The US Food and Drug Administration (FDA) has issued an update to the Philips CPAP/BIPAP Recall was first announced earlier this year. The agency said that recently completed the inspection of Philips manufacturing facilities where this device was made, noted that he looked into a silicone-based foam that was used as part of the device repair program.
In June, Philips Respironics considering certain CPAP and BIPAP engines, as well as ventilator used by medical facilities, because the sound reduction foam used in this model. The foam is made of polyester-based polyuretan (PUR) which can be damaged over time.
When the foam is damaged, according to the initial advisor issued by the FDA, users can inhale particles or small chemicals, have the potential to place them at risk of health problems- including, agencies warn, “serious injuries, which can be in the form of life- threatening, causing permanent disorders and requires medical intervention to prevent permanent injury for users. “
In addition to ventilator affected by this withdrawal, Philips has also given a number of CPAP and BIPAP models, including Dreamstation ASV, Systemone ASV4, Omnilab Advanced+, Dorma 400, Remstar SE Auto, and many more. Users affected by the company’s improvement program, who will exchange PUR foam with silicone-based alternatives.
In a new statement, the FDA renewed the public about this withdrawal and new inspection which was carried out by the manufacturing facilities owned by Philips Response. The agency said that he was looking for what might result in P-P-PU foam problems besides checking whether the company complies with the FDA manufacturing rules.
Inspection is broad, including everything from how employees are trained to the production and testing of this device. The agency has not published the final determination but said that the report closing the inspection related to this inspection is now available [PDF].
Inspection is anticipated and now finished, Philips will do its part and respond to the agency before the “next step” is taken. The FDA noted that they agreed to the company’s plan to replace the PUR foam with silicone-based alternatives earlier this year was partly based on the test data provided by Philips to the agency.
The agency update revealed that during the inspection, the FDA studied “additional information” that was previously not received involving alternative silicone -based foam. A “single device, similar marketed outside the US” failed “a safety test,” said the FDA, when it comes to the release of volatile organic compounds, a type of chemical that causes safety problems.
As a result, the FDA wants Philips to use an independent laboratory for additional silicone -based foam testing to determine whether it provides a safety risk to the user. The agency noted that he did not have enough data to determine whether silicone-based foam is at risk for users, it admitted, some patients have improved their devices to display alternative foam.
In a statement to the public about this, the FDA said: