INF ECT ION PR EVENT ION & CONT ROL
Disinfectant standards: what you need to know
Dr Tim Sandle looks at the current European standards on disinfectants and the key considerations for hospitals to ensure the biocidal efficacy of the chemistries they use.
Effective disinfection of surfaces, instruments and hands is critical to minimise infection risks (bacterial, fungal and viral) in hospitals especially during the current global pandemic. This requires the selection of the most appropriate disinfectants, their correct application, and an assessment of their capability to inactivate or kill microorganisms. There is a wide choice of disinfectant formulations available and it is essential to ensure the most appropriate disinfectants are selected for the use for which they are intended and are then used correctly. This article examines European Norms (EN) in relation to disinfectants, considers the importance of updates to these standards and offers some practical advice on ensuring that accurate comparisons between different disinfectants can be readily made. The main function of a disinfectant lies in its ability to kill or inactivate microorganisms. Therefore, a key step in the selection process is ensuring the disinfectant has the required level of biocidal activity. Disinfectant manufacturers provide efficacy data relating to the two key criteria of contact time and required concentration. This data should be based on product testing which is both rigorous and repeatable. In Europe, this means being tested to the European Norms (EN). Even with the UK’s departure from the EU, European Norms are likely to continue to provide the ‘gold standard’ tests for disinfectants in the UK, for the foreseeable future.
According to the EU, ‘a Standard (French:
Effectiveness is assessed through disinfectant efficacy testing, but a problem faced when selecting a disinfectant is the array of different standards.
norme, German: Norm) is a document that provides rules, guidelines or characteristics for activities or their results, for common and repeated use. Standards are created by bringing together all interested parties including manufacturers, users, consumers and regulators of a particular material, product, process or service.’ Each European Standard is identified by a unique reference code which contains the letters ‘EN’. All ENs will have been adopted by one of the three recognized European Standardization Organizations (ESOs): CEN, CENELEC or ETSI.
European standards for testing disinfectants are based on test methods orientated towards the practical use of the disinfectant. Theoretically, these standards should allow the direct comparison of disinfectants from different manufacturers, as they should have been tested using the same standard.
The key word is ‘should’. These standards are regularly reviewed and updated, but it is not mandatory for a disinfectant manufacturer to test to the latest standards. For example, EN13624:2003 specifies a
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test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectants in hospitals. The 2003 version has now been superseded by EN13624:2013, which specifies more rigorous efficacy testing. In practice this means that a disinfectant tested to the 2013 EN would need to be used at an increased concentration and / or a longer contact time, than if it were tested to the 2003 standard. If comparing two disinfectants and one was tested to EN13624:2003 and the other to EN13624:2013, it would not be an accurate comparison in terms of concentration or contact times required. There is no mandatory requirement for an updated standard to be adopted by a manufacturer within a set period of time. As standards become increasingly rigorous, to protect both patients and staff, there appears to be little incentive for disinfectant manufacturers to test to newer, tougher standards, which could mean increased disinfectant concentration times and longer contact times, to ensure microbial efficacy. There are some manufacturers who will always adopt and test to the latest norms,
OCTOBER 2020
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