Anti-Microbial Coating Innovations to prevent infectious disease: a consensus view from the AMiCI COST Action

Four years ago, when AMiCI was established, there was clear evidence that antimicrobial resistance (AMR) had emerged as a global health risk. While effective and prudent stewardship of antimicrobial products were being promoted as necessary for management and potential mitigation of this risk, there was increasing recognition of the possibilities that antimicrobial coatings (AMCs) presented.

AMCs and some associated technologies were not necessarily new. For instance, antimicrobial properties of copper and silver ions were well-known at the time of AMiCI launch, and had been utilised extensively in a variety of settings including, for example, biofilm retardation in the marine industry, in textiles, and medical devices.

However, the AMiCI COST Action represented a cohesive gathering of expertise from across Europe (33 countries in total) that allowed a holistic perspective across the spectrum of activities associated with AMC innovation leading, hopefully, to new effective products suitable for implementation in healthcare environments for the benefit of staff and patients, and indeed industry.

In particular, this large COST Action involved more than 300 experts from academic, clinical, regulatory, manufacturing and hygiene sectors.

Since its inception, AMiCI has held dozens of meetings and facilitated workshops, and has participated in focused international conferences. The COST Action has published its findings as Open Access articles in high-impact peer-reviewed journals in order to disseminate its consensus views widely. AMiCI has further focused on early career researchers in providing Short Term Scientific Missions, especially from Inclusiveness Target Countries and organized two training schools. The AMiCI activities have been highlighted on its dedicated website www.amici-consortium.eu. These activities have attracted considerable media interest.

However, in the four years in which the COST Action AMiCI has been pursued, the AMR risk has not diminished. In fact, its potential risk to global public health has become even more high profile, with consistent statements by credible, qualified experts regarding need for new antibiotics and careful management of existing antimicrobials.

Despite this evident opportunity, AMC technologies and products have not accelerated at a rate that might have been anticipated. Indeed, the current 2019/2020 WHO guidance documents regarding management of Healthcare Acquired Infection (HAI) do not refer to AMCs at all. The reasons are evident and have, to a considerable extent, been highlighted in the AMiCI Consortium outputs.

While there are thousands of patents, and associated inventions, relating to AMCs, the majority relate to settings divorced from HAI. Such settings require less stringent development, regulation and testing. And the potential impact for failure of their antimicrobial properties are less catastrophic.

In its outputs, AMiCI has outlined clearly the state-of-the-art regarding AMC technology, manufacturing challenges and limitations, the chemistry and biological activity mediating their effects, how they may be incorporated into real-world clinical settings and tested, their incremental benefits, their potential environmental impact, their potential for promotion of antimicrobial resistance, and even how they may be evaluated economically.

But, it is readily apparent that a gap exists between innovation and availability of AMCs in the market. REACH and the Biocidal Products Regulation impose safeguards for public, environmental and agricultural safety that are necessary but nonetheless represent considerable compliance challenges for commercial product development and launch.

But the potential of AMCs for healthcare settings use is, in fact, hindered most by a credibility threshold.

COST Action AMiCI has successfully developed a high performing network of experts covering the full scope of AMC development, from invention to clinical use, although it has done so in a way that arguably precedes availability of necessary proof of AMC efficacy.

• For industry, the cost of bringing a AMC successfully to market is significant. To fail to reach the market, or simply to not be successful in the market, can result in commercial disaster.
• For regulators, credible blinded, controlled proof of use in situ is scarce, and the risks of AMR remain undefined.  In addition, the data generated to date are not especially convincing; indeed many claims made currently cannot be substantiated.
• For hygiene professionals, AMCs are undefined, mysterious, and incomprehensible. And for their employees, the cleaners, they are entirely ignorable.
• For healthcare managers, the cost/benefit ratios are all-consuming and there is a paucity of evidence regarding AMC benefits. Do AMCs cost more (they are unlikely to cost less)?, are AMC effects durable and do they persist?, are there training implications for hospital staff?, what environmental monitoring is needed?, do AMCs work?, do AMCs prevent infections?, is the cost of their use less than the cost of treatment? Etc etc

HAI and AMR are real and imminent threats to public health.

Therefore, for European industry and global patient benefit the next iteration of the AMiCI network should, and will, build on this COST Action investment to provide a test bed that is available for proof of concept clinical studies using protocols that reflect safe end use, and accessible to those stakeholders who are invested in bringing AMCs products to market.

Why is AMiCI important?

This COST action aims to evaluate the impact of AMC in healthcare. AMiCI focuses on AMCs for touch surfaces in healthcare, but excludes AMCs that are used in medical devices.

Infections and infectious diseases are a continuous threat to human health. According to the European Centre for Disease prevention and Control (ECDC), over 4 million people are estimated to acquire a HealthCare Associated Infection (HCAI). The number of deaths occurring as a direct consequence of these infections is estimated to be at least 37 000, and these infections are thought to contribute to an additional 110 000 deaths each year.

What is COST?

COST is the longest-running European framework supporting trans-national cooperation among researchers, engineers and scholars across Europe.

COST funds pan-European, bottom-up networks of scientists and researchers across all science and technology fields. These networks, called ‘COST Actions’, promote international coordination of nationally-funded research.

Professor Colum Dunne (University of Limerick, Ireland) on behalf of 306 experts of the COST Action 15114 – AMiCI

All contributors:

The related article has been published in The Journal of Hospital Infection. Download the pdf version here.