CSC REVIEW
l Compatibility of chemical dilution with the product intended to be re-used, components of the EWD and rinse water quality.
Such requirements are validated and verified in the design stage (type testing), in the operational environment (performance qualification) and through ongoing validation frequencies as specified in the appropriate national guidance.
There is a great debate currently ongoing within the decontamination industry in regards the supply of chemicals and a possible ‘cartel’ with manufacturers supplying process chemicals for use with EWDs? Guidance and standards require that all detergents and disinfectants should be configured in line with EWD manufacturers’ instructions. This will include appropriate type test information, to include reproducibility of the detergent and disinfectant dosing system in accordance with the EWD manufacturers’ instructions. So where does this leave an organisation, using alternative chemicals from potentially more cost effective suppliers?
Is this scenario any different to a supplier of chemicals used within domestic dishwashers?
Does any person undergoing surgical procedures expect anything less than a medical device prepared in a safe manner and in compliance with an approved code of practise?
l Does any person undergoing a surgical procedure want to share bodily fluids that may remain within a device as a result of inadequate decontamination practises from a previous patient?
l Can suppliers of alternative chemicals provide the same re-assurance to patients?
l Additional risks to service also remain, as any conversion to chemicals will invalidate warranties put in place by the EWD manufacturers.
An EWD is a highly technical piece of equipment, with certain components that are only available from manufacturer, how can we guarantee continuity of service provision if an organisation breaks the appropriate service links?
Manufacturers have data to confirm the components used are compatible with their chemistry, there is no formal evidence to support the compatibility of alternative chemicals with the EWD components. So is it a cartel or compliance? Delegates at the Central Sterilising Club Annual Scientific Meeting thought it was a ‘cartel’ and that EWD manufacturers were using it as a way of guaranteeing income. The manufacturers would argue that capital costs remain low for the equipment as it is offset with ongoing chemical income. Truthfully, there are merits in both sides of the argument and chemical suppliers can reproduce to identical recipes, possibly more cost effectively. However, as summary, there
are some major factors to any organisation making such an important decision. l As an organisation, you are technically going against requirements of regulatory frameworks approved codes of practise
l Can your organisation justify its decision in a court of law?
l Can you guarantee integrity of the decontamination process against Type test information?
l Will the service provider guarantee the ability to repair the EWD, or any reprocessed endoscope, in event of all eventualities?
l Validation systems will have to provide accountable evidence that the alternative chemicals are achieving the required specification.
Whatever your thoughts, as a decision maker you have to ensure all eventualities are considered before any conclusion is considered. Listen to key stakeholders within your organisation, not sales teams who promise a brighter future. Is it a matter of compliance or do you believe it is a cartel? You decide.
Readers’ thoughts
Now you have had a chance to read both sides of the debate, we want to hear from you. Send your thoughts and comments to
chrisshaw@stepcomms.com A selection of reader’s comments will be published in a future issue of The Clinical Services Journal. CSJ
Belimed UK Shipley West Sussex RH13 8GQ
Email:
sales.uk@
belimed.com Tel: +44 (0) 1403 738811
JUNE 2018
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