Recommendations

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.

Background

The FDA recently received information from the CDC indicating that unopened bottles of nonsterile, multiuse ultrasound gel, manufactured by Eco-Med, tested positive for Bcc. While investigating this issue, the FDA independently confirmed that distributed product tested positive for bacterial contamination.

The effects of Bcc range from no symptoms to serious infections, including bloodstream infections that may result in sepsis or death.

To date, the use of Eco-Med ultrasound gels has been associated with at least 66 infections, including 60 bloodstream infections. Additional possible infections may have been associated with the use of Eco-Med ultrasound gels.

Potential routes of transmission leading to bloodstream infections associated with a contaminated non-sterile ultrasound gel may include:

• Use of the gel for visualization prior to, in preparation for, or during an invasive procedure, where instruments are introduced into the patient’s body, or
• Application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance

FDA Actions

The FDA is working to ensure that health care providers, health care facility risk managers, and procurement staff are notified to immediately stop using and to discard all ultrasound gel and lotion products manufactured by Eco-Med, due to the risk of Bcc bacterial contamination in products other than those included in Eco-Med’s recall. Since the FDA understands Eco-Med has shut down operations, the FDA is working directly with distributors to follow through with the recall. Due to the high level of the risk posed by the contaminated product, FDA is classifying the recall as Class I. FDA laboratories are also testing product samples to determine the extent of the contamination.

The FDA is monitoring imports of ultrasound gels and lotions manufactured by Eco-Med to prevent contaminated product from entering into the United States.

The FDA is working with the CDC and state and local health departments to evaluate the extent of contaminated products from Eco-Med and will continue to keep facilities, health care providers, and the public informed as new or additional information becomes available.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Eco-Med ultrasound gels or lotions.

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Additional Resources:

• CDC Outbreak and Patient Notification: Multistate Outbreak of Burkholderia cepacia Infections Associated with Contaminated Ultrasound Gel
• 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.
• All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).