More than 100 defective breathing machines have been replaced across the health service after they were linked to risks of harm to users.
Separate efforts are under way to track down thousands of the sleep and respiratory devices used in the community, often in patients’ homes.
Ninety per cent of the devices used in Ireland have been registered and are due to be repaired or replaced over the next year, according to manufacturer Philips.
Earlier this year the electronics giant announced it was recalling machines, used to treat sleep apnoea, because the polyester-based foam inside the devices to reduce noise can break down and be ingested by users.
The HSE is advising patients to continue using the CPAP (continuous positive airway pressure) devices until replacements are supplied or repairs are carried out.
The HSE, citing figures from Philips, says 23,000 devices have been distributed to Ireland since 2007, though many of these may no longer be in use. The devices are used in public and private hospitals, residential care homes and in patients’ homes.
No repairs have taken place yet because the relevant regulator, based in Germany, has not validated the repair process. This is expected to happen this month, it says.
To date in Ireland, 91 CPAP and 33 BiPAP (bilateral positive airway pressure) machines have been replaced, according to a HSE spokeswoman. “Distributors of these machines are expecting significant volumes of stock replacements to become available in November 2021 and this will accelerate the replacement programme for patients.”
The HSE is working with distributors to ensure devices are repaired or replaced, as well as developing specific clinical advice for consultants who have prescribed them.
Philips says the devices were all delivered through distributors “with whom we have been actively engaging and fully supporting through the voluntary field safety notice programme.
“Philips has been working to address this issue as expeditiously as possible and we have significantly increased our production capacity to deliver repair kits and replacement devices in large quantities,” a spokeswoman said. “We expect to complete the full global repair and replacement programme in each country, including Ireland, within approximately 12 months.”
Inhaled foam
In the US, more than 100 lawsuits have been filed over the issue, alleging a range of harms.
According to the HSE, the inhaled foam from the device may cause local airway irritation. Short-term adverse events have been reported, including coughs, headaches and sinus infections.
“Some of the volatile chemicals have been shown to be a possible carcinogenic risk. The degradation may be accelerated by unapproved cleaning methods, such as ozone.”
According to UK authorities, “there is currently no definitive data showing long-term harm to patients”.
The State Claims Agency, which handles legal claims against the HSE and other bodies, said it has not received any claims in relation to the devices.
Cork solicitor Michael O’Dowd confirmed he is acting for a client who used one of the devices and on whose behalf he has been instructed to begin legal proceedings against Philips and a company that services the device.*
*This article was amended on October 19th, 2021
