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July 25, 2022

FDA adds automated external defibrillators and other medical devices to shortage list

According to the FDA, there is short supply of wearable and non-wearable AEDs and other medical devices.

By GlobalData

Automated external defibrillators (AEDs) are used to help those experiencing sudden cardiac arrest. Chest drains are used to allow the draining of fluid or air from the chest. Autotransfusion systems allow for a person to receive their own blood for a transfusion instead of using a banked allogenic (separate-donor) blood. All three devices are vital in a hospital setting. Unfortunately, the Food and Drug Administration (FDA) has added both wearable and non-wearable AEDs, chest drains/suction canisters and autotransfusion systems to the list of medical devices in short supply. This is due to the level of supply expected for at least the rest of 2022. The FDA cited this due to both an increase in demand for these devices and a global shortage of semiconductors used in their manufacture.

The shortage of semiconductors has been occurring throughout the Covid-19 pandemic, mainly due to manufacturing disruption and high demand for cars and consumer electronics.

The medical device industry composes about 1% of the global demand for semiconductors. However, even giants like Medtronic are having a hard time obtaining semiconductor chips—at least, the exact kind needed for their devices. For Q1 2022, ending April 29, Medtronic reported sales revenue $350m lower than analyst projections. The CEO of Medtronic, Geoff Martha, stated that 75% of the miss was due to supply chain issues. Evidently, medical supply chain issues are very prevalent and not limited to semiconductor chips.

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

The medical device industry’s Advanced Medical Technology Association (AdvaMed) has lobbied the Biden administration to prioritize chip supplies for their industry. Meanwhile, lawmakers are advancing a $52bn package of subsidies for domestic chip manufacturing.

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

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