The Burkholderia cepacia complex (Bcc) is a group of closely related Gram negative, rod-shaped bacteria that can be found in soil and water. Bcc emerged in the healthcare setting as a significant and transmissible pathogen causing pulmonary infections among pediatric patients with cystic fibrosis.

Bcc can be spread by person-to-person contact, contact with contaminated surfaces, and environmental exposure. Outbreaks have been linked to intrinsic and extrinsic contamination of various products used in healthcare settings. These products usually have an aqueous component or are exposed to tap water. Bcc have intrinsic resistance to antimicrobials and preservatives which enhance their ability to contaminate aqueous products.

Bcc can form biofilms in building water systems, including healthcare facilities and product manufacturing sites.  Contaminated medical products which have led to outbreaks in healthcare facilities include saline flushes, mouthwash, oral liquid docusate, skin cleanser, ultrasound gel, nasal spray, nebulizers, antiseptics, disinfectant solutions, balloon pumps, and temperature probes.

Key Points:

• Maintain a low threshold (e.g., single case or small cluster) for reporting a Bcc outbreak or product concern.

 Featured Resources:

• The FDA MedWatch form is located here: MedWatch Online Voluntary Reporting Form (fda.gov).
• FDA has advised manufacturers of non-sterile, water-based drug products that Bcc continues to pose a risk of contamination. This resource includes a list of best practices for drug manufacturers, which can be helpful when conducting a Bcc contaminated medication investigation.
• Example line list and data collection tool for a Bcc outbreak investigation when a contaminated product is suspected (can be adapted by adjusting the fields to collect the specific case and exposure information relevant to the investigation).
• CDC website: Burkholderia cepacia in Healthcare Settings

Additional Resources:

Review Articles

• This paper by FDA authors reviews the regulatory and scientific impact of Bcc. It includes FDA guidance, manufacturing control measures, and identifies possible points of origin for microbial contamination. https://www.fda.gov/media/81867/download
• This article summarizes Bcc outbreaks and describes the mechanisms behind pharmaceutical product contamination. Burkholderia cepacia Complex Bacteria: a Feared Contamination Risk in Water-Based Pharmaceutical Products. 00139-19.pdf (nih.gov)
• This systematic review summarizes the investigation and control of 111 Bcc healthcare-associated outbreaks. Systematic review of healthcare-associated Burkholderia cepacia complex outbreaks: presentation, causes and outbreak control (nih.gov)

Examples of Outbreaks

• An outbreak due to an intrinsically contaminated non-sterile oral medication: A multistate investigation of health care–associated Burkholderia cepacia complex infections related to liquid docusate sodium contamination, January-October 2016 - ScienceDirect
• An outbreak due to an intrinsically contaminated non-sterile alcohol-free mouthwash: Multistate Outbreak of Burkholderia cenocepacia Colonization and Infection Associated With the Use of Intrinsically Contaminated Alcohol-Free Mouthwash - ScienceDirect
• An outbreak due to extrinsically contaminated multi-dose nebulizers (sterile medical product): An Outbreak of Burkholderia (Formerly Pseudomonas) cepacia Respiratory Tract Colonization and Infection Associated with Nebulized Albuterol Therapy | Annals of Internal Medicine (acpjournals.org)
• An outbreak due to intrinsic contamination of injectable (sterile medical product) saline flushes: Multistate Outbreak of Burkholderia cepacia Complex Bloodstream Infections After Exposure to Contaminated Saline Flush Syringes — United States, 2016–2017 (nih.gov)

An outbreak due to intrinsic contamination of a non-sterile skin cleanser product: Burkholderia cepacia complex outbreak linked to a no-rinse cleansing foam product, United States – 2017–2018 | Epidemiology & Infection | Cambridge Core