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FDA surprise checks, Action on Hospitals for reusing catheters, baloons


FDA surprise checks, Action on Hospitals for reusing catheters, baloons

Mumbai: In a surprise checks, Maharashtra FDA has found that at least four more hospitals have been reusing and reselling Drug Notified Medical Devices like balloon and guiding catheters used in angioplasty which are meant for one-time use at present. A show cause notices will be now be sent by FDA to the hospitals, located in Pune, Aurangabad, Nagpur and Mumbai

While speaking with The Hindu, Harshdeep Kamble, FDA Commissioner said “Our teams were spread across Maharashtra to identify hospitals reusing these devices. We have found four such hospitals. Our checks will continue.” The authority is also in the process of preparing a report regarding the same

“Depending on the findings, we will submit the report to the Central government authorities. Two of the hospitals served notices were charging patients blatantly, and the latter had absolutely no knowledge about it. This is not acceptable at all,” said Mr. Kamble.

In an investigation, it was found that after the first use, the catheters were sterilized, repacked and sent to the cathlab for the next angioplasty procedure and these sterilized catheters were reused on 45 patients at the Mulund hospital, 27 at the Vashi hospital and 69 patients at the Andheri hospital.

In this context, some doctors have informed that , while reusing such devices is cost-effective for patients, instances of benefits being passed on to patients are rare and they were unanimous in saying reuse is possible only after a meticulous process for disinfection and sterilization.

FDA had already sent Notices to Fortis Hospital, Mulund and Fortis-Hiranandani, Vashi last month regarding reuse of medical devices and charging considerable amounts on them. FDA had also sent notice to BSES Hopital in Andheri for reusing medical devices but BSES was not charging patients for this.



Source: with inputs
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