The Directorate General of Health Services (DGHS) has instructed all states and Union Territories to strengthen monitoring and enforcement against the reuse of single-use medical devices and disposable surgical items in government and private healthcare facilities.
The directive follows concerns over reports that some private and corporate hospitals have been sterilising and reusing medical devices labelled for single use, potentially exposing patients to infection and other safety risks.
Reuse Reported Across Specialised Medical Departments
According to the DGHS, instances of reuse have been observed in several critical medical specialties, including cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS), and neurosurgery.
The health authority also raised concerns over billing practices, noting that certain healthcare establishments were reportedly charging patients the full cost of medical devices that had already been used. In some cases, reimbursement claims for such items were submitted to government authorities.
DGHS Highlights Patient Safety and Regulatory Concerns
The DGHS stated that reusing devices intended for single use raises significant concerns regarding infection prevention, patient safety, regulatory compliance and healthcare expenditure.
The communication highlighted that such practices may violate provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010.
Healthcare facilities have been instructed to use single-use medical devices and disposable surgical products strictly according to the instructions and recommendations provided by their original equipment manufacturers (OEMs).
States Directed to Conduct Inspections and Ensure Compliance
In its communication to state and UT health secretaries, directors of health services, drug controllers and the Drug Controller General of India (DCGI), the DGHS called for strict vigilance over the use of disposable medical products.
Authorities have been asked to conduct inspections and monitor healthcare establishments to identify instances of non-compliance. The directive also calls for appropriate action under applicable laws and regulations wherever violations are detected.
Medical Device Industry Welcomes Directive
The Association of Indian Medical Device Industry (AiMeD) welcomed the Centre’s intervention, describing it as an important measure for protecting patients.
Rajiv Nath, Forum Coordinator of AiMeD, emphasised that devices labelled for single use must not be reused contrary to manufacturers’ instructions.
He also called for clear accountability in cases involving patient harm or device failure resulting from unauthorised reuse, stating that responsibility should rest with the individual or healthcare establishment involved rather than the manufacturer.
The directive places renewed emphasis on compliance with manufacturer instructions, monitoring of disposable medical devices and accountability in healthcare establishments across the country.
