Multistate Outbreak of Burkholderia cepacia Infections Associated with Contaminated Ultrasound Gel
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. Patients have developed Bcc infections, including bloodstream infections, after likely having undergone ultrasound-guided procedures in which MediChoice® M500812 ultrasound gel was used.
MediChoice® M500812 ultrasound gel was likely used to guide ultrasonography in preparation for or during:
- placement of central and peripheral intravenous catheters, and
- transcutaneous procedures, such as paracentesis.
On August 18, 2021, FDA requested healthcare providers, healthcare 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. FDA’s new guidance expands upon Eco-Med’s voluntary recallexternal icon, issued on August 4, 2021, which was limited to several lots of Eco-Gel 200® ultrasound gel. As noted, “FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.” Please refer to FDA’s website for full details on the announcement: Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers | FDAexternal icon.
As of August 18, 2021, CDC is aware of at least 59 patients in 6 states with Burkholderia stabilis infection with a bacterial strain that genetically matches the B. stabilis strain identified in 4 lots of MediChoice M500812 ultrasound gel. At least 48 of these cases are bloodstream infections, and many had undergone ultrasound-guided procedures prior to their infections. CDC is continuing to work with state and local public health partners to obtain additional information on already identified cases. Healthcare facilities are advised to contact the distributor that supplied ultrasound gel products to their facility if they have questions about the disposal of the products. Facilities should report any adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting programexternal icon.
As of August 6, 2021, preliminary testing indicates the presence of Burkholderia stabilis, a member of Bcc, in 4 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 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. Recall Noticeexternal icon
- The manufacturer has advised that all healthcare facilities 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 healthcare facilities to immediately stop use and quarantine all lots of the ultrasound gels distributed under these brand names. pdf icon[PDF – 6 Pages]external icon Please refer to https://eco-med.com/recall/external icon for additional information.
- CDC advises that healthcare 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 nonsterile ultrasound gel for visualization prior to such procedures (e.g., vein marking, visualizing ascites).
- Healthcare 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.
- Healthcare 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.
- Healthcare facilities should report any patient infections related to the use of potentially contaminated medical products to FDA’s MedWatch Adverse Event Reportingexternal icon
- FDA: Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200external icon
- Manufacturer Recall Notice: Eco-med recallexternal icon
- Burkholderia cepacia in Healthcare Settings
- Questions for CDC can be sent to: firstname.lastname@example.org.
- 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; 05 March 2021. [cited 03 August 2021]. Available at: https://www.aium.org/officialstatements/57external icon