Patients may be exposed to elevated levels of formaldehyde when a specific combination of compressors and ventilators is used, according to a warning from the Food and Drug Administration (FDA).
Compressors are used with ventilators when wall air is not available. General Electric (GE) HealthCare is investigating why preliminary tests have found its accessory components called the EVair or EVair 03 (Jun-air) compressors have been linked to the potential for elevated formaldehyde levels when used with used with Carescape R860 or Engström Carestation/Pro ventilators, respectively.
Elevated levels of formaldehyde can cause neurological or respiratory problems, which the FDA said is especially concerning for young children who may have immature pulmonary function or other coexisting conditions.
No adverse events have been reported to the FDA. The FDA and GE released the following recommendations.
- Review the Urgent Medical Device Correction notice that includes model numbers and Unique Device Identifier information.
- Do not use EVair and EVair 03 (Jun-Air) compressors to supply air to ventilators for neonatal and infant patients (0-2 years of age).
- Do not operate the compressors in a room with air temperature above 30 degrees Celsius (86 degrees Fahrenheit).
- Report any issues with use of the compressors to the FDA including any confirmed or suspected adverse events. Some users may be subject to the FDA’s User Facility Reporting Requirements or Medical Device Reporting regulations. Voluntary reports can be submitted to Medwatch.
Questions can be directed to the FDA’s Division of Industry and Consumer Education.
