UPDATE: 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 Food and Drug Administration (FDA) and several state and local health departments with an ongoing investigation of Burkholderia cepacia complex (Bcc) infections in health care facilities. On August 4, 2021, Eco-Med initiated a voluntary recall of EcoGel 200 Ultrasound Gel due to risk of bacterial contamination. At that time, CDC issued a notification that the same strain of Burkholderia stabilis had been isolated from 15 patients and four lots of unopened MediChoice® M500812 ultrasound gel. Upon further investigation, CDC is aware of at least 59 patients in six states with Burkholderia stabilis infection with the matching strain. At least 48 of these cases are bloodstream infections, and many had undergone ultrasound-guided procedures prior to their infections. No cases have been reported in Colorado. FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.    On August 18, 2021, FDA requested health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., due to risk of bacterial contamination with Burkholderia cepacia complex. Please refer to the website below for full details on the announcement including a list of Eco-Med ultrasound gel products and lotions. https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health?utm_medium=email&utm_source=govdelivery    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 The FDA recommends that health care providers and facilities: Immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med. Do not purchase ultrasound gels or lotions manufactured by Eco-Med. Consult Centers for Disease Control and Prevention (CDC) and professional society guidelines regarding use of ultrasound gel and appropriate ultrasound cleaning procedures (see Additional Resources). Contact the distributor that supplied these products to you if you have questions about the disposal of the products. Report any adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda    CDC advises that health care facilities should 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 non-sterile ultrasound gel for visualization prior to such procedures (e.g., vein marking, visualizing ascites). 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. Health care facilities should completely clean and appropriately disinfect ultrasound devices and any warming devices that may have had contact with the product after removing the potentially contaminated ultrasound gel from use in the facility. 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 CDC. Multistate Outbreak of Burkholderia cepacia Infections Associated with Contaminated Ultrasound Gel: https://www.cdc.gov/hai/outbreaks/b-cepacia-ultrasound-gel/index.html    FDA. Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers. https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health?utm_medium=email&utm_source=govdelivery    Eco Med Recall: https://eco-med.com/recall/    FDA. MedWatch: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda    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)