Single-Use Medical Devices: DGHS Tells States to Stop Hospital Reuse

The Directorate General of Health Services (DGHS) has told every state and Union Territory to stop hospitals from sterilising and reusing catheters, dialysers and other devices made for one use only, after it learnt that some private and corporate hospitals were doing so. The letter, dated 16 October and signed by DGHS director Loveneesh G. Krishna, went to chief secretaries, health secretaries, the Drug Controller General of India and state drug controllers, ThePrint and PTI reported. Akashvani News carried the advisory on the night of 24 October.

Catheters, Dialysers and Staplers on the List

The letter names cardiac catheters, guidewires, balloon and ablation catheters, introducer sheaths, dialysers and blood tubing, surgical staplers, laparoscopic trocars and orthopaedic drill bits. Reuse was reported mainly in cardiology, nephrology, oncology, cardiothoracic and vascular surgery, and neurosurgery. The ban applies to public and private facilities alike.

DGHS said a reprocessed device can carry leftover biological material or fail mid-procedure, with a risk of hepatitis B, hepatitis C, HIV and bacterial infection. It also said some patients were billed the full price of a device that had already been used, or the cost was claimed from government health schemes.

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A 2016 Memo Raised the Same Problem

This is not the first warning. The letter refers to a Central Government Health Scheme office memorandum of 21 December 2016 on reuse in CGHS-empanelled hospitals. In 2017, Maharashtra’s Food and Drug Administration reportedly found that eight private hospitals had reused 1,306 catheters on more than 1,000 patients, ThePrint reported. The letter cites the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017 and the Clinical Establishments Act, 2010. Rajiv Nath of the Association of Indian Medical Device Industry (AiMeD) welcomed the order. “Single use means single use,” he said.

Inspections Left to the States

States and drug regulators have been asked to inspect hospitals, monitor compliance and act against violations. The published reports of the letter do not set a date for states to report back, list penalties, or say how patients billed for a reused device can seek a refund. AiMeD has asked for regular inspections and for records that track each device from use to disposal. For more health policy news, see the Centre’s approval of 320 new PG medical seats in Himachal and other daily updates.

Source: Akashvani News report on the DGHS advisory. Also based on reporting by ThePrint and PTI via DT Next.

Image: Wikimedia Commons (representational photo of a dialysis machine).