Improving the circularity of MedTech

IEC eTECH

article here

Standards are helping the medical sector to move to more circular practices but ensuring that patients remain safe is the foundational principle behind these changes.

The global healthcare sector is under mounting pressure to reduce its environmental footprint. Medical devices themselves are a major contributor to waste, carbon emissions and resource depletion. As demand for healthcare rises, so does the volume of disposable products, electronic waste and high‑value equipment prematurely discarded.

According to a report by strategic consultancy EY, “approximately 90% of medical device waste comprises disposable, one‑time‑use products or components”. At the same time, healthcare accounts for “five percent of overall worldwide carbon emissions,” a figure that underscores the urgency of rethinking how medical devices are designed, used and recovered.

“Healthcare systems worldwide are under increasing pressure to reduce waste, carbon emissions and resource consumption, while improving efficiency and delivering safe, high‑quality patient care, despite growing demand and constrained resources,” says Kristina Lönnqvist, Global Corporate Sustainability Director at a Swedish MedTech company specializing in sustainable solutions. “The narrative has broadened beyond environmental concerns and is increasingly about resource security and supply‑chain resilience. So it's also becoming business critical as well.”

Circularity, which can be described as the principle of designing products and systems to eliminate waste, extend their material life and regenerate resources, is emerging as a powerful problem-solving framework. But unlike consumer electronics or industrial equipment, medical devices operate in a uniquely sensitive environment. Patient and medical staff safety, sterilization, biocompatibility and regulatory compliance are paramount.

“Designing for circularity is about creating products and solutions that maximize the value of resources, minimize waste and help improve patient outcomes,” says Lönnqvist. “This means that, where safe and appropriate, products are designed to be recycled or recirculated in a way that supports a circular economy where resources are kept in use for as long as possible.”

The growing problem of medical waste

The MedTech industry is dominated by single-use disposable products and, as EY notes, these “play a significant role in generating large amounts of non-recycled waste.” The COVID‑19 pandemic accelerated this trend, with single‑use PPE, testing kits, and consumables driving unprecedented waste volumes.

The environmental consequences are severe. Single‑use devices generate a high level of carbon emissions due to manufacturing, sterilization, packaging and transport. Take just one product: single-use catheters which are made of synthetic plastics such as Polyvinyl Chloride (PVC). The UK’s National Health Service uses 100 million each year, at an estimated cost of GBP 200 million, and throws them all away - though new research into reusable catheters is expected to challenge this.

Harvard Medicine Magazine estimates that between 4,4% and 5,2% of the world’s greenhouse gas (GHG) emissions are directly traceable to the healthcare sector. Research published by the National Library of Medicine in the US found medical devices accounted for 6-10% of national health systems’ carbon footprints. 

Increasing volumes of digital devices (comprising sensors, monitors, batteries) and products like smart catheters also contribute to growing e‑waste streams. In addition, poor disposal practices expose communities to toxic materials, infectious agents and pollution. The World Health Organization  (WHO) reports that 15% of healthcare-related waste is judged hazardous because of biological, chemical or radioactive contamination. For example, there are 16 billion injections administered every year, but not all needles and syringes are disposed of safely, “creating a risk of injury and infection.”

Despite the environmental cost, single‑use devices remain attractive to clinicians and hospital administrators for reasons of safety, workflow and regulation. Single‑use devices simplify logistics, enabling hospitals to avoid the need for a sterilization infrastructure, tracking systems, maintenance schedules and staff assigned to reprocessing. Furthermore, a lack of clear and consistent guidelines has resulted in “confusion around standards for reusable device reprocessing,” according to researchers.

The role of circularity in MedTech

Nonetheless, circularity in medical devices is progressing. Some companies are shifting towards designing products with modular components, using bio‑based plastics (such as surgical drapes made from bio‑materials rather than petroplastics) and with easier disassembly.

Some devices can be reused safely after decontamination. Catheters are being redesigned using silicone, making them easier to clean, thereby reducing antibiotic use and potentially saving hospitals millions of  any currency.

High‑value systems are prime candidates for refurbishment. MRI, ultrasound and computed tomography/CT machines are increasingly being “retrofitted and refurbished to achieve significant lifetime expansions.”

Some manufacturers incentivize customers to trade-in their older models in exchange for refurbished ones. This reduces demand for raw materials and lowers carbon emissions. “The question of sustainability is not as simple as single‑patient use versus multi‑patient use,” Lönnqvist cautions. “We need to look at the evidence across the full lifecycle and balance environmental, human and economic impacts so we understand which solution delivers the best overall outcome for the specific clinical application.”

