Centre Bans Reuse of Single-Use Medical Devices

The Centre has prohibited the reuse of single-use medical devices and disposable surgical items in all public and private healthcare facilities across the country, citing concerns over patient safety and infection control.

The directive follows findings by the Directorate General of Health Services (DGHS) that certain private and corporate hospitals were sterilising products labelled for single use and using them on more than one patient.

In a letter dated October 16, the DGHS said the practice had come to its notice in specialised medical fields. It asked states and Union Territories to ensure strict vigilance and effective enforcement of the ban on single-use medical devices.

States told to enforce the single-use medical devices ban

The DGHS letter was addressed to state and Union Territory health secretaries, directors of health services, drug controllers and the Drug Controller General of India. It directs authorities to inspect healthcare establishments, monitor compliance and take action against violations under applicable laws.

The directive states that single-use medical devices and disposable surgical items must be used strictly in accordance with the instructions and recommendations of their original equipment manufacturers. Equipment meant for one procedure should not be subjected to reprocessing and used again when the manufacturer has marked it for single use.

The DGHS said medical device reuse of this kind raised serious concerns over patient safety, infection prevention and control, regulatory compliance and healthcare expenditure.

Hospitals caught reusing single-use medical devices

The practice was observed particularly in critical specialties such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery, the DGHS said. 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 have also been identified among items being reused, according to the Association of Indian Medical Device Industry (AiMeD), an industry body that tracks the sector.

The DGHS also flagged instances in which the full cost of these items was allegedly charged to patients or reimbursed by government authorities even when the devices had been reused. In some cases, patients paid for items that were never new.

Risks of reusing single-use medical devices

Single-use medical devices are engineered and labelled to be used on a single patient during a single procedure and then discarded, rather than reprocessed or sterilised for reuse.

Even after sterilisation, devices designed for one-time use may not be safe for reuse, the directorate said. Inadequate reprocessing or deterioration of the material can compromise performance and leave biological material behind.

Reusing devices intended for one-time use could expose patients to cross-infection, device malfunction, loss of performance and other procedure-related complications, the DGHS said.

The practice may also violate provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010, besides standard infection prevention protocols and biomedical waste management rules.

AiMeD welcomes the order

AiMeD welcomed the decision, describing it as a patient-first measure. The association said stricter enforcement would protect hospital safety and push hospitals to follow manufacturer guidance instead of cutting costs through reuse.

The body argued that enforced rules on single-use products would raise hospital safety standards across private facilities. It said patients should receive new, sterile products, and that medical device reuse of any kind puts that expectation at risk.

The DGHS has asked authorities to undertake inspections and monitoring of healthcare establishments to ensure strict compliance with the directions and to take necessary action under applicable laws and regulations where violations are found. The crackdown on single-use medical devices is now in the hands of state health departments and drug regulators.