The environmental impact of medical devices: from Life Cycle Assessment to transparent communication

“Life Cycle Assessment, or LCA, is now the international reference methodology for translating the technical solutions adopted into measurable environmental impacts and is becoming increasingly important as a global reference framework,” says Carlo Brondi, a researcher at STIIMA-CNR and coordinator of the “Chemical Products and Processes” working group of the Italian LCA Network.
“LCA provides a means of integrating environmental sustainability into healthcare technologies based on objective evidence,” confirms Sergio Paddeu, Environmental Regulatory Manager at Esaote. 
“It is a methodology developed within the scientific community that assesses the environmental impacts of a product from raw material extraction through production, transport, use and maintenance, all the way to end-of-life management. It is a key tool for generating reliable insights and supporting continuous improvement,” adds Paddeu. “By integrating environmental considerations alongside quality, safety and clinical performance, LCA strengthens the approach to sustainable innovation and responsible product development.” The goal is to combine continuous technological innovation with sustainable development. 
Brondi describes an evolving landscape, with LCA serving as a cornerstone of this transition. “LCA is increasingly being incorporated into design, industrial control and product reporting tools. In the field of medical technologies, where innovation, regulation and patient protection intersect, the application of LCA calls for even greater rigour,” he explains.

The ISO 14040 and ISO 14044 standards define the primary requirements for life cycle assessment. The process begins with the definition of the goal and scope, continues with an inventory of material and energy flows, evaluates potential impacts and concludes with the interpretation of the results. This approach is already well established across many product categories through specific guidelines, but its application to medical devices is still at the forefront of the field.
The first key element is the functional unit: the reference point against which alternatives providing the same function are compared. For a syringe, it may correspond to a single administration; for an endoscope, to an examination that meets equivalent clinical standards; for imaging equipment, to a certain number of diagnostic examinations performed over its useful life. If this unit is not correctly defined, any subsequent comparison will have limited significance.
The second key point concerns the system boundaries: an analysis limited to production can indicate which product uses less material or generates fewer emissions at this stage. A comprehensive analysis must include the production of materials and components, transport, energy consumption at the healthcare facility, disinfection and sterilisation procedures, packaging materials, repairs and end-of-life treatment. For an electronic device, the actual lifespan, the possibility of upgrading software and components, the availability of technical support and the ability to recover complex materials are also important.
One of the main objectives of an LCA study is to identify environmental hotspots, i.e. the life-cycle stages that contribute most to the overall environmental impacts. Identifying them makes it possible to focus interventions where they can generate the most significant environmental benefits.
The carbon footprint alone, expressed in kilograms of CO2 equivalent, provides important but partial information. As a comprehensive methodology, LCA considers a number of additional environmental aspects and impact categories, such as water consumption, resource use, acidification, particulate matter formation and ecotoxicity, as well as other impact categories depending on the method adopted. The method selected must be declared, because each method uses characterisation factors, assumptions and databases that influence the results.
In the case of medical devices, moreover, a product has value when it safely performs its intended function. LCA does not replace clinical evaluation, risk analysis, post-market surveillance or regulatory compliance. It adds an environmental dimension to the assessment, making visible impacts that would otherwise remain distributed throughout the supply chain.
The European Medical Device Regulation (MDR 2017/745) does not currently require Life Cycle Assessment studies to be performed or an Environmental Product Declaration to be published as a prerequisite for CE marking. However, the growing European focus on sustainability, the circular economy and the transparency of environmental information is prompting an increasing number of manufacturers to voluntarily integrate these tools into their design, development and communication processes.
 

