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