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Sahyadri Hospital reuses catheters, FDA issues notice

Sahyadri Hospital reuses catheters, FDA issues notice

Pune: The officials of Food and Drug Administration (FDA ) in their special inspection last month found that  well-known Sahyadri Multi-Speciality Hospital on Karve Road, Pune was reusing medical devices meant for single use against guidelines of Drugs and Cosmetics Act.

The hospital was found to be recycling catheters or drug-notified medical devices on multiple patients without their consent against rules laid down by the Drug Controller of India which stipulate that catheters cannot be reused.

“Since January, the hospital has conducted more than 287 angioplasties — 151 medical devices were re-used for patients between January and May,” said P P Mhangar, assistant commissioner of FDA (drug), adding, “We have received a reply regarding the activity, and a hearing will now be called between the hospital and the FDA, after which a further course of action will be decided upon,” reported by PuneMirror

However doctors say sterilised catheters are recycled internationally and reuse of medical device is accepted worldwide. Benefits of reuse include not only cost saving but a favorable impact on environment. However, certain requirements should be met for reuse to be safe and effective.

The devices, which can be reused, should be clearly defined, a meticulous process for dis-infection and sterilization followed and its functionality ascertained before use. Further, an appropriate consent should be obtained where necessary and the cost saving entailed should be directly passed on to the patient.

Earlier also it has been reported from time to time that some Private hospitals make a huge profit by reusing disposables without consent of patients.

Read also: Maha Hospitals reused catheters, charged patients 77 percent of MRP: Maharastra FDA

Source: with inputs
2 comment(s) on Sahyadri Hospital reuses catheters, FDA issues notice

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  1. Hospital usually do not keep correct record of validation of equipments
    Resuse of catheter can result in infection and can be fetal for the patients , reused must be stoped , and management be punished
    For use of drugs or device that cause grave injury to patients
    Under drugs and cosmetic act 1940 and rules there under

  2. FDA need to be strict with this. It only adds to the profit of hospital and doctors. Catheter reuse should be done only with patients consent and the benefit should go to patient only. In any case, hospital and doctors need to follow law of land and can not be law themselves.