Chicago, IL—Infection control researchers investigating a rare bacterial outbreak of Burholderia cepacia complex (Bcc) identified contaminated nasal spray as the root cause of the infections, leading to a national recall of the product. An article in the August issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America (SHEA), describes how researchers were able to trace the outbreak back to the nasal decongestant spray.
Bcc is a group of Gram-negative bacteria that can cause hard-to-treat infections. Patients with underlying medical conditions such as lung disease and weakened immune systems are at greater risk of contracting Bcc. When patients in a Denver children's hospital began testing positive for the bacteria in 2003, investigators suspected that a batch of Major Twice-a-Day Nasal Spray, a brand that each of the patients had used, might be to blame. However, standard tests of the spray did not find any bacteria initially.
Noticing some peculiarities in the initial tests, the investigators decided to retest the spray using a non-standard culture medium. The second set of tests was positive for Bcc, the same strain as was identified in patients. The nasal spray contained a preservative agent that can interfere with standard bacterial cultures and the second set of tests neutralized the preservative, allowing the detection of the bacteria.
The spray was voluntarily recalled by the manufacturer, but the findings raise lingering questions about how manufacturers should test nasal spray products before distribution. "If standard culturing methods were used by the manufacturer then they may not have [discovered] this organism," the researchers write.
"Nasal spray products are among the most widely used over-the-counter pharmaceuticals, but to date they are not required by the FDA to be sterile," said Susan Dolan, one of the article's authors. "Given the implications of Bcc infections we question this decision."
Other products, such as mouthwash, nebulization therapy, tap water, disinfectants, and reusable temperature probes have previously been implicated as Bcc outbreak sources.
Susan A. Dolan, Elaine Dowell, John LiPuma, Sondra Valdez, Kenny Chan, and John F. James, "An Outbreak of Burkholderia cepacia Complex Associated with Intrinsically Contaminated Nasal Spray." Infection Control and Hospital Epidemiology 32:8 (August 2011).
Infection Control and Hospital Epidemiology provides original, peer-reviewed scientific articles for anyone involved with an infection control or epidemiology program in a hospital or healthcare facility. The journal is ranked in the top 20 Public, Environmental & Occupation Health Journals globally in the latest Journal Citation Reports from Thomson Reuters. It is published by a partnership between The Society of Healthcare Epidemiology of America and The University of Chicago Press.
SHEA is a professional society representing more than 1,900 physicians and other healthcare professionals around the world with expertise in healthcare epidemiology and infection prevention and control. SHEA's mission is to prevent and control healthcare-associated infections and advance the field of healthcare epidemiology. The society leads this field by promoting science and research and providing high-quality education and training in epidemiologic methods and prevention strategies. SHEA upholds the value and critical contributions of healthcare epidemiology to improving patient care and healthcare worker safety in all healthcare settings. www.shea-online.org
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