The Union health ministry has directed states to stop hospitals from reusing single-use medical devices. The order highlights patient-safety risks, billing concerns and potential regulatory violations.The Union health ministry has asked states to crack down on private and corporate hospitals that reuse single-use medical and surgical devices, flagging cases where the full cost of such items is still billed to patients or reimbursed by government authorities.In a letter to states that was issued last week, the Directorate General of Health Services (DGHS) said reuse was being reported in critical specialities such as cardiology, nephrology, oncology, cardiothoracic and vascular surgery and neurosurgery.Sources said the single-use devices being used in multiple patients included those needed during procedures such as angiography and angioplasty and there had been instances where ex-planted pacemakers had been re-implanted in other patients.“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 directorate called the practice “a serious concern from the perspective of patient safety, infection prevention and control, regulatory compliance, and healthcare expenditure”. Reuse, it warned, may expose patients to “cross-infection, device malfunction, loss of performance, and other procedure-related complications”.It added that the practice may violate the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017 and the Clinical Establishments Act, 2010.HOSPITALS UNDER SCANNER The letter lands amid sharper scrutiny of how hospitals bill for consumables.A survey of Maharashtra’s hospital consumables found an IV infusion set bought for 11.05 carrying a printed price of 325, a markup of 2,841%.
Maharashtra FDA commissioner Tukaram Mundhe told the Department of Pharmaceuticals and the drug pricing regulator that many categories of medical devices fall outside strict statutory price controls.An earlier analysis by the National Pharmaceutical Pricing Authority (NPPA) of four major private hospitals found margins of up to 1,737% on drugs, consumables, devices and diagnostics.DEVICES THAT GET REUSEDSeveral products labelled for single use are reported to be reused in India, often without the patient’s informed consent. In cardiac care, these include diagnostic and guiding catheters and guidewires used in angiography and angioplasty apart from introducer sheaths and some accessories;Even balloon catheters used in angioplasty that are complex, hard to clean and resterilise, and lose performance after one use and electrophysiology and ablation catheters, which are costly and often reprocessed, are also reused.Industry sources said that a separate and more serious practice is re-implanting explanted pacemakers after cleaning.In nephrology, dialysers are widely reused in dialysis units even when labelled single-use.
So are haemodialysis bloodlines, AV fistula needles and some catheters.Other commonly reported items include surgical staplers, laparoscopic trocars, orthopaedic burrs and drill bits. "Disposable syringes and needles are a long-standing problem, which is why auto-disable syringes exist and some countries have made them mandatory," said a source.The practice has also surfaced before.In 2017, for instance, Maharashtra’s FDA had said that eight private hospitals had reused 1,306 catheters across more than 1,000 patients, with devices sent to the pharmacy after use and charged to the inpatient bill.ENFORCEMENT AND LIABILITYThe ministry has decided that reuse “shall be strictly prohibited” in all public and private facilities. State health secretaries, state health directors, the Drug Controller General of India (DCGI) and state drug controllers have been asked to ensure “strict vigilance and effective enforcement”.Authorities may inspect and monitor establishments and act against non-compliance.
Single-use items must be used strictly as the original manufacturer instructs.Indian device makers, meanwhile, backed the move.Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), called it a patient-first decision. He said a failure or harm from a reused product cannot be attributed to the manufacturer, and that responsibility “must rest with the person or establishment that reused it”.He asked that this be clearly reflected in enforcement and in any liability framework.- Ends