New Delhi: Flagging the continued reuse of medical devices meant for one-time use in hospitals, the Directorate General of Health Services (DGHS) has asked state health authorities and drug regulators to step up enforcement, citing risks to patient safety and concerns over treatment costs.
In a letter dated 16 October 2026, DGHS Director Loveneesh G. Krishna said such devices were being reused in some private and corporate hospitals, particularly in cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.
Devices reportedly reused include cardiac catheters, guidewires, balloon and ablation catheters, and introducer sheaths; dialysis equipment such as dialysers and blood tubing; and surgical instruments such as staplers, laparoscopic trocars and orthopaedic drill bits. Syringes and needles are also among items identified as most reused by the Association of Indian Medical Device Industry (AiMeD), which represents domestic medical device manufacturers.
“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,” the letter said. It added that in some cases, the full cost of these items was still being charged to patients or reimbursed by the concerned government authorities.
Even when these devices are cleaned and sterilised, they may not be safe for reuse. Devices designed for one-time use can deteriorate, lose performance or retain biological material if reprocessing is inadequate, potentially exposing patients to infections such as hepatitis B and C, HIV and bacterial infections, as well as device failure and other complications.
The DGHS said the practice raised concerns about patient safety, infection prevention, regulatory compliance and healthcare expenditure. Reuse could expose patients to cross-infection, device malfunction, loss of performance and other procedure-related complications, it warned.
The issue also comes amid concerns about high mark-ups on hospital consumables. In an affidavit filed before the Supreme Court, the government had earlier acknowledged that mark-ups on hospital consumables could range from 100 to 1,000 percent or more.
The concerns are not new. In 2017, Maharashtra’s Food and Drug Administration reportedly found that eight private hospitals had reused 1,306 catheters across more than 1,000 patients. In 2018, at least 33 people tested positive for HIV in Bangarmau, Uttar Pradesh, after an unqualified medical practitioner injected some of them with an infected syringe, Reuters reported.
The letter referred to the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, the Clinical Establishments Act, 2010, infection prevention protocols and biomedical waste management provisions, stating that reuse could violate applicable requirements.
The DGHS has asked health secretaries and directors of health services in states and Union Territories, the Drug Controller General of India (DCGI) and state drug controllers to ensure effective enforcement.
“All single-use devices/disposable surgical items should be utilised strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM),” the notice said.
It added that authorities could inspect healthcare establishments, monitor compliance and take action under applicable laws and regulations. The letter also referred to a Central Government Health Scheme (CGHS) office memorandum issued 21 December 2016 on the issue for hospitals empanelled under the scheme.
AiMeD welcomed the directive, saying devices designed and validated for one-time use should not be cleaned, resterilised or reused.
Rajiv Nath, forum coordinator at AiMeD, said, in some cases, this may happen without patients’ informed consent.
“This is a patient-first decision. Single use means single use,” he said. He added that enforcement should clarify responsibility when devices were reused contrary to their labelled instructions.
Nath argued that manufacturers should not be held liable for failures or harm caused by reuse against their instructions. Responsibility, he said, should rest with the individual or establishment that reused the product. “We ask that this be clearly reflected in enforcement and in any liability framework,” he said.
AiMeD called for regular inspections of healthcare establishments, traceable records of device use and disposal, and action under the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010. It also recommended training hospital staff in infection prevention and biomedical waste handling.
“Safer and more affordable single-use alternatives should be supported so that cost does not become a reason for reuse,” the industry body said. It sought clarity on manufacturers’ liability when products were reused contrary to their labelling.
(Edited by Viny Mishra)
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