Legislation Requiring Anti-Choking Devices in NJ Schools Draws Doctors’ Concern

File Photo

By Dana DiFilippo, New Jersey Monitor
January 7, 2022

Devices touted to be a revolutionary new tool to stop people from choking look like little plastic plungers — one inventor said he was inspired to make his version of portable anti-choking devices after a shopping trip to Home Depot.

Their inventors claim the devices have saved hundreds of lives. One contends they are safer and more effective than the Heimlich maneuver and back blows, while another asserts theirs is “bound to become a standard of care.”

So it may be little surprise that lawmakers lined up to sponsor bipartisan legislation to mandate the devices in New Jersey’s 3,700 public and private schools, at a potential cost of close to $600,000.

Problem is, some medical experts say there’s insufficient scientific evidence showing they’re effective — and warn they could even cause injury.

The American Red Cross — an authority on CPR training — doesn’t train people on them because “these devices have not been validated by the evidence,” spokesman Don Lauritzen said. A children’s hospital in Boise warned against using them, saying they shouldn’t substitute for CPR training.

The devices are not regulated by the federal Food and Drug Administration, which worries some watchdogs who say they should be.

Dr. Robert Baratz, a Massachusetts internist and past president of the National Council Against Health Fraud, questioned why the state would spend hundreds of thousands of dollars on devices the FDA has not declared safe and effective.

“That’s nuts,” Baratz said. “If your child was choking, wouldn’t you rather have a trained firefighter there than to have a teacher fumbling with this suction thing that’s like a toilet plunger?”

Now, several lawmakers behind the effort to put such devices in every school cafeteria and school nurse’s office are backing away from the bill, after the New Jersey Monitor brought medical experts’ concerns to their attention.

“At this point, I’m going to withdraw my support for the bill,” said Assemblyman Jon Bramnick (R-Union), a prime sponsor and the Assembly’s Minority Leader.

Bramnick said he would be more supportive if the FDA approved the devices.

Assemblywoman Carol Murphy (D-Burlington), another prime sponsor, said she won’t advance the bill either, until her office can investigate further.

“If he’s pulled it back, I have no intention of going forward with it until we’re ready to do it, until we can make sure our children are safe and our faculty, schools, teachers — everyone is safe from any kind of harm, and that includes this equipment as well,” Murphy said.

A bill can proceed as long as it has prime sponsors, and Assemblywoman Angela McKnight (D-Hudson) is the third prime sponsor on the bill. McKnight spokeswoman Regina Wilder referred questions to Bramnick and Murphy, so it’s unclear if McKnight remains supportive.

On the Senate side, prime sponsor Sen. Kristin Corrado (R-Passaic) said she still supports the bill — and will reintroduce it in the next legislative session if it fails to pass in the remaining days of the current lame-duck session, which ends Tuesday. She also envisions expanding it to nursing homes, adult daycares, and “any kind of facility where it can save a life.”

“Certainly we don’t want anyone to be harmed, but we think it could save more lives than it could hurt, so we would be continuing with the bill,” Corrado said. “If somebody brings concerns to our attention, we would certainly listen.”

Insufficient scientific scrutiny?

In recent years, two companies — LifeVac and Dechoker — have dominated the burgeoning market for handheld manual plungers promoted as anti-choking devices.

They promote their products with slogans like “because every second counts!” and list clinical studies on their websites as proof of their devices’ efficacy. They offer running tallies online of “lives saved.” And they’ve scored plenty of fawning coverage on news sites, parenting blogs, and social media.

Both also note on their websites that they are “registered by the FDA.”

But FDA registration merely means the FDA is aware of the devices. The FDA classifies anti-choking devices as Class II Exempt devices, which carry “moderate risk” but are exempt from pre-market review.

Class III devices like pacemakers and infusion pumps require FDA approval or clearance. Approval requires rigorous testing to show devices are safe and effective, while clearance requires a general review by the FDA. No portable anti-choking devices have been cleared or approved by the FDA, a spokeswoman said.

The FDA inspects facilities that manufacture medical devices, and did so at Dechoker’s Colorado operations last February. In May, the agency sent a warning letter to Dechoker CEO Alan Carver outlining multiple violations — including “failures to establish and maintain adequate procedures to control the design of the device” — and threatening regulatory action if it doesn’t correct violations the FDA identified.

It’s unclear if they have been corrected. An FDA spokeswoman said the agency does not comment on “ongoing, open compliance matters.”

Critics contend that the companies’ online accounts of lives saved are anecdotal and scarce on details.

“We have a saying in the medical profession that the plural of anecdote is not data,” Baratz said. “Just because someone says something, they don’t deserve an equal stand on the stage with real science, unless they’re prepared to undergo the same scrutiny science does. Show me the scientific study that shows they have saved a lot of lives, instead of stories.”

While both companies list studies endorsing their devices, none tested the devices on live humans.

“A lot of these studies are done on mannequins, and that’s a problem,” said Dr. Michael Gerardi, an emergency medicine physician at Morristown Medical Center’s Goryeb Children’s Hospital.

One study, published in the Annals of Emergency Medicine in 2017, is problematic because the researchers who declared LifeVac devices successful are the sister, the brother-in-law, and an employee of LifeVac inventor Arthur Lih.

Researchers in a separate study involving a cadaver found the devices were not effective, failing to remove grapes and cashews lodged in their throats and injuring the tongue.

