As many of you know we have been without any CPAP and bilevel devices for a couple of months now. We receive calls and emails daily asking when we will have these products back in stock but unfortunately we can’t honestly answer that question at this time. Hopefully the information below will shed some light on the current situation we are in.
In June of this year Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life. A complete list of impacted products is available on philips.com/src-update.
As a result of the mitigation plan for this recall, Philips stopped selling any new cpap and bilevel units. They stopped selling new devices so they could direct those resources towards the repair/replacement of devices impacted by the recall. Philips Respironics is one of the largest manufacturers of cpap and bilevel devices so pulling these products off the market led to a huge shortage in supply. In addition to Philips Respironics, DeVilbiss Healthcare recently stopped production of their cpap and bilevel devices citing supply chain issues and cost of components. APEX Medical is another manufacturer whose products we’ve carried but they have stated it will probably be several months before they get FDA approval for their new device platform. This has led to a surge in demand for devices produced by ResMed and a few other manufacturers but they were already experiencing electronic component shortages and shipping delays related to the Covid 19 pandemic. Understandably, the few remaining manufacturers have been unable to meet the increased demand and it has caused an industry wide shortage of cpap and bilevel devices.