The reliability of an LCA largely depends on the quality of the data behind it. For a manufacturer, the primary data collected from its own processes are particularly valuable and relate to aspects such as energy consumption, materials, waste, yields, transportation, packaging and end-of-life scenarios. However, a substantial portion of the inventory must be reconstructed using databases when supplier-specific LCA data are not available. These databases model upstream processes, such as the production of polymers, metals, electronic components, as well as energy generation, transportation, and waste management.
The availability of this information is growing. Ecoinvent, one of the leading providers of impact modelling databases, reports that version 3.12 includes more than 26,000 peer-reviewed datasets, covering sectors including energy, chemicals, plastics, metals, transport, waste and supply chain components. Greater coverage helps characterise complex products, but it does not eliminate the issue of representativeness: an average European or global dataset may be a poor approximation of a specific supply chain. Primary supply chain data are therefore preferable.
In this regard, the Italian LCA Database is being developed at national level by ENEA as part of the ARCADIA project. The platform compiles datasets relating to more than twenty national production chains. It does not constitute a comprehensive database for medical devices, but it demonstrates the importance of having geographically representative and interoperable inventories, which are also useful when assessing products manufactured or assembled in the country.
The quality of information is not determined by its quantity. For each dataset, it is necessary to know the reference year, the geographical area, the technology described, the allocation rules, the completeness and the uncertainty. The origin of an electronic component, the electricity mix used for sterilisation, or the actual destination of medical waste can change the order of magnitude of the results. For this reason, independent review and methodological traceability are crucial, especially when a comparison is used for tenders, commercial communications or investment decisions.

ISO 14071:2024 strengthens this framework by defining requirements and competencies for the critical review of LCA studies. The new ISO 14025:2026 defines the principles and requirements and provides guidance for Environmental Product Declaration (EPD) programmes and their associated EPDs, based on ISO 14040 and ISO 14044. Independent verification does not automatically make two analyses conducted with different objectives comparable; however, it does allow the methodology, data, interpretation and communication to be assessed against the stated principles. It is an important safeguard against numbers that appear precise but are based on assumptions that are not immediately evident. 
The demand for independently verified environmental product information is growing. In May 2026, the International EPD System announced that it had surpassed 20,000 published Environmental Product Declarations and reached 3,000 customers worldwide, following the milestone of 10,000 EPDs in September 2024. EPDs are Type III environmental declarations, based on LCA and product category rules, and designed to provide transparent information on the environmental performance of products.
Thanks to LCA and EPD, environmental information is taking on a verifiable form, enabling comparisons within clearly defined rules and facilitating its integration into supply chain processes. Medical devices can benefit from this infrastructure, adapting it to their specific clinical and regulatory requirements.

The growth of environmental declarations places increasing emphasis on data quality. A footprint calculated using uncertain system boundaries, incomplete inventories or undeclared assumptions does not provide a solid basis for comparisons in hospital procurement or between technologies. At the same time, environmental criteria are becoming increasingly important in public and private procurement policies. In this context, environmental information based on recognised methodologies and subject to independent verification can contribute to a more objective assessment of products' environmental performance throughout their life cycle. For this reason, independent verification is playing an increasingly important role. 
“For manufacturers and suppliers of medical devices, verifiable environmental data is nevertheless becoming a competitive factor,” notes Brondi. It can influence procurement specifications, supplier qualification, maintenance and reconditioning programmes, and the design of more traceable supply chains. The difference will not be made by those who communicate a more favourable figure, but by those who can document its origin, methodology, limitations and updates throughout the life cycle.

“Digitisation can make LCA more useful in everyday decision-making,” explains Brondi. Until now, a significant amount of environmental information has been made available through static documents, often in PDF format, making it difficult to integrate into design, procurement, or hospital management software.
Structured, machine-readable datasets, on the other hand, make it possible to update analyses, link materials and components to databases, perform consistency checks, and simulate different scenarios.
“Europe is building part of this architecture with the Digital Product Passport established under the ESPR regulation,” adds Brondi. On 20 July 2026, the European Commission launched the Digital Product Passport Registry, together with a testing environment. The Registry supports products covered by the ESPR, as well as product groups covered by other EU legislation requiring Digital Product Passport registration.
For medical devices, it is important to avoid drawing a direct equivalence: the Registry does not introduce an immediate, generalised Digital Product Passport requirement for all medical devices. The ESPR itself provides that, when defining ecodesign requirements for medical devices and in vitro diagnostic medical devices, the Commission must consider the need to ensure that these requirements do not adversely affect the health and safety of patients and users. Nevertheless, the overall direction is relevant: interoperable data, unique identifiers, controlled versions and accessible information across the value chain can contribute to more reliable environmental traceability.

