Defibrillators, chest drains added to FDA's list

TIME:2022-07-22 15:52 点击次数:
  • Defibrillators, chest drains added to FDA's list of device shortages

  • The Food and Drug Administration added automated external defibrillators (AED) and chest drains to its list of medical devices in short supply.
  • The shortage of chest drains with autotransfusion indications and suction canisters is because of increased demand, the agency said in an update on Tuesday. The AED supply disruption reflects both surging demand and problems sourcing 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 shortage list the agency drew up in the first months of the pandemic.
  • The FDA has continued to update the device shortage list since the CARES Act gave it the authority to help prevent or mitigate supply disruptions during or in advance of a public health emergency, while also seeking feedback on the notification process.

    Having initially focused 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 wearable and non-wearable AEDs, the supply disruption is expected to last for the duration of 2022, the FDA said.

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

    The FDA has less information on the chest drain shortages, saying only that they were caused by increased demand and that there is insufficient data to estimate the duration of the disruption. Companies including Medtronic and Fresenius Kabi have 510(k) clearances for devices with the same product code as those in short supply.

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

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