New Delhi: The Centre has prohibited the reuse of single-use medical devices and disposable surgical items in all public and private healthcare facilities in all states and union territories (UT).
The move comes after the Directorate General of Health Services (DGHS) found that certain private and corporate hospitals were sterilising such products and using them on more than one patient, despite their being designated for single use only.
DGHS said the practice had been noticed particularly in critical specialties such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery (CTVS) and neurosurgery, and other specialised clinical services.
It added that in certain instances, the full cost of these reused items was being charged to patients or reimbursed by the concerned government authorities.
The ministry cautioned that reusing such items is a serious concern for patient safety, infection prevention and control, regulatory compliance and healthcare expenditure.
It said the practice may constitute a violation of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, and the Clinical Establishments Act, 2010.
In a letter addressed to state and UT health secretaries, directors of health services, drug controllers, and the Drug Controller General of India (DCGI), the DGHS directed to ensure strict vigilance and effective enforcement within their jurisdictions.
It added that all single used devices/disposable surgical items should be utilized strictly in accordance with the instructions and recommendations of the Original Equipment Manufacturer (OEM).
It also directed the concerned authorities to undertake appropriate inspections and monitoring of healthcare establishments to ensure strict compliance with the above directions and take necessary action, as per applicable laws and regulations, in cases of non-compliance.
The Association of Indian Medical Device Industry (AiMeD) welcomed the decision, calling it a patient-first step.
Rajiv Nath, Forum Coordinator, AiMeD, said: “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.”
