"This supply chain disruption disproportionally affects the pediatric population due to the already limited number of products available for this patient population and the spike in cases of respiratory illnesses in children," says Jillian Hillman, ECRI's senior manager, Functional Equivalents - Device Evaluation.
To help reduce the burden on healthcare providers and promote patient safety, ECRI has issued this functional equivalents report. ECRI will offer updated guidance as this situation unfolds.
The shortage includes the Bivona® tracheostomy tubes manufactured by ICU Medical. The shortage may be related to difficulties in getting the raw materials needed to make the tracheostomy tubes.
The FDA stated that this shortage could affect pediatric patients and pediatric healthcare providers more severely because the “because the supply of alternative tubes with similar functionality may be limited.” This is especially challenging currently, as 71% of the US’s pediatric beds are now filled.
The FDA said also that it is working with manufacturers and other stakeholders to “to help quickly resolve supply challenges and support availability of these critical devices for patients who need them.”
ECRI recommends that providers refer to our functional equivalents report to find vendors, including Medtronic and Tracoe, as both manufacturers that make alternatives to the pediatric products. ECRI also encourages you to follow the FDA’s recommendations and guidance, including reusing tracheostomy tubes, and following the manufacturer's guidance on cleaning, sanitizing, and reusing the tubes.
ECRI shared the FDA’s recommendations in its recently issue alert.
Report quality problems relating to the use of these devices to the device manufacturer and FDA’s Voluntary MedWatch Reporting system. Please be aware that this is an evolving situation, so check back for updates to ECRI’s functional equivalents report.
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