The Sidebar

If I've missed any, please e-mail links to Peter.Heimlich@gmail.com 

For information originating from Dechoker LLC (Wheat Ridge, CO), click here for the company's home page. Click the links for the websites of Dechoker UK (Northampton), Dechoker Spain (Madrid), and Dechoker Sweden (Gothenburg).

Also see Caretakers Detail How “Indispensable” Dechoker Has Saved Dozens of Lives, a February 15, 2019 Dechoker LLC blog item which includes links to case reports signed by Randall Snook MD who practices at Advanced Integrative Medicine, Lone Tree, CO.

Click here for my similar compilation re: the LifeVac anti-choking device.

A. MEDICAL

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A couple weeks ago I blogged, Olean, NY-area* school principal arranged purchase, installation, staff training of controversial anti-choking plunger device -- has he also received sales commissions?

In response to my subsequent reporting, a few days ago Tony Giannicchi, the district's superintendent of schools sent me a two-page letter that included:

Please be advised that District employees and Board members will not respond to any further communication from you, with the exception of requests for (public records)... 

That put me in a bind.

Here's why.

Via Dechokers at A-L expected to keep kids safe by staff reporter Kate Day Sager, Olean Times Herald, October 5, 2018:

(Tim) Hite, a professional firefighter, now promotes the Dechoker life-saving medical device which is used to suction objects from the airways of toddlers, children and adults.

Recently, Hite sold several sets of the Dechokers to the Allegany-Limestone Central School District, the first school district in the state to purchase the items.

Per a letter I received about three years ago, it's unclear if the Dechoker is approved by the New York State Department of Education.

From the same Times Herald article:

(Allegany-Limestone) Middle-High School Principal Cory Pecorella said the school district purchased two packages of the suction devices for each of the campuses.

...Pecorella said he learned of the device from Hite, whom he serves with in the Allegany Volunteer Fire Department.

“(Hite) contacted me and wanted to demonstrate the product for us,” Pecorella said. “We bought right into it.

Per my blog, it's unclear if Mr. Pecorella and Mr. Hite have a business relationship.

Finally, according to this recent interview conducted by reporter Amanda Gilbert (KWWL-TV, the Waterloo, IA NBC affiliate) with David Stilley MD, Medical Director at Iowa Department of Public Health Bureau of Emergency and Trauma Services, the Dechoker is of unproven benefit and safety.



(The interview was conducted for her May 31, 2018 report, Heimlich alternative? KWWL investigates new medical device offered to Iowa school.)

Those concerns seemed like reasonable grounds on which to request an investigation in order to determine if the Allegany-Limestone school's purchase and implementation of the devices was in compliance with applicable guidelines.

My problem? I don't know the appropriate office where to file that and per Superintendent Giannicchi's letter, if I ask him or another district employee or the school board how to proceed, they're prohibited from responding.

The only option I could think of was to request guidance from New York State Commissioner of Education MaryEllen Elia -- see below. (Click here to download a copy.)

If/when I receive a reply, I'll report the results.



* My original headline began "Olean, NY school principal..." H/T to a knowledgeable reader who informed me "Allegany-Limestone Central Schools are not Olean schools. The two districts abut each other, but are separate," so I changed to "Olean, NY-area."

UPDATE, 10/29/18: Per my item below, in an 8/24/18 e-mail, Olean, NY fireman/Dechoker vendor Timothy Hite claimed he had an 8/30/18 meeting scheduled with NY State Sen. Catharine Young & Assemblyman Joseph Giglio "to start writing legislation to make it mandatory for all eatery areas to have a Dechoker (anti-choking plunger device), kind of like NY did for first aid and CPR." 

In response to my inquiries, today Sen. Young's spokesman John Eberth left me a voice message and Assemblyman Giglio sent me an e-mail. Both confirmed the meeting took place but that no legislation is pending.

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Via Dechokers at A-L expected to keep kids safe by staff reporter Kate Day Sager, Olean Times Herald, October 5, 2018:

(Tim) Hite, a professional firefighter, now promotes the Dechoker life-saving medical device which is used to suction objects from the airways of toddlers, children and adults.

Recently, Hite sold several sets of the Dechokers to the Allegany-Limestone Central School District, the first school district in the state to purchase the items.

Middle-High School Principal Cory Pecorella said the school district purchased two packages of the suction devices for each of the campuses. Each package contains three Dechokers in adult, youth and toddler sizes. The packages will be kept in the nurse’s office and the cafeteria.

