NEW DELHI: The Centre has directed public and private healthcare facilities across the country to strictly stop reusing medical devices and disposable surgical items meant for one-time use, flagging patient safety risks from the practice, particularly in critical care.In a letter dated Oct 16, the Directorate General of Health Services (DGHS) said it had come to its notice that some private and corporate hospitals were reusing single-use devices after sterilising them, including items used in cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS), neurosurgery and other clinical services.The DGHS said that reuse could expose patients to cross-infection, device malfunction, reduced performance and other complications. It said the practice could violate provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, the Clinical Establishments Act, 2010, and applicable infection-control and biomedical waste management requirements.
The DGHS said that reuse could expose patients to cross-infection, device malfunction, reduced performance and other complications.
The directive calls on 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 govt health scheme (CGHS), also flagged cases in which patients were charged the full cost of devices that had been reused, or the cost was reimbursed by govt authorities.The DGHS said the CGHS had issued an office memorandum on the issue in Nov 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.
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Welcoming the directive, the Association of Indian Medical Device Industry (AiMeD) said 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. It also urged govt 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 UT authorities. However, the letter does not specify a new inspection schedule or a separate penalty for hospitals found reusing such devices.