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DGHS directs states and drug controllers to enforce the prohibition; CGHS had issued a similar order in 2016
The DGHS said it had come to its notice that certain hospitals were reusing single-use devices, particularly in critical specialities such as ‘cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS), and neurosurgery’. Representational image
The central government has strictly prohibited the reuse of single-use medical devices and disposable surgical items in all healthcare institutions across the country, after it found that some private and corporate hospitals were sterilising and reusing such items.
In a letter dated October 16, seen by News18, DGHS chief Dr Loveneesh G Krishna said the Health Ministry had viewed the matter seriously and decided that reuse “shall be strictly prohibited in all healthcare organisations”, covering both public and private facilities under the jurisdiction of the Centre, states and union territories.
What does the directive say?
The DGHS said it had come to its notice that certain hospitals were reusing single-use devices, particularly in critical specialities such as “cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS), and neurosurgery”. Items used for one procedure were being sterilised and reused despite being designated for single use only. In some instances, the full cost of these items was also being charged to patients or reimbursed by government authorities.
The letter flags concerns over patient safety, infection prevention and control, regulatory compliance and healthcare expenditure. It says such practices may violate the Drugs and Cosmetics Act, 1940the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010, besides standard infection prevention and control protocols and biomedical waste management provisions. Reuse may expose patients to cross-infection, device malfunction, loss of performance and other procedure-related complications, it adds.
States, drug controllers told to enforce
The letter has been addressed to additional chief secretaries, principal secretaries and secretaries (health), directors of health services of states and union territories, the Drug Controller General of India, and state and union territory drug controllers. They have been asked to ensure strict vigilance and effective enforcement. All single-use devices and disposable surgical items should be used strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM), it says.
At A Glance
The central government issued a directive on October 16 strictly prohibiting the reuse of single-use medical devices and disposable surgical items across all healthcare institutions.
The Directorate General of Health Services flagged that certain private and corporate hospitals were sterilising and reusing items designated for single use, particularly in critical specialities.
Medical experts noted that the ban prioritises patient safety and infection prevention, while raising concerns that procedure costs and out-of-pocket expenses for patients may increase.
Authorities may also carry out “inspections and monitoring of healthcare establishments and take action as per applicable laws in cases of non-compliance”. The DGHS has asked for “wide dissemination” of the directions among healthcare organisations.
‘Patient safety must take precedence’
Welcoming the move, Dr Sudhir Kumar, neurologist at Apollo Hospitals, Hyderabad, said that reuse of devices labelled as single-use has been reported in some healthcare settings, often driven by cost pressures. “However, from a patient safety and regulatory perspective, reuse of devices intended for single use is difficult to justify because such devices are not designed or validated for repeated use.”
The government’s directive prohibiting the reuse of devices and surgical items that are labelled by manufacturers as “single-use” is an important patient safety measure, said Dr Kumar. “Such devices are designed, tested, and approved for only one use. Reprocessing and reusing them can increase the risk of infection, device malfunction, reduced performance, and procedure-related complications, particularly in high-risk specialities such as cardiology, neurosurgery, oncology, and cardiovascular surgery,” he added.
Dr Pragya Shukla, head, clinical oncology at Delhi Cancer Institute, also welcomed the order. “I welcome this order, because single-use medical devices are not designed to be sterilised, reheated or autoclaved again and again. Repeated reprocessing degrades the material, and for any medical device, compromised quality is unacceptable. Single-use devices also reduce the risk of cross-infection through blood and body fluids, which can lead to sepsis. That is the intent behind single-use disposables.”
Cost concerns raised by experts
Both experts pointed to the financial side of implementation. Dr Kumar from Apollo said, “At the same time, implementation will require healthcare systems to address the financial implications of increased use of single-use devices, especially in resource-constrained settings. Policymakers, hospitals, insurers, and manufacturers should work together to ensure that safer practices do not inadvertently reduce access to essential procedures. Patient safety and affordability must go hand in hand.”
Dr Shukla said patients could end up paying more. “The concern is cost. If consumables must now be single-use, the cost of procedures may rise. Most TPAs and insurers don’t reimburse consumables, and I believe even the Delhi Government’s health scheme and CGHS don’t account for them. So patients’ out-of-pocket expenses will naturally go up.”
“That is a real concern, but from the point of view of medical care, this is a very welcome move,” she added.
The DGHS letter itself notes that in certain instances the full cost of such items is charged to patients or reimbursed by government authorities.
“It has been observed that such devices and disposable surgical items, after being used for one procedure, are being subjected to sterilisation and subsequently reused, despite being designated for single use only. In certain instances, the full cost of these items is also being charged to patients or reimbursed by the concerned Government authorities,” the letter noted.
According to Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), “This is a patient-first decision. Single-use means single-use. Where a product is used contrary to its labelled instructions, such as being reused, any failure or harm cannot be attributed to the manufacturer. Responsibility must rest with the person or establishment that reused it. We ask that this be clearly reflected in enforcement and in any liability framework.” AiMeD represents domestic manufacturers of medical devices.
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Ask News18The central government prohibited the reuse of single-use medical devices and disposable surgical items after discovering that certain private and corporate hospitals were sterilising and reusing these items, particularly in high-risk specialities like cardiology and neurosurgery. This practice raised serious concerns regarding patient safety, infection control, and regulatory compliance.
Ask News18About the Author
Himani Chandna, Senior Associate Editor at CNN-News18, tracks healthcare, pharma and medical research, bringing clarity to complex science and policy.
October 24, 2026, 04:36 IST
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