The FDA has updated its guidance on GE HealthCare’s EVair compressor, confirming that formaldehyde emissions are within safety limits, while previous recommendations remain in place for the EVair 03 (Jun-Air) compressor.
RT’s Three Key Takeaways:
- EVair Compressor Cleared: Final testing shows that formaldehyde emissions from GE HealthCare’s EVair Compressor are within safety limits, lifting previously recommended actions on its use.
- EVair 03 (Jun-Air) Recommendations Unchanged: Due to no new/unused EVair 03 (Jun-Air) devices being available for testing, prior safety recommendations for this compressor still apply.
- Updated Usage Guidelines: The FDA’s letter outlines the safe operating conditions and usage recommendations for both compressor models in ventilator support.
The US Food and Drug Administration (FDA) issued a letter to health care providers with an update on the recall of GE HealthCare’s EVair compressor, clarifying safety recommendations for ventilator use after final testing on formaldehyde emissions.
Previously, on Dec 29, 2023, GE HealthCare issued an Urgent Medical Device Correction notice to inform users about the potential for elevated levels of formaldehyde, based on preliminary testing when the EVair or EVair 03 (Jun-Air) optional compressors are used with the Carescape R860 or Engström Carestation/Pro ventilators, respectively.
On Oct 11, 2024, GE HealthCare issued an updated notice based on final testing results which demonstrated that formaldehyde emissions are below the safety threshold set for the intended patient population when using the EVair Compressor.
As a result, GE HealthCare has concluded that the recommended actions indicated in the previous letter for EVair Compressors no longer apply.
No new/unused EVair 03 (Jun-Air) devices were available for final testing. Therefore, the previous recommendations for EVair 03 (Jun-Air) compressors have not changed and continue to apply.
Recommendations:
- Review the Urgent Medical Device Correction update from GE HealthCare for the EVair and EVair 03 (Jun-Air) Compressors, which includes model numbers and Unique Device Identifier (UDI) information.
- Updated Recommendations for EVair Compressors:
- EVair Compressors can be used to supply air to Carescape R860 ventilators for all patient populations, including neonatal and infant patients (0-2 years of age).
- EVair Compressors can be used in a room with maximum air temperature of 40 degrees C (104 degrees F).
- Continued Recommendations for EVair 03 (Jun-Air) Compressors:
- Do not use EVair 03 (Jun-Air) Compressors to supply air to ventilators for neonatal and infant patients (0-2 years of age).
- The maximum room air temperature for use of EVair 03 (Jun-Air) Compressors is 30 degrees C (86 degrees F).
- If you have questions about this recall update, contact GE HealthCare Service or your local Service Representative at 1-800-437-1171.
- Report any issues with use of the compressors to the FDA.
Compressors are optional accessories for ventilators and used when wall air is not available.
The EVair compressor is intended for use with a Carescape R860 ventilator as a supply of compressed air. The EVair 03 (Jun-Air) compressor is intended for use with an Engstrom Carestation/Pro ventilator as a supply of compressed air.
The FDA notes in the letter that it will continue to work with the manufacturer to monitor the postmarket performance of these devices and will keep the public informed if any significant new information becomes available.