An alleged risk of patients breathing in or swallowing small particles of foam from degrading sleep aids has prompted the federal government to take legal action.
Multinational health technology company Philips is accused of selling defective ventilators aimed at assisting with sleep apnoea and, after those products were recalled in June 2021, selling a further device which was also dangerous.
In the lawsuit filed on Monday, the Therapeutic Goods Administration claims both sets of devices did not meet Australian safety standards.
Devices sold prior to June 2021 contained a polyester-based polyurethane foam used for noise suppression.
"There was a real risk of the (foam) degrading and then particulates being inhaled or ingested by the patient," the agency wrote in a statement.
The potential harms from these devices included skin, eye and respiratory tract irritation, headaches, asthma and impacts on the reproductive system.
Long-term exposure could damage or kill a patient's cells, cause genetic damage or cause cancer, the health watchdog alleges.
"The probability of degradation, and consequential harm to the patient, was unacceptable, given the potentially serious consequences," the lawsuit claims.
Philips did not conduct any risk analysis on the products until early 2021, the government agency says.
Ten devices sold under the BiPAP, DreamStation, OmniLab and REMstar brands were recalled globally in June that year.
After this date, Philips allegedly sold a further defective device, the Trilogy 100.
This contained silicone foam which could become detached from its housing, obstructing the air path.
Potential adverse health effects included increased carbon dioxide levels or low oxygen levels in the patient's blood.
The TGA is seeking pecuniary penalties and orders that Philips pay its legal costs.
A Philips spokeswoman said the lawsuit only revolved around the company's activities before and during the 2021 recall.
"The proceeding does not make allegations about the quality and safety of products currently marketed in Australia by Philips," she said.
The spokeswoman said extensive testing had been conducted internally as well as with five independent laboratories and third-party experts since June 2021.
This testing concluded that the use of Philips sleep therapy devices presently sold on the market "is not expected to result in appreciable harm to health in patients".
Philips would review the court documents filed by the TGA and engage constructively as required, she said.
