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Times of India
28 May 2011
Mumbai, India

Work Out Ways To Deal With Changes In Rules On Life–Saving Device
Hospitals Toe FDA Line on Stents
It is transition time in hospitals offering cardiac care. A week after the Food and Drug Administration (FDA) showed the rulebook to hospitals regarding storage and sale of cardiac drug–eluting stents, hospitals are working out ways to deal with the changes.

They are buying stents, producing invoices and/or seeking extended payment periods from distributors and wholesellers who provide them with medicated stents. The FDA had raised objections to stents being stored in hospitals on a consignment basis without purchase bills. As per FDA rules, stents are drugs that need purchase bills to be stored in hospitals. However, the practice was to keep stents in hospitals on a consignment basis which allowed them to make payment only after a patient purchased one of the devices.

A hospital administrator told TOI that while he had purchased a dozen stents, his hospital was studying the law about its various interpretations. "Previously, I could get stents of various length and diameter as soon as possible because various distributors kept their consignment with us, but now with my limited stock it is cumbersome," he said.

However, all administrators agreed on one factor–they will follow the FDA guideline. "We will follow rules. If there is a prescribed method, then why shouldn’t we follow it?" asked Dr Brian Pinto, who heads the cardiology department of Holy Family Hospital in Bandra.

Asian Heart Institute’s Dr Ramankant Panda said, "At present, we are seeking invoices of each stent. We will have to see how the situation develops." FDA officials had inspected the Asian Institute in BKC last week and found that stents were stored without doing proper paperwork or obtaining a licence.

The FDA survey on stents is part of a larger project to get a feel of how medical devices classified as drugs are stored, distributed and sold. FDA’s A V Giri told TOI that the survey is still on. "We have surveyed most big hospitals in the city. We will prepare our report thereafter," he said, adding that most hospitals were open to the idea of not keeping consignments without payment. "They told us that they will follow our guidelines."

There are some hospitals like Jaslok Hospital on Peddar Road that have been buying its stocks for years. Jaslok Hospital CEO Colonel M Masand told TOI, "We have been buying stents in bulk for many years now. If one buys 14 stents, one gets a discount. And we always pass the discount on to the patients."

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