Health regulators have stopped short of recalling hospital saline products linked to the death of a patient and the bacterial infections of dozens others.
The Therapeutic Goods Administration has instead ordered the national quarantining of two InterPharma saline products amid fears of contamination, meaning they can remain on shelves in hospitals and health clinics until further notice.
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“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,” the TGA said on Tuesday.
More than 40 patients have been infected with Ralstonia pickettii, a bacteria normally found in soil and water.
One patient, an elderly man, died last week in a private hospital on the Sunshine Coast in Queensland.
“We are aware of Ralstonia pickettii cases in patients across multiple states and territories,” the TGA said.
“We are working closely with state and territory health departments to investigate the possible role of therapeutic goods.
“On November 24, 2023, we took the precautionary measure of initiating a nationwide quarantine for some InterPharma saline products to minimise possible risk to patients.
“This decision was made after the 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.”
Queensland’s Chief Health Officer John Gerrard said he could not comment on the extent to which the infection contributed to the elderly man’s death because the matter was before the coroner.
He said there were another two confirmed infections and three probable cases in Queensland but they were considered mild.
Three private hospitals in Queensland have been linked to Ralstonia cases.
No cases have been identified in Queensland public hospitals.
The identified saline products were in use across seven Queensland Health services.
“An investigation has been underway across all the states of Australia to identify the source of the infection,” Gerrard said.
“Microbiologists in the ACT identified the organism in at least one likely source in saline products imported from overseas.
“These products have been removed from Australian public and private hospitals following an alert issued by the Therapeutic Goods Administration on Friday.”
He said the multi-state investigation was still underway to determine whether there were other infection sources.
“I do not want to say … that all risk has been removed,” he said.
Gerrard said Ralstonia was usually harmless and couldn’t spread from one person to another.
“Ralstonia is a common organism in the environment,” he said.
“It thrives in water. It is commonly identified in rivers, streams and lakes.
“The biggest risk is if a person is injected by some means into the blood with the organism.”
Queensland Health issued an urgent patient safety alert on Friday after Ralstonia was linked with previous outbreaks from contaminated medical fluids in healthcare settings.
The bacteria is of particular concern for patients with underlying health conditions and those with implanted medical devices.
Last month NSW Health authorities asked every state to be on the lookout for Ralstonia cases after a cluster of infections was identified, but with no apparent cause.
Tasmania’s health department said the state had recorded one confirmed case and four probable cases, none of which had caused clinical illness.
The department had provided advice to healthcare providers and no interruptions to patient care were expected, a spokesperson said.
No cases have been reported in Victoria or Western Australia.
Scientists in the ACT had identified products from India and Greece as a possible source of contamination, Queensland Health Minister Shannon Fentiman said on Tuesday.