In under the microscope
By Rodney E . Rohde , PhD , MS , SM ( ASCP ) CM SVCM , MBCM , FACSc
Burkholderia cepacia Complex Triggers Recall
September column , I discussed B . pseudomallei and the recent outbreak in four states . This genus , Burkholderia , unfortunately packs quite a punch with several species . A member of the Proteobacteria , its pathogenic members include a diverse group of species responsible for several dangerous and often deadly infections .
For our medical laboratory professionals , it can be difficult to isolate and differentiate in the typical clinical microbiology laboratory , which sometimes leads to issues of misidentification or other laboratory tests to assist in understanding the case . Finally , like many other groups of bacteria that I have written about this genus can create biofilms , which interact with environmental and human surfaces . Biofilms play a significant role in mediating cell-to-cell communication . During this type of interaction , bacteria release protein toxins in the environment . Cells with a corresponding protective protein ( usually bacteria of the same strain ) are not inhibited to grow or die . Lastly , recipient cells with the corresponding protein undergo gene expression changes and phenotype , which augments biofilm communities . Importantly , even if the recipient cell was not of the same bacterial strain this can happen showing the critical importance this genus can have in the environment . Ultimately , biofilms create “ persister ” cells , which can share antimicrobial resistance and other factors detrimental to human health .
In this column , I will focus on the B . cepacia complex ( Bcc ) as it relates to outbreaks as a dangerous contaminant in water-based pharmaceutical products .
BCC and water-based products
On July 7 , 2021 , the Food and Drug Administration ( FDA ) advised drug manufacturers of non-sterile , water-based drug products that Burkholderia cepacia complex ( Bcc or B . cepacia ) continues to pose a risk of contamination . BCC is a group of Gram-negative bacteria comprising more than 20 species that has been linked to multiple instances of opportunistic infections . For example , Paroex ® Chlorhexidine was recalled in 2020 due to objectionable microbial contamination including the BCC species B . lata . Inadequate design , control , or maintenance of pharmaceutical water systems have led to contamination with BCC and other water-borne opportunistic pathogens .
Multistate Outbreak of Burkholderia cepacia Infections Associated with Contaminated Ultrasound Gel
Following the FDA advisement in July , on Aug . 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 Bcc .
Background via Centers for Disease Control and Prevention ( CDC )
CDC is assisting the FDA and several state and local health departments with ongoing investigations of this issue . Patients have developed Bcc infections , including bloodstream infections , after likely having undergone ultrasound-guided procedures in which MediChoice ® M500812 ultrasound gel was used . This 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 .
As of Aug . 18 , 2021 , CDC is aware of at least 59 patients in six states with Burkholderia stabilis infection . The species strain genetically matches the B . stabilis strain identified in four lots of MediChoice M500812 ultrasound gel . At least 48 cases are bloodstream infections , and many had undergone ultrasound-guided procedures prior to their infections . Ongoing investigations at the local public health level are being conducted to gather additional data on these cases . Recommendations from CDC include :
● All healthcare facilities under manufacturer order should identify the affected products by lot number and immediately destroy or return products . 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 . Refer to
https :// eco-med . com / recall / 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 .
• This includes avoiding use of bottles of nonsterile ultrasound gel for visualization prior to such procedures ( such as 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 Reporting
Rodney E . Rohde , PhD , MS , SM ( ASCP ) CM SVCM , MBCM , FACSc , serves as chair and professor of the Clinical Laboratory Science Program at Texas State University . Follow him on Twitter @ RodneyRohde / @ TXST _ CLS , or on his website : http :// rodneyerohde . wp . txstate . edu /
American Institute of Ultrasound in Medicine ( AIUM ). 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 . March 5 , 2021 . Available at :
https :// www . aium . org / officialstatements / 57