India Bans Reuse of Single-Use Medical Devices in Hospitals: What the DGHS Order Means for Patient Safety and Treatment Costs

The Health Ministry directive flags patient safety risks, regulatory violations, and instances of hospitals charging full price for reprocessed single-use surgical items
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The DGHS said that it had come to its notice that some hospitals were reusing single-use devices, especially in critical specialties such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS) and neurosurgery.Patrick/pexels
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By: Akanksha

The Centre has banned the reuse of single-use medical devices (SUDs) and disposable surgical items at all healthcare facilities, after it found that some private and corporate hospitals were sterilizing and reusing them.

In a letter dated October 16, 2026, Directorate General of Health Services (DGHS) chief Dr. Lavenessh G. Krishna said that the Health Ministry had taken the issue seriously and decided that reuse of single-use devices “shall be strictly prohibited in all healthcare organizations”, including both public and private facilities under the Centre’s, states and Union Territories, jurisdiction. 

Which SUDs and Surgeries Were Hospitals Reusing?

The DGHS said that it had come to its notice that some hospitals were reusing single-use devices, especially in critical specialties such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS) and neurosurgery.

The devices that were reportedly reused in India include cardiac catheters, guidewires, balloon and ablation catheters and introducer sheaths used  in angiography and angioplasty, dialysis equipment (dialyzers and blood tubing) and surgical instruments (staplers, laparoscopic trocars, orthopedic drill bits). Syringes and needles are also among the most reused items reported by the Association of Indian Medical Device Industry (AiMed), a domestic MedTech industry trade body. 

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Was the Full Cost of Disposables Being Charged to Patients? 

The DGHS letter said: “It has been observed that such devices and disposable surgical items, after being used for one procedure, are being subjected to sterilization and subsequently reused despite being designated for single use only. In certain instances, the full cost of such items is also being charged to the patients or reimbursed by the concerned Government.”

Authorities had earlier informed the Supreme Court that the mark-up on hospital consumables could be between 100 and 1,000 per cent or more, as The Print reported the government’s affidavit filed before the court. The letter referred to the Central Government Health Scheme (CGHS) office memorandum issued in 2016 on the issue for hospitals empanelled under the scheme. 

What Are the Risks and Violations of Reusing SUDs? 

The letter highlights issues of patient safety, infection prevention and control, regulatory compliance and healthcare expenditure. Even when these devices are properly reprocessed, they can be prone to wear, tear, deformation, loss of performance or retention of biological material, possibly causing infections, such as, hepatitis B and C, HIV, bacterial infections, and device failure and related complications. 

Have Such Incidents of Device Reuse Been Reported Earlier? What are the Legal Provisions? 

In 2017, Maharashtra’s Food and Drug Administration reportedly found that eight private hospitals had used 1,306 catheters on more than 1,000 patients. In 2018, at least 33 people tested positive for HIV in Bengarmau, Uttar Pradesh, after an unqualified medical practitioner injected some of them with infected syringes, Reuters reported. 

DGHS said such reuse may violate the Drugs and Cosmetic Act, 1940, Medical Devices Rules, 2017, Clinical Establishment Act, 2010, as well as “infection prevention and control norms” and biomedical waste management provisions. 

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What Will the State and Drug Controllers Do to Ensure Compliance? 

The letter was addressed to the health secretaries, directors of health services of states and Union Territories, the Drug Controller General of India (DCGI), state and UT drug controllers, and the CGHS, to ensure they are vigilant and take effective enforcement measures. 

As quoted by The Print, the notice said: “All single-use devices/disposable surgical items should be utilized strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM).”

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The letter highlights issues of patient safety, infection prevention and control, regulatory compliance and healthcare expenditure. https://kaboompics.com/pexels

Authorities may also carry out “inspections and monitoring of the healthcare establishments and take action as per applicable laws in case of non-compliance” and the DGHS requested “wide dissemination” of the directions. However, the letter does not mention a new inspection schedule or a penalty for hospitals found to be reusing the said devices. 

What do Clinical Experts Say about Patients Safety vs Cost of Procedures? 

Welcoming the move in News18. Dr. Sudhir Kumar, neurologist at Apollo Hospitals, Hyderabad, said that reused SUDs had been reported, partly due to cost considerations. “However, from a patient safety and regulatory perspective, reuse is difficult to justify, because such devices are not designed to be reused,” he said.

Dr. Pragya Shukla, bead, clinical oncology at Delhi Cancer Institute, also welcomed the order in News18. “I welcome this order since single-use medical devices are not meant to be sterilized and reheated again and again. The repeated reprocessing degrades the material and for any medical device, material compromise is unacceptable. Single use devices also reduce the risk of cross-infection through blood and body fluids, which can result in sepsis. That is the intent of single-use disposables,” she said.

Will the Ban Add to Out-of-Pocket Expenses? 

Both clinicians mentioned the financial aspect. Dr. Kumar said: “Policymakers, hospitals, insurers and manufacturers need to work together to ensure that safer practices do not lead to reduced access to essential procedures. Patients safety and affordability must go hand in hand.”

Dr. Shukla told News18: “The concern is cost. If consumables have to be single-use, the cost of procedures may go up. Most TPAs and insurers do not reimburse consumables and I believe even the Delhi Government's health scheme and CGHS do not account for these. So inevitably patients’ expenses will go up.” She added, “That is a worry, but from the point of view of medical care, this is a very welcome move.”

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What is the Industry Saying About the Ban?

According to Rajiv Nath, forum coordinator, AiMed: “This is a patient-first decision. Single-use means single-use. Where a product is being used contrary to its labelled instructions (such as being reused), any failure or harm can not be attributed to the manufacturer and the onus must lie with the person or establishment that reused it. We request this to be clearly reflected in the enforcement and in any liability framework.”

The industry body also asked for regular inspections, traceable records of SUDs use and disposal, staff training, and affordable alternatives, so that cost is not a driver for reuse. 

The Medical Technology Association of India (MTaI) also welcomed the directive in ET HealthWorld stating: “The directive’s efficacy will now depend on consistent enforcement by states, regulators and healthcare institutions. Equally crucial is raising patient awareness and arming them to understand and assert their rights to safe and ethical care. ”

(Rh/APC)

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