Government prohibits reuse of single-use medical devices in healthcare facilities

Key facts

• The government has prohibited the reuse of single-use medical devices and disposable surgical items in both public and private healthcare facilities, citing patient safety risks.
• The directive was issued by the Directorate General of Health Services (DGHS) after it observed that some private and corporate hospitals were reusing such items, especially in cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.
• The DGHS directive was sent to states and union territories, the Drug Controller General of India (DCGI) and the Central Government Health Scheme (CGHS), asking them to ensure compliance.
• Authorities have been asked to inspect healthcare facilities, monitor compliance and act against violations under applicable laws.
• The DGHS said reuse may violate the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010, along with infection control and biomedical waste management provisions.
• The Association of Indian Medical Device Industry (AiMeD) said responsibility for harm from reuse of single-use devices should rest with the hospital or person reusing them, not the manufacturer.