NEW DELHI, Oct 24: The Centre has directed states and Union Territories to strictly enforce a prohibition on reusing single use medical devices and disposable surgical items across public and private healthcare facilities, warning that the practice could endanger patients and lead to financial irregularities.
In a letter dated October 16, the Directorate General of Health Services (DGHS) said it had received reports of certain private and corporate hospitals sterilising and reusing medical products intended for one-time use. The practice was reportedly observed in critical specialities, including cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.
The directorate said such devices were being cleaned and sterilised after procedures before being used again, despite manufacturers designating them for single use. It flagged concerns over patient safety, infection prevention, regulatory compliance and healthcare costs.
The DGHS also raised concerns that some patients were allegedly charged the full price of these products even when the equipment had been reused. In other instances, the costs were reportedly reimbursed by the concerned government authorities.
Items identified as being reused include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysis equipment, surgical staplers, laparoscopic trocars and orthopaedic drill bits. Syringes and needles were also listed among the products reportedly subject to reuse, according to the Association of Indian Medical Device Industry (AiMeD).
The directorate warned that sterilisation alone does not necessarily make a single-use device safe for another procedure. Improper reprocessing or material deterioration can leave biological contaminants behind or compromise the equipment’s functionality.
Such practices could expose patients to cross-infections, device malfunction, reduced performance and other medical complications. The potential infections cited include hepatitis B, hepatitis C, HIV and bacterial infections.
The DGHS said the practice could also violate provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010, along with applicable requirements for infection control and biomedical waste management.
The letter stated that the reuse of single-use medical devices and disposable surgical items would be strictly prohibited across healthcare organisations under the administrative jurisdiction of the Centre, states and Union Territories.
To ensure compliance, the DGHS has called on chief secretaries, state health department officials, directors of health services, the Drug Controller General of India (DCGI) and state and Union Territory drug controllers to strengthen monitoring and enforcement.
Authorities have been instructed to maintain vigilance, inspect healthcare establishments and take appropriate action wherever violations are detected. Hospitals have also been directed to use medical devices strictly in accordance with the instructions and recommendations issued by their original equipment manufacturers.
The communication further referred to a Central Government Health Scheme (CGHS) office memorandum issued in December 2016 concerning the reuse of such devices in hospitals empanelled under the scheme.
The latest directive places renewed emphasis on ensuring that medical equipment is used according to its intended purpose, patient safety standards are maintained and healthcare charges accurately reflect the services and products provided.