Vent manufacturers reassure providers

YARMOUTH, Maine – Manufacturers are fielding calls from providers seeking guidance after Resmed issued a field safety notice for certain Astral ventilators and federal officials announced the end of COVID-era emergency use authorizations.

Resmed on July 15 issued a voluntary global medical device correction/field safety notice for its Astral 100 and Astral 150 ventilators built prior to October 2024 due to the potential of supercapacitors leaking over time. The leakage, the company says, could damage internal parts and result in the vents incorrectly entering a protective safety mode.

Several weeks earlier, on June 30, the U.S. Department of Health and Human Services (HHS) announced that the EUA it initiated during the COVID-19 pandemic for medical devices will end in 180 days.

“We’re getting calls asking us if we can help,” said Chris Southerland, commercial senior vice president for the Americas region at Breas Medical. “The providers that want to stay in the vent business need to make sure they have a stable supply chain.”

These recent developments come on top of two other major changes that have challenged the ventilator provider network: New guidelines that took effect in October requiring providers to meet more stringent documentation and therapy compliance requirements, and a Philips recall in 2021 of certain vents.

“Things had been starting to calm down before now,” Southerland said.

React Health says it is also hearing from existing and prospective provider customers.

“Which tells us,” said Bill Shoop, CEO, “that there is real uncertainly in the market.”

Southerland says providers are currently evaluating their needs, including what ventilators may need to be swapped out and which patients should be prioritized.

“They’re taking our temp,” he said. “We have inventory on hand, but we’re also feeding in high-, medium- and low-probability cases for what demand might look like to make sure we have everything we need for them.”

Shoop says React Health also has inventory on hand and additional capacity in its Bothwell, Wash., manufacturing facility if needed.

“It’s worth remembering that React Health – as Ventec Life Systems at the time – worked closely with HHS, General Motors and the first Trump Administration to build (vents) for the Strategic National Stockpile (SNS) during COVID and are experienced at successfully scaling production as needed to fulfill market demands,” he said.

Both manufacturers say the industry is better positioned to respond to supply disruptions than it was during the height of the pandemic and Philips recall, thanks in part to lessons learned over the last several years.

“Manufacturers learned a lot about having redundant suppliers,” Southerland said.

Shoop says these most recent events are less about making changes and more about continuing what React Health has always done.

“We have always had an experienced team of specialists in the field working directly with hospitals and providers to educate them on (our) value,” he said.