...“What it does is it replaces the abdominal thrust” which was previously referred to as the Heimlich maneuver, Hite explained. “It creates a negative pressure in the mouth area as you pull back and it forces the object out in reverse.”

...Pecorella said he learned of the device from Hite, whom he serves with in the Allegany Volunteer Fire Department.

“(Hite) contacted me and wanted to demonstrate the product for us,” Pecorella said. “We bought right into it. We have something that’s going to keep our kids safe and a better way to locate an object in someone’s throat.”

Pecorella sad he or Hite will train the faculty and staff how to use the items.

Along with some other quick questions I sent yesterday, per these e-mails I obtained via a public records request, I asked principal Pecorella if he'd received any commissions selling the Dechoker.

 

I also asked whether he'd seen any of these media reports about the Dechoker, published months before he arranged purchase of the devices.

Can New Devices Match Heimlich to Stop Choking? LifeVac and Dechoker pose alternative to abdominal thrusts -- LifeVac and Dechoker pose alternative to abdominal thrusts by Laura Johannes, Wall Street Journal, July 11, 2016.

Anti-choking device business raided, accused of investment scheme by investigative reporter Matthew Grant, FOX46-TV News, Charlotte, NC, March 12, 2018.

'Dechoker' anti-choking device claims to save lives but has never been tested on humans by Jackie Callaway, WFTS-TV News, Tampa, FL, May 21, 2018.

Heimlich alternative? KWWL investigates new medical device offered to Iowa school by Amanda Gilbert, KWWL-TV News, Waterloo, IA, May 31, 2018; click here for the video.

Also from Ms. Sager's Times Herald article:

Tim Hite remembers a time when he tried to help a man who was choking on a sandwich, but couldn’t save him...During one incident in his hometown of Camden, he and other emergency personnel couldn’t help an older individual who was choking. The man, who was disabled, had tried to eat two peanut butter sandwiches at once, causing him to choke.

By the time we got to him, he was already in cardiac arrest” and died, he lamented.

..."(The) Cattaraugus County Sheriff’s Office has a first aid kit with an adult size (Dechoker) in it at their dispatch center.”

Yesterday I sent some quick questions to Mr. Hite asking for more details about the choking death and the placement of the Dechoker in the Sheriff's dispatch office.

Per Mr. Hite's August 24 e-mail (copied above) I'm also curious about his meeting with New York State Senator Catharine Young and New York State Assemblyman Joseph Giglio, so I'll inquire about that.

I'll report the results of my inquiries in a future item.

Via my records request to the school district, here are price quotes for the Dechokers from Mr. Hite's company, C3 Safety Products LLC:

* My original headline began "Olean, NY school principal..." H/T to a knowledgeable reader who informed me "Allegany-Limestone Central Schools are not Olean schools. The two districts abut each other, but are separate," so I changed to "Olean, NY-area." 

Last month IMediaEthics published a solid report by ace reporter Sydney Smith about how in January a couple of leading UK newspapers published -- but then promptly "disappeared" -- a bogus choking rescue story and how my efforts resulted in both papers cleaning up the mess.

One of papers (the MailOnline) held out for eight months(!) and only agreed to address the problem after I filed a complaint with UK's Independent Press Standards Organisation.

Via IPSO's website:

We hold newspapers and magazines to account for their actions, protect individual rights, uphold high standards of journalism and help to maintain freedom of expression for the press.

In what may be a journalism first, today I filed another IPSO complaint against another UK newspaper which "disappeared" another article about another questionable choking rescue.

This one involves a controversial anti-choking plunger called the Dechoker. As it happens, the company's UK distributor claims that since the beginning of the year, this unapproved experimental  gadget has saved the lives of six -- I repeat, six -- elderly choking victims in nursing homes around the country.


Independent Press Standards Organisation (IPSO)
Gate House
1 Farringdon Street
London
EC4M 7LG

To whom it may concern:

This is to request that your agency investigate IPSO member organization the Northampton Chronicle & Echo for publishing and subsequently scrubbing an online news report after being informed that the story was problematic and possibly a hoax. Almost four months since publication and three months after the paper's editor claimed he had initiated an investigation, the article is still missing from the paper's website.

On 15 June 2018, Northampton care home staff save residents' [sic] life after he started choking by staff reporter Carly Roberts was published on the paper's website. Here's the complete text:

An Airway Clearance Device (ACD) made by a Northampton-based business has helped to save a second care home resident from choking to death.

