FDA refuses to revoke Sion Hospital blood bank Suspension

Hundreds of people planning to undergo surgeries at the Sion hospital later this month are likely to be inconvenienced as the hospital stands a bleak chance of revoking the suspension of its blood bank licence.

Hundreds of people planning to undergo surgeries at the Sion hospital later this month are likely to be inconvenienced as the hospital stands a bleak chance of revoking the suspension of its blood bank licence.

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On Thursday, the Food and Drug Administration (FDA) had suspended its licence for a week starting May 11 after a probe found that a patient had died last November owing to wrong blood transfusion. The probe had also found that the hospital did not have a full time blood transfusion officer (BTO).

On Friday, hospital authorities asked the FDA for some more time to fix problems with its blood bank operation, but FDA officials said that only a court can revoke the suspension. “The order has already been passed, now it’s beyond our control to revoke the suspension,” said K Shende, joint commissioner, FDA.

With the absence of a functional blood bank, the hospital that conducts about 150 surgeries (including emergency cases) a day might have to cancel planned surgeries, said officials. The hospital requires at least 70-80 units of blood everyday to continue with the emergency and planned surgeries.

While the FDA has suspended the hospital’s blood bank licence for 15 days, Manohar Naik, minister of state for FDA reduced the period by a week.

“According to the suggestions given by the FDA we had submitted a plan, which was approved by them. There are few more changes they [FDA] want us to do and we are ready to do that, if given some time. We have already started the process to fill the vacancy for the BTO positions,” said Dr Suleman Merchant, acting dean of Sion hospital.

He added, “Being a public hospital we cater to poor people and it would be difficult for them to run around to get blood units. If the suspension is not revoked, we will have to rope in blood banks to keep the hospital functioning.”

A senior doctor said, “Sometimes we have emergency patients who are not accompanied by the relatives, how will blood for such patients be arranged?”