The Centre has directed states and Union Territories to strictly enforce a ban on the reuse of single-use medical devices and disposable surgical items in public and private healthcare facilities, citing infection risks and instances of patients being charged the full cost of reused equipment.
In a letter dated October 16, the Directorate General of Health Services (DGHS) said it had come to its notice that certain private and corporate hospitals were sterilising and reusing devices meant for one-time use, particularly in critical specialities such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery.
"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.
The DGHS said the practice raised concerns relating to patient safety, infection prevention and control, regulatory compliance and healthcare expenditure.
It also flagged instances in which patients were allegedly charged the full cost of these devices despite their reuse, or the cost was reimbursed by the concerned government authorities.
Also Read: Emerging era of software as medical device
Devices reportedly being reused include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysis equipment such as dialysers and blood tubing, surgical staplers, laparoscopic trocars and orthopaedic drill bits. Syringes and needles have also been identified among items being reused, according to the Association of Indian Medical Device Industry (AiMeD).
Even after sterilisation, devices designed for one-time use may not be safe for reuse, as inadequate reprocessing or deterioration can compromise their performance and leave biological material behind, the directorate said.
The practice could expose patients to cross-infections, device malfunction, reduced performance and other procedure-related complications, the DGHS warned. These infections may include hepatitis B and C, HIV and bacterial infections.
The directorate said the practice could violate provisions of the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017, the Clinical Establishments Act, 2010, and applicable infection prevention and biomedical waste management requirements.
"It has accordingly been decided that the reuse of single-use medical devices and disposable surgical items shall be strictly prohibited in all healthcare organisations, including both public and private healthcare facilities, under the administrative jurisdiction of the Government of India, states and Union Territories," the letter said.
The DGHS has asked chief secretaries, state health department officials, directors of health services, the Drug Controller General of India (DCGI) and state and UT drug controllers to ensure strict vigilance and effective enforcement.
Authorities have been asked to inspect and monitor healthcare establishments, ensure compliance with the directive and take appropriate action in cases of violations.
"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 letter said.
The letter also referred to a Central Government Health Scheme (CGHS) office memorandum issued in December 2016 concerning the reuse of such devices in hospitals empanelled under the scheme.