Pediatric Airway Balloon Dilation: Urge for Safety Redesign

Area of Science:

• Otolaryngology
• Medical Device Safety

Background:

• Airway balloons are a common tool for otolaryngologists treating laryngotracheal stenosis.
• Accidental airway irrigation is a potential, though rarely reported, adverse event associated with these devices.

Conclusions:

• Accidental airway irrigation is a serious adverse event that can occur with airway balloon devices.
• Current safety reporting systems may not fully capture the incidence of such events.
• Redesign of the Acclarent airway balloon device is recommended to prevent accidental irrigation and improve patient safety.