Dear Editor, I read with great interest the article by Sethi and Dhir,1 titled “Performance and Safety of Reused Kahook Dual Blade for Combined Cataract and Minimally Invasive Glaucoma Surgery in Open-Angle Glaucoma.” While the study addresses the issue of affordability of the Kahook dual blade (KDB) in resource-limited settings, its ethical and safety implications warrant further discussion. The KDB is explicitly labeled and designed by the manufacturer for single use. Reusing such devices represents a deviation from the manufacturer’s instructions and constitutes an off-label practice that may raise regulatory and medico-legal concerns. The authors mention that informed consent was obtained from patients for the use of a reused device. However, it is unclear whether this disclosure included the potential risks associated with reuse or the lack of regulatory approval for such practice. The study justifies reuse on the grounds of cost reduction for patients in low-income settings. However, this approach inadvertently creates a disparity in the standard of care—one for patients who can afford new devices and another for those who cannot. While reducing costs is a commendable objective, it should never come at the expense of patient safety or lead to inequitable surgical standards as even under stringent protocols, device reuse carries an element of unpredictable risk. Post sterilization, the structural integrity of KDB blade may vary depending on handling and processing conditions, which are not standardized across all surgical centers. Surgeons in this study noted issues such as difficulty in blade engagement, intraoperative resistance, incomplete trabecular meshwork excision, and blade deformation. These findings suggest that even a single sterilization cycle may alter the mechanical properties of the device. A dull or misaligned blade could lead to incomplete excision of the trabecular meshwork or microtrauma to adjacent ocular tissues. Additionally, inadequate cleaning could leave residual tissue debris, increasing the risk of postoperative inflammation or peripheral anterior synechiae formation, as observed in this study. The reported case of toxic anterior segment syndrome (TASS) following the use of a reused KDB underscores the critical importance of validated sterilization protocols. Although ethylene oxide sterilization is commonly used, it may leave behind toxic residues or fail to eliminate microscopic debris completely. From an ethical perspective, even when informed consent is obtained, the reuse of single-use medical devices raises ongoing regulatory and medico-legal challenges that necessitate clearer international guidelines. Before reuse can be considered safe or equitable in glaucoma surgery, rigorous validation, transparent patient communication, and long-term safety data are essential.
Tarannum Mansoori (Wed,) studied this question.