Three Mumbai hospitals recycle medical device implants

Three Mumbai hospitals recycle medical device implants

MUMBAI,April27: Barely three months after the government cracked down on overpriced stents, the state Food and Drug Administration (FDA) has found three city hospitals guilty of not only reusing medical devices meant for single use, but also charging multiple patients for the same.

Fortis Hospital in Mulund, Hiranandani Hospital in Vashi, which is managed by the Fortis group, and BSES Hospital in Andheri have been issued show-cause notices for violating the Drug and Cosmetics Act. “Based on information of recycling and reuse of medical devices on multiple patients, the FDA ‘s intelligence branch carried out an investigation between March 29 and April 1,” said FDA commissioner Dr Harshdeep Kamble. “These hospitals reused devices without taking consent or without giving prior information to patients,” he added.

The FDA team checked on drug notified medical devices such as guiding catheters and balloon catheters that are used for angioplasty -performed to remove blockages in arteries.
The raids also exposed the huge gap -up to four times -between the device’s purchase price for hospitals and their MRP (maximum retail price).”Some hospitals charged an MRP of Rs 26,000 for catheters they purchased for Rs 6,000,” said FDA inspector Kondiba Gadewar. Assistant commissioner (intelligence team) Madhuri Pawar said patients given the used (but sterilised) device were also charged at two of the hospitals. BSES didn’t charge the second users.

Elaborating on the method, the officials said the devices were, after single use, sent to the pharmacy for charging on the inpatient bill. “Later, these devices were sent to the central sterile supply department where they were cleaned and sterilised using ethylene oxide,” they said. In Fortis Hospital in Mulund, 66 of the medical devices were re-used for 45 more patients between January and March. “This means 66 devices meant for single use only were used 11 times,” said Pawar.

In the same period, 44 of drug notified medical devices were reused for 27 patients at Hiranandani-Fortis, Vashi. BSES Hospital, Andheri, had re-used 95 of these devices for 69 patients.

FDA officials said the hospitals have stopped re-use since the raids. A spokesperson for the two Fortis hospitals said: “We have received a notice from the FDA; we will evaluate the observations shared, and will respond appropriately .” Efforts to reach BSES failed.

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