Burkholderia cepacia complex Infections in Multiple States Associated with Contaminated Ultrasound Gel

 

To: Facility Administrators, IPs, Medical Professionals   From: CDPHE Healthcare-Associated Infections and Antimicrobial Resistance Program   Background information Centers for Disease Control and Prevention (CDC) is assisting the Food and Drug Administration (FDA) and several state and local health departments with an ongoing investigation of Burkholderia cepacia complex (Bcc) infections in healthcare facilities. On August 4, 2021, CDC issued a notification regarding Bcc infections associated with the use of MediChoice® M500812 ultrasound gel. As of August 4, 2021, preliminary testing indicates the presence of Burkholderia stabilis, a member of Bcc, in four lots of unopened bottles of MediChoice® M500812 ultrasound gel (Lot # B031, B040, B048, B055). These B. stabilis product isolates genetically match B. stabilis isolates obtained from at least 15 patients across multiple states. Additional laboratory testing of isolates or specimens from patients with reported Bcc infections and of additional lots of MediChoice® M500812 ultrasound gel is currently underway.   The source(s) of the bacterial contamination is currently unknown and is under investigation. The effects of B. stabilis (and Bcc) infection on people vary widely, ranging from no symptoms to serious infections. Bcc bloodstream infections may result in sepsis and potentially death. Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure, or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance. Procedures could include ultrasound-guided placement of central and peripheral intravenous catheters and transcutaneous procedures including amniocentesis, paracentesis, and biliary drainage. While sporadic cases of Bcc infection are not a public health reportable condition in Colorado, cases of any condition associated with an outbreak are reportable to public health.   Recommendations / guidance As of August 4, 2021, the manufacturer of MediChoice®M500812 ultrasound gel (Eco-Med Pharmaceutical, Etobicoke, ON, Canada) has issued a recall of Eco-Gel 200® ultrasound gel (also labeled as MediChoice® M500812, among others) with lots: B029, B030, B031, B032, B040, B041, B048, B055. The lot numbers are identifiable on all labels on the cases and bottles. The manufacturer is instructing all health care facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med. Additionally, Eco-Med is instructing all health care facilities to immediately stop use and quarantine all bottles, regardless of lot, of the following ultrasound gels distributed under the brand names listed here: https://eco-med.com/wp-content/uploads//2021/08/Eco-Med_Recall-Communication_08-04-21.pdf. The Eco-Med product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and are not indicated for sterile procedures. Please refer to https://eco-med.com/wp-content/uploads//2021/08/Eco-Med_Recall-Communication_08-04-21.pdf for additional information.   CDC advises that health care facilities always use single-use, sterile ultrasound gel packets for ultrasonography used in preparation for or during transcutaneous procedures, such as placement of central and peripheral intravenous lines, amniocentesis, and paracentesis. This includes avoiding use of bottles of nonsterile ultrasound gel for visualization prior to such procedures (e.g., vein marking, visualizing ascites). Prior to performing a sterile procedure, ensure thorough skin preparation and antisepsis, especially if a non-sterile ultrasound gel is used before [1]. Health care facilities should also review facility practices related to ultrasound probe reprocessing to ensure they are aligned with manufacturer’s instructions for use and appropriate professional society guidelines [2].   If a healthcare facility identifies contaminated gel that was used at their facility, thoroughly clean and disinfect all storage and surrounding surfaces and items that may have come in contact with the gel (e.g., consoles, warmers, shelves, drawers). Standard EPA-approved hospital-grade disinfectants are effective against Bcc. Follow manufacturer’s instructions for use for cleaning and disinfection of all medical devices and equipment.   Reporting   Health care facilities and providers should report any Bcc or Burkholderia species infections related to the use of contaminated ultrasound gel to CDPHE via email: marlee.barton@state.co.us.   Health care facilities should report any patient infections related to the use of potentially contaminated medical products to FDA’s MedWatch Adverse Event Reporting program at https://www.fda.gov/safety/medwatch-fda-safetyinformation-and-adverse-event-reporting-program.   Further information 1. Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. Healthcare Infection Control Practices Advisory Committee (HICPAC). CDC. Available at: https://www.cdc.gov/hai/pdfs/bsi-guidelines-2011.pdf 2. Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as well as Safe Handling and Use of Ultrasound Coupling Gel. American Institute of Ultrasound in Medicine. AIUM; Cited 05 August 2021. Available at: https://www.aium.org/officialstatements/57 CDPHE Contact Information   Marlee Barton, Healthcare-Associated Infections/Antimicrobial Resistance Prevention and Response Epidemiologist marlee.barton@state.co.us   CDPHE Communicable Disease Number: 303-692-2700 or 303-370-9395 (after hours)