Dozens of infections nationally and a woman’s death in Queensland are suspected to be linked to saline contaminated with the bacteria Ralstonia.
The national medicines regulator has told hospitals and clinics to stop using two InterPharma sodium chloride products immediately, after an outbreak first detected in New South Wales.
There are at least 43 suspected cases of Ralstonia in Australia, including five cases at private Queensland hospitals.
What is saline used for?
Saline is a sterile solution used to clean wounds and dilute medicine, so the contaminated product has likely been applied to broken skin or intravenously, infectious disease physician Dr Paul Griffin said.
He said contamination was “very rare”.
“Saline is something that is used very commonly in clinical practice, and given how rare these sorts of events are, the vast majority of times it is as sterile as we expect it to be,” he said.
The last time Australians were infected by saline contaminated by Ralstonia was 1990, Queensland’s Chief Health Officer Dr John Gerrard said.
Nineteen people were infected and six died in that outbreak.
What is Ralstonia?
Ralstonia picketti can be found in soil and riverbeds but rarely infects people, Dr Griffin said.
What’s different here is the way people are being exposed — potentially intravenously, or through a wound.
“There’s a very large number of defences to stopping people getting infections, and in this case, we’re potentially bypassing a few of those, and in those who are inherently vulnerable, that’s when we can actually see the infections arise,” Dr Griffin said.
“It’s not the expectation that everyone who’s been near this product will get an infection with this organism, but we do want to make sure we find all that are out there.”
The organism was found in the blood of the elderly patient who died at Buderim Private Hospital on the Sunshine Coast.
Dr Gerrard said her death could not be definitively linked to the bacteria.
“If you look at the 1990 cluster, there were six patients who died. All of them had other medical problems and other potential explanations for their death, so they’re mostly not straightforward patients.”
In the five other Queenslanders found to be infected, the Ralstonia infection was mild, Dr Gerrard said.
He said it was likely those patients had wounds “irrigated” with contaminated saline.
How dangerous is an infection?
A Ralstonia infection can be “significant” and even lead to sepsis, Dr Griffin said.
“In a vulnerable host, and if they get exposed to a significant enough amount, it can go on to cause more severe infection as it appears we have one case of that already,” he said.
“We expect there to be a few additional cases, but we do want to make sure if there are any, we diagnose them as quickly as possible and get people on the right treatment, because as a bacterial infection, we have excellent treatment in the form of antibiotics.”
Dr Griffin said people who believe they have been exposed and feel unwell, should seek medical help.
“People won’t be aware what product was used on them — if they did have a wound that was potentially exposed or if they had medications that were diluted — so the simple fact is, if people are unwell or have any concern, have a chat to their GP or service provider,” he said.
Where did this product come from?
The saline products were imported from India and Greece, Queensland Health Minister Shannon Fentiman said.
She said no cases had been linked to public hospitals or clinics.
“In mid-September, NSW health authorities asked Australian states to be on the lookout for Ralstonia cases after a cluster of infections was identified, but with no apparent cause,” Ms Fentiman said.
InterPharma has suspended supply of the “suspected product” and told hospitals and pharmacies to quarantine their stock, with the company adding that “no causal link has been established”.
“In response to current reports of possible adverse events linked to sodium chloride, InterPharma is working in close contact with the Therapeutic Good Administration and investigations are ongoing,” InterPharma, which describes itself as specialising in the sales, marketing and distribution of healthcare products, said in a statement.