The company’s portfolio spans wound care, staff clothing, drapes, surgical gloves, antiseptics and procedure packs. Many products remain single‑use for safety and infection‑prevention reasons, but circularity is being built into the design, manufacturing and customer support.

One example is that instead of procuring single‑packed items, the company customizes a solution for a specific surgical intervention, claiming to reduce packaging waste by up to 90% compared to single-packed supplies. “MedTech companies that choose to adopt circular product designs can make a real difference while maintaining profitable operations,” EY concludes.

International standards play a key role but gaps remain

International standards are essential to ensure that circular practices do not compromise safety or performance. “Standards are critical to scaling circular solutions,” Lönnqvist says. “They create common definitions, methodologies and metrics that build trust, uphold patient and medical staff safety and allow actors across the value chain to work in the same way. If we are to scale a new circular‑economy business model, all ecosystem partners need to have the same confidence in the system.”

However, standards must align with existing medical‑device regulations - an area where gaps remain. In the European regulatory landscape, according to Lönnqvist, these include, firstly, the lack of a clear definition of secondary raw materials: “We would like to see clearer and more harmonized frameworks for how we define secondary raw materials for medical devices. This means when waste becomes a resource that can safely re‑enter the value chain.”

Secondly, common methodologies for sustainability assessment and product‑level sustainability data are required: “Healthcare providers need to be able to more easily compare solutions consistently. That doesn't exist today.”

Lastly, more work is needed on the treatment of medical waste: “Much of the waste is currently incinerated due to regulatory requirements, particularly when it is contaminated, meaning valuable materials are lost from the system. At the same time, alternative technologies such as mechanical and chemical recycling are available, creating an opportunity for policy and innovation to evolve together.”

This is precisely where international standards play a defining role. IEC technical committees, particularly TC 62, which issues standards for medical devices, software and systems, and TC 111, which prepares environmental standards for electronics, are laying the foundation for safe, effective and globally harmonized circular practices. Their work is essential to enabling refurbishment, reuse, recycling and responsible end-of-life treatment without compromising clinical performance.

IEC 63077 provides guidelines for the refurbishment of medical imaging equipment “ensuring safety and performance comparable to new equipment.” It covers repair, software/hardware updates and replacement of worn parts. It excludes endoscopic and radiation therapy equipment but sets a global benchmark for safe refurbishment.

IEC TR 62635 concerns recyclability and recoverability. This technical report “provides a comprehensive methodology for information exchange between manufacturers and recyclers”. It defines recyclability rates, recoverability rates and end‑of‑life scenarios as well as removal requirements for hazardous components. It applies to all electrical and electronic equipment, including medical devices. For supply chain transparency IEC TR 62635 enables recyclers to understand device composition and safe handling requirements.

Yet another important development is the creation of a new joint committee between IEC and ISO, ISO/IEC JTC 5, which is preparing the framework for digital product passports (DPPs). A DPP is a digital record that stores key information about a product, such as its origins, repairability and how it should be recycled or reused, promoting greater transparency and efficiency across global value chains (Read more about DPPs in the interview with the new Chair Adrian von Mühlenen).

Lastly, testing and certification can ensure the standards are applied and used correctly by industry. The IEC administers four different conformity assessment systems, two of which have some relevance here. IECEE (IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) covers testing and certification for the safety, reliability, efficiency and overall performance of electrical equipment for medical use to IEC International Standards, whether new or refurbished. 

IECQ (the IEC Quality Assessment System) operates an international ecodesign certification scheme  which assesses product design in accordance with IEC 62430, the dual IEC and ISO logo standard which defines the principles, requirements and guidance for environmentally conscious design. It encourages manufacturers, including of medical equipment, to think of reuse in the early design stages of the product. (For more on this aspect and  IEC Standards, read: ...).

Advances vary in different regions

While the trend toward sustainable MedTech is global, momentum is not uniform. “Even within European markets, there are more mature, more advanced markets where we already see procurement and tender requirements around circular solutions,” Lönnqvist reports. European Union regulations such as EU MDR 2017/745 impose strict requirements for reprocessing, traceability, and component replacement. This is being amended to include “reprocessing” for single-use devices which includes cleaning, disinfection, sterilization and related procedures.

Lönnqvist welcomes the change to the regulation but stresses, “patient safety comes first and must remain the main concern of the EU MDR. We are confident there are ways to reduce the environmental footprint without putting patients at risk. If we can combine environmental performance with creating value in circular business‑economy models for healthcare providers, circular solutions have the potential to move from individual initiatives into a scalable business model. We are convinced of that.”

The next decade will determine whether healthcare can resolve its escalating waste challenge and significantly reduce emissions. Standards will be the foundation on which that transformation is built.