GE Healthcare notice about ventilator formaldehyde risk triggers FDA alert

Dive Brief:

The Food and Drug Administration is alerting healthcare professionals about the potential for GE Healthcare ventilator accessories to expose patients to formaldehyde.
GE Healthcare sent an urgent medical device correction on Dec. 29 to warn customers about elevated levels of the toxic gas when its EVair or EVair 03 optional compressors are used in certain conditions.
The actions, which include a recommendation against using the compressors with children aged two years and under, follow earlier concerns about formaldehyde levels in neonatal incubators.

Dive Insight:

The FDA alerted healthcare providers 11 months ago about the potential for neonatal incubators to emit airborne chemicals. For incubators distributed before Sept. 5, GE Healthcare adopted a new process to reduce the levels of formaldehyde by having the device run for a week prior to clinical use.

Separately, the FDA provided an update last week telling healthcare providers that Drager has fixed the airborne chemical concern in its new neonatal incubators.

However, problems with other devices have recently come to light. GE Healthcare learned that elevated levels of formaldehyde are seen when its EVair or EVair 03 compressors, used with its Carescape R860 or Engström Carestation/Pro ventilators when wall air is not available, are run under certain conditions.

The conditions are unlike those seen in typical clinical use. Elevated formaldehyde was seen when the accessories were used at a room temperature of 104 degrees Fahrenheit, at the lowest possible flow condition and with all of the gas being supplied from the compressor. GE Healthcare does not know how much formaldehyde is present during typical clinical use, or whether there are potential health risks.

No reports of patient injury or adverse effects related to potential exposure to formaldehyde are linked to the devices, but GE Healthcare has proposed actions to mitigate the theoretical risk. The company has lowered the maximum room air temperature for operation of the compressors to 86 degrees Fahrenheit, and is advising against the use of the compressors with children aged two years and under.

The FDA shared the recommendations in its letter to healthcare providers. GE Healthcare is working with the agency to “conduct additional testing to further evaluate this issue.”