Centre Orders Strict Ban On Reuse Of Single-Use Medical Devices In Hospitals

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 government and private hospitals. The move comes amid concerns over patient safety, infection risks and reports of hospitals charging patients for equipment that has already been used.

In a letter dated October 16, the Directorate General of Health Services (DGHS) said it had come to its notice that some private and corporate hospitals were sterilising and reusing medical devices meant for one-time use. The practice was particularly reported in specialised departments such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.

Hospitals Reusing Disposable Equipment

According to the DGHS, certain hospitals were sterilising medical devices after a procedure and using them again, even though the equipment was specifically designed for single use.

The directorate said the practice raised serious concerns about patient safety, infection prevention, regulatory compliance and healthcare costs. It also flagged instances in which patients were allegedly charged the full price of reused devices or the expenses were reimbursed by government authorities.

From Cardiac Catheters To Syringes

Several medical devices have reportedly been reused, including cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, surgical staplers, laparoscopic trocars and orthopaedic drill bits, PTI reports.

Dialysis equipment, including dialysers and blood tubing, was also among the items identified. According to the Association of Indian Medical Device Industry (AiMeD), even syringes and needles have been found among the medical items being reused.

Why Reusing Devices Is Dangerous

The DGHS warned that sterilising a medical device does not necessarily make it safe for another procedure. Equipment designed for one-time use may deteriorate after its first use, while inadequate sterilisation could leave behind biological material.

Such practices could expose patients to cross-infections, device malfunction, reduced performance and complications during medical procedures. The directorate warned that infections could include hepatitis B, hepatitis C, HIV and bacterial infections.

The warning highlights a serious patient safety concern, particularly when people undergoing critical medical procedures may have no way of knowing whether the equipment being used on them is new or has already been used.

Reuse May Violate Existing Laws

The DGHS said reusing single-use medical devices could violate provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010.

The practice could also breach applicable infection prevention and biomedical waste management requirements.

The directorate made it clear that the reuse of such devices and disposable surgical items must be strictly prohibited in healthcare facilities under the administrative jurisdiction of the Government of India, states and Union Territories.

States Told To Step Up Inspections

The DGHS has directed chief secretaries, state health department officials, directors of health services, the Drug Controller General of India (DCGI) and state and Union Territory 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 wherever violations are detected.

The directorate also instructed healthcare facilities to use disposable medical devices strictly according to the instructions and recommendations of the original equipment manufacturer (OEM).

Earlier Directive Also Cited

The letter referred to an office memorandum issued by the Central Government Health Scheme (CGHS) in December 2016 concerning the reuse of single-use medical devices in hospitals empanelled under the scheme.

The latest direction reinforces the need for hospitals to follow existing safety requirements and prevent the reuse of equipment intended for a single procedure. Strict enforcement will be crucial to ensuring that patients are not exposed to avoidable medical risks or charged for devices that should not have been reused.