Abstract
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.