COFAR blog

It was a scary moment for Suzanne Marshall when she learned that her brother Gary had nearly choked to death while eating in his group home in Lexington in January.

Gary uses a wheelchair and can’t assist in efforts to administer the Heimlich maneuver or CPR on him.

As Gary was choking, a staff member first applied several sharp blows to his back, which did not dislodge the food particle. Then a male staff member dragged him out of his wheelchair, placed him on the floor and administered CPR, which successfully dislodged it.

While the episode had a fortunate outcome, Suzanne is concerned that it could happen again, and that this time, a staff member capable of getting Gary out of the wheelchair might not be available.

Suzanne noted that often at the group home, there are either only one or two female staff working. She is concerned that in this situation, a single staff person may not be strong enough to pull her brother out of his chair. He is a total dead weight, she said, and is heavy.

Gary Marshall

Then Suzanne heard about a small airway suction device, which she said has been used successfully in Gary’s day habilitation program.

Called the LifeVac, it is meant to be placed over a choking victim’s mouth and nose while air is compressed out of it, causing a vacuum. If the LifeVac is used, the victim can remain seated in their wheelchair.

Suzanne contends there is a good chance the LifeVac, or another device of similar quality, could save her brother’s life if he were to experience another choking episode and all other measures had failed. In that case, the device would do no harm even if it was also unsuccessful.

Gary, who is 68, is intellectually disabled. He has a tendency to eat too quickly, which can cause choking problems. Due to a craniotomy for cancer and subsequent chemotherapy and radiation, Suzanne said, Gary has continued to decline both physically and intellectually. She said his tendency to choke is due both to dysphasia and his intellectual disability.

Suzanne first asked the manager of Gary’s group home, which is run by JRI, whether the staff could be trained to use the LifeVac as a last resort if existing protocols for helping Gary in a future choking episode were unsuccessful. But her request was denied by JRI, so she contacted the Department of Developmental Services (DDS), which funds the provider.

On June 4, Suzanne received a reply from Meghan Allen, the DDS ombudsperson, stating that the DDS area office and the medical staff were “unable to clear the usage of a non-FDA cleared device should your brother experience another choking event.”

Allen maintained that the device “is not in common use,” and contended that it “has the potential to evacuate air from the lungs and leave the object stuck in the airway. Upon your continued interest in using LifeVac,” Allen added, “the staff did outreach and research and could not find evidence that supports its use in this setting.”

But when Suzanne looked further into the issue, she said, she found studies had recommended the LifeVac. She also found out that the FDA doesn’t clear or approve Class II suction devices, which is how the LifeVac is classified. The FDA requires only that companies that make such devices register with the agency, which the LifeVac company has done.

But none of that has swayed either JRI or DDS. They have continued to deny the use of the device in the group home.

State legislator contacted

Suzanne tried turning to State Representative Michelle Ciccolo, whose district includes Lexington, where Gary’s group home is located. Ciccolo’s legislative aide did contact DDS. But Ciccolo was apparently satisfied with DDS’s position after hearing back from Allen.

I wrote to Ciccolo on June 20, rebutting the arguments put forward by Allen. I also wrote to Allen, similarly rebutting the arguments against using the LifeVac device.

Rebutting statements that the LifeVac is not in common use and allegedly leaves objects stuck in airway

In my messages to Ciccolo and Allen, I noted that with regard to the LifeVac’s usage, the company maintains that the device has been “reviewed, purchased, and implemented” in over 7,900 schools, 330 fire departments, 230 police departments, and 45 hospitals, as well as in “numerous Emergency Response Training Centers, disability facilities, eldercare homes, medical offices, dental practices, restaurants, corporations, and churches, (and) in over one million homes across the country.”

As noted, the LifeVac is used by Gary’s dayhab program. That is, in fact, how Suzanne found out about the device.

With regard to the claim that the LifeVac device leaves objects stuck in the airway, a peer reviewed study says the opposite. The study, published in The International Journal of Clinical Skills, specifically says objects getting stuck in the airway do not constitute a risk with the device.

The study noted that after the LifeVac’s face mask is applied, “a one-way valve on the plunger generates negative pressure. On downward thrust of the plunger, air is forced out the sides of the device and not into the victim. This,” the study said, “avoids the possibility of pushing an obstructing object further into the airway.”

While risks of the LifeVac can include edema and bruising from the generated suction, the study concluded that “the benefit of saving a life clearly outweighs these small risks.”

The study recommended that the LifeVac “be available for use in settings with high risk for choking such as nursing homes and day care centers, and possibly all public eating facilities.”

LifeVac operation instructional diagram

Several peer reviewed studies have been highly positive about the LifeVac

As noted, Allen had further had stated that DDS and medical staff had done research, but couldn’t find evidence supporting the LifeVac’s use.

Allen didn’t describe the research she was referring to. In my messages to Allen and Ciccolo, I noted that Suzanne had provided DDS with a list of eight peer-reviewed studies, which found the LifeVac device to be highly effective.

One of the studies, published by the Frontiers journal, described self-reported data regarding the use of the LifeVac device “in adult patients with oropharyngeal dysphagia during real-world choking emergencies recorded between January 2014 and July 2020.” According to the study:

Over a 6-year monitoring period, the (LifeVac) device has been reported to be successful in the resuscitation of 38 out of 39 patients with oropharyngeal dysphagia during choking emergencies…This portable, non-powered suction device may be useful in resuscitating patients with oropharyngeal dysphagia who are choking.

To be clear, Suzanne is not suggesting that the LifeVac device be authorized to replace existing choking protocols at the group home. As noted, she has asked that the device be used as a last resort should all existing protocols fail.

We hope DDS will take another look at Suzanne’s request with regard to this device. If used as a last resort, as intended, the device will do no harm.

At best, the LifeVac will, and has, saved lives. It makes no sense to us that DDS is unwilling to make it available at least for Gary, and potentially for all clients who are prone to choking.