Centre directs States to crack down on reuse of single-use medical devices in hospitals

The Union Health Ministry has directed States and Union Territories to ensure strict enforcement of the prohibition on reusing single-use medical devices and disposable surgical items in healthcare facilities, citing reports of hospitals sterilising and reusing such products despite their being intended for one-time use.

The Directorate General of Health Services (DGHS) said the practice had been observed in certain private and corporate hospitals, particularly in specialised departments such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.

The directive prohibits the reuse of single-use medical devices and disposable surgical items in all public and private healthcare organisations under the administrative jurisdiction of the Centre, States and Union Territories. Single-use medical devices are equipment, instruments, or supplies engineered and labeled to be used on a single patient during a single procedure and then discarded rather than reprocessed or sterilised for reuse.

The DGHS said the practice raised serious concerns over patient safety, infection prevention, regulatory compliance and healthcare expenditure. Reusing devices intended for one-time use could expose patients to cross-infection, device malfunction, loss of performance and other procedure-related complications, it said.

The letter also flagged instances in which the full cost of these items was reportedly being charged to patients or reimbursed by government authorities, even when the devices were reused.

The DGHS said such practices could constitute violations of applicable provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, the Clinical Establishments Act, 2010, standard infection prevention and control protocols, and biomedical waste management requirements.

The letter has been addressed to the Chief Secretaries and senior Health Department officials of States and Union Territories, Directors of Health Services, the Drugs Controller General of India (DCGI), State and Union Territory drug controllers, and the Director General of the Central Government Health Scheme (CGHS).

They have been asked to ensure strict vigilance and effective enforcement within their respective jurisdictions. The letter also directs that single-use devices and disposable surgical items be used strictly in accordance with the instructions and recommendations of their original equipment manufacturers.

The DGHS has asked the concerned authorities to undertake appropriate inspections and monitor healthcare establishments for compliance. Necessary action may be taken in cases of non-compliance under applicable laws and regulations, the letter said.

The centre had also issued a similar directive in 2016. The latest communication calls for strict compliance with the directions and their wide dissemination among healthcare organisations.

Responding to the development, Medical Technology Association of India (MTaI), an association of medical device manufacturing companies, said the directive’s effectiveness will now depend on consistent enforcement by state authorities, regulators and healthcare institutions.

“We welcome the directive, prohibiting the reuse of single-use medical devices (SUDs) and disposable surgical items across public and private healthcare facilities. This is a significant step towards strengthening patient safety, and ultimately improving the patient outcomes. The directive’s effectiveness will now depend on consistent enforcement by state authorities, regulators and healthcare institutions. Equally important is raising patient awareness, empowering them to understand and assert their rights to safe and ethical care.” said the association. 

Published on October 23, 2026