Notes from the Field: Contamination of Alcohol Prep Pads with Bacillus cereus Group and Bacillus Species --- Colorado, 2010

In October 2010, a child at The Children's Hospital (TCH) in Aurora, Colorado, with newly diagnosed leukemia developed clinical sepsis 24 hours after insertion of an implanted vascular access device. The child also developed extensive cellulitis at the insertion site, requiring surgical debridement, intensive care, antibiotics, prolonged wound management, and outpatient treatment. Cultures of the child's blood and tissue specimens grew Bacillus cereus. An investigation found neither breach of infection control procedures nor any violations of sterile surgical technique.

In November 2010, an afebrile infant with congenital heart disease was admitted to TCH for respiratory distress and developed fever and became clinically septic 4 days after an internal jugular line was placed. Four blood cultures from the infant grew B. cereus. The line was removed, and the infant had an extended hospital stay for treatment with intravenous antibiotics before being discharged.

The subsequent TCH investigation into the two cases focused on the following three single-use, disposable items used in the treatment of both patients: 1) sterile syringes prefilled with sterile saline solution, 2) sterile applicators packaged with a 2% chlorhexidine gluconate/70% alcohol solution for skin preparation, and 3) pledgets packaged with 70% isopropyl alcohol (alcohol prep pads [APPs]). The APPs were not labeled as either sterile or nonsterile on the outside of the individual APP packages or the box the APPs were contained in. Bacterial cultures of samples from three saline syringes and the liquid and pads from nine packages of chlorhexidine gluconate/alcohol skin preparation applicators were negative. The internal alcohol pads from 60 APPs, obtained from various locations around TCH, also were cultured. Hospital investigators found that 40 of 60 pads, representing eight of 10 different manufacturing lots, yielded B. cereus or Bacillus spp. All of the pads were supplied by a single manufacturer. TCH contacted the Colorado Department of Public Health and Environment, which notified CDC and the Food and Drug Administration and performed confirmatory testing of TCH laboratory findings.

Twenty-nine B. cereus isolates, 21 from cultured APPs and eight from TCH patients with positive cultures during May--November 2010, were characterized by pulsed-field gel electrophoresis. Wide diversity was observed among the isolates, and no patient isolates matched APP isolates. Given this diversity and the time lapse between positive patient specimens and subsequent APP sampling, the lack of a match between the two groups was not considered to rule out APPs as the source of the B. cereus isolated from patients.

APPs are supplied both as sterile and nonsterile products. Sterile products are clearly labeled as such and should not be mistaken and/or interchanged for nonsterile products. B. cereus group and Bacillus species are resistant to killing by alcohol (1) and have caused health-care--associated outbreaks of invasive disease (2,3). Pseudoinfections caused by B. cereus--contaminated products also have been reported (4). Health-care facilities, health-care providers, and users of APPs should know whether the APPs in clinical use are sterile or nonsterile and be aware of the risk for iatrogenic infection if nonsterile APPs are used. Manufacturers should know the importance of clearly labeling their products as sterile or nonsterile to avoid misuse by health-care facilities and health-care providers.

Based on the findings in this investigation, on November 19, TCH halted any use of nonsterile APPs and began using sterile APPs exclusively from another manufacturer. In January 2011, the manufacturer voluntarily recalled all of its alcohol wipe products because of potential contamination (5).

Reported by

SA Dolan, MS, E Dowell, C Littlehorn, MP Glode, MD, JK Todd, MD, The Children's Hospital, Univ of Colorado School of Medicine, Aurora, Colorado; W Bamberg, MD, MK Cichon, Colorado Dept of Public Health and Environment.

References

1. Hsueh PR, Teng LJ, Yang PC, Pan HL, Ho SW, Luh KT. Nosocomial pseudoepidemic caused by Bacillus cereus traced to contaminated ethyl alcohol from a liquor factory. J Clin Microbiol 1999;37:2280--4.
2. Bryce EA, Smith JA, Tweeddale M, Andruschak BJ, Maxwell MR. Dissemination of Bacillus cereus in an intensive care unit. Infect Control Hosp Epidemiol 1993;14:459--62.
3. Meites E, Taur Y, Marino L, et al. Investigation of increased rates of isolation of Bacillus species. Infect Control Hosp Epidemiol 2010;31:1257--63.
4. Berger SA. Pseudobacteremia due to contaminated alcohol swabs. J Clin Microbiol 1983;18:974--5.
5. Food and Drug Administration. Triad Group issues a voluntary nationwide recall of all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks due to potential microbial contamination. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2011. Available at http://www.fda.gov/safety/recalls/ucm239219.htm. Accessed March 3, 2011.