NEW DELHI, OCT 24 (PTI): Centre has directed states and Union Territories to strictly enforce a nationwide ban on reusing single-use medical devices and disposable surgical items in public and private healthcare facilities, citing infection risks and instances of patients being charged the cost of reused equipment.
In an October 16 letter, the Directorate General of Health Services (DGHS) said private hospitals were sterilising and reusing devices intended for one-time use.
The practice raised concerns over patient safety, infection prevention, regulatory compliance and healthcare expenditure. The DGHS also flagged instances where patients were allegedly charged the full price of reused devices or the costs were reimbursed by government authorities. Devices reportedly being reused include cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysis equipment, surgical staplers, laparoscopic trocars and orthopaedic drill bits. Syringes and needles have also been identified, according to the Association of Indian Medical Device Industry (AiMeD).
The directorate warned that sterilisation does not necessarily make single-use devices safe for reuse. Inadequate reprocessing or deterioration could compromise performance and leave biological material behind, exposing patients to cross-infections, device malfunction and complications, including hepatitis B and C, HIV and bacterial infections.
DGHS said such practices could violate the Drugs and Cosmetics Act, 1940, Medical Devices Rules, 2017, and Clinical Establishments Act, 2010. The letter stated that reuse of single-use medical devices and disposable surgical items was strictly prohibited in all public and private healthcare facilities under the jurisdiction of the Centre, states and Union Territories.
DGHS has asked chief secretaries, state health department officials, directors of health services, Drug Controller General of India and state drug controllers to ensure enforcement. Authorities have been directed to inspect and monitor healthcare establishments, ensure compliance and take appropriate action against violations. The letter instructed facilities to use single-use devices strictly according to original equipment manufacturers’ recommendations. It also referred to a December 2016 Central Government Health Scheme memorandum concerning reuse of such devices in empanelled hospitals.
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