Warning as 7 patients infected with gel contaminated with life-threatening bacteria during routine NHS procedure
SEVEN patients, two of whom were critically ill, have been infected with a contaminated gel during NHS procedures.
The patients across four regions in the UK were found to be infected with burkholderia stabilis, the said.
They had been exposed to contaminated ultrasound gel.
Ultrasound gel can become contaminated during manufacturing or after opening if not properly stored.
If used in invasive procedures on broken skin, for example, burkholderia stabilis can enter the body and cause infections.
This includes respiratory, urinary tract, skin and bloodstream (sepsis) infections.
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It can lead to outbreaks with potentially fatal consequences, especially in ICU settings or in patients with weakened immune systems or chronic lung conditions like cystic fibrosis.
The cases occurred in England between July and October 2024 in patients aged between 11 and 79 years. Four of them were male.
Five out of seven of the patients had exposure to the ultrasound gel.
And two cases were considered to have "clinically significant infections" from the bacteria, meaning an infection that is severe enough to cause noticeable symptoms, require medical treatment, or potentially lead to complications in a patient's health.
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Both serious cases were already critically ill before the infection, according to UKHSA.
The bacteria was found in both opened and unopened bottles of non-sterile ultrasound gel.
The hospital and healthcare settings impacted have not been named.
The manufacturer of the ultrasound gel issued a voluntary recall on October 17, 2024 due to risk of Burkholderia stabilis contamination.
The recall was then expanded twice - in November 7, 2024 to include a second lot of the same product, and in December 20, 2024 to include multiple lots of two additional non-sterile ultrasound gel products.
Since October 2, 2024, no new cases have been reported, and the UKHSA continues to monitor for new cases.
Health officials have issued a warning about the appropriate use of ultrasound gel and its potential risks.
Guidelines for safe ultrasound gel use in healthcare settings have since been updated.
Dr Sarah Milligan, Consultant in Public Health at UKHSA, said: “In 2024, UKHSA investigated a small number of cases of Burkholderia stabilis in hospitals in England.
"Our investigations identified a particular brand of ultrasound gel used within the NHS and some other settings.
"This product was recalled and there is no need to stop routine use of ultrasound gel.
"We are reiterating our infection prevention control guidance to healthcare professionals when using ultrasound gel and UKHSA continues to work with the NHS and MHRA to assess and address risks to ensure patient safety.”
Previous outbreaks
In December 2020, Public Health England identified a cluster of Burkholderia contaminans cases across multiple hospitals.
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The investigation revealed that a single brand of non-sterile ultrasound gel was the contamination source.
In 2022, the Centers for Disease Control and Prevention (CDC) identified 119 Burkholderia stabilis infections in 10 US states, which led to a recall of all ultrasound gel products from Eco-Med Pharmaceutical.
What is ultrasound gel used for?
Ultrasound gel is used to improve the transmission of ultrasound waves through the body during medical imaging procedures.
It's also known as ultrasound coupling gel or sonographic gel.
While many people will be familiar with the use of ultrasound for pregnancies, it's also used for ultrasound-guided intravenous (IV) line insertion, a procedure that uses ultrasound to help guide a needle into a vein.
It's often used when it's difficult to insert an IV using traditional methods.
There are a number of ultrasound procedures where ultrasound gel is used, including:
- Abdominal organs - to image the liver, kidneys, and other organs in the abdomen.
- Heart - to view the heart and blood flow through it.
- Musculoskeletal system - to assess joint inflammation, muscle tears, and tendon weakness.
- Breast - to examine breast tissue and lumps.
- Thyroid - to check the thyroid gland.
- Genital and prostate problems - to find problems in the genitals and prostate.
- Bone disease - to evaluate metabolic bone disease and assess bone fragility.
- Kidney stones - to pinpoint the location of a kidney stone and break it into smaller pieces.
- Pregnancy - to monitor the growth and development of the fetus, including the fetal heart rate.