Hossmann Stefanie, Brandt Derek, Heinemann Lutz
Diabetes Center Berne, Berne, Switzerland.
Faculty of Medicine, University of Bern, Switzerland.
J Diabetes Sci Technol. 2025 Aug 25:19322968251367063. doi: 10.1177/19322968251367063.
Reducing the environmental footprint of medical devices used by people with diabetes remains a challenge within the constraints of current regulatory frameworks. These frameworks, which rightly prioritize patient safety, sterility, and traceability, introduce substantial scientific, operational, and legal barriers to sustainable innovation. Efforts to integrate recycled or biodegradable materials, minimize packaging, or redesign products are often impeded by the complexity of revalidation processes, extensive documentation requirements, and a general lack of regulatory precedent. This commentary examines how such structural constraints hinder progress toward sustainable device design, despite mounting evidence of the environmental toll of single-use technologies. It advocates for a strategic shift toward "Design for Sustainability." Coordinated systemic incentives and regulatory evolution are essential to align sustainability objectives with prevailing safety and quality imperatives.
在当前监管框架的限制下,减少糖尿病患者使用的医疗设备的环境足迹仍然是一项挑战。这些框架正确地将患者安全、无菌和可追溯性作为优先事项,但却给可持续创新带来了重大的科学、操作和法律障碍。整合回收或可生物降解材料、尽量减少包装或重新设计产品的努力,往往因重新验证过程的复杂性、大量的文件要求以及普遍缺乏监管先例而受到阻碍。本评论探讨了尽管有越来越多证据表明一次性技术对环境造成了破坏,但这些结构性限制如何阻碍了可持续设备设计的进展。它主张向“可持续设计”进行战略转变。协调一致的系统性激励措施和监管演变对于使可持续性目标与现行的安全和质量要求保持一致至关重要。