FDA Announces AED Shortage – What This Means & Why It’s a Big Deal
Since the beginning of the COVID-19 pandemic, supply chain disruptions have impacted the production of goods across industries, and medical technology is no exception. From baby formula to cars, from garments to lumber, things have been harder to get.
In July, the FDA officially added AEDs, both units and parts, to their device shortage list, citing an overall “demand increase for the device,” along with a “shortage or discontinuance of a component, part or accessory” for the delays in production. While the increase in demand speaks to a positive shift in public preparedness and, overall, seems like a good thing, the lack of device availability poses two key problems for the industry and public health at large:
- The shortage of batteries and pads is rendering some public AEDs useless, with owners unable to maintain their devices, and
- New and existing establishments and organizations cannot procure new devices, leaving their populations vulnerable and underprepared to respond to Sudden Cardiac Arrest (SCA).
Although AEDs are composed of hundreds of unique parts, the lack of just one can impact the device’s stock for distributors everywhere. The shortage of semiconductors has stalled AED production for the last year, and the FDA expects the delays to last through the end of 2022.
Semiconductors are vital components of electronic chips, which are found in anything computerized–so patient monitoring devices, TVs, washing machines, not to mention cell phones and cars all rely on this single part. Needless to say, AED manufacturers have to compete with the demand of various industries, and the life saving nature of the device is no guarantee when it comes to parts allocation or procurement. Medical devices represent the minority of semiconductor demand, which is why large companies like Philips, Stryker, BD, and ResMed have been advocating for medical technology organizations to receive first priority when it comes to accessing these chips.
In a piece for the World Economy Forum, Royal Philps CEO Frans van Houten wrote, “Due to the urgent need for these in the medical technology industry, representing just 1% of the total supply, we call for chip allocations to be prioritized to a level that enables the industry to meet the medical-device manufacturing demands of today.”1 He claims AED lead times, “have ballooned to more than 52 weeks,” and argues that the lack of devices can pose a threat to public safety.
Confirmed by several nonprofits, AED lead times have been either extremely long, vague, or nonexistent.
Tina Eisenbeis who runs The London Strong Foundation, a nonprofit out of Grand Blanc, Michigan, says she has had difficulty obtaining these devices since last year. Her foundation raises awareness for SCA in children after her daughter, London, suffered SCA while at a waterpark in 2018. By offering low-cost CPR courses, advocating for heart screenings, and donating AEDs, Tina is working hard to inspire change in her community. However, the shortage has impacted her ability to fulfill her mission to grant AEDs to local organizations, “Last week we had our huge annual race, and every year I donate an AED in person, and I didn’t do it this year. It’s another promise I can’t fulfill.”
It’s been over eleven months since Tina has been able to obtain an AED for The London Strong Foundation, and she says, “it’s so frustrating because we’re still having these events, and I still have money sitting there waiting. There’s just nothing to give.”
Nonprofit organizations across the country have expressed similar difficulties, “We normally donate 50-75 AEDs a year, but we have had to close our program indefinitely until the AED shortage is [over],” says the Peyton Walker Foundation of Camp Hill, Pennsylvania.
Tina isn’t the only nonprofit leader feeling the effects of the backorders and considering the greater social implications. The Peyton Walker Foundation’s Asheleigh Forsburg sheds light on some of the larger problems resulting from the shortage, “We’re going to be losing a lot of people’s focus on the importance of having an AED available.” This loss of momentum not only impacts the work of nonprofit organizations, but it has the potential to negatively impact community health as it stifles efforts to combat SCA. “When disruptions in the systems like this occur, it’s going to detract people from even trying to protect their organization…if they have to wait a year, they’re not gonna wait,” says Asheleigh.
The current AED shortage is compounded by the fact that even before supply chain delays, AEDs, historically, have not made it into enough public spaces to provide meaningful improvements to SCA patient outcomes. With even fewer AEDs available now, people may be even more vulnerable.
Additionally, AED batteries and electrode pads expire over time and must be replaced regularly. Because of the supply shortages, many of these AED disposables are not available for replacement, rendering many devices that need maintenance useless. At Avive, we’re constantly looking for ways to solve existing industry problems and improve our society’s response to SCA, and we look forward to sharing new ways we hope to address these challenges in the future.
It is our hope that the medical device industry will be a priority when it comes to manufacturing and distributing these limited quantities of semiconductors. The need for AEDs is growing as public awareness of SCA strengthens, largely due to community grassroots effort and the work of nonprofit organizations, and it is essential to preserve these endeavors in order to create a safer, more prepared society.
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