Dear Editor, We read with interest the article titled “Performance and Safety of Reused Kahook Dual Blade (KDB) for Combined Cataract and Minimally Invasive Glaucoma Surgery in Open-Angle Glaucoma” by Sethi et al. The authors address an issue of increasing relevance in India, where ophthalmic care must balance efficacy, safety, affordability, and sustainability.1 While the study provides useful insights, certain considerations may further strengthen the discussion on KDB reuse. We note that their cleaning and sterilization protocol used an enzymatic detergent, which, despite adequate cleaning, may occasionally leave behind residues capable of provoking toxic anterior segment syndrome (TASS). Detergent or disinfectant residues, residual biological matter, or microcorrosions have been implicated in the development of TASS. Notably, the TASS outbreak investigated by Verma et al.2 highlighted the importance of avoiding chemicals in sterilization underscoring the importance of avoiding such detergent agents during reprocessing of intraocular instruments. Most Indian practices instead rely on thorough mechanical cleaning with demineralized sterile water followed by ethylene oxide (ETO) sterilization to ensure a more reliable safety and sterility profile for reuse of such intraocular instruments. The structural alterations observed in their reused blades, such as deformation, rusting, and retained trabecular remnants, reiterate the importance of routine microscopic inspection before and after each sterilization cycle to define safe reuse limits. The study assessed only a single reuse cycle; however, several high-volume glaucoma practices in India do reuse KDB blades two or three times under stringent reprocessing protocols. Unpublished surgeon experience suggests that functional performance remains fair to good when appropriate sterilization workflows are followed. Moreover, the study did not separately evaluate cataract-surgery-related intraoperative or postoperative events, which may independently influence inflammation and IOP in combined procedures. Differentiating these factors would allow clearer attribution of outcomes specifically to blade reuse. Environmental considerations also warrant attention. The Aravind Eye Care System has shown that regulated reuse of phacoemulsification tubing can substantially reduce biomedical waste and resource use without compromising surgical safety,3 reinforcing the feasibility of sustainable practices within high-volume Indian settings. The authors are to be commended for undertaking a similar study on KDB reuse and publishing their results. A crucial dimension is the regulatory and medico-legal landscape. The Drugs and Cosmetics Act, 19404 and the Medical Device Rules,5 2017 do not explicitly address the reuse of single-use devices (SUDs) or define practitioner liability in case of reuse-related complications. This ambiguity parallels national analyses highlighting the ethical and legal vulnerabilities clinicians face when reprocessing SUDs in the absence of standardized guidelines.6 International regulatory reviews similarly emphasize the importance of validated reprocessing protocols, traceability, and oversight to ensure patient safety. Establishing India-specific guidelines is therefore essential. We note that the glaucoma surgeon is left unprotected in the event of an unfortunate legal notice or litigation in the absence of clear guidelines. Economic considerations further underscore the relevance of this discussion. Given that most Indian patients incur out-of-pocket expenses, the high cost of the Kahook Dual Blade significantly increases the financial burden of MIGS procedures. Safe reuse, when clearly documented and supported by informed consent, can meaningfully reduce procedural costs. The authors have not calculated the cost of reprocessing and ETO sterilization. Transparency is a key point in this discussion, and the patient must be kept informed that the procedure that they have been subjected to has involved a reused instrument which is against the manufacturer’s single use guideline. However, insurance reimbursement policies remain unclear—specifically, whether insurers will honor the maximum retail price (MRP) of a new device or adjust claims when reuse is undertaken—highlighting the need for policy clarity. In conclusion, the study by Sethi et al. contributes meaningfully to the discourse on KDB reuse in India. Future investigations incorporating validated sterilization workflows, detailed morphological assessment, multi-cycle evaluation, cataract-surgery-related outcome stratification, environmental analysis, and regulatory frameworks under the Drugs and Cosmetics Act, 1940 will be essential to establish safe, sustainable, and legally sound reuse practices suited to Indian ophthalmology.1
Zacharia et al. (Wed,) studied this question.