Follow SlashGear, the FDA said it recently concluded an inspection of the Philips manufacturing facility that manufactures the recalled devices, including looking at the silicone-based foam used as part of the recall program. device repair program.
In June 2021, Philips Respironics recalled a number of CPAP/BiPAP machines as well as ventilators used by medical facilities when acoustic foam was used in them. This foam can age to become toxic over time, and when the foam breaks, users can inhale small particles or chemicals that can lead to serious life-threatening injuries, even cancer.
A ventilator from Philips
In addition to the ventilators affected by the above recall, Philips has also recalled a number of CPAP and BiPAP models, including DreamStation ASV, SystemOne ASV4, OmniLab Advanced+, Dorma 400, REMstar SE Auto, etc. Affected users are protected. Covered by the company’s repair program, which will swap polyester-based polyurethane (PE-PUR) foam with a silicone-based substitute.
Now, in an updated statement about this recall program, the FDA says it has performed an inspection of the Philips Respironics manufacturing facility. According to the FDA, they are looking into what could have led to problems with the PE-PUR foam and whether the company is complying with FDA manufacturing rules.
Testing is extensive, to include everything from how employees are trained to the manufacturing and testing of these devices. Although the FDA has yet to announce a final decision, it says it is looking into the process of replacing PE-PUR foam with a silicone-based alternative that is safe. In its report, the FDA said that a small number of these replacement devices failed a safety test when it came to volatile organic compounds — a type of chemical that raises safety concerns. .
The FDA requires Philips to use an independent laboratory to test the use of the substitute to see if it poses a safety risk to the user. The agency notes that it does not yet have enough data to determine whether foam made from the new material poses a risk to users.
For users, the FDA said that because things are still inconclusive, discontinuing use of one of these devices could do more harm to a patient’s health and quality of life. According to the FDA, they will issue an update to the report in the future as more data becomes available on the silicone-based foam substitutes used on these products.