Resident at Timken Grange care home in Duston, Bryan Kett, 87, was enjoying lunch when he began to choke on a piece of food, which had become stuck in his airway.

Care staff immediately stepped in to assist, and when the obstruction proved firmly stuck, they reached for their Dechoker. Within moments the piece of food had been removed and the resident recovered almost immediately.

“Choking is responsible for around six care home deaths every month,” said Matt Oakley, director at Dechoker UK. “We are both pleased and proud that once again Dechoker has been shown to be effective in a choking emergency.”

The home has Dechoker devices on every floor with their care teams comprehensively trained both how and when to use them.

The product resembles a large syringe attached to a gas mask. It is placed over their mouth and the operator then pulls the suction pump, creating a vacuum and extracting the item from their throat in a short time.

Staff at Dechoker say the effects of a choking death are far-reaching. Initially, there will be an emotional impact on the other residents and staff having to have dealt with and witnessed a very traumatic incident.

Choking is regarded as an unexpected death and as such there will be a Coroner’s investigation, which often takes many months. Not forgetting, throughout this entire process the family and friends of the resident are having to come to terms with both the cause of death and the ongoing implications as a result.

Timken Grange Home manager Rachel Cadd said: "We are delighted that our carers have been trained and are comfortable with using the Dechoker.

"We are confident that we would not hesitate in using the device again should the occasion arise.”

Based on my research/reporting and a string of investigative reports by U.S. journalists* about the Dechoker device -- which were published online before Ms. Roberts' story and which she could have easily located -- I had serious questions about the accuracy and competency of her reporting, so on 22 June I e-mailed her an inquiry and copied editor David Summers. I didn't receive a reply so on 25 June I re-sent my inquiry.

I didn't receive a reply to that either, so I sent a 19 July inquiry to Mr. Summers detailing some of my concerns:

Among other information missing from Ms. Roberts' poorly-reported article: the date of the alleged incident and what type of food the victim allegedly choked on; the names of the alleged rescuers and any eyewitnesses; quotes from the alleged rescuers, from Bryan Kett or from any members of his family or his legal guardian; whether or not Mr. Kett received subsequent medical care and the name of his attending physician; and no information about the case of the first care home patient allegedly saved from choking to death by the device.

I've made best efforts to verify the above information, including: multiple inquiries to Ms. Roberts (on which you were copied, see below my signature); inquiries to executives at Timken Grange and to Matt Oakley.

No replies were received from Ms. Roberts or from the Timken Grange executives. Mr. Oakley refused to provide any information about the reported incident and would not even provide me with the name(s) of the Timken Grange employee(s) who informed him about the alleged incident. Further, it's unclear if Mr. Oakley ever attempted to verify any of the facts or interviewed anyone associated with the case.

Further, multiple attempts to contact Bryan Kett, members of his family, and his legal representative were unsuccessful. Further, employees at Timken Grange would not even confirm that they have a resident named Bryan Kett.

Long story short, I haven't been able to obtain any substantiating evidence that the incident your paper reported took place. And based on Ms. Roberts' incompetent reporting, how can your readers be certain that she didn't get punk'd?

I didn't receive a reply so I sent him a 23 July follow up to which I received a polite same-day reply.

As I was preparing to respond to that, I discovered that sometime between 19 July and 23 July, Ms. Roberts' article had been scrubbed from the paper's website and the URL at which it was posted now redirected to the paper's home page https://www.northamptonchron.co.uk/news/northampton-care-home-staff-save-residents-life-after-he-started-choking-1-8536207 I included that information in my 23 July reply to Mr. Summers.

In his next-day reply, without explanation Mr. Summers claimed he was "not in a position" to do any fact-checking of the story and that, "In relation to the article no longer appearing online, it is standard practice to remove articles, as a neutral act, while investigations are carried out." Copies of our e-mails are posted here http://tinyurl.com/ycppohjy

Since then I've provided Mr. Summers with considerable related information, including this 23 September 2018 investigation request I filed with the Care Quality Commission (CQC) and the Medicines and Healthcare products Regulatory Agency (MHRA) http://tinyurl.com/y7o3cx4p According to all published information about the alleged choking rescue at Timken Grange, staff violated this 30 August 2017 MHRA directive re: the acceptable use of the device http://tinyurl.com/y7d9yn3r

In my opinion, the information I provided to Mr. Summers -- which included the investigative reports copied below my signature -- would persuade any responsible journalist to take a closer look at the case. At minimum, why wouldn't he at least attempt to verify whether or not Timken Grange actually has a resident named Bryan Kett?