Brondi highlights a second innovation: digitalisation also enables LCA to be used more rapidly and in a more forward-looking, or predictive, way. A company can model design alternatives before production and estimate the impact of using materials from different sources, reducing packaging, modifying logistics, or improving repairability. Brondi provides an example: “Using this methodology and digital data, an Italian steel plant, in a project I oversaw, was able to estimate whether it could meet its decarbonisation targets,” he says.
These estimates remain scenarios and should be recognised as such. However, they are useful for determining where better data need to be collected and which technical choices merit investment.

Artificial intelligence can support data cleansing, technical information extraction, anomaly detection and the estimation of missing values when gaps occur in the inventory. Its use, however, requires clear rules. An algorithm cannot transform incomplete data into a definitive measurement: documented provenance, human oversight, uncertainty ranges and subsequent verification of results are required. In the medical device sector, where the quality of technical data can also affect compliance and safety, automation must make the process more robust and controllable, rather than less transparent.

One of the most important contributions of LCA is its ability to identify the stages of the life cycle where decisions can reduce environmental impacts without compromising the delivery of healthcare.
For durable equipment, design must take into account durability, reliability, maintainability, repairability, upgradability and the potential for component recovery.
A lighter device is not necessarily preferable if it requires more frequent replacement. Energy-efficient equipment may have a higher initial environmental impact, which can only be justified if its service life is sufficiently long. A device take-back programme can be effective if collection is logistically sustainable, materials are recoverable and regulatory responsibilities are clearly defined. LCA serves precisely to quantify these trade-offs, preventing improvements at one stage of the life cycle from shifting the environmental burden to another stage.
This perspective also extends to the design of hospital spaces and processes. A procurement system that requires consistent information on service life and maintenance can favour products designed for longer service lives. A waste management system that effectively separates different waste streams can improve data quality and increase the potential for material recovery, where compatible with healthcare regulations.
LCA alone cannot address the full environmental complexity of healthcare. However, it does provide a common language for engineering, clinical practice, procurement, regulation and research. In the medical technology sector, this common language can make long-term consequences of today's decisions more visible across supply chains that will continue to generate impacts for years to come.

The evolution of LCA reflects a broader shift, with multiple stakeholders increasingly moving in the same direction: towards effective and measurable sustainability based on rigorous methodologies, "thus avoiding the risk of greenwashing," notes Paddeu. 
Manufacturers, regulators and purchasers all have an important role to play in this transition. 
“Healthcare systems around the world are placing increasing importance on sustainability in procurement and operational management strategies, and access to robust environmental information is becoming a decisive factor for customers, healthcare professionals, investors and regulatory stakeholders,” says Paddeu. “The transition to a more sustainable healthcare sector requires collaboration, innovation and an ongoing commitment to training,” he adds. “This is the path Esaote has taken, with the activities we have in progress. At the beginning of 2026, we successfully completed the Environmental Product Declaration (EPD) for two ultrasound devices: MyLab™A50 and MyLab™Fox, the result of a specific Life Cycle Assessment (LCA) study to evaluate the environmental impact throughout the entire life cycle of these products. The EPD represented an important step for Esaote in strengthening its sustainability strategy, supporting both environmental communication to customers and stakeholders and the development of our innovation and circularity processes. I am convinced that by combining technological excellence and data-driven environmental management, we can contribute to a healthcare ecosystem that is both innovative and increasingly sustainable.” Paddeu concludes: "The challenge of the coming years will be to transform environmental data into concrete criteria for designing, purchasing and managing more sustainable medical technologies. In this process, data quality, digitalisation and independent verification will be key elements."

Alessandro Longo

is a journalist specializing in technology. He is Editor-in-Chief of AgendaDigitale.eu and a contributor to La Repubblica and Il Sole 24 Ore. In 2020, he published Artificial Intelligence: The Impact on Our Lives, Rights, and Freedoms (Mondadori Education, Milan).

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