Association ofBacillus cereusInfection with Contaminated Alcohol Prep Pads

Abstract

Background.Bacillusspecies have caused healthcare-associated outbreaks of invasive disease as well as pseudo-outbreaks. We report an outbreak investigation of blood cultures positive forBacillus cereusassociated with alcohol prep pads (APPs) contaminated withB. cereusandBacillusspecies resulting in a rapid internal product recall and subsequent international product recall.Design.Epidemiologic and microbiologic outbreak investigation.Setting.A 300-bed tertiary care children's hospital in Aurora, Colorado.Patients.Patients with blood or cerebrospinal fluid cultures positive forB. cereus.Methods.Three patients with blood cultures positive forB. cereuswere identified in late 2010. Breaches in procedural and surgical techniques, common interventions, and products were explored. The following 3 common products were cultured: sterile saline syringes, chlorhexidine/alcohol skin preparation solution, and APPs. Repetitive sequence-based polymerase chain reaction (Rep-PCR) was used to compare isolates obtained from patients and from APPs and was confirmed by independent pulsed-field gel electrophoresis.Results.There appeared to be a significant increase in blood cultures positive forB. cereusduring 2009-2010.B. cereusand otherBacillusspecies were cultured from the internal contents of 63.3% of APPs not labeled as sterile, and 8 of the 10 positive lots were manufactured after 2007. None of the isolates obtained from the patients matched strains isolated from the APPs. However, some lots of APPs had strains that were indistinguishable from one another.Conclusions.APPs that were not labeled as sterile were contaminated withBacillusspecies. The product was immediately recalled internally and replaced with APPs from another manufacturer that were labeled as sterile. On January 3, 2011, the manufacturer voluntarily recalled its APPs. Healthcare facilities, healthcare providers, and users of APPs should avoid the use of APPs not specifically labeled as sterile.