Instead -- and this appears to be the extent of Mr. Summers' "investigation" -- he sent me a Timken Grange press release which was the basis of Ms. Roberts's 15 June 2018 report.

But even that's problematic. The press release -- issued by Sian Ellis, marketing Director at Oakdale Care Group, Timken Grange's parent corporation -- is dated 6 July 2018, three weeks after Ms. Roberts' article was published.

I received no indication that Mr. Summers or any other Chronicle & Echo staffer asked Ms. Ellis for any further information. On the contrary, the paper seemed determined to avoid obtaining additional information -- a peculiar approach to journalism, to be sure.

I, on the other hand, sent multiple e-mail inquiries to Ms. Ellis last month in an attempt to verify the information she provided to the Chronicle & Echo. (I copied Mr. Summers.) Despite receiving multiple confirmations of receipt, I didn't receive any responses http://tinyurl.com/y98meses

In any event, Ms. Roberts' article is still M.I.A., but I've attached a pdf copy. Here's a link to direct download a copy http://tinyurl.com/y9zp4zhg

It's unclear what's going on at Timken Grange and the Chronicle & Echo -- Ms. Roberts and Mr. Summers certainly don't seem inclined to find out -- but perhaps filing this complaint with your agency will produce more information.

Thanks for your time/consideration and I look forward to your reply. If you require any additional information and/or records I might be able to provide, please don't hesitate to ask.

Sincerely,

Peter M. Heimlich
REDACTED
Peachtree Corners, GA 30096 USA
ph: (208)474-7283
website: http://medfraud.info
blog: http://the-sidebar.com
e-mail: peter.heimlich@gmail.com
Twitter: @medfraud_pmh
bio: http://tinyurl.com/ych7o7dr

* 12 March 2018: Anti-choking device business raided, accused of investment scheme by Matthew Grant, 12 March 2018, FOX46 Charlotte North Carolina http://tinyurl.com/yd6tydmn

26 March 2018: "Growing pains" for company selling anti-choking device? NC state "investment scheme" investigation & three debt collection lawsuits, one filed by former top executive, The Sidebar (my blog), http://www.the-sidebar.com/2018/03/growing-pains-for-company-selling-anti.html

21 May 2018: 'Dechoker' anti-choking device claims to save lives but has never been tested on humans by Jackie Callaway, ABC Tampa Florida http://tinyurl.com/y9g5x8vu

31 May 2018: Heimlich alternative? KWWL investigates new medical device offered to Iowa school by Amanda Gilbert, 31 May 2018, NBC Waterloo Iowa: http://tinyurl.com/ydbz2xkr Complete interview with Iowa State EMS Director David Stilley MD https://www.youtube.com/watch?v=eczgssoPF9g

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The past couple of years have been challenging for Dechoker LLC, the Denver company that markets an anti-choking plunger of the same name for humans and for pets.



Per my blog, the company was named as a defendant in three lawsuits alleging unpaid debts, one of which was filed in a Louisville, KY, court by the company's former COO.

Then in March, FOX46 Charlotte, NC aired an investigative report by Matthew Grant, Anti-choking device business raided, accused of investment scheme.

A few months later, ABC Action News in Tampa broadcast 'Dechoker' anti-choking device claims to save lives but has never been tested on humans by investigative reporter Jackie Callaway:

A few weeks later, Amanda Gilbert at the NBC News affiliate in Waterloo, Iowa, reported that the supervisor of a local school district which had installed the devices would remove or sent them back to Dechoker LLC "until they can provide FDA approval on them."

But if you think the company's down for the count, think again.

Via Dechoker is Moving Forward! by company president Alan Carver in an August 31, 2018 post on the company's blog:

We just wanted to make a quick post to bring everyone up to date on a few of exciting things going on at Dechoker!

TWO MORE LIVES SAVED - We received confirmation of two more lives saved, these two were both in assisted living homes in UK. This bring the total to 20 lives that would not otherwise be here today if not for Dechoker!

...MEDICAL DIRECTOR - We have brought on a Medical Director for Dechoker. The Medical Director will further help in assisting drive the Dechoker device through education and promotion within the public and medical community.

