On Oct. 31, 2022, The Food and Drug Administration added tracheostomy tubes to the administration’s medical device shortage list, including Bivona tracheostomy tubes manufactured by ICU Medical, San Clemente, Calif. The Bivona shortage is more likely to affect pediatric patients
The safety communication was issued to notify caregivers and healthcare providers that tubes may be in short supply due to the impact of COVID-19 on the global supply chain. The FDA is working closely with manufacturers to quickly help resolve shortage issues of these critical devices.
In addition, the FDA recommends the following protocols for patient caregivers and healthcare providers.
For patient caregivers:
- Follow the manufacturer’s instructions for cleaning, sanitizing, and reusing tubes for the maximum number of times allowed.
- Work with healthcare providers and durable medical equipment (DME) suppliers to determine if there are appropriate alternatives that can be used. (View the FDA-cleared tracheostomy tubes using different raw materials at www.bit.ly/TrachAlternatives.)
For healthcare providers:
- Discuss FDA recommendations and conservation strategies with all patients who use tracheostomy tubes and their caregivers.
- Contact your distributor or the manufacturer directly to inquire about current inventory, including any appropriate alternatives. (View the FDA list above.)
You can read the full safety communication at www.bit.ly/FDATrachSafety.