Centre bans reuse of single-use medical devices across hospitals

Single-use medical devices are medical items marked by the original equipment manufacturer for one-time use. They are not intended to be cleaned, sterilised and used again. The directive covers devices and disposable surgical items used in healthcare facilities across India.

Reported examples include cardiac catheters and guidewires used in angiography and angioplasty. The list also includes dialysis equipment, certain surgical instruments, disposable syringes and needles. These devices appear in services including cardiology, nephrology, oncology, CTVS and neurosurgery.

The key rule is simple: devices labelled for single use must follow the manufacturer’s instructions and recommendations. The Centre’s direction applies to both public and private healthcare facilities. It asks health authorities and drug controllers to watch for reuse and act when establishments violate applicable laws or safety requirements.

The DGHS said it had learned that some private and corporate hospitals were reusing devices designed for one-time use. The directive therefore applies to public and private healthcare facilities, although the reported cases specifically mention private and corporate hospitals.

The reuse has reportedly occurred in several specialised fields. These include cardiology, nephrology, oncology, cardiothoracic and vascular surgery, known as CTVS, neurosurgery and other clinical services. Devices mentioned include cardiac catheters, guidewires, dialysis equipment, some surgical instruments, syringes and needles.

The article does not provide a number of hospitals involved or measure the scale nationally. Instead, it directs state and Union Territory authorities, drug controllers and other responsible bodies to maintain vigilance. Inspections and monitoring are intended to identify establishments reusing single-use devices and support action under applicable laws.

The Centre ordered hospitals to stop reusing devices labelled for one-time use because patient safety may be compromised. The DGHS particularly highlighted critical care, where a device failure or infection can create serious complications. A manufacturer’s one-time-use label means the device must be used according to the maker’s instructions.

The directive identifies several risks. Reuse can cause cross-infection, device malfunction, reduced performance and other complications, even when a hospital sterilises the item. Patients may also be unaware that a disposable device has been reused. The concern is greater when they are charged the full price or when government authorities reimburse that cost.

The DGHS said reuse could violate the Drugs and Cosmetics Act, Medical Devices Rules, Clinical Establishments Act and infection-control and biomedical-waste requirements. The order also seeks to prevent cost-saving practices from overriding safety, transparency and proper disposal.

A reused single-use device can harm patients in several ways, even after sterilisation. The DGHS specifically listed cross-infection, device malfunction, reduced performance and other complications. These risks matter especially in critical care and specialised procedures, where devices may be inserted into the body or relied on for precise performance.

For example, cardiac catheters and guidewires used in angiography or angioplasty may be reused after sterilisation. Dialysis equipment, certain surgical instruments, syringes and needles have also reportedly been reused. Sterilisation may address some microorganisms, but it does not change the manufacturer’s design limits or guarantee that the device will work properly again.

Patients may also be unaware that a disposable item was reused. The article flags cases where patients were charged the full device cost, or government authorities reimbursed it. This combines a safety concern with a transparency and financial concern.

The directive places enforcement responsibility on state and Union Territory authorities. It calls on them and drug controllers to maintain strict vigilance, inspect healthcare establishments, monitor their practices and take action against violations under applicable laws and regulations.

The letter was addressed to health authorities in states and Union Territories, the Drugs Controller General of India and the Central Government Health Scheme. These bodies are involved in implementing or overseeing the response. The CGHS had already issued an office memorandum on the issue in November 2016 for hospitals empanelled under the scheme.

The article does not announce a new inspection schedule or a separate penalty for hospitals found reusing these devices. Instead, enforcement is expected through existing laws and requirements. AiMeD urged regular inspections, traceable records of use and disposal, staff training and action against violations.

Cost may create pressure to reuse disposable devices, although the article does not identify a specific reason for every hospital. It notes that AiMeD urged the government to ensure cost does not become a reason for reusing them. Patients may also be charged the full cost even when a device has been reused.

The safer alternative is to use a new device for each indicated procedure, following the original equipment manufacturer’s instructions. Beyond the article, better procurement planning, adequate hospital budgets and negotiated purchasing can reduce financial pressure without weakening safety. These measures should not turn a single-use device into a reusable one.

The article supports regular inspections, traceable records of device use and disposal, staff training and action against violations. Transparent billing and reimbursement checks could also reduce incentives for unsafe reuse. The directive’s forward aim is stronger monitoring, accountability and patient protection.

Sterilisation is a process used to destroy or remove microorganisms from a device. Healthcare facilities may use methods such as heat, chemicals or radiation, depending on the item. The goal is to reduce or eliminate contamination before a device is used.

However, sterilisation does not automatically make a single-use device suitable for another patient. Cleaning may miss hidden contamination, while the sterilisation process can damage materials, coatings, seals or delicate parts. Repeated handling can also reduce strength or precision. Most importantly, the device was designed and validated by its manufacturer for one use, not repeated use.

The article therefore warns that reuse can still cause cross-infection, malfunction, reduced performance and other complications. It says devices labelled for single use must follow the original equipment manufacturer’s instructions. The DGHS directive seeks to stop hospitals treating sterilisation alone as permission to reuse disposables.