Supply shortages hit trachea tubes and single-use biopsy equipment, FDA warns

An overloaded and understaffed supply chain has led to shortage after shortage of crucial medical gear since the start of the COVID-19 pandemic.

Latest to see their supplies dwindle are certain makers of tracheostomy tubes and disposable equipment used in MRI-guided biopsy procedures. In a pair of safety notices this week, the FDA urged healthcare providers to either seek out in-stock alternatives to the affected products or, in the case of the tracheostomy tubes, reuse them as many times as possible.

In a tracheostomy, a tube is inserted through the front of a patient’s neck into a surgically created hole in the windpipe. The tube is then connected to an oxygen supply and ventilator to help the patient breathe.

There’s currently a shortage of many of those tubes, according to the FDA, which specifically noted the reduced availability of ICU Medical’s Bivona tracheostomy tubes. The agency said the shortage stems from difficulties in accessing the silicone raw materials needed to make the products and confirmed that it’s already taking steps to help boost supply.

In the meantime, however, the FDA offered a pair of suggestions to help meet demand. First, healthcare providers should make a point of reusing the tubes to their maximum abilities. The Bivona versions, for example, can be cleaned, sanitized and reused in the same patient up to five times for children and 10 times for adults.

Since reuse of the tubes is limited, the FDA offered up a backup recommendation: Healthcare providers may want to look into alternative FDA-cleared tubes, including those that use different raw materials than the Bivona tubes and other similar options.

Even with those recommendations, the regulator noted that pediatric patients may be hit especially hard by the shortage because “the supply of alternative tubes with similar functionality may be limited” and because, going by the reuse standards, they’ll go through tubes at twice the rate of their adult counterparts.

In an attempt to mitigate those effects, the FDA said it’s working with manufacturers, durable medical equipment suppliers and the U.S. Department of Health and Human Services’ strategic preparedness and response agency to boost the makers’ access to raw materials and help speed up their production of the tubes.

Meanwhile, Philips has also reported shortages of several grid plates and needle blocks used in MRI-guided biopsy procedures, the FDA said in the second of this week’s notices.

The full list (PDF) of affected devices—all meant to be thrown away after use—includes grid plates that are used during breast biopsies to help doctors chart out the exact location of a possible abnormality detected in an MRI scan. Needle blocks are inserted into the grids to help guide a biopsy needle into the correct location.

Philips said on its website that “the delays have been caused by several factors,” without going into further detail. The company confirmed that “shipments are continuing and backorder times are decreasing” for the affected products, but the FDA noted that the shortage “is estimated to continue through the end of 2022.”

Until supply is back to normal, the FDA is recommending that healthcare providers who are short on the biopsy gear send their patients to undergo needed procedures at other nearby facilities that do have the products in stock. The agency, which has been working with Philips to ramp up shipments, said the duo is currently prioritizing areas without any alternative imaging centers nearby.