Hospital Chains Urge Centre to Withdraw Ban on Reuse of Single-Use Medical Devices

India’s leading hospital chains and healthcare associations have urged the central government to reconsider its blanket ban on reusing single-use medical devices, warning that the directive could increase the cost of medical procedures by 25–75% and disrupt essential treatments, including dialysis. The industry wants the government to introduce a regulated framework that allows selected devices to be reprocessed and reused under strict safety standards rather than prohibiting the practice across the board.

The demand follows an October 16, 2026, directive from the Directorate General of Health Services (DGHS), which instructed authorities to enforce a prohibition on reusing medical devices and disposable surgical items labelled for single use. Hospitals including Narayana Health, Manipal Hospitals, Fortis Healthcare, KIMS Hospitals and Medanta have reportedly joined industry representatives in asking the government to reconsider the decision. The debate now involves patient safety, treatment affordability, hospital operating costs and India’s medical-device regulations.

Key Takeaways

• Leading Indian hospital chains have asked the Centre to reconsider its ban on reusing single-use medical devices.
• The industry warns that certain medical procedures could become 25–75% more expensive.
• Dialysis services for approximately 500,000 patients could face disruption, according to industry estimates.
• The DGHS issued its prohibition directive on October 16, 2026.
• Hospitals want regulated reuse with sterilisation, safety testing, reuse limits and transparent billing.
• Medical-device manufacturers support the prohibition, citing infection and equipment-failure risks.
• Healthcare associations have requested a transition period of three to six months.

Why Have Hospital Chains Approached the Government?

The disagreement began after the DGHS directed authorities to prevent healthcare facilities from reusing devices that manufacturers have designated for single use.

The October 16 communication highlighted reports of hospitals sterilising disposable medical equipment and using it again, particularly in specialised departments such as cardiology, nephrology, oncology, cardiothoracic surgery and neurosurgery.

The government also raised concerns about billing practices. According to the directive, there have been instances in which patients were charged the full price of devices even after those products had been reused. Government authorities were also reportedly reimbursing the full cost in some cases.

The DGHS said the practice could expose patients to cross-infections, device malfunction, reduced performance and other medical complications.

Following the directive, hospital groups and healthcare associations submitted representations asking the government to reconsider a blanket prohibition.

The Association of Healthcare Providers (India), or AHPI, and NATHEALTH have raised concerns about the financial and operational consequences. Their position is that the government should distinguish between devices that can be safely reprocessed under controlled conditions and products that should never be reused.

Why Hospitals Say the Ban Could Increase Treatment Costs

One of the industry’s biggest concerns is the cost of replacing equipment that hospitals currently reuse under existing practices.

Some medical devices used during complex procedures are expensive. If a hospital must purchase a new device for every patient or procedure, the additional expense could increase the overall treatment bill.

Business Standard reported that the hospital industry’s representation estimates procedure-cost increases of 25–75% in certain cases.

One example cited in the representation is a tissue stabiliser used during coronary artery bypass grafting, which costs approximately ₹85,000.

Hospitals argue that purchasing a new device for every procedure could make certain treatments difficult to provide at existing reimbursement rates, particularly under government healthcare schemes.

The financial impact could extend to insurance providers and patients paying out of pocket.

However, the estimated increase is not a universal prediction for every medical procedure. The actual impact would depend on the device, treatment, procurement cost and reimbursement arrangement.

Dialysis Services Face a Major Challenge

Dialysis is among the most significant concerns raised by hospital groups.

Industry estimates shared with Business Standard suggest that more than 60% of dialysis sessions in India involve multiple-use dialysers. These sessions account for approximately 40 million treatments annually for around 500,000 patients.

A dialyser is a specialised medical device used in haemodialysis to filter waste products and excess fluid from a patient’s blood.

If hospitals are required to use a new dialyser for every session, annual device requirements could increase six to seven times, according to industry estimates.

This could create additional pressure on dialysis centres, particularly facilities operating under public-private partnerships and government-funded healthcare programmes.

Why the Pradhan Mantri National Dialysis Programme Matters

The industry has also highlighted a potential conflict with existing government dialysis guidelines.

The Pradhan Mantri National Dialysis Programme allows dialysers to be reused for the same patient, subject to prescribed conditions and limits.

The new DGHS directive has therefore raised questions about how the prohibition will interact with the existing programme.

Healthcare associations want the government to clarify the rules and establish a practical implementation framework so that dialysis services are not disrupted.

For patients who require regular maintenance haemodialysis, missing scheduled sessions can have serious consequences. This makes continuity of treatment an important part of the policy debate.

Hospitals Want Regulated Reuse Instead of a Blanket Ban

Hospital groups are not simply asking the government to permit unrestricted reuse. Their representation proposes a framework that identifies which devices may be safely reprocessed and establishes conditions for their use.

