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01/31/08

NEW YORK:  State Health Commissioner Calls on FDA to Ban Multidose Vials After Hepatitis C Incident


The Food and Drug Administration should work towards eliminating the manufacture and distribution of medications in multidose vials due to the risk of contamination, New York Health Commissioner Richard Daines said yesterday.

Daines was one of nine doctors and health officials on a panel discussion of infection control at Hofstra University. He made the recommendation while acknowledging that some medicines must be administered using multidose vials. "You go in with a goal even though there may be exceptions," he said.

However, "engineering out" the possibility of human error is the best way to ensure infection control, said Daines. Needles and syringes are only supposed to be used once, he noted. But if they are not, discontinuing multidose vials would eliminate a possible contamination source, he said.

In November, the state Department of Health was criticized after it was revealed that due to complicated lab tests and legal delays, it had waited almost three years before telling the public that Dr. Harvey Finkelstein of Dix Hills had reused syringes in multidose vials. At least one hepatitis C case has resulted. And on Jan. 15, the state announced that a Manhasset obstetrician-gynecologist, Dr. E. Jacob Simhaee, reused syringes in a multidose vial when giving flu shots; no disease transmission has been reported.

According to Daines, New York is the only state that requires providers to undergo infection control training every four years, and imposes strict infection prevention requirements in hospitals and at outpatient clinics performing surgeries. Nevertheless, five hepatitis C and hepatitis B outbreaks in New York have been caused by poor infection control since 2001, he said.


Source: Newsday (Melville):: Ridgely Ochs; Courtesy of the CDC National Center for HIV, STD, and TB Prevention