Defibrillators and chest drains added to FDA’s list of device shortages

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Diving Brief:

  • The Food and Drug Administration added automated external defibrillators (AEDs) and chest drains to its list of medical devices in short supply.
  • The shortage of chest tubes with indications for autotransfusion and suction canisters is due to increased demand, the agency said in an update Tuesday. The disruption in DEA supply reflects both increasing demand and supply issues for a component, part or accessory.
  • The FDA also removed medical gowns and surgical masks from the list of device shortages. Both products were on the list of shortages the agency drafted in the early months of the pandemic.

Overview of the dive:

The FDA has continued to update the list of device shortages since the CARES Act gave it the authority to help prevent or mitigate supply disruptions during or before a public health emergency, while also ask for feedback on the notification process.

After initially focusing on personal protective equipment, testing supplies and ventilators, the list has expanded to cover a range of shortages, some of which are only indirectly related to the pandemic.

For portable and non-portable AEDs, the supply disruption is expected to last for the duration of 2022, the FDA said.

In a footnote, the FDA added that there is a global shortage of semiconductor chips that are essential for some medical devices. The regulator linked to the footnote in its description of issues with a component, part, or accessory that affect AEDs. Six entries – two DEAs and four ventilators – are linked to the chip shortage.

The FDA has less information on chest drain shortages, saying only that they were caused by increased demand and that there is not enough data to estimate how long the disruption will last. Companies such as Medtronic and Fresenius Kabi have 510(k) clearances for devices with the same product code as those out of stock.

While the FDA removed medical gowns and surgical masks from the shortage list, other personal protective equipment such as gloves and surgical respirators remain in short supply, he said.

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