The US Food and Medicine Administration (FDA) has published an update in Philips CPAP / bipap remember first announced earlier this year. Agency said recently wrapping Philips manufacturing facility inspection where this device was made, noting that he looked into silicon-based foam which was used as part of the device repair program.
Recall.
In June, Philips Respironics remembers certain CPAP and BIPAP machines, as well as ventilators used by medical facilities, because the sound reduction foam used in these models. The foam is made of polyesteretan based polyester (PE-PUR) which can be damaged over time.
When foam is damaged, according to the initial advisor published by the FDA, users can breathe in small particles or chemicals, potentially put them at risk of health problems – including, the agency warns, “serious injury, which can live threaten, causing permanent interference and requires intervention Medical to prevent permanent injury to users. “
In addition to the ventilator affected by this remember, Philips has also given a number of CPAP and BIPAP models, including DREAMSTATION ASV, SYSTEMONE ASV4, Omnilab Advanced +, Dorma 400, Remstar SE Auto, and more. The affected user is covered by the company’s repair program, which will exchange PE-PUR foam with silicon-based alternatives.
Update inspection
In a new statement, the FDA updates the public about this withdrawal and recent inspection carried out on manufacturing facilities owned by Philips Respironics. The agency said she was looking into what might result in the problem of PE-PUR foam besides checking whether the company adheres to the FDA manufacturing rules.
This inspection is wide, covering everything from how employees are trained for the production and testing of this device. The agency has not published the final determination but said that closeout inspection reports related to this inspection are now available [PDF].
The inspection is anticipated and now it’s finished, Philips will do the part and respond to the agency before “the next step” is taken. The FDA noted that he approved the company’s plan to replace PE-PUR foam with silicon-based alternatives earlier this year based on part in the testing of Philips data provided by agencies.
Foam replacement
Agency updates revealed that during the inspection, the FDA learned “additional information” which was previously not accepted involving alternative silicone-based foam. “Singular, a similar device marketed outside the US” failed “one safety test,” said the FDA, when it comes to the release of a fluctuating organic compound, a type of chemical that raises safety concerns.
As a result, the FDA wants Philips using an independent laboratory for extra testing of silicon-based foam to determine whether it presents the risk of safety for users. The agency noted that it did not have enough data to determine whether silicon-based foam was a risk for users – and, it admitted, some patients had improved their devices to display alternative foam.
In a statement to the public about this, FDA said:
At present, while independent testing is done, the FDA does not recommend that patients who have participated in repairs and changing programs to stop the use of their products. The FDA has achieved this determination based on the assessment of the overall benefit risk. At this time, the agency has determined that the termination of using one of these devices may be more dangerous for the health and quality of life of patients.
The FDA will issue updates in the future after having more data on alternative silicon-based foam used in these products.
