Thursday, September 12, 2024

Compilation of statements by government agencies, medical organizations & medical experts re: handheld suction plungers marketed as choking rescue devices (Updated 11/5/24)


NOTE: To my knowledge, no medical organizations or resuscitation experts recommend devices of this nature. If I've oerlooked any, please email details to Peter.Heimlich@gmail.com and I'll include - PMH
 
I. GOVERNMENT AGENCIES

A. Federal

FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication, April 22, 2024:
The U.S. Food and Drug Administration (FDA) encourages the public to follow established choking rescue protocols, which are step-by-step guides, approved by the American Red Cross* and the American Heart Association to relieve the airway obstruction in choking victims.

These rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults. These protocols do not include anti-choking devices. The safety and effectiveness of anti-choking devices that are being sold over-the-counter have not been established; they are not FDA approved or cleared. Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to take them out of packaging, assemble them, and follow device instructions, which may delay the use of established rescue protocols.
* From an October 30, 2024 email I received from American Red Cross Communications Officer Don Lauritzen (don.lauritzen@redcross.org):

The American Red Cross does not endorse any anti-choking device and does not recommend the inclusion of these devices in a first aid kit nor are these devices included in the Red Cross training curriculum.

The American Red Cross Scientific Advisory Council, a group of internationally recognized specialists, recommends the use of standard first aid for choking protocols (back blows and abdominal thrusts). There is no reliable evidence to support using anti-choking devices, and some available data may be scientifically biased due to the nature of the studies and reports. In most cases, back blows and/or abdominal thrusts can be used on a wheelchair-bound person, or the person can be quickly moved to the floor for abdominal/chest thrusts or CPR.

The Council recognizes and endorses the need for further high quality, independent, randomized studies of such devices, as well as FDA approval.

B. State

1) Health departments (in alphabetical order)

ILLINOIS: Pre-hospital use of Anti-Choking Devices from Jason Kegg, MD, FAAEM, FACEP, CHSE IDPH EMS Medical Director Ashley Thoele, MSN, MBA, RN Division Chief, EMS and Highway Safety, July 6, 2022
IDPH has received requests for the use of suction anti-choking devices by EMS Provides thru their EMS System to be included as new pieces of equipment on their EMS vehicles.
In an effort to consistently provide safe, evidence-based, and data driven care to the people of Illinois, we rely on equipment that have stood the rigors of research and proven benefit including equipment approved by the FDA.

At this time, these devices (ex. LifeVac, DeCHOKER, etc.) are not approved for use by the FDA or by IDPH and if used, could delay treatments that have been shown to be effective. In addition, this device may cause serious injuries. We strive to operate based upon evidence, and not anecdote, and any such device shall not be stocked, deployed, or utilized on any emergency service vehicles licensed and operating with IDPH approved protocols.
IOWA: Re: Anti-Choking Devices, Bureau of Emergency Medical and Trauma Services, October 9, 2024 

The Iowa Bureau of Emergency Medical and Trauma Services (BEMTS) has received inquiries concerning devices that are marketed as “anti-choking” or devices that may be utilized in the case of foreign body airway obstruction in the community setting and if such devices could be used by authorized EMS clinicians and EMS service programs within the State of Iowa. Such devices include, but are not limited to, Lifevac® and Dechoker®.

...Concerning this matter and the information that has been reviewed, BEMTS does not endorse nor approve the utilization of these devices by the State of Iowa authorized EMS clinicians of any level or by the State of Iowa authorized EMS service programs. Further research and validation are needed to establish credibility and effectiveness in the EMS setting. BEMTS continues to endorse that EMS clinicians and EMS service programs follow the AHA guidelines for managing foreign body airway obstruction that are appropriate to their level of training and authorization.

MASSACHUSETTS: Using LifeVac Devices From Dr. Safdar Medina, Physician Consultant to MDPH School Health Services re LifeVac devices, June 8, 2023:
Over the past few months, many school districts have been contacted about the use of the LifeVac device during an acute choking episode. At this time, unbiased, peer reviewed data to support its use is lacking. The device is not approved by the FDA and has not been endorsed by the American Red Cross or the American Heart Association. The American Academy of Pediatrics, in 2021, published a statement warranting further research of use of LifeVac in resuscitation of pediatric choking victims if established protocols fail. Current Basic Life Support training provides the universally accepted choking guidelines for both the pediatric and adult populations.

