FDA Recommends Reusing Tracheostomy Tubes or Switching to Appropriate Alternatives Because of Shortage
On October 31, 2022, the U.S. Food and Drug Administration (FDA) alerted (https://www.fda.gov/medical-devices/safety-communications/reuse-tracheostomy-tubes-or-switch-appropriate-alternatives-during-shortage-fda-safety-communication?utm_medium=email&utm_source=govdelivery) patients, caregivers, and healthcare providers of a tracheostomy tube shortage, including Bivona tracheostomy tubes manufactured by ICU Medical, because of difficulty obtaining required raw materials. FDA said it is working with manufacturers and other stakeholders to help resolve supply challenges and support the devices’ availability.
The Bivona tracheostomy tube shortage may affect pediatric patients in particular because the supply of alternative tubes may be limited. Although other tracheostomy tubes are FDA-cleared (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&Center=&Panel=&ProductCode=joh&KNumber=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=10/03/2022&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=500) for pediatric patients, their availability may be insufficient to mitigate the shortage. ICU Medical reported that it provided customers with additional details on supply constraints and efforts to reduce the shortage.
To reduce the number of tracheostomy tubes used during the shortage, FDA recommended that patients and caregivers:
- Follow the manufacturer’s instructions for cleaning, sanitizing, and reusing tracheostomy tubes for the maximum number of times allowed.
- Work with their healthcare providers and durable medical equipment suppliers to determine if alternatives are available, such as other FDA-cleared tracheostomy tubes that may use different raw materials (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&Center=&Panel=&ProductCode=joh&KNumber=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=&ClinicalTrials=&Decision=&DecisionDateFrom=&DecisionDateTo=10/03/2022&IVDProducts=&Redact510K=&CombinationProducts=&ZNumber=&PAGENUM=500).
FDA recommended that healthcare providers:
- Review the recommendations for patients and caregivers.
- Discuss the recommendations with patients who use the affected devices and their caregivers.
- Consider using the recommended conservation strategies in healthcare settings as well as encouraging it in home settings.
- Contact their distributors or manufacturers to ask about inventory and whether appropriate alternatives are available.
FDA said that it is working with manufacturers to help obtain materials and expedite supplies of tracheostomy tubes that meet FDA safety and effectiveness standards , and it added tracheostomy tubes to its medical device shortage list (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency#shortage). Contact FDA about a medical device supply chain issue (https://www.fda.gov/medical-devices/medical-device-safety/contact-fda-about-medical-device-supply-chain-issue) if you are experiencing tracheostomy tube supply issues.
Healthcare professionals should report any adverse reactions or quality problems (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda) they suspect are associated with the device to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.