India Directs States to Enforce Ban on Reuse of Single-Use Medical Devices
India’s Directorate General of Health Services (DGHS) have issued a directive to states and Union Territories to stop single use medical devices and disposable surgical items from being reused in public or private healthcare facilities. The October 16th, 2026 directive outlines key issues around single use medical devices.
Why Has DGHS Issued This Directive?
DGHS outlined concerns that some single use medical devices are being sterilised and reused in private and corporate hospitals. This has been found to occur in specialist areas including cardiology, nephrology, oncology, neurosurgery and cardiothoracic and vascular surgery.
This creates a concern as sterilisation in itself does not mean that single use medical devices will be safe to use again or function correctly.
Risks associated include:
- Cross infection between patients
- Device failure and poor functioning
- Procedural complications
- Failure to comply with regulatory requirements
DGHS also outlined concerns that single use medical devices were being charged at full cost to the patient or government.
What Has DGHS Asked States and Hospitals to Do?
DGHS have asked state and Union Territory health authorities, DCGI and appropriate drug controllers to increase vigilance.
Appropriate audits should be carried out to ensure compliance. Where there are non-compliant issues, these should be dealt with using the appropriate legislation and regulation. Single use medical devices and disposable surgical items should be used as advised by the OEM.
What are the applicable regulations?
DGHS have referred to the following regulations:
- Drugs and Cosmetics Act 1940
- Medical Devices Rules 2017 (amended)
- Clinical Establishments Act 2010
- Applicable Infection Prevention and Control Protocols
- Applicable biomedical waste regulations.
Depending on the situation, there will be specific legal responsibilities. Healthcare facilities should ensure they are aware of any requirements
What does this mean for Medical Device Manufacturers?
This directive confirms the need for clear labelling of devices, correct use instructions and clear use conditions. Medical Device Manufacturers should ensure that single use devices are clearly labelled, with the correct handling and use instructions. Technical documentation should be maintained. The product information should be consistent with the required regulations.
Healthcare facilities should ensure that purchasing, handling, infection prevention and disposal processes are reviewed to ensure staff are following manufacturers’ instructions.
What Should Healthcare Providers and Manufacturers Do Next?
Ensure that purchasing, stock control, infection prevention and biomedical waste processes are reviewed to ensure single use medical devices are handled as per the manufacturer’s instructions.
Medical Device Manufacturers should ensure that their product labelling, use instructions (IFU) and disposal instructions are clear to show how the devices should be used. Regular training of staff and correct documentation will also help to ensure patient safety and the ability to meet the appropriate regulations.
How Can Operon Strategist Help?
Operon Strategist can help Medical Device Manufacturers with regulatory advice, technical documentation, quality management systems and risk management. We can help you to review medical device labelling, use instructions, risk documentation and requirements to ensure that the intended use and handling requirements are clearly communicated. This will ensure consistent regulatory documentation.
We can also help manufacturers to review documentation gaps, determine the appropriate regulatory requirements and ensure quality management processes are in line with medical device requirements. This will help to ensure that manufacturers are prepared for regulatory requirements.
Contact Operon Strategist for guidance on medical device documentation, quality systems, and Indian regulatory requirements.