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. In February 2015, the European Commission released a progress report on the 5 year action plan against the rising threats from AntiMicriobial Resistance (AMR) that was initiated in 2013. Key actions are focussed on an appropriate use of antimicrobials, effective prevention of microbial infections, development of effective antimicrobials (antibiotics) or alternatives, joining forces with international partners, and reinforcing research to combat AMR in an innovative way. However, the number of infections caused by multi-drug resistant bacteria continues to increase at a significant rate and resistance to last-line antibiotics continues to concern Europe. Vytenis Andriukaitis, European Commissioner for Health and Food Safety has said that AMR is one of the most pressing public health issues of our time. The AMICI-consortium is convinced that new methods, in addition or as an alternative to an appropriate use of disinfectants and antibiotics, are required to reduce microbial activity, associated infections and the increase of AMR. There is an urgent need for the European Commission to expand their investments in these alternatives. A potential and promising weapon against bacterial growth and possibly the development of multi-drug resistant bacteria has been found in AntiMicrobial (nano)-Coatings (AMC). In coatings fortified with an active ingredient, the ingredient is responsible for the elimination of the microorganisms.
Nowadays, a wide range of AMC is commercially available and has been applied or investigated by network partners. A recent study showed that 50% of the coatings contain nanosilver, and that these perform best in the ISO test for efficacy.
Nevertheless, silver release has been suggested to cause new forms of AMR, and the release into environment will cause problems in regulation. An existing COST Action iPROMEDAI particularly aims at research on timed presentation and local delivery of antimicrobial active compounds from medical devices, such as catheters, to reduce the incidence of device-associated infections that originate from bacteria developing in biofilms. The AMICI Action network will focus on innovative AMC on non-invasive materials and surfaces, such as operating tables, walls, the interior of ambulances, door handles, textiles etc.
So far, little is known about the effectiveness of the application of AMC on surfaces on the prevention of spreading infections and their impact on induction of multi-drug resistant bacteria in the healthcare (e.g. hospitals and nursery homes). The presence of active substances in AMC may promote / induce resistance mechanisms and this needs to be understood and alternative strategies sought.
A balanced risk-benefit analysis of its widespread application is needed to guide a ‘Safe by Design’ development and introduction in complicated chains with high demand for compliance such as healthcare.
Reasons for the so-far limited introduction of innovative AMC in Healthcare include:
- Systematic, international coordinated research on the effects (both positive and negative) of AMC in heathcare or other sectors is not yet available.
- There is a lack of know-how regarding the availability and use of different materials and mechanisms of action of (nano)-coatings and the desired use in different applications, procedures and products.
- Little to no information is available on the possible adverse effects of AMC, e.g. the potential induction of new resistance mechanisms in bacteria or emission of toxic agents into the environment.
- The lack of a standard performance assessment for AMC, applicable in laboratory settings makes it difficult to directly compare the different coatings from different producers.
- Laboratory tests only check the functionality of coatings in a(n) (extreme) test condition, field tests or benchmark methods to assess the efficacy in field conditions are lacking. There is no communication or publication of best-practices by individual hospitals or the suppliers.
Challenge to the value chain
The above issues are the major challenges of this consortium and its members hypothesize that introduction of (nano-based) AMC into hospital settings can offer a number of new opportunities to prevent infections and the induction of multi-drug resistant bacteria. However, before these coatings can be widely used in healthcare, new challenges have to be met. Firstly, there is an urgent need to establish a representative field or field simulation test, to describe the actual performance of coatings, and directly relate the outcome of this test to an actual status of HCAI.
Challenge for the entire chain
Although we claim that the introduction of coatings will decrease the environmental impact of conventional cleaning and its chemicals, the toxicological impact of AMC itself has to be examined, as well as the possible development of AMR to (the active ingredient of) coatings. Although the appearance of resistance is mainly linked to the use of antibiotics, bacteria have become resistant to some biocides such as Triclosan. The potential to develop such resistance has been debated for several years. Although most of the producers of active ingredients with antimicrobial action state that their ingredient does not lead to the development of resistant organisms, there is insufficient evidence to prove and generalise that statement. For these investigations there is no standardised method to predict if an active ingredient invokes either resistance or cross-resistance.
Challenge for suppliers
AMC with an active ingredient need to comply with the new European Biocidal Products Regulation. A new Regulation, the first to build in the new Commission definition on Nanomaterials, is meant to simplify and streamline the requirements for approving active substances and authorizing products.
All currently used active ingredients need to be submitted to ECHA (European Chemicals Agency) before 01-09-2016. Therefore, a further assessment for different antimicrobial products is required with regard to identify and release of (active) ingredients from the coatings into the environment.
AMiCI primary objective:
To evaluate the impact of (introducing) AntiMicrobial Coatings in healthcare on the spread of infections and on the efficacy in fighting HealthCare Associated Infections and bacterial resistance to current antibiotics.
AMiCI secondary objectives:
This Action will coordinate international and cross sectoral research efforts, by a variety of activities such as collaborating with existing projects, organizing new events, jointly developing and implementing working groups, so that forces can be joined in combatting AMR. This Action will stimulate collaboration between industry and research institutes using available knowledge, and disclose state of- the- art nanotechnology and biotechnology knowledge, to industrial partners. This will lead to more effective AMC and successful new market applications.
In particular AMiCI Action aims:
- To develop and maintain a European network including producers, distributors, processors of AMC, and (potential) users of AMC in healthcare, as well organisations involved in the compliance with (international) standards on hygiene.
- To consult and support policy and the healthcare sector with regard to further actions and application of AMC against microorganisms and the prevention of the spread of infectious diseases.
- To use the know-how and expertise of the network to stimulate development and optimisation of antimicrobial materials for noninvasive surfaces.
- To gather best practices and convert these into recommended standardised methods to evaluate and compare the effectiveness of AMCs in a laboratory setting, with possibilities to extrapolate the method to field tests.
- To gather best practices and convert these into recommended field tests that enable the evaluation of the effectiveness of the use of AMC in the prevention of the spread of infections in various settings within the healthcare sector.
- To gather information on the impact of the introduction of AMC in various settings on the development of multi-drug resistance, and the possible development of AMR to AMC.
- To establish an approach for a risk-benefit analysis for using AMC in different healthcare environments, weighing potential adverse effects (e.g. eco- and cyto-toxicity) versus long- term savings and benefits.
- To determine the effects of (semi)-permanent coatings on procedures and downstream effects (costs, sustainability) in the cleaning process in healthcare (the new cleaning approach).
- To disseminate knowledge on AMC innovations and laboratory and field tests to stakeholders such as coating suppliers and producers, healthcare sector and knowledge institutes.
- To disseminate findings on the new cleaning procedures and logistics upon introduction of AMC into healthcare and other sectors such as food processing industries.