The proposed safeguards include:

Proposed safeguard	Purpose
Validated sterilisation	Reduce contamination and infection risks
Device safety testing	Check whether equipment remains functional
Reuse limits	Restrict the number of permitted reuse cycles
Regular audits	Monitor hospital compliance
Patient consent	Improve transparency about device handling
Transparent billing	Prevent patients from being charged incorrectly
Traceability	Maintain records of device use and reprocessing

The industry also wants the government to consider international regulatory approaches and conduct clinical-risk assessments before implementing a complete prohibition.

Healthcare associations have requested a transition period of approximately three to six months to adjust procurement contracts, insurance arrangements, supply chains and hospital procedures.

Medical-Device Manufacturers Support the Ban

The hospital industry’s position is not shared by all healthcare stakeholders.

Domestic medical-device manufacturers, represented by the Association of Indian Medical Device Industry (AiMeD), have supported the DGHS directive.

Manufacturers argue that products labelled for single use are not necessarily designed or validated for cleaning, sterilisation and repeated use.

Even when a device appears clean after sterilisation, reprocessing may not eliminate all biological contamination or restore its original performance.

Repeated use could also damage delicate components and increase the risk of equipment failure during medical procedures.

The Medical Technology Association of India (MTaI) has also welcomed the prohibition, emphasising that its effectiveness will depend on consistent enforcement, inspections and patient awareness.

Manufacturers have additionally called for clearer liability rules when hospitals reuse devices contrary to their instructions.

This creates an important distinction in the debate: hospitals are asking for selected, regulated reuse, while manufacturers argue that devices designed for one-time use should be used according to their original instructions.

What Laws and Regulations Are Involved?

The DGHS has referred to several existing legal and regulatory frameworks in its communication.

These include:

• Drugs and Cosmetics Act, 1940: The broader legal framework governing drugs and medical devices.
• Medical Devices Rules, 2017: Regulatory requirements covering medical-device quality, safety and compliance.
• Clinical Establishments Act, 2010: Requirements applicable to healthcare establishments under the law’s relevant jurisdiction.
• Biomedical Waste Management Rules: Requirements concerning the handling and disposal of biomedical waste.

The directive instructs state and Union Territory authorities, health departments, the Drug Controller General of India and state drug controllers to ensure effective enforcement.

It also asks healthcare organisations to follow the original equipment manufacturer’s instructions for single-use devices.

The precise legal consequences of non-compliance will depend on the applicable provisions, jurisdiction and circumstances.

The Bigger Picture

The dispute highlights a structural challenge in India’s healthcare sector. Medical treatment must meet safety standards, but hospitals also operate within a system where equipment costs, insurance coverage and government reimbursement rates influence patient access.

A blanket prohibition could create additional expenses for hospitals and patients, especially where existing treatment programmes have been designed around reuse practices. At the same time, allowing devices labelled for single use to be repeatedly sterilised without validated procedures could expose patients to serious risks.

The central government’s next steps will therefore be important. A device-specific framework, clearer rules for dialysis and transparent billing requirements could help address some of the concerns raised by both sides.

Looking Ahead

Hospital associations are waiting for the government’s response to their representations. The immediate questions include whether the Centre will clarify the treatment of dialysis equipment, introduce a transition period or consider regulated reuse for selected medical devices.

The final outcome could influence treatment costs, hospital procurement practices and access to essential procedures across India. For patients, the most important consideration will be ensuring that any cost-saving arrangement does not compromise medical safety or transparency.

Frequently Asked Questions

1. Why are Indian hospital chains opposing the single-use medical device ban?

Hospitals argue that replacing every device after one procedure could significantly increase treatment costs and disrupt services such as dialysis. They want regulated reuse for selected devices under strict safety conditions.

2. Which hospital chains have approached the government?

Executives from Narayana Health, Manipal Hospitals, Fortis Healthcare, KIMS Hospitals and Medanta were among those associated with the joint industry representation reported by Business Standard.

3. When did the Centre issue the ban?

The Directorate General of Health Services issued its directive on October 16, 2026, instructing authorities to enforce the prohibition across public and private healthcare facilities.

4. How much could medical procedure costs increase?

Industry representatives estimate that certain procedures could become 25–75% more expensive. The actual increase will vary depending on the procedure and the devices involved.

5. Why is dialysis particularly affected?

Industry estimates suggest that more than 60% of dialysis sessions involve multiple-use dialysers. Requiring a new dialyser for every session could significantly increase procurement requirements and treatment costs.

6. What safeguards are hospitals proposing?

Hospitals want validated sterilisation, device-function testing, limits on reuse cycles, regular audits, patient consent and transparent billing.

7. Why do medical-device manufacturers support the ban?

Manufacturers argue that products labelled for single use are not designed or validated for repeated use. Reprocessing could leave contamination, damage components or reduce device performance.

8. Has the government withdrawn the ban?

No withdrawal has been confirmed in the reports available as of October 31, 2026. Hospital associations have submitted representations requesting reconsideration.