AiMeD supports the government's directive banning the reuse of single-use medical devices, citing serious patient safety risks like cross-infection and device failure, while calling for strict enforcement and clear manufacturer liability rules.
AiMeD Supports Ban on Single-Use Device Reuse
New Delhi [India], October 23 (ANI): The Association of Indian Medical Device Industry (AiMeD) warmly welcomes the Directorate General of Health Services' directive of October 16, 2026, to all States and UTs, the DCGI and CGHS, prohibiting reuse of single-use medical devices and disposable surgical items in all healthcare organisations, public and private. Reusing a device designed and validated for one use is a patient safety risk. Such devices are not built to be cleaned, resterilised or reused, and reuse can cause cross-infection, device failure, loss of performance and harm to patients. AiMeD thanks the Government for the directive, which asks that these devices be used strictly according to the manufacturer's instructions.
Establishing Liability and Enforcement
Rajiv Nath, Forum Coordinator, AiMeD, said: "This is a patient-first decision. Single-use means single-use. Where a product is used contrary to its labelled instructions, such as being reused, any failure or harm cannot be attributed to the manufacturer. Responsibility must rest with the person or establishment that reused it. We ask that this be clearly reflected in enforcement and in any liability framework."
AiMeD's Recommendations for Compliance
AiMeD recommended strict, regular inspections of healthcare establishments, with traceable records of device use and disposal; Clear action under the Medical Devices Rules, 2017 and the Clinical Establishments Act, 2010 against reuse; Awareness and training of hospital staff on infection prevention and biomedical waste handling; A clear statement that manufacturers are not liable for failures arising from reuse contrary to labelling; and support for safer and more affordable single-use alternatives, so that cost is no reason to reuse. (ANI)
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