Treated Articles

Silver first gained regulatory approval for use as an antimicrobial agent in the early 20th century, but its usage diminished with the introduction of antibiotics in the 1940s. Recently, however, topical silver has gained popularity once again, principally in the management of open wounds. This has been largely due to the spread of methicillin-resistant Staphylococcus aureus and the resultant reduction in first-line antibiotic prescribing. The increase in the use of topical silver has raised issues concerning silver resistance, together with questions about the standardization of antimicrobial testing methods for silver. Issues related to silver product testing include a failure to establish standard procedures for determining MIC values, an absence of recognized breakpoints, a lack of conformity in the way different products release silver and variations in the effects of microbiological media on silver release and the measurement of inhibitory activity. The clinical incidence of silver resistance remains low, and emergence of resistance can be minimized if the level of silver ions released from products is high and the bactericidal activity rapid.

This report provides guidance how to test efficacy of articles or material treated with biocides. There are two major groups: The first where the treatment is intended to protect the article itself. To prove efficacy, the material/article has to be tested against an untreated variant. In the second group, the treatment is intended to introduce new properties, e.g. to provide hygienic or insect repellency-functions. The problem which the treatment is intended to solve needs to be shown on the untreated article under normal conditions of use. This way, the benefit of the treatment can be shown.

The work on developing guidance for evaluating antibacterial activity of biocide treated materials started in 2008 within the then Task Force on Biocides (TFB) now Working Group on Biocides (WGB). An Expert Group on Biocides Treated Articles (EBTA) was formed, and the project included in the work plan of the Test Guidelines Programme in January 2011. Subsequently a Guidance Document for a Tier-1 Quantitative Method for Evaluating Antibacterial Activity of Porous and non-Porous Antibacterial Treated Materials ENV/JM/MONO(2014)18 was published in July 2014. The current document aims to extend the abovementioned Tier-1 guidance, on how to assess the efficacy of treated articles, with Tier-2 laboratory based testing. The below document divides treated articles into two major groups (preserving the functions of the article itself / introducing new properties), and provides example protocols for the second function (deposition by aerosols and splashes / deposition by hand contact). This Guidance Document was approved by the Working Group of the National Coordinators of the Test Guidelines Programme (WNT) at its 30th meeting in April 2018. The Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology agreed to its declassification on 30 June, 2018. This document is published under the responsibility of the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology.

This guidance document focuses on microbiological efficacy testing only. It covers efficacy testing of articles treated with antimicrobials in the manufacturing process with the intention of the achieving an external effect. Also included are articles which have been in some way modified during service so as to exert an antimicrobial effect.

est methods for efficacy assessment of antimicrobial coatings are not modelled on a hospital environment, and instead use high humidity (>90%) high temperature (37 °C), and no airflow. Therefore, an inoculum will not dry, resulting in an antimicrobial surface exhibiting prolonged antimicrobial activity, as moisture is critical to activity. Liquids will dry quicker in a hospital ward, resulting in a reduced antimicrobial efficacy compared to the existing test, rendering the test results artificially favourable to the antimicrobial claim of the product. This study aimed to assess how hospital room environmental conditions can affect the drying time of an inoculum, and to use this data to inform test parameters for antimicrobial efficacy testing based on the hospital ward. The drying time of different droplet sizes, in a range of environmental conditions likely found in a hospital ward, were recorded (n = 630), and used to create a model to inform users of the experimental conditions required to provide a drying time similar to what can be expected in the hospital ward. Drying time data demonstrated significant (p < 0.05) variance when humidity, temperature, and airflow were assessed. A mathematical model was created to select environmental conditions for in vitro antimicrobial efficacy testing. Drying time in different environmental conditions demonstrates that experimental set-ups affect the amount of time an inoculum stays wet, which in turn may affect the efficacy of an antimicrobial surface. This should be an important consideration for hospitals and other potential users, whilst future tests predict efficacy in the intended end-use environment.

Worldwide, millions of patients are affected annually by healthcare-associated infection (HCAI), impacting up to 80,000 patients in European Hospitals on any given day. This represents not only public health risk, but also an economic burden. Complementing routine hand hygiene practices, cleaning and disinfection, antimicrobial coatings hold promise based, in essence, on the application of materials and chemicals with persistent bactericidal or -static properties onto surfaces or in textiles used in healthcare environments. The focus of considerable commercial investment and academic research energies, such antimicrobial coating-based approaches are widely believed to have potential in reduction of microbial numbers on surfaces in clinical settings. This belief exists despite definitive evidence as to their efficacy and is based somewhat on positive studies involving, for example, copper, silver or gold ions, titanium or organosilane, albeit under laboratory conditions. The literature describes successful delay and/or prevention of recontamination following conventional cleaning and disinfection by problematic microbes such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE), among others. However, there is a scarcity of studies assessing antimicrobial surfaces other than copper in the clinical environment, and a complete lack of published data regarding the successful implementation of these materials on clinically significant outcomes (including HCAI). Through its Cooperation in Science and Technology program (COST), the European Commission has funded a 4-year initiative to establish a network of stakeholders involved in development, regulation and use of novel anti-microbial coatings for prevention of HCAI. The network (AMiCI) comprises participants of more than 60 universities, research institutes and companies across 29 European countries and, to-date, represents the most comprehensive consortium targeting use of these emergent technologies in healthcare settings. More specifically, the network will prioritise coordinated research on the effects (both positive and negative) of antimicrobial coatings in healthcare sectors; know-how regarding availability and mechanisms of action of (nano)-coatings; possible adverse effects of such materials (e.g., potential emergence of microbial resistance or emission of toxic agents into the environment); standardised performance assessments for antimicrobial coatings; identification and dissemination of best practices by hospitals, other clinical facilities, regulators and manufacturers.

The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has created a significant threat to global health. While respiratory aerosols or droplets are considered as the main route of human-to-human transmission, secretions expelled by infected individuals can also contaminate surfaces and objects, potentially creating the risk of fomite-based transmission. Consequently, frequently touched objects such as paper currency and coins have been suspected as potential transmission vehicle. To assess the risk of SARS-CoV-2 transmission by banknotes and coins, we examined the stability of SARS-CoV-2 and bovine coronavirus, as surrogate with lower biosafety restrictions, on these different means of payment and developed a touch transfer method to examine transfer efficiency from contaminated surfaces to fingertips. Although we observed prolonged virus stability, our results indicate that transmission of SARS-CoV-2 via contaminated coins and banknotes is unlikely and requires high viral loads and a timely order of specific events.