States urged to enforce ban on reuse of single-use medical devices
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The Directorate General of Health Services has issued a directive to prohibit the reuse of single-use medical devices. Violations by some private hospitals have raised concerns regarding patient safety and regulatory compliance. The directive specifically targets misuse in high-stakes medical fields such as cardiology and neurosurgery. Monitoring and enforcement of compliance by healthcare establishments have been mandated.
New Delhi: The Directorate General of Health Services (DGHS) has directed states to strictly enforce a ban on reuse of single-use medical devices and disposable surgical items, flagging possible violations by some private and corporate hospitals.In a directive dated October 16, the regulator said reusing such devices shall be strictly prohibited in all public and private healthcare facilities under the administrative jurisdiction of the Centre, states and union territories, warning that the practice endangers patient safety and violates medical device regulations.
DGHS said it has come to its notice that some hospitals reuse single-use devices and disposable items, particularly in cardiology, nephrology, oncology, cardiothoracic and vascular surgeries an neurosurgery after reportedl sterilising them.
The practice could expose patients to cross-infection, device malfunction, loss of performance and other procedure-related complications, it said.
“All single-use devices and disposable surgical items must be used strictly in accordance with the instructions and recommendations of the original equipment manufacturer (OEM),” DGHS said.
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It also flagged possible violations of the Drugs and Cosmetic Act, 1940, Medical Devices Rules, 2017, Clinical Establishments Act, 2010, applicable infection prevention and control protocols, and biomedical waste management provisions.
“In some instances, the full cost of these items was also being charged to patients or reimbursed by government authorities,” the directive said.
It asked additional chief secretaries, principal secretaries and secretaries (health), directors of health services, the Drug Controller General of India (DCGI), and state and union territory drug controllers to ensure strict vigilance and effective enforcement.
Authorities have also been asked to inspect and monitor healthcare establishments, and take action under applicable laws and regulations in cases of noncompliance.
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Figures reflect the source report and its stated period. This article is for information and is not investment advice.



