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Philips recall: Questions continue more than two months later

Philips recall: Questions continue more than two months later ‘I have no idea what machines will get just the foam and which will get replaced’

YARMOUTH, Maine – Philips’ announcement last week that it will begin repairing and replacing CPAP devices affected by a recall was welcome news to providers, but they still have more questions than answers. 

The company announced Sept. 1 that it had received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month. 

“The question I have is, are they going to allow companies like myself to, in fact, put the screwdriver to the machine to do the repair or will patients have to send the machine (to be repaired),” said Woody O’Neal, vice president of O2 Neal Medical in Pelham, Ala. 

Philips also announced that it has started shipping DreamStation 2 CPAP devices to replace certain affected first-generation DreamStation CPAP devices in the U.S. 

“I talked to Philips this morning and they told me 1,500 (replacement) machines are being shipped out every day,” said Richard Spafford, president of USA Medical Supply in Springfield, Mass. “I have no idea what machines will get just the foam switched out and which will get replaced.” 

Providers last week were also dealing with confusion created by an alert, sent by CMS, that made it seem like affected patients can get their CPAP devices replaced or repaired right away by providers. 

“No matter what we tell the customer, beneficiaries believe that whatever CMS says is the be all, end all and there’s no arguing at that point,” said Tyler Riddle, president of MRS Homecare in Tifton, Ga. “Our concern is the impact that has on our reputation as a company moving forward. Now it looks like we are defying a direct mandate from CMS.” 

The alert even prompted a phone call between Riddle, a CMS representative and a Medicare beneficiary, in which the rep suggested Riddle replace a Philips CPAP device with another manufacturer’s device.  

“Those are difficult to get, as well,” he said. “Now I’m replacing a CPAP from one manufacturer, with all the paperwork and purchase orders, with another unit we have not been paid for? It was challenging for them to understand my inability to do that.” 

Between the alert and what they say has been a lack of transparency from Philips in the months since the recall was first implemented, providers are expecting a rough several months ahead. 

“What’s going on behind the scenes?” said Josh Britten, owner of BritKare in Amarillo, Texas. “There’s never been a good time for a recall, but this is the worst time. It’s going to transform how the whole industry looks at our equipment moving forward. This is massive.”


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