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Delaware Health Alert Network #454

August 6, 2021 8:59 am


Health Update
UPDATES ON BCC INFECTIONS IN HEALTH CARE FACILITIES

The Delaware Division of Public Health (DPH) is issuing this health update to provide the health care community with additional information regarding reports of Burkholderia cepacia complex (Bcc) infections in health care facilities. Patients have developed Bcc infections, including bloodstream infections, after having undergone ultrasound-guided procedures in which MediChoice® M500812 ultrasound gel was used.

Summary

The Company, Eco-Med Pharmaceuticals, Inc. commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination.

The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not indicated for sterile procedures.

Background

On August 4, 2021, the company Eco-Med Pharmaceuticals commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. As of August 4, 2021, Eco-Med has additionally initiated quarantine due to bacterial contamination in the affected lots of ultrasound gel with Bcc. The source(s) of the bacterial contamination is currently unknown. Eco-Med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action.

The effects of the bacteria, Burkholderia stabilis, a member of the Bcc, vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and in certain cases, potentially death. Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections. Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing. 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.

Delaware does not have any cases of Bcc linked to ultrasound gels at this time.

Recommendations

Eco-Med is instructing facilities to immediately stop use and quarantine all lots of the following ultrasound gels distributed under recalled brand names. Please refer to https://eco-med.com/recall/ for additional information, including a list of the brand names.

Additionally, 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 nonsterile ultrasound gel for visualization prior to such procedures. 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

 

Reporting

Bcc is not a reportable disease in Delaware, however, health care providers are strongly encouraged to report suspected cases associated to the use of recalled ultrasound gels. Promptly report suspected cases of Bcc to the DPH Office of Infectious Disease Epidemiology (OIDE) at 302-744-4990 (normal business hours) or 1-888-295-5156 (outside of normal business hours), fax to 302-223-1540, or email to reportdisease@delaware.gov. Reporting enables appropriate public health follow-up for your patients, helps identify outbreaks, and provides a better understanding of disease trends in Delaware.

Additional Information/Resources

Facilities impacted by this recall should visit https://eco-med.com/recall/ and complete the form indicating the product and the lots/batch numbers identified and actions taken in the comment section.

The official notice of the recall can be found at https://eco-med.com/recall/External Link Disclaimer.


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  • Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
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