The FDA inspected the Philips Respironics’ manufacturing facility to decide what contributed to the foam concerns. The FDA’s inspections include evidence production and testing, systems intended to make sure the product meets quality standards, review of records, staff training, and operations.
In the course of an inspection, an FDA investigator did observe issues outlined in an inspection closeout report.
Initial Repair After Recall
After the recall, Philips Respironics put together a plan for repair of the foam. This repair was supposed to involve a different polyester-based polyurethane foam. The plan was based on testing. However, during an inspection, the FDA got more information about the silicone-based foam as it was used in a device marketed outside the country; that device failed a safety test for release of specific chemicals called volatile organic compounds.
The same testing provided by Philips Respironics to the FDA on devices that are supposed to be marketed in the country showed acceptable results, however. The FDA has asked that Philips Respironics use a lab to perform further testing to decide what, if any possible safety risks are presented by the silicone-based foam that is supposed to pose a fix for the company’s recalled products within the United States. The agency knows that some patients received devices that incorporate the silicone-based foam but doesn’t have enough information to decide whether what’s being used in repaired devices also poses risks to patients within the country.
Benefit-Risk Assessments
Patients who have been part of the repair program have not been asked to stop using the product. An overall benefit-risk assessment has allowed the FDA to come to a decision. The agency has figured out that discontinuing use of a device could cause more harm to a patient. Additional independent testing results are necessary for figuring out whether the silicone-based foam presents hazards to patients. The results of independent tests will determine the degree of risk and the FDA has announced it will let the public know what they are.
If you have a recalled ventilator or other recalled Philips Respironics device that has not been replaced, you should talk to your doctor about any concerns to figure out whether you should keep using it or switch to another device. Various organizations have been involved in work with the FDA and patients to figure out the best answers to patient questions.
If you were harmed by a Philips Respironics ventilator, CPAP machine, or BiPAP machine, call the Chicago-based product liability lawyers of the Moll Law Group. We’ve spent years sharpening our experience and knowledge to make sure that we can help consumers. One of our goals is to provide information that is easy for consumers to understand that will prevent injuries. However, if you’ve already been injured, we stand ready to represent you in protecting your rights in court. Please contact us through our online form or call us at 312.462.1700.