Millions of people across the country have been woken up this year by chilling news: an essential device they were prescribed and relied on every night to sleep has suddenly been branded a health hazard.
A massive voluntary recall suddenly took many sleep aids off the market without offering a replacement.
Now, newly released documents raise questions about whether the company at the center of this recall had known about the issues and risks with its devices for years, but didn’t act immediately.
For people with sleep apnea, a condition in which a person can stop breathing while sleeping, CPAP, BiPAP and ventilator devices from Philips Respironics were the most popular and often the preferred choice of physicians prescribing a sleep apnea device. sleep aid.
That’s why it came as a shock when Philips Respironics announced a voluntary recall of over 15 million devices in June. Half of those devices are in use in the United States, the company said earlier.
The reason for the recall: noise-canceling foam used inside the machine could degrade and, if inhaled, the user would be at serious risk of injury, or worse, cancer.
So many of these Philips devices have been recalled that there weren’t enough resources or machinery to offer patients a repair or replacement for up to a year, the company previously told NBC 5 Responds.
While the recall came as a surprising surprise to users of these devices, the issues at the heart of the problem came as no surprise to the company, as it may have been aware of the issues for some time, according to a Food and Drug Administration (FDA) investigation.
The voluntary Class 1 recall of the devices triggered multiple FDA inspections of Philips Respironics’ manufacturing plant in Pennsylvania last August and November.
Among many things, FDA inspectors reviewed company digital records, facility operations, and product testing, all in an effort to determine what may have caused or contributed to the foaming issues. that led to the recall and to assess whether the company had met federal manufacturing standards. requirements.
In case after case, investigators have alleged for years that staff at Philips Respironics knew about foam degradation issues in its devices but failed to act immediately. Additionally, the investigation revealed that the company’s senior executives had been aware of the issues for more than a year before issuing the voluntary recall.
According to the FDA inspection, there were warnings inside the company. This included “at least 14 tests or assessments” as early as 2016 where Philips staff were “aware of issues and concerns related to potential foam degradation”.
There were internal emails that FDA inspectors cite, including one in 2015 from a Philips employee at the company’s raw foam supplier that “implies that a customer made [Phillips] aware of the degradation problems of polyester polyurethane foam,” the report states.
After the company received complaints about foam degradation in its products, in 2018 inspectors found an email conversation with Philips staff acknowledging that the company’s own internal testing had confirmed that the foam could fall apart when exposed to high humidity or heat.
But, the FDA inspection found that, in that same conversation, Philips staff said the company had “made the decision not to change the design” and to continue to include the foam in its ventilation devices. .
And from outside the company’s walls, inspectors found there were external warnings, including tens of thousands of consumer complaints that the FDA said triggered no immediate action.
An analysis of consumer complaints sent to the company found that since 2008, Philips Respironics had received “over 222,000 complaints” which included the keywords “contaminants, particulates, foam, debris, airways, particles, airways and noir”.
Of these, at least 110 complaints from 2014 to 2017 were directly related to the foam degradation issues at the heart of the voluntary recall.
The FDA inspection found that Philips senior management was made aware of the potential foam degradation “as early as January 2020, or earlier, but did not implement any corrective action until April 2021.”
FDA inspectors said, “Additionally, [Philips Respironics] realized this [foam degradation] issue and related field complaints at least in 2015 or earlier. »
When asked for comment, Philips Respironics returned NBC 5 responds to a prepared list of FAQs that met some, but not all, of the FDA’s findings, as well as a statement from Royal Philips CEO Frans van Houten (Philips Respironics is a subsidiary of Royal Philips).
“We will work closely with the FDA to clarify and follow up on inspection results…” Van Houten said in part. “Until we have concluded these discussions, we are unable to provide further details publicly.”
In response to consumer complaints uncovered by the FDA, Philips said, “In previous years, there were few complaints related to foam degradation, which were assessed and addressed on a case-by-case basis.
The company added that issues involving “volatile organic compound (VOC) emissions” or chemicals that could impact a user’s health, “have begun to surface more recently…leading to actions at the first half of 2021”.
The FDA said the findings of its inspection and investigation are not considered a “final determination”. Regulators will review Philips’ response to these findings before taking any next steps, the FDA said, including to determine if any violations occurred.
Questions from the FDA investigation also focused on the devices Philips Respironics issued as part of its ongoing efforts to repair or replace all recalled machines.
After the initial recall, regulators said Philips Respironics plans to repair the polyester-based polyurethane foam in CPAP and BiPAP devices — the foam that degrades and can cause injury — with a different silicone-based foam.
Now, months later, the FDA is warning that the new silicone foam has failed a safety test and could be dangerous.
“During the inspection of the manufacturing facility, the FDA obtained additional information, which was not previously available to the agency, regarding the silicone-based foam used in a unique and similar device marketed in outside the United States, which has failed a safety test for the release of certain chemicals of concern,” a press release accompanying findings of FDA inspection bed.
At this time, the FDA said it does not have enough information to recommend users stop using these new devices.
“The FDA does not recommend that patients who have participated in the repair and replacement program discontinue use of their product,” the press release reads. “The FDA reached this decision based on an overall assessment of benefits and risks.”
Philips Respironics said the failed safety test was for a device that has not “been marketed worldwide” and that previous testing of the replacement device “has already been submitted to the FDA and demonstrated results acceptable”.
The FDA report also calls into question whether there could be more devices currently in use containing the hazardous foam that were not included in the company’s voluntary recall.
Inspectors found “no documented investigation, risk analysis or design analysis to support Philips’ justification that products containing polyester polyurethane foam were or were not included in the current recall”.
Recent news of what the FDA has discovered inside Philips Respironics does not put patients at ease.
Some users of Phillips Respironics devices, including those now part of a class action lawsuit against the company over the recall, believe it should be held responsible.
“The lack of communication once they find out what was wrong with these machines is just plain criminal,” said Shawn Woodruff of McHenry County, Illinois. “It’s terrible to do to people.”
Woodruff discovered the recall on his own earlier this year and told NBC 5 Responds he had trouble finding a replacement for his Philips CPAP machine.
Woodruff said the situation left him feeling less in control of what was going on with his own health.
“Are you kidding [people’s] lives,” Woodruff said. “Somebody has to be held accountable for that.”
Below is a full list of affected Philips Respironics devices, according to the FDA:
CPAP and BiPAP devices
|Device type||Model name and number (all serial numbers)|
|Continuous ventilator, minimal ventilatory support, use of facilities||E30 (Emergency Use Authorization)|
|Continuous ventilator, non-life support||DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+|
|Non-continuous fan||SystemOne (Q series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto|
|Device type||Model name and number (all serial numbers)|
|Continuous fan||Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent|
|Continuous ventilator, minimal ventilatory support, use of facilities||A-Series BiPAP Hybrid A30 (not for sale in the US), A-Series BiPAP V30 Auto|
|Continuous ventilator, non-life support||BiPAP A40 A-Series, BiPAP A30 A-Series|