TGA advises of possible saline contamination

Monday, 04 December, 2023

TGA advises of possible saline contamination

The TGA has advised it is aware of Ralstonia pickettii cases in hospital patients across multiple Australian states and territories. Though R. pickettii, a bacteria commonly found in the natural environment, rarely causes infection in humans, it may cause infection in people with weakened immune systems. In healthcare settings, it has been associated with contamination of medical products like saline solutions.

The recent Australian outbreak, which resulted in one death in Queensland, has been linked to contaminated saline.

Associate Professor Rietie Venter, Head of Microbiology at the University of South Australia, said the outbreak of infections in Queensland hospitals that are linked to contaminated sterile saline is particularly worrying as a sterile product should not contain any microbes. “There are rigorous tests that need to be done to confirm that a product is indeed sterile (absence of any microbes) before any pharmaceutical product can be sold as sterile,” Venter said.

“Products such as saline need to be sterile as it is used to dilute medications that will be injected directly into a patient’s bloodstream. This [outbreak] means that the medication (and the microbe) has bypassed many of our natural defences against disease-causing bugs,” she added.

On 24 November, the TGA initiated a nationwide quarantine for some Interpharma saline products to minimise possible risk to patients. This decision was made after its investigation identified that some batches of these products were likely to have been used in a cluster of patients who tested positive for R. pickettii.

The link between these cases and the Interpharma products has not yet been confirmed and therefore the goods have not been recalled from the market at this time.

Associate Professor Naomi Hammond, Program Head of the Critical Care Program at The George Institute for Global Health and Associate Professor in the Faculty of Medicine at The University of New South Wales, said that while contamination of sterile products with bacteria was an extremely rare event, health teams should be on the alert for any signs of infection, because it can lead to sepsis.

“Sepsis is a medical emergency and occurs when an infection triggers a chain reaction throughout the body, which can lead to organ failure and even death. Signs for patients and carers to be aware of include a rapid heart rate, a weak pulse, fever, shivering, feeling very unwell, shortness of breath, confusion and disorientation, extreme pain or low urine output,” Hammond said.

“If someone has any of these signs and has recently had an intravenous fluid drip or a wound cleaned, they should seek immediate medical advice.”

As of 28 November 2023, the TGA quarantine affected three products on the Australian Register of Therapeutic Goods (ARTG):

  • Sodium Chloride 0.9% 10 ml ampoules (AUST R 235989)
    • Batch numbers 2304400, 301530, 2301531, 2207874
  • Sodium Chloride 0.9% 30 ml ampoules (ARTG entries 370471 and 370408)
    • All batches.

As the sponsor of these products, Interpharma Pty Ltd is working with the TGA as part of the investigation.

The TGA will publish updates as new information becomes available.

Image credit: Kongkaew

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