Please also note that the LifeVac website states the device is "FDA Registered", which is not the same as FDA Approved. Please see the following link for an explanation of the difference: Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
NEW JERSEY: From Candace Gardner, Director, Office of Emergency Medical Services, New Jersey Department of Health to New Jersey EMS Community: May 2, 2023: 
The New Jersey Department of Health (Department) Office of Emergency Medical Services (OEMS) recognizes that there are several devices marketed to be used in the case of a foreign body airway obstruction (choking) in the community setting. Such devices include but are not limited to, Lifevac and Dechoker.

...OEMS does not endorse, nor approve of the utilization of these devices by pre-hospital health care providers (EMTs, paramedics, etc.) in pre-hospital settings or during non-emergency medical transports. As such, OEMS continues to endorse that pre-hospital providers follow AHA guidelines and the National EMS Scope of Practice for the management of foreign body airway obstruction appropriate to their level of training.
PENNSYLVANIA: Via EMMCO West (Emergency Medical Management Cooperative), March 25, 2022: 
EMMCO West, Inc. has been made aware that regional EMS agencies have been approached to use the Lifevac anti-choking device. The device has been reviewed by the PA Department of Health, Bureau of EMS, state medical advisory committee. It was identified that there are no published peer reviewed studies supporting the effectiveness and/or safety of this device. It is not recognized in AHA choking guidelines. It is NOT within the current PA scope of practice for EMS personnel. It is NOT authorized to be used by PA DOH licensed EMS agencies.

TENNESSEE: From a September 16, 2024 email from Hamilton County EMS Director Wade Batson:

(In) October 2023, we had planned on placing these devices on all medical first responder units. However on December 4, 2023, the State of Tennessee Medical Director, Dr. Holly, and the clinical issues committee rejected the use of these devices for first responders on medical units. The primary reason was that they are not FDA approved. All devices that had been issued to departments (EMS and Fire) were removed from units and pulled from the field.

We are unaware on what, if any, data is available related to the devices placed at restaurants, law enforcement agencies, etc. We had no usage or no device related data at Hamilton County EMS due to the decision of the State of Tennessee’s Clinical Issues Committee.

I (have attached) the meeting notes from the State’s December 4, 2023 meeting, and I will highlight the related section of discussion. This was also passed at the December 6 th board meeting and I (am including) those notes as well.

WISCONSIN: From 'Seems fair to recommend:' State EMS doc approves anti-choking device as backup option, WITI News (Milwaukee), December 19, 2018:
A top state health official is giving emergency workers the green light use a new anti-choking device. The inventor said his design was inspired by a sink plunger...

“It may be a terrific device. We just don’t know,” said Marc Cohen, executive director of the Wisconsin Emergency Medical Services Association (WEMSA).

...That meant getting the approval of Dr. Riccardo Colella, state medical director for the EMS Division at the Wisconsin Department of Health Services.

The EMS Advisory Board makes recommendations to the Wisconsin Department of Health Services, but its recommendations do not required DHS to take any specific action.

...Dr. Colella stopped short of endorsing Lifevac, but did sign off on the concept.

“I think there’s not a lot of harm in using this. I think it seems fair to recommend the use of a product like this,” he said.
2) Education departments

Wisconsin Department of Public Instruction, School Nurse Update by Louise Wilson, School Nursing/Health Services Consultant, September 21, 2023:

Some school districts are stocking their first aid kits with antichoking devices and there is nothing  prohibiting districts from doing so. It is an individual district decision. As is often DPI’s recommendation, I urge districts and school nurses to seek legal counsel when making decisions regarding the use of these devices.

There are reasons I urge caution and careful decision making by school nurses who provide consultation to districts on first aid protocols. Anti-choking  devices are registered with the FDA as a medical device to be used at the patient’s bedside or in surgery. None of the emergency response organizations (American Red Cross, American Heart Association, and the 2022 International Consensus on  Cardiopulmonary Resuscitation and Emergency Cardiovascular Care) support the use of anti-choking devices or place their use in their first aid protocols. 

Because there is no standardized training and no officially recognized protocol, districts or school nurses need to create their own training and protocols for use. Protocols generally include when, and for how long, to use the device or technique. Would staff be told to try back blows and chest compressions first, or would they wait until the device is available? At what point does staff engage EMS? When do staff stop using the device and start or continue with CPR? 

