FDA nixes state appeal to ban multi-dose vials

FDA nixes state appeal to ban multi-dose vials

The head of the U.S. Food and Drug Administration has rejected an appeal from New York State’s health commissioner to ban the manufacture of multi-dose vials, saying they are an important option for hospitals.

In January, state Health Commissioner Dr. Richard Daines and New York City’s health commissioner, Dr. Thomas Frieden, sent FDA Commissioner Dr. Andrew von Eschenbach a letter calling for the FDA to eliminate the manufacture and distribution of multi-dose vials.

Although there are federal and state guidelines against the practice, reusing syringes in multi-dose vials was the source of at least one hepatitis C transmission by Plainview pain management physician Dr. Harvey Finkelstein. The health department was criticized last November when it was revealed that because of legal delays and complicated lab tests, it had waited three years before telling the public of Finkelstein’s improper practice.

In a letter dated Jan. 18, both Daines and Frieden said that despite “numerous guidelines and recommendations,” some doctors continue to misuse needles and syringes, leading to contamination of multi-dose vials. Daines said he believed it was better to “engineer out” human error by getting rid of multi-dose vials.



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