Proactive Approach for Safe Use of Antimicrobial Coatings in Healthcare Settings: Opinion of the COST Action Network AMiCI
Abstract
:1. Introduction
- (i)
- Information on production and use volumes of particular biocides in current use;
- (ii)
- Epidemiological data indicating public health relevance of AMR;
- (iii)
- Data on the environmental stability and fate of individual products;
- (iii)
- (iv) Dose-response relationship and of the threshold triggering the emergence of AMR;
- (iii)
- (v) Generation of standards for the testing and surveillance of AMR at the international level.
2. Materials and Methods
- (i)
- What are the possible (eco)toxicological risks related to application of antimicrobial materials in healthcare settings?
- (ii)
- What are the possible risks related to potential development of antimicrobial resistance?
- (iii)
- Could these risks be addressed at the level of ‘safe-by-design’ of antimicrobial coatings?
- (iv)
- Adverse effects/risk-benefit analyses: who should be involved in the process?
3. Results
3.1. Question 1: What Are the Possible (Eco)toxicological Risks Related to Application of Antimicrobial Materials in Healthcare Settings?
3.1.1. AMCs: Classification and Mechanism(s) of Action
- Coatings that release the active substance; these are the oldest and most commonly used coatings prepared by simple impregnation, soaking or coating of a porous material with antibacterial compound;
- Coatings that have the active substance covalently anchored to the surface;
- Anti-adhesion surfaces which are specifically designed surface topographies that repel microbes or decrease their surface attachment.
3.1.2. Biocidal Chemicals Used in Antimicrobial Coatings Are Inherently Toxic
3.1.3. Relevant Regulations Involved in Europe
3.1.4. Risks Arising Due to the Use of Antimicrobial Coatings in Healthcare Settings: Silver Nanoparticles as a Model Compound
3.2. Question 2: What Are the Possible Risks of Antimicrobial Coatings Related to the Potential Development of Antimicrobial Resistance?
3.2.1. Antimicrobial Resistance as a Global Problem
3.2.2. Antimicrobial Coatings as Potential Inducers of Resistant Microbes
3.2.3. Contribution of Antimicrobial Coatings to the Development of Antimicrobial Resistance: Data-Gaps
3.2.4. Development of Antimicrobial Resistance Due to Antimicrobial Coatings: Potential Risks at Different Levels and over the Coatings’ Life Cycle
3.3. Question 3: Could the Ecotoxicological Risks and Risks Related to Potential Development of Antimicrobial Resistance Arising from the Application of Antimicrobial Materials in Healthcare Settings Be Addressed at the Level of ‘Safe-By-Design’?
3.3.1. Safe-By-Design Approach in Antimicrobial Coatings Use and Development
- Convenience of integration into existing industrial innovation processes;
- Early and easier identification of uncertainties and risks;
- Reduction of uncertainties and risk;
- Timely recycling or termination of projects with unacceptable risks;
- Decrease of a number of unforeseen events during the development process and market introduction;
- Preparedness for current and future regulatory requirements;
- Balanced safety, functionality and costs of final product;
- Improved design of products and better business models.
3.3.2. Quality, Efficacy and Safety Assessments of Antimicrobial Coatings
3.3.3. The Use of Safe-by-Design Principle in the Development of Antimicrobial Coatings
3.4. Question 4: Adverse Effects/Risk-Benefit Analyses of AMCs: Who Should Be Involved in the Process?
- (i)
- Producers, distributors and suppliers;
- (ii)
- End-users (hospitals, medical advisors, patients’ associations);
- (iii)
- Research institutions (research and development, know-how and expertise);
- (iv)
- Regulatory and standardization agencies (standards, reference materials, threshold values);
- (v)
- Environmental and health agencies (monitoring and safety assessment along the life cycle, exposure at the workplace, epidemiological data);
- (vi)
- Media, mass and social communication (dissemination of knowledge on AMCs innovation and potential risks to a wider audience avoiding negative public perception caused by the lack of information).
4. Different Aspects of Risk-Benefit Analysis of Application of AMC in Healthcare Setting
5. Conclusions
- Ecotoxicological hazard needs to be evaluated proactively, before the use of AMCs in healthcare settings’ surfaces in the environment of patients
- The lessons learnt in AMR should be taken on board when assessing the risks of AMCs
- The quality, efficacy and safety evaluation of antimicrobial materials in healthcare settings should be addressed at the level of safe-by-design approach
- Involvement of concerned stakeholders in the risk-benefit analysis is important for the responsible development of AMCs.
