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Published on: May 4, 2018
Pseudomonas aeruginosa contamination of mouth swabs during production causing a major outbreak
Bjørn G Iversen1, Hanne-Merete Eriksen, Gjermund Bø
1Division of Infectious Disease Control, Norwegian Institute of Public Health, Oslo, Norway. bjiv@fhi.no
Background:
In 2002 we investigated an outbreak comprising 231 patients in Norway, caused by Pseudomonas aeruginosa and linked to the use of contaminated mouth swabs called Dent-O-Sept. Here we describe the extent of contamination of the swabs, and identify critical points in the production process that made the contamination possible, in order to prevent future outbreaks.
Methods:
Environmental investigation with microbiological examination of production, ingredients and product, molecular typing of bacteria and a system audit of production.
Results:
Of the 1565 swabs examined from 149 different production batches the outbreak strain of P. aeruginosa was detected in 76 swabs from 12 batches produced in 2001 and 2002. In total more than 250 swabs were contaminated with one or more microbial species. P. aeruginosa was detected from different spots along the production line. The audit revealed serious breeches of production regulations. Health care institutions reported non-proper use of the swabs and weaknesses in their purchasing systems.
Conclusion:
Biofilm formation in the wet part of the production is the most plausible explanation for the continuous contamination of the swabs with P. aeruginosa over a period of at least 30 weeks. When not abiding to production regulations fatal consequences for the users may ensue. For the most vulnerable patient groups only documented quality-controlled, high-level disinfected products and items should be used in the oropharynx.
Insights
Contaminated mouth swabs caused a Pseudomonas aeruginosa outbreak in Norway. Biofilm formation in production led to widespread contamination, highlighting the need for strict adherence to regulations to prevent patient harm.
Area of Science:
- Microbiology
- Infectious Disease Epidemiology
- Public Health
Background:
- An outbreak in 2002 involving 231 patients in Norway was linked to Pseudomonas aeruginosa in contaminated mouth swabs (Dent-O-Sept).
- This study investigates the extent of swab contamination and identifies critical production failures contributing to the outbreak.
Purpose of the Study:
- To determine the level of microbial contamination in Dent-O-Sept mouth swabs.
- To identify critical control points in the manufacturing process that allowed for contamination.
- To provide recommendations for preventing future outbreaks.
Main Methods:
- Environmental investigation including microbiological examination of production, ingredients, and the final product.
- Molecular typing of bacterial isolates to confirm strain identity.
- A system audit of the production process and review of healthcare institution practices.
Main Results:
- Pseudomonas aeruginosa (P. aeruginosa) outbreak strain found in 76 of 1565 swabs from 12 batches produced in 2001-2002.
- Over 250 swabs showed contamination with various microbial species.
- Production audit revealed significant breaches of regulations; healthcare facilities reported improper swab usage and purchasing weaknesses.
Conclusions:
- Biofilm formation in the wet sections of the production line is the likely cause of continuous P. aeruginosa contamination for at least 30 weeks.
- Failure to adhere to production regulations can lead to severe patient consequences.
- High-level disinfected, quality-controlled products are essential for vulnerable patients receiving oropharyngeal care.
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