Welcome
Pharmaceutical & Life Sciences News

Broken Ventilators Require Easier Fixes, Black Leaders Demand

April 29, 2020, 9:45 AM

Broken ventilators are the latest problem facing black communities that have so far borne the brunt of coronavirus deaths.

States and large cities recently received damaged ventilators from the U.S. stockpile, rendering them unusable. With ventilators in short supply, minority advocates demand governments and manufacturers take steps to make it easier to fix broken equipment.

Ventilators are necessary not just for Covid-19 patients but also those with respiratory conditions like asthma, which is three times more likely to kill black people, according to the Centers for Disease Control and Prevention.

Color of Change, a civil rights advocacy organization, in an April petition called on ventilator manufacturers including Medtronic and GE Healthcare and trade group AdvaMed to release design specifications to enable hospitals to fix the broken devices. But device manufacturers are struggling to balance the rising demand for usable ventilators with the need to protect their brands and reduce liability risks.

“We’re definitely preparing to ramp up our pressure because they feel like they don’t have to be accountable in these ways and they can be dismissive of the race disparities that we’re seeing play out right now,” Brandi Collins-Dexter, senior campaign director at Color of Change, said. “It’s on these companies to release the full design specifications of the ventilators to make them more useful for hospitals so they can be fixed. That will fill the gap and increase production.”

Medtronic in March announced it would make specifications available for one of its ventilators. Hospitals already have service manuals for basic troubleshooting, but making its material more widely available won’t increase the number of ventilators at hand, the company said.

Repair Handbook Fears

California Gov. Gavin Newsom tweeted that Los Angeles received 170 broken ventilators from the stockpile in March. Northwell Health, the largest health system in New York state, told Bloomberg Law that most of the few hundred ventilators it received were missing air hoses and stands. A spokesman for the New York State Department of Public Health said only one of the 2,140 ventilators the state received from the strategic national stockpile had to be sent out for maintenance first. All of the equipment was checked before being sent out to hospitals, he said.

As ventilator demand keeps rising, medical device makers may not want to release repair information to protect their spot within the market, according to Marissa Fayer, CEO of HERHealthEQ, a medical advocacy group for women.

“Medical device manufacturers hold the intellectual property and patents for their equipment, so only themselves or licensed service providers would be able to perform maintenance,” Fayer said. “In a normal world, this is a large source of revenue for them, so it would be natural that their IP is protected, as not to have copies in the market.”

Ventilator makers may also fear potential product liability claims if the device malfunctions, according to Benjamin Fenton, partner at the Fenton Law Group, a health-care firm in California.

“If the manufacturer tries to make the good faith effort, which we want them to do, and say we’re going to work with hospitals so they can repair these defective machines, and then there is a mistake by the hospital in attempting to fix, then you possibly expose the manufacturer to liability, and the manufacturer is worried that attempting to make unusual concessions to fix the devices will come back and bite them if there are mistakes,” he said.

Medical device company trade group AdvaMed said it appreciated Color of Change for reaching out, but that device makers have to adhere to strict Food and Drug Administration regulations to ensure products are safe and effective.

“The bottom line is that medical technology companies or their designated representatives are best equipped to service their products and keep patients who use them safe, and they are effectively serving the needs of patients and health care providers to respond both to the Covid-19 pandemic and other, ongoing health care needs,” Jim Jeffries, an AdvaMed spokesman, said.

‘Right to Repair’

The federal government enforced the Defense Production Act in March to require manufacturers such as General Motors Co. to produce ventilators amid Covid-19.

But, what happens when they break? States are trying to come up with that answer.

States such as California and New York are considering “right-to-repair” bills, which would allow hospitals to fix equipment and require companies to provide them parts and service information.

“This legislation recognized as a norm would make it more feasible and it would be easier for the makers to understand why it should make this information available,” Olivia Webb, outreach coordinator at iFixit.com, said.

iFixit.com crowdsourced thousands of repair manuals to hospitals with ventilators and anesthesia machines when the crisis hit, Webb added.

“We have roughly 21 states that have introduced it, but we’re still pushing for it,” she said.

Hurting the Most Vulnerable

The black communities have been significantly hit by coronavirus deaths, despite only accounting for 13% of the U.S. population.

For example, black residents constitute roughly 41% of Maryland’s Covid-19 deaths, but only make up roughly 30% of the state’s total population. In Chicago, black residents account for almost 60% of the city’s Covid-19 deaths, whereas the community comprises about 30% of the population, according to data released by the city’s Department of Public Health.

And in Washington, D.C., nearly 60% of Covid-19 deaths are from the black community, despite accounting for nearly 45% of the city’s population as of early April, according to the district’s reported data.

“It becomes more of a dire circumstance when patients with respiratory issues—particularly African Americans—worsen to the point where they need a ventilator because there isn’t a high rate of survival with that,” Leon McDougle, National Medical Association president-elect and family physician, said.

To contact the reporter on this story: Ayanna Alexander in Washington at aalexander@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

To read more articles log in. To learn more about a subscription click here.