall’ units [ dirty to clean ] are priced at about twice the cost of standard units. The Scottish NHS have said these are the answer for all new builds . This policy favours certain models of washer disinfector and adds considerably to costs.
Aseptic handling and transport of endoscopes post washing is easy and affordable and means much greater flexibility – after all the endoscope still has to be moved to the point of use even it enters a clean room first. Acceptance of this principle would allow for all the models to be considered.
Manufacturers who state that washers should perform what are currently pre-wash protocols automatically, are flying in the face of HTM 2030, which demands the visual inspection of the endoscopes. The dishwasher type designs with channel flush facilities are indeed efficient at removing soil – Medipure has built two or three dishwasher type designs which can be used in pre-wash at a cost of between £200 and £400 . They do an excellent job BUT the human inspection side of the HTM guideline must always remain a cornerstone of the overall wash procedures.
This document cannot be a ‘WHICH’ report although we think such a document would be useful for medical equipment .
We should at this point, declare a conflict of interest because of our input into a number washer disinfector designs. It should be said that we genuinely believe that all the suppliers of washer disinfectors do their best to meet the HTM standards and constantly strive to improve their product. This market is now getting crowded – it will soon have a more discerning client base as NHS buyers get their act together and become more knowledgeable.. All manufacturers will have to add value to their product if they are to survive in the market.
Cassette washing of endoscopes is a new concept and patents are filed . This document discusses the concept of cassette washing comparing it to the best features of the rest on the market. The BES Decon RACER machine will be available for delivery in April 2004.
Schematics of Washer Types – Simply referred to as :-
[a] ‘Dishwasher Spinner ‘ Type
[b] Sink Type
[c] Tunnel washer or ‘Through the Wall’
[d] Hybrids of above designs
[e] Cassette Type - unique
All work in different ways using the tray and sink principle to wash endoscopes. Some designs are hybrids incorporating spray spinners or ultra- sonics in an attempt to improve the wash efficiency. These features have merit.
Most washer designs are made to be used with proprietary disinfectants allowing the user the choice. Most can be operated with Glutaraldehyde , peracetic acid , chlorine dioxide or electrolysed brine technologies. This gives the widest choice to the user
All modern designs incorporate channel diagnostics which tell the user of problems such as blockages or leaks on the endoscopes being washed.
Cassette Washer
Principle of Operation.
[a]
General Spec
The BES Decon Racer Cassette washer can wash solid stainless instruments ; cannulated instruments or flexible endoscopes . The disinfectant of choice is Suprox and advanced formula superoxidised water. Supplied in bulk or generated on site.
BES seek full Olympus approval on the use of Suprox . Trials indicate that Suprox ANK does not damage endosopes in any way and yet is sporicidal and more importantly kills mycobacteria .
The whole unit was developed by both engineers and microbiologists . The unit was developed to meet HTM 2030 standards. The NHS Estates Draft Model Engineering specs were read with great interest all 3472 lines .Each detailed requirement was taken on board at the design stage.
[b]
The unit was designed to have certain basic advantages which others do not have,
these can be listed :-
[1] Fresh sterile wash sink every time with all of the sink area wetted. Such is the design of the cassette.
[2] Dedicated cassette per endoscope if required.- no cross contamination in the cassette.
[3] Alcohol Channel flush / Hepa air drying of channels
[4] Hepa warm air dry into the cassette
[5] Safe storage – Endoscope is stored in aseptic conditions and can be transported to the point of use aseptically
[6] The channel diagnostics are very advanced and measure exact flows .
[7] All dosed volumes of liquid are guaranteed to be actual doses - not timed pumps.
[8] The simultaneous washing of 4 cassettes is possible each can be at different parts of the cycle. Working out the logistics of washing endoscopes within a busy facility is made much easier.
[9] Flexible operating systems and types of cassette allow this washer to multi task .
[10] Most up to date blue tooth designs and touch screen controls ensure reliability.
[11] Service packages include full HTM validation ; training and guarantees on downtimes.
[12] Channel flush capability was developed using a wide range of micro-organisms all the proprietary soils and the toughest biofilms . These exhaustive tests lead to the best and most robust systems with good backup built into the design .
[c]
Operation
The unit can be used in cassette mode or sink mode.
In cassette mode it will reprocess endoscopes after pre-wash in dedicated cassettes, which can be used as storage. The endoscopes are washed dried and stored within the cassette.
In sink mode the benefits of four sinks all with independent plc controlled wash processes can be harnessed. The sink mode cassette can reprocess two endoscopes. This means that 8 endoscopes can be washed at any one time .
The flexibility in use of this machine will allow for the fastest turn round of any system currently in use.
In sink mode three cassette designs can be used :-
· Cannulated instrument design. Channel flush and optional Ultra sonics.
· Hard surgical instrument design which has industry standard racks within the cassette and uses heat as well as Suprox and protein cutting agents .
· A ‘spinner’ cassette with standard racks and spinners top and bottom – works for hard surgical instruments and endoscopes.
· These specialist cassettes are under development and will be available soon.
· Current data indicates a possibility of safe 24 hr storage in the aseptic conditions of the washer cassette.
· Telemetry
· Tracability
· Highly sophisticated channel diagnostics .
· Barcoding and compatibility with hospital data gathering systems.
· Large touch screen display
· User friendly – free training programme
· Technician friendly
· Full HTM 2030 Quarterly and Annual validation in with the maintenance.[ Full Micro ]
· Pledge on down time.- 24 hr response on breakdowns – new machine – no on site repair.
· The modular system lends itself to easy product improvement updates. The Racer is made by a company dedicated to developing a range of infection control products.
· The problems associated with instrument washing can be complex . BES through its technical arm Medipure will seek to own the problems of water quality or any infection issues until they are solved. A wealth of expertise and backup represents the added value to the sale of the washer .
If this can be delivered it represents a massive improvement over products and services currently available to the NHS.
The
title of this discussion paper posed a question. “is this a quantum leap forward or just another washer ?”
The
answer is – This is not just
another washer – it is special !!
More
information is available from BES Decon 9
Cow Lane Cambridge
01223 882105