Dechoker has encountered other trouble. In 2018, state investigators in North Carolina accused the company of running an “investment scheme” and defrauding investors. Carver told Charlotte’s FOX TV station the company was fixing problems prosecutors identified and attributed the troubles to “growing pains that all companies go through.”

A British health care coalition claimed on social media that Dechoker UK posted misleading information on its website by claiming the coalition had endorsed its product.

Dechoker did not respond to multiple requests for comment. But LifeVac President Mike Plunkett said he has heard all the criticisms before.

“I would say the LifeVac is an effective alternative to dying,” he said. “That’s really what we’re talking about here. When you’ve tried your other protocol and it’s failed, are you just going to stand there?”

Plunkett said the LifeVac is intended as a “last resort.”

“We’re not saying don’t call 911. You should do that right away,” Plunkett said. “It’s not a rejection of current strategies. The abdominal thrusts and the Heimlich work, and they work a majority of the time. But if that doesn’t work, as a last resort then you go and try your LifeVac.”

Plunkett defended the dearth of studies on live humans.

“It’s hard to do studies like that, when you think about it, because are you going to say: ‘OK, lay on this table, and we’re going to choke you with a hot dog to see if this works?’” he said.

LifeVac has video proof that its device has saved choking victims, Plunkett added. The company also connected the New Jersey Monitor with one customer who said the device saved her son from choking on a sandwich in August.

Christine Zubrod, a mother of four from Ebony, Va., is an emergency medical technician who admits she was skeptical when her father first bought her a LifeVac. But when back blows couldn’t dislodge a wad of bread and cheese from her 4-year-old son’s throat, she grabbed the LifeVac, and the food popped out on her first try, she said.

“It was when I used it that I became an instant believer. It’s one of those things that you have and hope you never need, instead of need and not have it,” Zubrod said. “It needs to be everywhere — schools, nursing homes, day cares, restaurants.”

Plunkett said his company has sold more than a half million LifeVacs and has placed them in about 900 schools in the U.S.

New Jersey is the only state Plunkett is aware of where lawmakers are considering legislation mandating the devices. In October, LifeVac hired a Washington, D.C.-based lobbying firm, Tauzin Consultants, to advocate for the legislation, according to the New Jersey Election Law Enforcement Commission. Annual lobbying disclosure reports aren’t due until February, so it’s unclear how much money LifeVac spent on lobbying.

A similar measure in Wisconsin in 2019 failed.

Michael Yaple, a spokesman for the New Jersey Department of Education, would not comment on pending legislation.

Hands-on treatment still the standard

A5524/S3630 became a bill the way many bills do. Both Corrado and Bramnick said constituents brought it to their attention.

Bramnick said he was inspired to act because he was behind a 2012 measure to protect students at school, “Janet’s Law,” which requires schools to have portable defibrillators and train at least five school employees in its use and CPR. As for Corrado, she explained: “It just made so much sense – a simple solution to a problem that could be averted.”

The cause proved popular enough that 14 other lawmakers signed on as sponsors since Corrado and Bramnick introduced it last spring.

It’s unclear how often students choke in schools. But medical professionals say choking is most common among babies, toddlers, and small children, as well as elderly people.

Statistics from the state Health Department back that up. People 85 and older were consistently most at risk of choking to death between 2015 to 2019, according to the health department’s most recent data. Of 158 people who choked to death in 2019, three were young people, including a baby under 1 and two people between the ages of 15 to 24, the data shows.

In Gerardi’s view, the devices offer panicked parents and caregivers another tool to use in case traditional methods like chest thrusts don’t work.

Still, he noted, “it is a concern that there is a device out there without much rigorous study.”

Under the bill, the state Department of Education would reimburse public and private schools whatever they pay to get the devices — although no cost estimate is specified. The devices generally run $40 to $80 each, which means it could cost $298,000 to $598,000 to put two in each of the 3,736 public and nonpublic schools that are registered with the state Department of Education.

Dan Gerard thinks the state would be better off saving its money for something else, like getting more teachers and school staff trained in evidence-based CPR methods.

Gerard is president-elect of the International Association of EMS Chiefs. He worked as a paramedic and nurse for years in multiple North Jersey hospitals and communities. He remembers one Newark hospital in the 1980s buying portable anti-choking devices called the Throat-E-Vac.

The hospital quit using them after just a few weeks.

“It didn’t clear the obstruction, but it did bring up everything out of your stomach,” Gerard remembered. “Every time we used this device, it was an absolute nightmare. We had hundreds of these Throat-E-Vacs and we got rid of them because we had these vomiting issues.”

When it comes to choking, Gerard said, the best approach is already in everyone’s hands, literally.

“Abdominal thrusts and chest thrusts for an adult, and back blows and chest thrusts for an infant are the standards,” he said. “Choking can cause irreversible brain damage or death after four to six minutes. Even the simplest technology can fail, so when the device doesn’t work, we have to resort back to our head, our hands, our eyes, and our brain. We bring those with us to every emergency.”

GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX

New Jersey Monitor is part of States Newsroom, a network of news bureaus supported by grants and a coalition of donors as a 501c(3) public charity. New Jersey Monitor maintains editorial independence. Contact Editor Terrence McDonald for questions: [email protected]. Follow New Jersey Monitor on Facebook and Twitter.