After Making Millions Of Defective Sleep Apnea Machines, Company Ordered To Overhaul Manufacturing

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The company behind one of the biggest medical device recalls in history is being ordered to halt its production of CPAP machines in the United States until it meets a series of safety standards and requirements. This will leave many sleep apnea patients searching for a new brand – here’s what you need to know! 

What Is Sleep Apnea? 

Sleep apnea is a sleep disorder that causes breathing to stop and start dozens, sometimes hundreds of times throughout the night. Two of the most common symptoms of sleep apnea include loud snoring and daytime fatigue. 

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There are two types of sleep apnea – obstructive sleep apnea (blockage of the airways) and central sleep apnea (abnormal brain signals). Sleep apnea affects more than 39 million adults in the US and roughly one billion people worldwide. 

How Can A CPAP Machine Help? 

CPAP machines, also known as continuous positive airway pressure machines, are devices used to treat obstructive sleep apnea. It works by providing a constant stream of pressurized air into the upper respiratory tract – keeping the individual’s airways open while they sleep.

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A CPAP machine has three main components: the machine, the tube, and the mask. The mask attaches to the patient’s mouth and nose, and the tube attaches to the machine. It’s the most common form of treatment for sleep apnea. 

Philips Recalls More Than 5 Million Devices

In June 2021, Philips – one of the leading CPAP machine manufacturers – warned consumers that the sound-dampening foam used in their machines ‘can break down over time, leading users to potentially inhale tiny black particles or hazardous chemicals while they sleep.’ 

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The company has recalled more than five million devices over the past few years—far more than it expected when it began the recalls in 2021. The Dreamstation and SystemOne CPAP models were the most popular devices recalled. 

FDA Claims That Philips Knew About The Problem

Between August and November of 2021, the FDA ran a series of inspections of Philips’ Pennsylvania offices. They found a variety of red flags that raised concern, including 14 instances between 2016 and 2021 where Philips was made aware of the problem. 

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“No further design change, corrective action or field correction was conducted,” the FDA claimed in their report. One customer, dating back to 2015, warned the company that the foam could degrade over time, but nothing was done as a result. 

Jeffrey Reed One Of Many People Affected

One customer, Jeffrey Reed of Marysville, Ohio, had been using a Philips CPAP machine for seven years before the recall. During that time, he experienced persistent sinus infections and two bouts of pneumonia. 

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“I worry about my long-term health,” Reed said – adding that he applied for a replacement within a week of the recall. “I used this machine for years and no matter what money I might get out of this, what’s going to happen?” 

Prefers To Use Competitor’s Device Over Philips

Unfortunately for Reed (and many other customers), his replacement didn’t come right away. In fact, it took Philips several months to respond to his inquiry, and when they did, they told him the model he was requesting had been discontinued. 

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While he eventually got his hands on a new Philips model, he says he prefers to use a competitor’s CPAP machine instead. “It’s disappointing that a provider of life-saving equipment treats people like this,” he said – adding that he doesn’t trust the company.

Efforts To Replace Devices Continue

When Philips announced the recall in June 2021, they expected to have all units repaired and/or replaced within a year. That estimate was a little ambitious, but they failed to deliver. In fact, the company is still dealing with replacements to this day. 

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In 2022, the FDA ordered Philips to improve its outreach to customers about the recall – demanding that it focus on detailing ‘clearer information about the health risks of its products.’ 

Philips Agrees to Halt Production In The US

In January 2024, it was revealed that Philips had agreed to a tentative agreement with federal officials – including the Food and Drug Administration and the Department of Justice. The deal wasn’t finalized at the time, but it was a step in the right direction. 

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As part of the agreement, Philips would continue servicing previously sold machines in the U.S., but would halt production until it met corrective actions laid out by the FDA. The agreement was expected to cost the company nearly $400 million. 

Finally Reaches Settlement With FDA and DOJ

On Tuesday (April 9), federal officials announced that it had finally agreed to a long-awaited settlement with Philips. In addition to the details listed above, the company was being ordered to overhaul its manufacturing and quality control systems. 

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While Philips has yet to admit to any wrongdoing, federal officials are alleging that it failed to comply with good manufacturing practices – putting customers’ health and safety at risk. 

Must Hire Independent Auditors To Ensure Safety

Not only that, but federal officials are ordering Philips to hire independent auditors in an effort to ensure they follow best practices moving forward. The auditors will help plan and monitor the company’s efforts to fix and replace the recalled devices. 

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As for the foam that was causing the problem, officials are asking Philips to certify that the new foam meets FDA safety standards. The goal is to leave no stone unturned as they work on gaining back the trust of their customers. 

U.S. Attorney Committed To Holding Philips Accountable

One U.S. Attorney, Eric Olshan, released a statement declaring the FDA’s intent on holding companies like Philips accountable for their actions. 

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“This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk,” he said in a statement.

Philips CEO Promises To Put Health and Safety First

During a quarterly earnings update in January, Philips CEO Roy Jakobs promised analysts and investors that the company was putting ‘safety and quality at the center of everything we do with a greater level of accountability.’

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It comes as the company is facing more than 750 personal injury lawsuits from customers who experienced health problems as a result of the foam. While those cases have been consolidated in court, the company is facing similar lawsuits in other countries, including Canada, Australia, Israel, and Chile. 

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Ryan Handson

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