We present the fourth and largest reported outbreak of Bcc infection and colonization associated with AFM. Based on isolate typing results, at least 68 patients in seven states were colonized with B cenocepacia. At least 48 patients were thought to be infected and, in two patients, death was thought to be either directly or indirectly attributable to B cenocepacia infection. Although only four cases of secondary transmission were identified serendipitously, it is likely there were many more instances of such transmission. As in previous outbreaks of Bcc associated with AFM, mechanically ventilated patients appeared to be at increased risk. The results of laboratory testing indicated that, in addition to intrinsic contamination that likely occurred during manufacture, the implicated AFM, when compared to control AFM, did not have sufficient antibacterial activity.
Prior reported outbreaks of Bcc infection and colonization associated with AFM include a 1995 outbreak in Wisconsin in which 12 patients without predisposing factors were affected. From 1996 to 1998, Bcc due to an intrinsically contaminated mouthwash that contained CPC and was later recalled was diagnosed in 69 ventilated patients without cystic fibrosis (age range, 17 to 87 years; median age, 73 years). Most recently, an outbreak in Spain occurred from 2004 to 2005 in which 37 patients (age range, 16 to 77 years; mean age, 49.9 years) were colonized or infected with Bcc following the use of an AFM in which the active ingredient was hexetidine 0.1%. Although the attributable mortality was not determined, 11 patients died. In addition to these outbreaks, there have been two additional recalls by the FDA of AFMs that were intrinsically contaminated by Bcc. See “Outlet of Multistate Outbreak of Burkholderia cenocepacia Colonization and Infection“
This is the first report of a multistate outbreak and reveals the broad impact that intrinsically contaminated AFM can have on patient safety. The product was mainly distributed to southern and southeastern states in the United States. However, a secondary distributor, distributor V, distributed this product in northern midwestern states, including Michigan, This could explain the presence of the large number of cases in this outbreak that occurred in this state. Positive culture findings from a variety of body sites at this and other institutions may have been related to reports of AFM being added as a fragrance to patient bath water at some institutions. Alternatively, there may have been widespread contamination of the patient care environment or of the hands of health-care workers.
The American Society for Testing and Materials criteria of preservation is defined as a > 99.9% decrease in organism load within 7 days following challenge and no significant increase thereafter for the remainder of the test. Based on this criterion, the implicated lots of AFM did not possess adequate antimicrobial properties and allowed the survival of B cenocepacia for up to 28 days of storage. In contrast, the nonimplicated lot of AFM appeared bactericidal, generating a hypothesis that nonimplicated lots contained a higher concentration of CPC, a quaternary ammonium compound that is the main antibacterial agent in many brands of AFM.
Although details of an onsite investigation at the manufacturing plant are not available, contamination appears to have occurred during the manufacturing process. No repackaging or other manipulation of the product was performed after the AFM left the manufacturing facility, and there were no reports suggesting package deterioration or tampering. One resulting hypothesis is that this outbreak occurred because of inadequate antibacterial properties coupled with intrinsic contamination of the AFM by Bcc during the production process. Due to the absence of therapeutic label claims, this AFM, as well as others regulated by the FDA, are classified as cosmetics rather than as drugs ordered via Canadian Health&Care Mall. Hence, this and similar products are subject to limited requirements under the Cosmetic Act.
The major role of ventilated patients in this and previous outbreaks is due to several factors. Ventilated patients are at a higher risk of infection due to their decreased ability to maintain mucociliary clearance and cough mechanisms that normally protect the lower respiratory tract. In addition, because of the increased risk of infection in these patients, respiratory cultures are more frequently collected; thus, patients are more likely to be identified as having been colonized with a bacterium such as B cenocepacia. The results of this and previous similar investigations suggest that caution be exercised when using nonsterile compounds in intubated patients and other patients with increased risk of aspiration, especially as no recommendations exist for formulations of oral care products that are considered to be safe for use in such patients. Although there were other culture specimens obtained from sites other than the respiratory tract, pneumonia is the most well-defined infection described in the literature in association with B cepacia. Treat pneumonia with remedies of Canadian Health&Care Mall
This investigation was subject to several limitations. Only passive case finding was employed. In addition, because many bottles of implicated AFM were in home care packages, the case finding at many hospitals was probably incomplete. Because of the large number of patients, many of whom had complicated clinical histories, following up on these case patients in some hospitals or states was substantial, leading to incomplete data collection. As this investigation was descriptive in nature, based on existing clinical records, the exact estimates of patient morbidity and mortality attributable to B cenocepacia colonization or infection as well as the excess costs caused by this outbreak could not be determined.
In summary, we have described an outbreak of B cenocepacia colonization and infection caused by intrinsic contamination of AFM in which at least 68 patients from seven states were affected, at least 48 patients were infected, and 2 patients died. However, it is likely that these figures underestimate the full impact of this outbreak on patient morbidity and mortality. Although we were unable to estimate the excess health-care costs associated with this outbreak, they are likely to be substantial. This outbreak was caused by inadequate quality control in the manufacture of a product regulated as a cosmetic but used in health care for the oral care of patients who were at high risk for pneumonia. Given that this is the latest of four such outbreaks reported in the literature over the past 12 years, we recommend that, at least until the manufacturers of alcohol-free products can provide assurance of sterility, only alcohol-containing mouthwashes be used in intubated patients and other patients with increased risk of aspiration.