The Centre has directed 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 infection risks and instances of patients being charged the full cost of reused equipment.
It also flagged instances in which patients were allegedly charged the full cost of these devices despite their reuse, or the cost was reimbursed by the concerned government authorities. The practice could expose patients to cross-infections, device malfunction, reduced performance and other procedure-related complications, the DGHS warned. These infections may include hepatitis B and C, HIV and bacterial infections. 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 strict vigilance and effective enforcement. Authorities have been asked to inspect and monitor healthcare establishments, ensure compliance with the directive and take appropriate action in cases of violations.
In a letter dated October 16, the Directorate General of Health Services (DGHS) said it had come to its notice that certain private and corporate hospitals were sterilising and reusing devices meant for one-time use, particularly in critical specialities such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery . The directorate said 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 prevention and biomedical waste management requirements.
The DGHS said the practice raised concerns relating to patient safety, infection prevention and control, regulatory compliance and healthcare expenditure.
