- The FDA said there was a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical Inc ICUI.
- The agency said the shortage was due to difficulties in raw material procurement and would most likely impact pediatric patients.
- A shortage of Bivona tracheostomy tubes is more likely to impact pediatric patients because the supply of alternative tubes with similar functionality may be limited.
- Bivona tracheostomy tube is commonly used in pediatric patients because the tube is made from a flexible silicone material, making it easier to insert in pediatric patients.
- A tracheostomy tube is used to help people breathe following a tracheotomy (a surgical procedure that creates a small opening in the neck directly into the windpipe or trachea).
- A tracheostomy tube is placed through the neck opening to allow patients to breathe through the tube instead of through their mouth or nose.
- The health regulator has recommended reusing tracheostomy tubes after following proper sanitary procedures to deal with the current shortage.
- Bivona tracheostomy tubes may be cleaned, sanitized, and reused up to five times for pediatric sizes and ten times for adult sizes.
- Price Action: ICUI shares closed at $148.41 on Monday.
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