There is no evidenced based research to support any decisions made so those making such decisions are doing so without  official guidance. I do point out that the 2022 International Consensus on  Cardiopulmonary Resuscitation and Emergency Cardiovascular Care does suggest “against  the routine use of suction-based  airway clearance devices.” School nurses have asked me about liability issues. I am unqualified to answer that question and again refer you to your own legal counsel.

3) Child protective services

Pennsylvania Office of Childhood Development and Early Learning (OCDEL), The Use of Manual Airway Clearance Devices in Child Care Settings, November 22, 2021:
The Office of Child Development and Early Learning (OCDEL) received questions on the use of manual Airway Clearance Devices (ACD). OCDEL’s current regulation is that all child care staff employed in a child care facility are required to have training in pediatric first-aid and pediatric cardiopulmonary resuscitation (CPR). OCDEL recommends child care providers continued use of approved pediatric first-aid and CPR training.

Child care providers may wish to consult with their own legal counsel and insurance company before deciding whether to use an ACD in their facility. It is best practice for the child care provider to have policies and procedures in place to address parental consent.

Per the child care regulations, signed written parental consent is required prior to administration of minor first-aid procedures by facility staff and must be kept current. (55 Pa. Code §3270.181(b), §3270.182(5), §3280.181(b), §3280.182(5), §3290.181(b), §3290.182(5)).

If an ACD is used on a child, but the parent/guardian consent is absent from the child’s file, this will result in violation of the regulations at 55 Pa. Code §3270.181(b), §3270.182(5), §3280.181(b), §3280.182(5), §3290.181(b), §3290.182(5).

Parent/guardian are not required to provide consent if they don’t want this device used on their child while in care at the facility.

II. MEDICAL ORGANIZATIONS 

A. United States

a) American Academy of Pediatrics (Wisonsin chapter): July 20, 2023 letter in opposition to proposed legislation to supplying Anti-Choking Devices in Schools

Given there are no specialty societies (including The American Heart Association, The American Red Cross, and the 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care) that support the use of anti-choking devices, and that the American Academy of Pediatrics does not have a policy in place, we cannot advocate in favor of the use of these.

B. EUROPE



Also, from a March 2017 Safety Advisory issued by the East Riding of Yorkshire Council regarding report by National Health Service's Hull and East Yorkshire Hospitals (HEY):

• The (LifeVac) device’s use is not currently recommended in existing International Liaison Committee Guidelines on Resuscitation (and therefore not in UK Resus Council Guidelines)
• There are no clinical trials to support the device’s use
• The only trial to date has been on a non-living adult (ie. an unrealistic scenario)
• Successful use of the device has been reported – however these examples only involve adults (anatomically very different to children) with known neurological conditions, which make them more prone to choking. The nature of the cause of the choking is therefore known. The difference with children is the foreign body they may be choking on itself- children are more likely to choke on solid food or small toy objects.
• If the obstruction is in the trachea, the device would simply empty the stomach rather than remove the obstruction, which could make the situation worse.

b) Sweden: April 5, 2018 Swedish CPR Council report by Henrik Wagner MD PhD, Jan Gelberg MD, and Andreas Claesson RN PhD. Click here for the original Swedish version; click here for an English version via Google Translate

c) Spain: April 25, 2019 position statement by the Spanish Council of Cardiopulmonary Resuscitation. Click here for original Spanish version; click here for an English version via Google Translate

d) Republic of Ireland: March 31, 2023, position statement by the Emergency Medicine Programme and the Irish Association of Emergency Medicine


III. MEDICAL EXPERTS VIA MEDIA REPORTS & BLOGS (chronological order)

Clip from ABC7 Sarasota, FL, April 7, 2016 story by investigative reporter Kate Flexner, Sarasota Police Department using LifeVac anti-choking device




I’m a nurse and mom and this is what you need to know about anti-choking devices by Sarah Hunstead RN, Pediatric nurse and CPR Kids founder, New York Post, August 8, 2023



What’s an Anti-Choking Device and Does It Work? by Christine Giordano, MD, Reviewed by Mandy Armitage, MD, GoodRX.com, September 10, 2024
Posted by Peter M. Heimlich at 5:12 PM
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