Around 1,000 people who use a type of breathing machine to help their sleep disorder are being contacted by the local agent following a global voluntary recall of the device.
There are concerns that users could be inhaling cancer-causing chemicals through a type of foam embedded in the Philips Respironics machines.
The foam is used to reduce the sounds and vibrations emitted by the devices used by people with sleep apnea – a disorder that can cause breathing to stop repeatedly during sleep.
As a precaution we are providing clients with a temporary filter for free
In the voluntary recall, Philips said it was concerned that the foam may break down into small particles which, if inhaled, could lead to health issues.
George Bonello, chief executive of Sidroc – the local agent for Philips – explained that the company was in the process of contacting all 1,000 patients on their database who used the machines.
“As a precaution, we are providing clients with a temporary filter for free. This will ensure that foam particles will never reach the patient.
"Meanwhile, we have provided Philips with all the serial numbers of the machines and we are waiting to hear from them regarding the way forward. Philips will either provide clients with new foam filters or they will replace the machines entirely,” Bonello said.
'Shock over recall'
Paul Baldacchino, who has been using the machine for more than three years, said that while he was offered the filter some weeks ago it was not made clear why it was needed.
He was shocked when, some weeks later he read about the global recall online.
On June 30, the US Food and Drug Administration issued a safety communication following the voluntary recall. According to the American FDA, Philips Respironics voluntarily recalled certain ventilators, which includes bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) sleep apnea devices.
The company said it would either replace or repair the affected devices within a year.
The CPAP and BiPaP machines work by pushing air into the lungs of people with sleep apnea.
Left untreated, sleep apnea can put people at risk for hypertension, heart failure, increased risk of heart attack and stroke, and decreased quality of life. People feel tired and, in the worst cases, can fall asleep during the day causing accidents and injuries.
Back in 2004, a man was cleared of causing the death of a woman in a traffic accident in Għajn Tuffieħa after a magistrate heard how he lost control of his car because he suffered from sleep apnea – a medical condition he was not aware of at the time.