Acknowledgments
Author Contributions
Conflicts of Interest
Abbreviations
AMC | antimicrobial coating |
AMR | antimicrobial resistance |
HCAI | HealthCare Associated Infection |
NM | nanomaterials |
NP | nanoparticle |
SbD | Safe-by-Design |
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Group of Organisms/Toxicity Endpoint | Median L(E)C50 ** or MIC *, on Compound Basis, mg/L | ||
---|---|---|---|
Ag NPs | CuO NPs | ZnO NPs | |
Crustaceans (LC50) ** | 0.01 (17) | 2.1 (8) | 2.3 (10) |
Algae (EC50) ** | 0.36 (17) | 2.8 (5) | 0.08 (5) |
Fish (LC50) ** | 1.36 (17) | 100 (1) | 3.0 (4) |
Bacteria (MIC) * | 7.10 (46) | 250 (13) | 622 (15) |
Lowest L(E)C50, MIC | 0.01 | 2.1 | 0.08 |
Most sensitive organisms | crustaceans | crustaceans | algae |
Issue | Description | Need |
---|---|---|
Identification/characterisation of NM-based biocidal agent | Knowledge on the key characteristics that influence the release, exposure, behaviour, effects and subsequent environmental and human risks of NMs. | Reasonably priced, accessible, standardized and validated methods and procedures to characterize NM in different media according to the EC definition. |
Transformation of NM-based biocidal agent | Knowledge on the circumstances, extent and rate of dissolution; change of the structure of NM throughout the different stages of their life cycle. | Life Cycle Assessment in different biological and environmental matrices; standardized and validated methods to test or predict the extent and rates of the transformation of NMs. |
Dose metrics | Dose that determines a particular response in a test system; production volume of the substance; dose levels at which toxicity effects are observed in experimental tests and which can be compared to the estimated exposure levels to estimate the risk. | Development and use of standardized protocols for sample preparation and characterization of NM within exposure and toxicity studies; identification of the most appropriate metrics for each type of NM within each specific route of exposure and toxicological endpoint. |
Extrapolation | Information (on physico-chemical characteristics, exposure and/or hazard) of different forms, types and sizes of NMs (or the bulk material) for extrapolation, read across or grouping within the risk assessment of NMs. | Development of nano-specific approaches for extrapolation, interpolation, read across and grouping based on the key characteristics/properties that influence the release, exposure, behaviour (fate and kinetics), effects (hazards) and subsequent risks of NMs. |
Fate and kinetics | Interaction of NMs with their environment that change their physico-chemical characteristics, including their surface composition, ability to aggregate, agglomerate and/or dissolve. | Knowledge on the key characteristics that influence the fate, behaviour and kinetics of NM with respect to the life cycle assessment of nanoproducts (including the release of NMs from products). |
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Ahonen, M.; Kahru, A.; Ivask, A.; Kasemets, K.; Kõljalg, S.; Mantecca, P.; Vinković Vrček, I.; Keinänen-Toivola, M.M.; Crijns, F. Proactive Approach for Safe Use of Antimicrobial Coatings in Healthcare Settings: Opinion of the COST Action Network AMiCI. Int. J. Environ. Res. Public Health 2017, 14, 366. https://doi.org/10.3390/ijerph14040366
Ahonen M, Kahru A, Ivask A, Kasemets K, Kõljalg S, Mantecca P, Vinković Vrček I, Keinänen-Toivola MM, Crijns F. Proactive Approach for Safe Use of Antimicrobial Coatings in Healthcare Settings: Opinion of the COST Action Network AMiCI. International Journal of Environmental Research and Public Health. 2017; 14(4):366. https://doi.org/10.3390/ijerph14040366
Chicago/Turabian StyleAhonen, Merja, Anne Kahru, Angela Ivask, Kaja Kasemets, Siiri Kõljalg, Paride Mantecca, Ivana Vinković Vrček, Minna M. Keinänen-Toivola, and Francy Crijns. 2017. "Proactive Approach for Safe Use of Antimicrobial Coatings in Healthcare Settings: Opinion of the COST Action Network AMiCI" International Journal of Environmental Research and Public Health 14, no. 4: 366. https://doi.org/10.3390/ijerph14040366