On the global issue of repairing or replacing patient apnea devices, Philips is “substantially and structurally” lacking in communication with stakeholders. The Health and Youth Care Inspectorate (IGJ) will inform you on Thursday NRCna coverage of Nieuwsuur† The inspection wants Philips to specify when patients, practitioners and other involved receive information about the repair and replacement plan of the devices, which may have caused health problems for thousands of users. The majority of patients would still not know when to receive this information.
The electronics company is repairing or replacing millions of machines – which blow air into users’ lungs through a mask at night – in 130 countries. A year ago, Philips reported that the sound-damping foam, made of plastic, appears to be crumbling from some devices. A recent data update from the US health watchdog FDA shows that more than 21,000 people reported health problems – including pneumonia, difficulty breathing and dizziness – and that 124 people using the device died. The FDA does say that it has not been proven whether these people died because of the use of the apnea device.
The IGJ says it has been working “intensively” on the issue since the announcement of the global recall, and is now increasing “the pressure” on Philips. This was despite a long public silence on the issue, with the FDA being openly critical of Philips on several occasions. The IGJ now states that it supports its recommendation to continue using the devices, but says it understands that this “does not remove all concerns” for users. The Inspectorate does not say when Philips must provide clarity to patients at the latest.
Also read this article about other safety issues at Philips with medical devices