Dechoker is continuing to push for eradicating choking deaths throughout the globe. 

I was unable to locate any substantive details about details about the claimed 20 lives saved by the device, but I found this YouTube video embedded on the home page of Dechoker LLC's website featuring Randall L. Snook MD who practices at Advanced Integrative Medicine in Lone Tree, a suburb of Denver:

It's unclear if Dr. Shook is the company's new medical director, but he's featured in the new Dechoker testimonial video:



It's unclear if Dr. Snook has any background in resuscitation but a quick Google search turned up the following information.

He also promotes PHatea, a "100% Natural Chinese Dark Tea" :


Randall Snook MD Pha Tea from iHeartMediaDenver on Vimeo.


Via PHatea.com, whose website includes an undated CV for Dr. Snook:


Dechoker LLC appears to be trying to make a new start after facing some serious challenges.

A quick Google search revealed that, re: a widely-reported story about 18 years ago (NY Times, ABC7 Denver, etc.), Dr. Snook appears to have done the same.

Via Fallout stuns Romo's doctor by staff reporter Mike McPhee, Denver Post, October, 11, 2000:

The physician who wrote prescriptions for diet pills that were allegedly given to Denver Broncos linebacker Bill Romanowski says he had no idea the consequences would be so grave.

"It's not even banned by the NFL," Dr. Randall Snook said Monday, referring to the appetite suppressant phentermine. "If I had written the prescriptions for Bill, none of this would have happened."

But Snook didn't, and he lost his Littleton practice as well as his 4,000 patients. Last spring, the internal medicine/gerontologist pleaded guilty to a misdemeanor charge of unlawfully dispensing a controlled substance.

Via Romanowski says trial verdict restores his reputation, Associated Press, June 30, 2001:

Saying his reputation was restored, Denver Broncos linebacker Bill Romanowski was acquitted of getting prescription diet pills illegally.

...(Defense lawyers never denied that Dr. Randall Snook prescribed phentermine for other people that was meant for Romanowski. But they said Romanowski committed no crime because he was acting on the advice of Snook. They also said Snook told the Romanowskis they were doing nothing wrong.

...Snook pleaded guilty to providing the pills.

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Below the hash marks is a considerably abbreviated version of an investigations request letter I sent on August 28, 2018 to:

Daniel R. Levinson, Inspector General
U.S. Department of Health and Human Services

Andy Beshear, Kentucky Attorney General

Steve Davis, Inspector General
Kentucky Cabinet for Health and Family Services

My letter, entirely based on publicly-available information, includes links and quotes from three recent television news investigative reports about an anti-choking device called the Dechoker; a letter from a former executive associated with the device; and a testimonial letter from a ResCare vice president.

Click here to download a copy.

Also see my March 26, 2018 item, "Growing pains" for company selling anti-choking device? NC state "investment scheme" investigation & three debt collection lawsuits, one filed by former top executive.


Dear Mr. Levinson, Mr. Beshear, and Mr. Davis:

Via the web page https://www.rescare.com/about/

(ResCare Inc., founded and headquartered in Louisville, Kentucky is) the largest diversified health and human services provider in the U.S., ResCare* is the largest private provider of services to people with disabilities, the largest privately-owned home care company, the largest provider of specialized high-acuity neuro-rehab in community settings and the largest career center workforce contractor in the U.S.

Based on the following information, ResCare Inc. appears to be using residents at over 2600 of their facilities to test an unapproved, experimental medical device called the Dechoker.

To my knowledge, no research has been published in the literature about the device which is intended for use in life or death choking emergencies.

Further, to my knowledge, the device, which is sold by Dechoker LLC (formerly based in Concord, NC, now in Denver, CO), is not recommended by any medical organizations or by resuscitation experts.

I have no knowledge whether or not residents of ResCare facilities or their legal guardians have been informed about the potential use of the device. However, according to the attached February 20, 2018 testimonial letter signed by a senior ResCare executive, the Dechoker has been employed in at least seven choking emergencies at ResCare facilities.

...This is to request that you obtain and review any relevant information regarding ResCare’s purchase of and placement of the Dechoker “in all 2,600+ ResCare facilities across the country”; that you determine if that purchase and placement complies with all applicable regulations; and that you make public the results.

This is also to request that you investigate the cases in which...the Dechoker has (allegedly) been used to save the lives of seven choking victims in ResCare facilities, and that you make public the results including but not limited to the dates and locations of the cases and the names and job titles of all participating ResCare employees.

