Navigating the Shadows – Lack of Standardisation and Data
EN 14885 Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics plays a crucial role in ensuring the efficacy, safety, and quality of chemical disinfectants and antiseptics used in various settings, including healthcare. Chemical disinfectants in Europe and the UK follow this guidance as it specifies the requirements for the testing of chemical disinfectants and antiseptics to support the antimicrobial claims they make.
(Bolten, Schmidt and Steinhauer, 2022)1
The standardisation of disinfectant test methods is critical because it:
No standardised method for testing a UV-C machine intended for the disinfection of semi-critical devices has been published. Manufacturers of UV-C machines are using the standard methods within the EN 14885 to demonstrate the effectiveness of their systems. However, these standards were developed specifically for chemical disinfection systems. They include practical methods that simulate how chemical products are intended to be used in a real-world application and include microorganisms that are explicitly challenging for chemical disinfectants.
UV-C machines are not chemical systems. Existing test methods within EN 14885 are not designed for non-chemical products, which inevitably leads to the UV-C manufacturers modifying these methods to suit their products. When deviations from the standard methods are made, the benefits of standardisation are lost, and we are left with no assurance that the product has been challenged appropriately.
The EN 148852 states:
‘In certain cases, it can be necessary or recommendable to modify even the test organism(s) to match the requirements of the area. Conformity to the standard used shall not be claimed, but it should be stated that the product was tested in accordance with the principles of the standard.’
‘Where there is no appropriate standard for an application within a specific area, a standard from another area may be recommended for use. If later on an appropriate standard is published, this new standard shall be used.’
The BS 8628 is the first of its kind and provides methods for quantitative testing of automated UV disinfection activities by direct illumination. This standard is now the most appropriate standard for testing UV machines intended for disinfection and is derived from the pre-existing standard EN 17272, which outlines methodologies for the microbiological efficacy testing of airborne disinfection processes/systems.
In this case, BS 8628 is the minimum we should expect from all UV-C machines claiming to high-level disinfect semi-critical medical devices on the market.
References
1Bolten, A., Schmidt, V. and Steinhauer, K. (2022). Use of the European standardization framework established by CEN/TC 216 for effective disinfection strategies in human medicine, veterinary medicine, food hygiene, industry, and domestic and institutional use – a review. DOAJ (DOAJ: Directory of Open Access Journals), 17, pp.Doc14–Doc14.
2British Standards Institution (BSI). EN 14885: Chemical Disinfectants and Antiseptics – Application of European Standards for Chemical Disinfectants and Antiseptics. Brussels: European Committee for Standardisation (CEN); 2022.