The FDA has asked Philips to conduct more testing on foam in its recalled ventilators following an inspection at its manufacturing plant
FDA asks Philips to conduct more testing on foam in recalled ventilators
November 17, 2021
by John R. Fischer, Senior Reporter
The FDA has told Philips to conduct more testing on the foam it uses in ventilators that it recently recalled.
Back in June, Philips recalled some of its breathing devices and ventilators when it found that the polyurethane foam used to dampen the machines’ sounds may degrade and release small particles that irritate the airways and become toxic, potentially causing cancer. It announced in September that it would replace up to four million of these devices, as a result.
The request by the FDA came Monday, following an inspection of its Murraysville facility in Pennsylvania, where it found several new issues. It also says the company has failed to show why other devices made with the foam should not be recalled and that Philips’ procedures for design change may not be adequate, according to Reuters.
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing," Philips CEO Frans van Houten said in a statement.
The agency found between April 2016 and January 2021 that Philips was aware of 14 instances related to issues with potential foam degradation within its different sleep and respiratory devices.
While it initially approved a plan that Philips developed to replace the foam with a different silicone-based foam, the inspection at the plant revealed that the new foam failed one test on a device marketed for sale outside the U.S. The test was for the release of certain concerning chemicals, called volatile organic compounds, reported Bloomberg News. As a result, the FDA has requested that Philips conduct additional testing on the new foam in an independent lab to determine what, if any, potential safety risks it may pose.
Philips says the tests it has carried out on the replacement has shown acceptable results, and that it is already working with third-party test labs. It also has put aside 500 million euros ($572.50 million) in provision for the recall costs, and expects to complete testing on the original foam in the fourth quarter. The recall and related lawsuits resulted in lower financial results for the year, according to Reuters.
And while the FDA is not yet sure if the silicone-based foam that Philips is using instead is safe either, it does not recommend that patients stop using the company’s products, due to the risks versus the benefits of them.
"Until we have concluded these discussions, we are not able to publicly provide further details,” said van Houten.
Two of the company’s other devices recalled in June were its V60 and V60 Plus ventilators, which were found to pose a risk of reducing oxygen flow to patients in certain situations. The issue was part of its software version 3.00 and 3.10 upgrades and specifically had to do with a safety mechanism of the High Flow Therapy option that limits both pressure and flow rate when the system hits its maximum limit. This leads to a partial obstruction in the breathing circuit, according to Philips.
The FDA in August labeled the V60 and V60 Plus recall as Class one, the most serious type of recall. It said that the use of such devices could result in serious injury or death and reported 61 incidents and 25 injuries that could be traced back to them.
Back in June, Philips recalled some of its breathing devices and ventilators when it found that the polyurethane foam used to dampen the machines’ sounds may degrade and release small particles that irritate the airways and become toxic, potentially causing cancer. It announced in September that it would replace up to four million of these devices, as a result.
The request by the FDA came Monday, following an inspection of its Murraysville facility in Pennsylvania, where it found several new issues. It also says the company has failed to show why other devices made with the foam should not be recalled and that Philips’ procedures for design change may not be adequate, according to Reuters.
“We will work closely with the FDA to clarify and follow up on the inspectional findings and its recent requests related to comprehensive testing," Philips CEO Frans van Houten said in a statement.
The agency found between April 2016 and January 2021 that Philips was aware of 14 instances related to issues with potential foam degradation within its different sleep and respiratory devices.
While it initially approved a plan that Philips developed to replace the foam with a different silicone-based foam, the inspection at the plant revealed that the new foam failed one test on a device marketed for sale outside the U.S. The test was for the release of certain concerning chemicals, called volatile organic compounds, reported Bloomberg News. As a result, the FDA has requested that Philips conduct additional testing on the new foam in an independent lab to determine what, if any, potential safety risks it may pose.
Philips says the tests it has carried out on the replacement has shown acceptable results, and that it is already working with third-party test labs. It also has put aside 500 million euros ($572.50 million) in provision for the recall costs, and expects to complete testing on the original foam in the fourth quarter. The recall and related lawsuits resulted in lower financial results for the year, according to Reuters.
And while the FDA is not yet sure if the silicone-based foam that Philips is using instead is safe either, it does not recommend that patients stop using the company’s products, due to the risks versus the benefits of them.
"Until we have concluded these discussions, we are not able to publicly provide further details,” said van Houten.
Two of the company’s other devices recalled in June were its V60 and V60 Plus ventilators, which were found to pose a risk of reducing oxygen flow to patients in certain situations. The issue was part of its software version 3.00 and 3.10 upgrades and specifically had to do with a safety mechanism of the High Flow Therapy option that limits both pressure and flow rate when the system hits its maximum limit. This leads to a partial obstruction in the breathing circuit, according to Philips.
The FDA in August labeled the V60 and V60 Plus recall as Class one, the most serious type of recall. It said that the use of such devices could result in serious injury or death and reported 61 incidents and 25 injuries that could be traced back to them.