FDA Adds Automated External Defibrillators and Others to Shortages List

Automated external defibrillators (AEDs) are used to help people who have suffered sudden cardiac arrest. Chest tubes are used to allow drainage of fluid or air from the chest. Autotransfusion systems allow a person to receive their own blood for transfusion instead of using banked allogeneic (separate donor) blood. All three devices are essential in the hospital setting. Unfortunately, the Food and Drug Administration (FDA) has added portable and non-portable AEDs, chest drains/suction boxes, and autotransfusion systems to the list of medical devices in short supply. This is due to the level of supply expected at least for the remainder of 2022. The FDA cited this due to both an increase in demand for these devices and a global shortage of the semiconductors used in their manufacturing.

The shortage of semiconductors has occurred throughout the Covid-19 pandemic, primarily due to manufacturing disruptions and high demand for cars and consumer electronics.

The medical device industry accounts for approximately 1% of global semiconductor demand. However, even giants like Medtronic are struggling to get semiconductor chips, at least the exact type needed for their devices. For the first quarter of 2022, ending April 29, Medtronic reported revenue $350 million lower than analysts’ projections. Medtronic CEO Geoff Martha said 75% of misfires were due to supply chain issues. Clearly, medical supply chain issues are widespread and not limited to semiconductor chips.

The FDA is currently working with federal partners and stakeholders to mitigate challenges associated with semiconductor shortages. They have also published guidance documents, including policies regarding the circumstances in which manufacturers may consider changing their devices due to supply chain issues.

The medical device industry’s AdvaMed (Advanced Medical Technology Association) has been lobbying the Biden administration to prioritize chip supplies for their industry. Meanwhile, lawmakers are proposing a $52 billion subsidy package for domestic chip manufacturing.

However, there is good news: medical gowns and surgical masks have been removed from the list of medical device shortages.

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Shirlene J. Manley