Outbreak inquiry Highlights Drug Safety Issues

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An outbreak of bloodstream infections in the United States a few years ago was caused by contagion 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 enhanced.

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 inquiry traced the problem to pre-filled syringes from a single manufacturer.

"Close collaboration among federal agencies, public health authorities and clinicians was dangerous 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 exposed poor compliance with the U.S. Food and Drug Administration's Good Manufacturing Practices and quality system regulations. A few days after the scrutiny, the company stopped making medical products, the authors of the report noted.

"In the course of the search, 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 professionally in the future," Blossom and colleagues wrote.

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