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India Bans Reuse of Single-Use Medical Devices & Disposable Surgical Items (DGHS Order 2026)

India Bans Reuse of Single-Use Medical Devices & Disposable Surgical Items (DGHS Order 2026)
India Bans Reuse of Single-Use Medical Devices 2026

INDIA BANS REUSE OF SINGLE-USE MEDICAL DEVICES

DGHS Directive No. Z.28017/38/2026-SAS-III Dated 16.10.2026
Issuing AuthorityDirectorate General of Health Services (DGHS)
MinistryMinistry of Health & Family Welfare
Order Date16 October 2026
SubjectProhibition on Reuse of Single-Use Devices
Major Directive: The Ministry of Health & Family Welfare has issued a strict directive prohibiting the reuse of single-use medical devices and disposable surgical items in all healthcare organisations (both public and private) across India. This order comes into force with immediate effect.

Order No.

Z.28017
SAS-III / 2026

Prohibited

Reuse
Single-Use Devices

Effective Date

16 Oct 2026
Immediate effect

Applicable To

All Hospitals
Public & Private

Important Details

  • Order No.: D.O. No. Z.28017/38/2026-SAS-III
  • Date: 16 October 2026
  • Issued By: Dr. Loveneesh G. Krishna, MS (Ortho), DNB (Ortho), Director General of Health Services, Government of India.
  • Subject: Prohibition on Reuse of Single-Use Devices and Disposable Surgical Items in Healthcare Organisations Across the Country.
  • Effective: With immediate effect across all States and Union Territories.

Why Has the Government Banned Reuse?

The DGHS observed that certain private and corporate hospitals are reusing single-use medical devices — particularly in critical specialties such as Cardiology, Nephrology, Oncology, Cardiothoracic and Vascular Surgery (CTVS), and Neurosurgery — after sterilisation, despite the devices 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 Government has identified the following serious concerns with this practice:

  • Patient Safety Risk: Reuse exposes patients to cross-infection, device malfunction, loss of performance, and other procedure-related complications.
  • Infection Prevention & Control: Violates Standard Infection Prevention and Control protocols and Biomedical Waste Management provisions.
  • Regulatory Violations: Constitutes violations of the Drugs and Cosmetics Act, 1940, Medical Devices Rules, 2017, and Clinical Establishments Act, 2010.
  • Financial Exploitation: Charging patients or Government authorities the full cost of items that were reused instead of being disposed of.
  • Key Directives to Authorities

    • Strict Prohibition: Reuse of single-use medical devices and disposable surgical items is strictly prohibited in all healthcare organisations (public and private) under the jurisdiction of the Government of India, States, and Union Territories.
    • Vigilance & Enforcement: All Additional Chief Secretaries, Principal Secretaries, Secretaries (Health), Directors of Health Services, DGCI, and State Drug Controllers are requested to ensure strict vigilance and effective enforcement within their jurisdictions.
    • OEM Compliance: All single-use devices and disposable surgical items must be utilised strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM).
    • Inspections: Concerned authorities may undertake appropriate inspections and monitoring of healthcare establishments to ensure strict compliance, and take necessary action as per applicable laws in cases of non-compliance.
    • CGHS Note: The Central Government Health Scheme (CGHS) has already issued an Office Memorandum dated 21.12.2016 regarding this matter to hospitals empanelled under CGHS.

    Frequently Asked Questions

    What is the DGHS Order 2026 regarding single-use medical devices?
    The Directorate General of Health Services (DGHS) has issued a strict directive prohibiting the reuse of single-use medical devices and disposable surgical items in all healthcare organisations across India, effective immediately.
    Which hospitals does this order apply to?
    The order applies to all healthcare organisations — including both public and private hospitals — under the administrative jurisdiction of the Government of India, all States, and Union Territories.
    Why is the Government banning reuse of these devices?
    The ban is due to serious concerns regarding patient safety, infection prevention and control, regulatory compliance, and healthcare expenditure. Reuse exposes patients to risks like cross-infection, device malfunction, and procedure-related complications.
    Which laws and regulations are being violated by reuse?
    The reuse of single-use devices constitutes violations of the Drugs and Cosmetics Act, 1940, Medical Devices Rules, 2017, Clinical Establishments Act, 2010, Standard Infection Prevention and Control protocols, and Biomedical Waste Management provisions.
    What is the role of OEM instructions?
    The order strictly mandates that all single-use devices and disposable surgical items must be utilised strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM).
    What actions can authorities take for non-compliance?
    Concerned authorities may undertake appropriate inspections and monitoring of healthcare establishments. In cases of non-compliance, necessary action will be taken as per applicable laws and regulations.
    Where can I download the official notification?
    You can download the PDF using the "Download Order PDF" button above, or visit the official Ministry of Health & Family Welfare website at mohfw.gov.in.