Thank you for your time, attention, and I look forward to your reply. Please feel free correspond with me via e-mail and if you have any questions I might be able to answer, please don’t hesitate to ask.

Sincerely,

Peter M. Heimlich
STREET ADDRESS REDACTED
Peachtree Corners, GA 30096 USA
ph: (208)474-7283
website: http://medfraud.info
blog: http://the-sidebar.com
e-mail: peter.heimlich@gmail.com
Twitter: @medfraud_pmh
bio: http://tinyurl.com/ych7o7dr

* According to an August 15. 2018 press release, “BrightSpring Health Services is the new name for Kentucky-based ResCare...”

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Dechoker LLC -- which in recent years has been selling a plunger device intended for sucking foreign body obstructions from the airways of humans -- now has a version for our four-legged friends.

The company -- which recently relocated to Denver, Colorado in the wake of a reported $2m securities fraud investigation by the North Carolina Secretary of State -- offers three sizes for dogs and a one-size-fits-all model for cats.

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At this writing, two of the models -- medium and large sizes for fido -- are sold out.

But all four sizes appear to be available from a Bismarck, North Dakota company called Balkowitsch Enterprises, Inc.

source

According to a story aired last week by the NBC affiliate in Waterloo, Iowa, Heimlich alternative? KWWL investigates new medical device offered to Iowa school by staff reporter Amanda Gilbert, a local school district installed Dechokers, then removed them, apparently after viewing this interview with State EMS Medical Director David Stilley MD:



However, Dr. Stilley didn't share his opinion regarding the Dechoker for pets so if any veterinarians want to weigh in, feel free to e-mail me and I may publish submissions.

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For background see my March 26 item, "Growing pains" for company selling anti-choking device? NC state "investment scheme" investigation & three debt collection lawsuits, one filed by former top executive.

According to the website of Dechoker LLC, the company has moved from Concord, North Carolina to Denver, Colorado. 

Updates via the North Carolina Secretary of State Securities Division:

Via Anti-choking device business raided, accused of investment scheme a March 12, 2018 investigative report by Matthew Grant, FOX46 Charlotte, NC:






II. Christopher Kellogg c. Dechoker LLC, case no. 16-CI-005356, Jefferson County, KY Circuit Court,10/26/16 plaintiff's complaint & 12/21/16 defendant's response:




Via FDA approves new lifesaving device based out of Louisville by Ann Bowdan, WLKY News (Louisville, KY), October 30, 2015:

(Recently) the Food and Drug Administration approved a new device being touted as an alternative method to the Heimlich.

The alternative device is called the Dechoker, and its headquarters is right here in Louisville.

"The Heimlich works on positive pressure and we work on negative pressure, or suction. In other words, it's a vacuum,” Dechoker CEO Christopher Kellogg said.

The concept for the Dechoker came while Navy Captain Alan Carver was taking a first aid course with his fellow seamen.

"They're 200 miles off the coast and the instructor says, ‘If the Heimlich doesn't work guys, then there isn't anything else,’” Kellogg said.

...Kellogg set up shop in Louisville as it was tested and approved.

[NOTE: The WLKY story provides no indication that Ms. Bowdan ever contacted the FDA. If she had, she might have learned that the agency simply registered the Dechoker, not "approved" it. In other words, the headline and lead of her story are wrong.]


III. Greenleaf Health Inc. (Washington, DC) vs. Dechoker LLC, case no. 2017CA003434CAAXWS, Pasco County, FL, Sixth Judicial Circuit Court:

Via the website of the Medicines and Healthcare products Regulatory Agency (MHRA):

What we do

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.

This week the MHRA released two identical August 30, 2017 determination letters re: the Dechoker and the LifeVac, two unrelated handheld anti-choking devices being marketed in the UK by Dechoker UK (Northampton) and LifeVac Europe Ltd (Devon) respectively. 

Both devices were developed by companies in the U.S., Dechoker LLC (recently relocated to Denver, CO) and LifeVac LLC (Springfield Gardens, NY).

Page down for copies of each letter. Here's the text.

30 August 2017

I am writing to you further to my letter of 19 May, when I requested additional information which was necessary for the MHRA to give full consideration to the regulatory issues relating to placing your product on the UK market. I am grateful to you for providing that information in a timely manner; we have now had the opportunity to consider the additional information and have reached a conclusion on how we propose to proceed.

