Philips: Don't use bacteria filters with CPAPs

CAMBRIDGE, Mass. – Philips does not recommend using bacteria filters with CPAP/BiLevel devices as a means of mitigating chemical emission or particulate matter, it says in a new document related to a recent recall. 

“Due to an influx of questions, additional information is being provided about the use of bacteria filters with CPAP/BiLevel devices,” the company states. “According to FDA regulation 868.5260, bacteria filters are medical devices that are intended to remove microbiological and particulate matter from the gases in the breathing circuit. Therefore, these bacteria filters should not be used on CPAP/BiLevel devices as a means of mitigating risk of PE-PUR foam chemical emission or particulate matter.” 

Philips lists a number of reasons for not using bacteria filters with CPAP/Bi-Level devices, including: 

• Bacteria filters do not provide protection from the chemical emissions resulting from manufacturing or continued foam degradation. Furthermore, possible gas emission of the degraded foam has not been fully characterized yet throughout the life of the CPAP/BiLevel device. 
• Bacteria filters need to be replaced frequently, as referenced in the bacteria filter manuals or as deemed necessary upon inspection by a medical professional. 
• Bacteria filters increase the resistance to airflow and will impact device performance of CPAP/BiLevel devices. Filters alter device performance by negatively impacting the maximum airflow, dynamic pressure and static pressure delivered by the CPAP/BiLevel devices. The extent of performance degradation will vary dependent upon prescribed therapy settings and air leakage which are different for each patient. Because of this, device performance may not meet the approved device’s specifications. 
• When an inline bacteria filter is used with a CPAP/BiLevel device the pressure reported by the device may be different than the prescribed pressure as well as the pressure received by the patient. 
• Certain circuits are unable to be used with bacteria filters due to an increased airway resistance that can affect device performance: 12mm circuit or heated humidifier circuit. 
• Bacteria filters may alter algorithms that govern therapy on many CPAP/BiLevel devices. Different modes (AutoCPAP, ASV, AVAPS, AVAPS-AE, Flex) require airflow sensing and demonstrate varying degrees of performance impact.