FDA: GE HealthCare EVair, EVair 03 Compressors Pose Potential Risk of Chemical ExposureFDA: GE HealthCare EVair, EVair 03 Compressors Pose Potential Risk of Chemical Exposure

In a recent letter to healthcare providers, FDA warned of potential exposure to certain chemicals with the use of GE HealthCare’s EVair and EVair 03 (Jun-air) compressors with certain ventilators.

Compressors are optional accessories for ventilators and used when wall air is not available, which is atypical in most hospital settings. 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 Engström Carestation/Pro ventilator for the same purpose.

Originally issued as an Urgent Medical Device Correction on Dec. 29, 2023, GE Healthcare informed users that elevated levels of formaldehyde had been detected when EVair or EVair 03 compressors were used with the Carescape R860 or Engström Carestation/Pro ventilators, respectively. The elevated formaldehyde rates were observed in preliminary testing conducted at an “elevated room temperature of 40°C (104°F), at the lowest possible flow condition of 2 L/min (worst-case, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (ie, FiO2 of 21% / no supplemental oxygen),” according to the company.

Exposure to elevated levels of formaldehyde may lead to neurological impairment or respiratory issues including asthma, decreased lung function, inflammation, or irritation. This is particularly concerning for neonates and infants “who may have immature pulmonary function or other coexisting conditions,” according to the notice.

While the test conditions were not representative of typical clinical use conditions, the company said it is lowering the maximum room air temperature for operation of the compressors from 40°C (104°F) to 30°C (86°F) to reduce potential exposure to the chemical. Additionally, GE HealthCare is recommending medical providers not use EVair and EVair 03 compressors for neonatal and infant patients (zero to two years old).

The user manual will be updated with both the new operating conditions and indications to not use the compressors on zero- to two-year-old patients.

The company is continuing to evaluate the root cause of the chemical’s elevated levels and is working will FDA to conduct additional testing to further investigate the issue. FDA said it is not aware of any reports of adverse events due to the problem.

“Patient safety is our top priority," a GE HealthCare spokesperson told MD+DI. "Our testing was done in worst-case conditions that are not expected to occur in the clinical environment. However, we are taking a precautionary measure in providing customers with updated recommendations for use of GE HealthCare compressors with our ventilators. We are not aware of any patient injuries or adverse effects related to this potential issue.”