New Delhi, October 24: The Centre has directed all states and Union Territories to strictly enforce a ban on the reuse of single-use medical devices and disposable surgical items in public and private healthcare facilities, citing serious concerns over patient safety, infection risks and alleged overcharging.
In a letter dated October 16, the Directorate General of Health Services (DGHS) highlighted reports that certain private and corporate hospitals were sterilising and reusing medical devices intended for one-time use, particularly in critical specialities such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.
The directorate noted that some hospitals were reportedly sterilising devices after their initial use and deploying them again despite manufacturers designating them for single use.
The DGHS said the practice raised concerns about infection prevention, regulatory compliance, patient safety and healthcare costs. It also flagged allegations that patients were being charged the full price of devices even when the equipment had been reused, or that the costs were reimbursed by government authorities.
According to the Association of Indian Medical Device Industry (AiMeD), devices reportedly being reused include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysis equipment such as dialysers and blood tubing, surgical staplers, laparoscopic trocars and orthopaedic drill bits. Syringes and needles were also among the items identified.
The DGHS warned that sterilisation does not necessarily make single-use devices safe for repeated use. Improper reprocessing or deterioration of equipment could leave biological material behind, compromise performance and increase the risk of complications.
Potential dangers include cross-infections such as hepatitis B, hepatitis C, HIV and bacterial infections, along with device malfunction and reduced effectiveness during medical procedures.
The directorate stated that 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.
Under the directive, the reuse of single-use medical devices and disposable surgical items has been prohibited across healthcare organisations under the administrative jurisdiction of the Centre, states and Union Territories.
The DGHS has asked chief secretaries, state health department officials, directors of health services, the Drug Controller General of India (DCGI), and state and UT drug controllers to ensure effective implementation.
Authorities have been instructed to maintain strict vigilance, conduct inspections, monitor healthcare establishments and take appropriate action against violations.
The directorate further emphasised that all single-use devices and disposable surgical items must be used strictly in accordance with the instructions and recommendations of the original equipment manufacturer (OEM).
The letter also 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.
