The FDA has alerted healthcare suppliers about potential publicity to elevated ranges of formaldehyde when GE Healthcare accent elements referred to as the EVair or EVair 03 (Jun-air) compressors are used with sure ventilators.
On December 29, 2023, GE Healthcare issued an Pressing Medical System Correction to tell customers in regards to the potential for elevated ranges of formaldehyde based mostly on preliminary testing when the EVair or Jun-Air elective compressors are used with the Carescape R860 or Engström Carestation/Professional ventilators, respectively.
The EVair compressor is meant to be used with a Carescape R860 ventilator as a provide of compressed air. The EVair03 (Jun-Air) compressor is meant to be used with an Engstrom Carestation/Professional ventilator as a provide of compressed air.
Publicity to elevated ranges of formaldehyde might result in issues resembling neurological impairment or respiratory issues (resembling bronchial asthma, decreased lung perform, irritation, or irritation), which is especially regarding for neonates and infants (0-2 years of age) who might have immature pulmonary perform or different coexisting circumstances.
In line with the FDA alert, the company just isn’t conscious of experiences of opposed occasions attributable to this subject so far and says GE Healthcare is continuous to guage the basis trigger for these elevated ranges of formaldehyde.
The FDA issued the next suggestions:
- Evaluate the Pressing Medical System Correction discover from GE HealthCare for the EVair and EVair 03 (Jun-Air) Compressors, which incorporates mannequin numbers and Distinctive System Identifier (UDI) info.
- Don’t use EVair and EVair 03 (Jun-Air) compressors to provide air to ventilators for neonatal and toddler sufferers (0-2 years of age).
- Bear in mind that GE HealthCare is reducing the utmost room air temperature for operation of the compressors from 40 levels C (104 levels F) to 30 levels C (86 levels F) to additional cut back the potential for affected person publicity to formaldehyde.
- Bear in mind that GE HealthCare is updating person directions with the up to date working circumstances (30 levels C (86 levels F) most room air temperature) and indications to be used specifying that the compressors aren’t really useful to be used with neonates and infants (0-2 years of age).
- Report any points with use of the compressors to the FDA.