Mumbai: The Food and Drug Administration (FDA) will conduct surprise visits at city hospitals to check if they are reusing and reselling drug notified medical devices like catheters. Earlier this week, the FDA issued show cause notices to three hospitals for reusing balloon and guiding catheters in angioplasty procedures.
“Given that three city hospitals were reusing the medical devices, it could be a common practice among profit-driven medical setups. Two hospitals were blatantly charging the second and third users of the medical devices. This is a clear violation of the Drugs and Cosmetics Act,” Harshdeep Kamble, Commissioner, FDA told The Hindu on Friday.
After the practice was exposed by a member of the medical device industry, the FDA sent notices to Fortis Hospital, Mulund, Fortis-Hiranandani, Vashi and BSES Hopital, Andheri. While BSES was not charging patients for used catheters, both Fortis hospitals were doing so. The investigations found that after the first use, the catheters would be sterilized, repackaged and sent to the cathlab for the next angioplasty procedure. Angioplasties are procedures wherein a stent is implanted into the blocked artery of a patient. Balloon catheters, guiding catheters and wires are accessories required in the process of stenting. “We hope the show cause notices act as a deterrent for other hospitals,” Mr. Kamble said.
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Doctors say reuse of certain medical devices is common, and the benefits are mostly passed on to patients from the economically weaker section. Guidance on reuse of cardio-vascular catheters and devices in India: A consensus document , an article recently published in the Indian Heart Journal, said, “Reuse of medical devices is accepted worldwide. Benefits of reuse include not only cost saving but have a favourable impact on the environment.
However, certain requirements should be met for reuse to be safe and effective. The devices which can be reused should be clearly defined, put through a meticulous process for disinfection and sterilisation and checked for functionality before use.”
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The article said Balloon Mitral Valvuloplasty (BMV) is a potentially life-saving procedure performed most frequently on poor patients suffering from rheumatic mitral valve stenosis. Each year, close to 10,000 patients undergo BMV in India , most in public hospitals. Where it is not offered free-of-cost, a maximum reimbursement of ₹60,000 (the approximate cost of a BMV procedure in a governmental hospital is between ₹15,000 and ₹30,000) is applicable.
The State government health scheme sanctions only ₹20,000 for the BMV procedure, thereby presupposing that there would be reuse of Single Use Devices (SUD), as the BMV catheter and accessories cost around ₹1 lakh. \
When the cost of other SUDs used in the procedure are taken into account, the total hardware cost for this life-saving procedure would be in excess of ₹1.2 lakh. “A ‘no reuse policy’ for such procedures would be detrimental to a vast majority of Indian patients,” the article added.