New Delhi, Oct 24 : The Centre has directed all states and Union Territories to strictly enforce the ban on the reuse of single-use medical devices and disposable surgical items in public and private hospitals. The directive aims to protect patient safety, prevent hospital-acquired infections and address concerns over patients being charged the full cost of reused medical equipment.
In a letter dated October 16, the Directorate General of Health Services (DGHS) said it had received reports of certain private and corporate hospitals sterilising and reusing medical devices designed for one-time use. The reported practice was particularly concerning in critical specialities, including cardiology, nephrology, oncology, neurosurgery, and cardiothoracic and vascular surgery.
Reuse of Single-Use Medical Devices Raises Patient Safety Concerns
According to the DGHS, medical devices intended for a single procedure were reportedly being sterilised and reused despite manufacturers’ instructions. The directorate warned that such practices could compromise patient safety, infection control, device performance and regulatory compliance.
Medical devices reportedly being reused include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysis equipment, surgical staplers, laparoscopic trocars and orthopaedic drill bits. Syringes and needles have also been identified among the items being reused, according to the Association of Indian Medical Device Industry (AiMeD).
The DGHS cautioned that sterilisation does not necessarily make single-use medical equipment safe for reuse. Inadequate reprocessing or damage to devices could leave biological material behind, affect their performance and increase the risk of complications.
Reused Medical Equipment May Spread Serious Infections
The Centre has warned that the reuse of disposable medical devices could expose patients to cross-infections, equipment malfunction and other procedure-related complications. Potential infections include hepatitis B, hepatitis C, HIV and bacterial infections.
The directive also highlighted concerns over healthcare costs. In some reported cases, patients were allegedly charged the full price of medical devices even when the equipment had been reused. The cost was also reportedly reimbursed by the concerned government authorities in certain instances.
Centre Orders Strict Enforcement in Public and Private Hospitals
The DGHS has directed that the prohibition on reusing single-use medical devices and disposable surgical items be strictly enforced across healthcare organisations under the administrative jurisdiction of the Centre, states and Union Territories.
The directive has been sent to chief secretaries, state health department officials, directors of health services, the Drug Controller General of India (DCGI), and state and Union Territory drug controllers.
Authorities have been instructed to maintain strict vigilance, conduct inspections, monitor healthcare establishments and take appropriate action against violations.
Hospitals Must Follow Medical Device Manufacturers’ Instructions
The DGHS has emphasised that all single-use medical devices and disposable surgical items must be used strictly according to the instructions and recommendations of the Original Equipment Manufacturer (OEM).
The directorate also referred to a Central Government Health Scheme (CGHS) office memorandum issued in December 2016 regarding the reuse of such devices in hospitals empanelled under the scheme.
The latest directive reinforces the Centre’s focus on patient safety, infection prevention, regulatory compliance and transparency in hospital billing. Healthcare facilities are expected to follow the applicable rules and ensure that medical devices intended for one-time use are not reused.
