India directs states to enforce ban on single-use medical device reuse

The Indian central government has directed all states and Union Territories to strictly enforce a nationwide ban on the reuse of single-use medical devices and disposable surgical items in both public and private healthcare facilities. The directive, issued by the Directorate General of Health Services (DGHS), follows reports that some private and corporate hospitals were sterilizing and reusing equipment intended for one-time use.

The practice has been observed in critical specialties, including cardiology, nephrology, oncology, neurosurgery, and cardiothoracic surgery. Identified items include cardiac catheters, guidewires, dialysis equipment, surgical staplers, laparoscopic trocars, and orthopedic drill bits, as well as syringes and needles. The DGHS warned that sterilization may not prevent risks such as device malfunction, performance deterioration, or cross-infections like HIV and hepatitis B and C.

Beyond clinical risks, the government flagged instances of financial exploitation where patients were allegedly charged the full market price for reused equipment. The Association of Indian Medical Device Industry (AiMeD) welcomed the decision, noting that such practices shift liability away from manufacturers and pose significant safety risks. Authorities have been instructed to monitor healthcare establishments and ensure compliance with the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010.