India

Centre Orders Nationwide Ban on Reuse of Single‑Use Medical Devices

By Anuja Jaiswal

The Indian government has ordered all public and private hospitals to cease reusing medical devices and disposable surgical items that are intended for one‑time use, citing patient safety risks, especially in critical care settings. In a letter dated 16 October, the Directorate General of Health Services (DGHS) noted that some private and corporate hospitals were sterilising and reusing single‑use devices, including those used in cardiology, nephrology, oncology, cardiothoracic and vascular surgery, neurosurgery and other clinical services. The DGHS warned that such reuse could expose patients to cross‑infection, device malfunction, reduced performance and other complications, and could violate the Drugs and Cosmetics Act, 1940; the Medical Devices Rules, 2017; the Clinical Establishments Act, 2010; and applicable infection‑control and biomedical waste management regulations. The directive instructs state health authorities and drug controllers to maintain strict vigilance, inspect and monitor healthcare establishments, and take action against violations under applicable laws and regulations. Devices labelled for single use must be used in accordance with the instructions and recommendations of the original equipment manufacturer. The letter, addressed to health authorities in states and Union Territories, the Drugs Controller General of India (DCGI) and the central government health scheme (CGHS), also highlighted cases where patients were charged the full cost of devices that had been reused, or where the cost was reimbursed by government authorities. The DGHS noted that the CGHS had issued an office memorandum on the issue in November 2016 for hospitals empanelled under the scheme. Single‑use devices reportedly reused in India include cardiac catheters and guidewires used in angiography and angioplasty, dialysis equipment, certain surgical instruments and disposable syringes and needles. Such practices raise concerns about infection risks and patient safety, particularly when patients are not informed. The Association of Indian Medical Device Industry (AiMeD) welcomed the directive, stating that reuse of devices designed and validated for one‑time use could put patients at risk. Its forum coordinator, Rajiv Nath, said enforcement should also clarify responsibility when a device is reused contrary to the manufacturer’s instructions. AiMeD called for regular inspections, traceable records of device use and disposal, staff training and action against violations, and urged the government to ensure that cost does not become a reason for hospitals to reuse disposable devices. The directive places the responsibility for enforcement on state and Union Territory authorities, but does not specify a new inspection schedule or a separate penalty for hospitals found reusing such devices.