Providers assess Philips recall

YARMOUTH, Maine – HME providers had far more questions than answers as they scrambled to field patient inquiries and craft game plans in the days following the news of a voluntary recall of Philips’ first generation DreamStation CPAP devices. 

Philips announced the recall on June 14 to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in certain Bi-Level, CPAP and mechanical ventilator devices. 

“We’re doing a lot of talking right now, discussing how to move forward not knowing what we don’t know,” said Tyler Riddle, president of MRS Homecare in Georgia. “We’re communicating with physician referrals and sleep labs, but as far as going after affected customers, we haven’t begun that yet because we don’t know how to accommodate them.” 

Philips says it has begun preparations, including obtaining the relevant regulatory clearances, to replace the current foam with a new material, but at press time, the company hadn’t yet announced those clearances. Philips has launched a website specifically for the recall, www.philips.com/src-update, where providers can get more information and register affected units. 

As part of the announcement, Philips advised Bi-Level and CPAP patients to discontinue using affected devices and work with their physicians or HME providers to determine the most appropriate options for continued treatment. The first call should be to physicians, providers say. 

“We have asked them to stop telling patients to go to their DME, as we do not feel we should be guiding medical care and the physician should do that,” said Eric Mongeau, national sales director of sleep and respiratory for Aeroflow in North Carolina. “We’ve put up a voice recording on our phone system that tells patients, if they are calling about the recall, we recommend you speak to your physician. Everybody’s in the dark.” 

In addition to updating their phone systems, providers have updated their websites with important links from Philips. O’Neal Medical has also provided potential options to affected patients, such as receiving a replacement machine or, if they’re not a customer, privately purchasing or renting-to-own a device. 

“We’re also getting inquiries from people using (devices made by other manufacturers),” said Woody O’Neal, vice president. “This creates concerns in the consumer’s mind. It’s a fair question.” 

Although Philips provided a glimpse of the problem during an April earnings call, in which CEO Frans van Houten said the company was “proactively” working to address a possible safety concern, providers say the scope of the issue is probably far greater than anyone originally thought. Just performing repairs on that many devices – a reported 3 million to 4 million – is overwhelming. 

“When I ran a report of affected DreamStation units, we had 6,800,” said Riddle. 

Then there are the more general impacts on an already stressed supply chain for CPAP devices, not only for Philips but also for other manufacturers, providers say.  

“ResMed is telling us that we are going to get our current order, but no more until after July 5th or 6th,” said George Kucka, president of Fairmeadows Home Health in Indiana. “We will be taken care of as a longtime customer, but new people will have to stand in line and will probably go to an allocation system.” 

Still other concerns include the impact on patient compliance rates and the potential ripple effect throughout the health care industry as word spreads. Riddle said one of his customer service reps was asked by a payer what CPAP machine she was seeking an authorization for.  

“The rep said they are not giving auths on affected units right now,” he said.