Global sustainability experts joined forces with European regulators to debate one of the most divisive topics in green ophthalmology.
Sustainably reprocessing single-use instruments is one thing. But navigating the complex regulatory landscape around the process could be a whole different beast.
A roundtable session featuring some of green ophthalmology’s biggest global voices at the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2025) explored the lay of the land for the practice across Europe, including ongoing tension between environmental responsibility and patient safety.
Dr. Diana Silva (Portugal), who moderated the session, opened with stark statistics that underscored the urgency of sustainable healthcare practices. And by the end of the session, former ESCRS President Prof. Oliver Findl (Austria), Dr. David Chang (United States) and representatives from government and industry joined the fray to shed light on single-use instrument reprocessing—and where we go from here.
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The sustainability imperative
According to Dr. Silva, healthcare ranks as one of the world’s largest emitters. If it were a country, it would be the fifth largest emitter globally.
And the stakes to economic prosperity and human life couldn’t be higher. Climate change is expected to cause 250,000 additional deaths annually, with direct health costs reaching $2-4 billion USD per year by 2030.
Ophthalmology has a large role to play in the destruction, and Dr. Silva illustrated the environmental impact through visualization: A single cataract surgery is equivalent to cutting down three trees. With approximately 30 million cataract surgeries performed globally each year, the cumulative environmental footprint becomes staggering.
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Differing sustainability practices around the world only serve to highlight where we are—and where we could be.
“When we compare the current footprint of one cataract surgery in the UK, we know that one cataract surgery can actually equate to 32 cases in India,” Dr. Silva explained. “Even though our colleagues in India reprocess their materials, their endophthalmitis rate is exactly the same as ours—0.04%.”
This is just part of the intriguing case for sterilizing and reusing single-use instruments,
Part of the solution is global action, and Dr. Silva introduced iSustain, a network of eye societies and ophthalmologists collaborating to make ophthalmic care more sustainable both economically and environmentally.
Navigating the legal framework
Another part of the path forward for reprocessing instruments is the regulatory environment, and Ms. Sidsel Aabroe (Denmark), a representative to the European Union from the Danish Medicines Agency, provided crucial insight into the EU’s regulatory approach. The Medical Device Regulation (MDR) Article 17 permits reprocessing of single-use medical devices, but only if authorized through national law.
The regulatory framework includes a derogation allowing reprocessing according to common specifications if performed within healthcare institutions, provided the safety and performance of reprocessed devices remain equivalent to original devices. Ms. Aabroe revealed that currently, only 11 out of 27 EU member states have permitted reprocessing through national legislation.
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The approach varies significantly between countries. While Belgium allows multiple forms of reprocessing, Poland permits reprocessing but prohibits making those devices available for reuse within Poland—they can only be provided to other member states or third countries.
But there are efforts currently underway to streamline this process. One starting point is knowing just what devices even qualify for sterilization and reuse.
“We are currently discussing how we can harmonize all the different efforts,” Ms. Aabroe said. “For the countries that do allow reprocessing of single-use medical devices, we can discuss making some sort of positive list of medical devices that we know can be reprocessed,” Ms. Aabroe said.
Industry perspectives and practical realities
Ms. Lene Laursen (Denmark), representing MedTech Denmark, kicked off the discussion from the industry perspective, noting a historical irony. The shift from reusable to single-use devices occurred approximately 20 years ago at the request of healthcare professionals concerned about infections.
“Industry made the switch from reusable surgical products to single-use products, and that was actually because clinicians and healthcare institutions were asking us to out of concern for infections,” Ms. Laursen explained.
She cautioned against assuming reprocessing is always more environmentally sustainable, citing the need for case-by-case life cycle analyses. The reprocessing pathway involves multiple transportation steps, chemical treatments, testing and repackaging—all of which add to carbon footprint and detract from environmental benefits.
“This is just to say that [reprocessing] is not black and white. I think there are many nuances and it really comes down to the type of product that you would like to reprocess,” Ms. Laursen said.
Clinical experience and liability concerns
Dr. David Chang (United States) countered by raising important questions about liability and regulatory consistency, drawing parallels to off-label drug use in medicine. He noted that in the United States, the FDA requires extensive validation for reusable labeling, making single-use labeling the default option regardless of actual safety data.
“It [single-use labelling] is simply an assumption. And yet in medicine, every day, nine out of 10 things we might do are off-label, because no one submitted data that says I can use this steroid for these conditions,” Dr. Chang pointed out. “It would seem that you’d want to say that you validated reuse 10 times… And then a third label would be ‘reuse has not been validated,’ which is really truthful.”
Professor Oliver Findl (Austria) contributed practical insights from clinical experience, describing successful long-term reuse of surgical instruments. His facility tracks instrument lifecycles precisely, finding that lid speculums average 1,200 uses before replacement.
“We know exactly which ones we had to rebuy, because they were broken over the last 15 years and we have [these records] on the computer,” Prof. Findl explained. “The life cycle of these, or the many times you can use these instruments, is pretty high.”
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Looking forward
The session highlighted the complexity of balancing environmental sustainability with regulatory compliance and patient safety. While some EU member states have embraced reprocessing frameworks, the lack of harmonization across the union creates challenges for both healthcare institutions and medical device manufacturers.
The discussion revealed an emerging consensus that the future lies not just in reprocessing single-use devices, but in encouraging manufacturers to develop more reusable products from the outset. The goal, according to all participants, is to create meaningful change that doesn’t compromise the primary mission of healthcare: ensuring patient safety while being responsible stewards of the environment.
Editor’s Note: The 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS 2025) is being held from 12-16 September in Copenhagen, Denmark. Reporting for this story took place during the event. This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.