Imported "inferior" IV fluids containing as much as 12 times more air than those made in Australia are posing a heightened air embolism risk in emergencies for clinicians to manage.
As Australia began to grapple with a global shortage of critical IV fluids in 2023, the Therapeutic Goods Administration (TGA) moved to approve multiple products from overseas to help fill the gap.
But having helped with one problem, those alternatives are now posing another: they contain significantly more air than the IV fluids manufactured in Australia.
An example cited by NSW Health shows the stark contrast between an IV fluid bag made in Australia, containing about 5 millilitres of air, and an imported bag from the US, containing about 60 millilitres of air.
Australian and New Zealand College of Anaesthetists (ANZCA) president David Story said the additional air could pose an issue in an emergency situation, when using what is called a pressurised infusion.
"For patients who are getting what we call maintenance fluids, virtually all the pumps we use in Australia have an air detector so that reduces the risk," he said.
"However when we have a crisis — so a patient may be bleeding heavily — we need to get fluids in quickly, we sometimes put a pressure bag around the bag of fluid to really force the fluid in as fast as we can get it in to resuscitate the patient.
"And that is where it is possible for air, where the bags are pressurised, to be pushed into the patient."
Professor Story said in rare cases that could cause an air embolism, where an air bubble enters a vein or artery, which can sometimes stop blood flow, causing a cardiac arrest or stroke.
"If you have only fairly small amounts of air sometimes the lungs can absorb it … however, a much bigger volume — and 60 millilitres is the sort of volume we're talking about — you can get an air bubble lock in to the heart or the arteries or the lungs, which could prevent blood flow and effectively produce a cardiac arrest," he said.
"This is a very rare event and what we try to avoid, but by having a product coming into the country — particularly where most of the products used in Australia do not have air in them — clinicians may not immediately think about the air problem, particularly in a crisis."
Professor Story said the bags with more air could be particularly problematic for infants and children, because of their size.
"The threat of death is associated with the size of the gas volume compared to the size of the patient," he said.
"At about one to two millilitres per kilo is where there's complete loss of blood flow. So the smaller the person, the smaller the volume that would be required to produce very serious complications, including a cardiac arrest."
IV fluids like saline and sodium lactate solution are essential medicines used across the sector for everything from treating dehydration to helping patients in intensive and post-operative care.
Australia has received about 1.5 million units of imported IV fluids since 2023.
Professor Story said while the overseas-made fluids weren't of the same quality as the locally made bags, they were necessary in the grip of a global shortage.
"The products being imported are inferior to the ones we routinely use in Australia, but we have had an urgent need to have more fluids," he said.
"And unfortunately, this is one of the consequences and things we have to deal with."
A response group set up to examine the shortage, comprised of the states, territories and various stakeholders, raised the issue at its meeting in February.
The communique, obtained by the ABC, notes the taskforce agreed The Australian Commission on Safety and Quality in Healthcare — which develops clinical standards — would review safety messaging regarding the risk of air embolisms, to determine if further detail was required.
Australian Medical Association (AMA) President Danielle McMullen said the response group was working to both mitigate the risk of air embolisms and communicate it to clinicians.
"There's now a good understanding across the sector that this is a potential risk, and I want to emphasise that it is still low risk but in medicine, we take everything really seriously, and obviously, if there is a risk, we want to manage it," she said.
"[Health practitioners] are using the local supply in the urgent scenarios and then using the international products where clinicians might not be as familiar with them in lower risk scenarios, like just hanging a bag of extra fluids when people are up on the ward and it's being given quite slowly."
The response group also noted there continues to be reports of difficulties with supply of fluids, particularly in community practices.
In March the federal government announced Australian production of IV fluids would ramp-up dramatically, following criticism over its handling of severe shortages of the essential medicine.
Health Minister Mark Butler said the move would shore-up Australia's supply of the critical medicine and reduce reliance on products made offshore.
The ongoing shortage has frustrated doctors, who have complained of being instructed to "gatekeep" IV fluids by having decide which patients to give them to.
The ABC also revealed that at the height of the shortage, patients were having to stay in hospital care units after surgery for longer because doctors were rationing the fluids.
A spokesperson for the TGA said "all bags of IV fluids contain varying amounts of air".
"The risk of air embolism under pressurised infusion is not unique to section 19A approved products," they said.
"Regardless of the amount of air, there is a risk of air embolism when administering any IV fluid without the use of an in-line air detection device.
"Risk mitigation strategies should always be considered when administering any IV fluid via pressurised infusion, regardless of the amount of air in the bag."
