FDA Encourages Tracheostomy Tube Reuse Due to Supply Shortages

Update (April 19, 2023): As of April 19, 2023, the US FDA did not post an update to their safety communication originally published on October 31, 2022, on the tracheostomy tube shortage. As of April 19, 2023, the FDA’s medical device shortage list still includes products classified as JOH (Tube Tracheostomy and Tube Cuff) and BTO (Tube, Tracheostomy (w/wo Connector), and indicates that data is still not available to estimate the duration of the shortage. In addition, on November 15^th, 2022, Andrew Georgilis, president and CEO of Bryan Medical, a manufacturer of tracheostomy tubes and speaking valves, told ENTtoday that the tracheostomy tube shortage likely “isn’t going to be over until the end of 2023.”

Originally published November 28, 2022:

The US Food and Drug Administration (FDA) released a safety communication on October 31, 2022, indicating there is a tracheostomy tube shortage, including a shortage of Bivona tracheostomy tubes manufactured by ICU Medical. Pediatric patients are the most prone to be impacted by the shortage of Bivona tracheostomy tubes because there could be a limited supply of alternative tubes with a similar function.

The FDA has also issued an advisory for patients, caregivers and healthcare professionals who are or will be using these products.

What is a Tracheostomy Tube?

A tracheostomy is the surgical creation of a hole (stoma) in the windpipe (trachea) to support an alternative airway for breathing. The instrument used in a tracheostomy is called a tracheostomy tube, which can be connected to a ventilator in order to monitor breathing. The type of tube depends on the patient’s needs, and many of these tubes are authorized for reuse after proper cleaning and sanitization.

FDA’s Alert To Patients and Caregivers

To better handle the supply shortage, the following steps are advised by the FDA:

• Carefully read and follow the user instructions for the tracheostomy tubes to understand the maximum number of times a tracheostomy tube can be cleaned, sanitized and reused.
  • For instance, the user manual for Bivona tracheostomy tubes indicates that they may be cleaned, sanitized and reused for single-patient use up to five times for pediatric sizes and up to ten times for adult sizes.
• Communicate with the respective healthcare provider and durable medical equipment (DME) supplier to learn if there are suitable alternatives, such as FDA-cleared tracheostomy tubes that might use different raw materials.

The FDA’s Recommendations to Health Care Providers

The FDA recommends that health care providers also review the recommendations for patients and caregivers and to discuss these recommendations with patients and caregivers who use tracheostomy tubes.

According to the FDA, health care providers should consider using the recommended tracheostomy tube conservation strategies in health care settings in addition to encouraging the use of these conservation strategies in home settings.

The FDA also recommends that health care providers can contact their manufacturer or distributor to get updates on current inventory and learn if suitable FDA-approved alternatives are available.

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Why is There a Shortage of Tracheostomy Tubes?

Manufacturers have encountered difficulties in obtaining the raw materials needed to produce tracheostomy tubes. The FDA stated that the shortage is primarily due to the manufacturers’ challenges in accessing the silicone raw materials needed to produce the product. The FDA is working with the manufacturers and suppliers to mitigate the emergency by expediting the supply of the raw materials.

Reporting to the FDA

The FDA encourages users who have supply issues for tracheostomy tubes or other devices to contact the agency about a medical device supply chain issue.

In case of any problem with a medical device, the FDA urges individuals to report the problem by using their MedWatch Online Voluntary Reporting Form.