Medical device deliveries stalled after sterilization plant closed

Earlier this year the Illinois Environmental Protection Agency issued an order that shut down operations at a large sterilization facility in Willowbrook, Ill., owned by Sterigenics. Now, despite the FDA preparing for delays and potential device shortages, several devices are in short supply, according to a notice on the FDA website and several device manufacturer letters obtained by Becker's Hospital Review.

The FDA alerted providers to a shortage of pediatric breathing tubes manufactured by Smiths Medical. The Bivona tracheostomy tubes are used in healthcare facilities and at home to help adult and pediatric patients breathe. While approved for use in both adult and pediatric patients, the temporary shortage is likely to affect pediatric patients because there is a limited supply of other alternatives, according to the FDA notice.

The FDA is working with Smiths Medical to "quickly resolve their sterilization challenges and bring these critical devices to the patients who need them as quickly as possible," according to the notice. They expect the critical devices to be available again the week of April 22.

Another supplier, Guerbet USA,  alerted customers in March that its "consumables for Optistar, Optivantage and Illumena power injectors may experience limited availability" until the sterilization issues are resolved.

Additionally, Cardinal Health alerted customers of a temporary supply shortage of its Kendall intrauterine pressure catheter related to the sterilization facility closure, according to a customer letter obtained by Becker's.

The shortages are expected to be temporary.


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