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Outbreak Investigation Highlights Drug Safety Issues

Noncompliance with manufacturing regulations led to contaminated syringes, report says

TUESDAY, Oct. 13 (HealthDay News) -- An outbreak of bloodstream infections in the United States a few years ago was caused by contamination of pre-filled heparin and saline syringes made by a company that wasn't following safety regulations, according to a new report that identified areas in medical monitoring systems that need to be improved.

Between October 2007 and February 2008, 162 bloodstream infections caused by the bacteria Serratia marcescens were reported at health-care facilities in nine states. An investigation traced the problem to pre-filled syringes from a single manufacturer.

"Close collaboration among federal agencies, public health authorities and clinicians was critical to the identification of the cause of this outbreak," wrote Dr. David Blossom, of the U.S. Centers for Disease Control and Prevention, and colleagues.

An inspection of the company's manufacturing facility revealed poor compliance with the U.S. Food and Drug Administration's Good Manufacturing Practices and quality system regulations. A few days after the inspection, the company stopped making medical products, the authors of the report noted.

"In the course of the investigation, we also identified several challenges to medical product tracking that should be addressed promptly so that disease outbreaks caused by exposure to contaminated medications can be dealt with more efficiently in the future," Blossom and colleagues wrote.

For example, none of the syringes had the manufacturer's name on the label, which instead had the names of subsidiaries or different companies. A large number of distributors acted as middlemen between the maker and the health-care facilities that used the contaminated syringes.

The report appears in the Oct. 12 issue of the Archives of Internal Medicine.

In an accompanying editorial, one expert called for improvements in the FDA's ability to monitor drug safety in the United States.

"We simply must, as a nation, recognize that we cannot reverse this trend toward globalization, that the solution to a safe drug supply is a strong FDA, not reliance on foreign governments," wrote former FDA associate commissioner William K. Hubbard. He called for increased funding and staffing for the FDA.

More information

The U.S. Food and Drug Administration has more about drug safety.

SOURCE: JAMA/Archives journals, news release, Oct. 12, 2009

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