In my letter, I referred to MEDDEV 2.7/1, a guide produced by the European Commission, that promotes a- common approach to clinical evaluation and specifically highlighted the section which referred to devices for unmet medical needs. One of our main concerns has been a lack of sufficient data demonstrating effective use of this device and we understand that due to the nature of the device, clinical trials would be extremely difficult. The proposals set out below are intended to allow you to gather clinical data in a controlled environment, with trained healthcare professionals, which will allow you to generate more robust results over time. These can then be incorporated into your clinical evaluation which, once sufficient evidence has been generated, may allow agreement of extending the availability of the device.

We are therefore requesting that you take all reasonable steps to ensure that your device should only be used in the following situations:

• By registered healthcare professionals or individuals with advanced life support training, only if currently recognised basic life support protocols have failed; or
• In situations where emergency services are unable to respond, for example on aeroplanes or ships, only if currently recognised basic life support protocols have failed; or
• On individuals in moulded wheelchairs, only if currently recognised basic life support protocols have failed.

Taking this into account, we would request that you alter your instructions for use, as well as any relevant supplementary marketing information to emphasise that your device should only be used under these conditions.

We would also request that you cease to market your device for use on children, in schools and in other public places such as restaurants and shopping centres.

I should advise that, based on the information provided to us thus far, we do not consider that your current plans for post-market surveillance, in particular the lack of structured post-market clinical follow-up, would be able to generate sufficient clinical evidence to expand the use of your device. The approach that we have proposed above should allow you to refine your plans for post-market surveillance; healthcare professionals will understand the experimental nature of your device and how it fits with basic life support and provide more structured post-market surveillance data.

I would like to thank you for your patience and co-operation in this matter. The MHRA believes the approach outlined in this letter, which at this stage is based on voluntary cooperation as opposed to formal regulatory action, strikes a balance that will allow you to continue your business but also gather information for clinical evaluation in a more controlled clinical environment that minimises the potential patient safety issues.

I would be grateful for a response to this letter by 20 September setting out your acceptance of the conditions in this letter and an outline of how you intend to comply with them.

Yours sincerely,

Graeme Tunbridge
Group Manager - Devices Regulatory Affairs
Tel: 0203 080 6901
Email: graeme.tunbridge@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ
United Kingdom
www.gov.uk/mhra
 

Three Dechoker devices in cabinet installed in Iowa's Union Community School District

On March 8, I blogged An Iowa school district recently installed Dechoker anti-choking device to respond to choking emergencies -- I've asked the state education department to review.

Based on a March 15, 2018 reply I received from Department of Education Director Ryan Wise -- see below -- when it comes to medical guidelines, apparently the state has zero oversight.

How much discretion do local districts have to determine what medical treatments are provided to their students? Are the districts equipped to make those determinations? Are students receiving the highest standard of care?

Read on...

From: Peter.Heimlich@gmail.com 
Subject: blogger inquiry
To: t_fleshner@union.k12.ia.us Cc: ryan.wise@iowa.gov
Date: Tue, 20 Mar 2018 14:10:53 -0400

Travis Fleshner
Superintendent
Union Community School District (UCSD)
200 Adams St.
La Porte City, IA 50651

Dear Mr. Fleshner,

Per the attached pdf [see below], I was referred to you - albeit indirectly - by Ryan Wise, Director of the IA Department of Education.

In a March 8, 2018 e-mail (published on my blog), I asked Mr. Wise to review the reported incorporation and installation of a plunger device called the Dechoker in your district's schools to be used to respond to a choking emergency.

Via my e-mail:

The Dechoker is not included the standards and guidelines of the American Heart Association, the American Red Cross, the American Academy of Pediatrics or, to my knowledge, any established medical organization. And a keyword search today for Dechoker on PubMed provided no results, so it appears the device has not been the subject of any research published in the literature.

In other words, the effectiveness and safety of the device appears to be unproven. Therefore, it's unclear on what basis the (UCSD) chose to equip its schools with the devices, hence this outreach.

...(It's also unclear if any district) officials obtained opinions from any medical experts or first aid organizations, or an opinion from the school district's risk manager. Would you please look into that and provide me with the results?

Via Mr. Wise's March 15 reply:

We have reviewed your inquiry and have determined that this is a local issue. The Department does not have authority over the district's decision to use these devices and there are no State rules that would prohibit the district's use of the devices.

Based on that determination, I'd appreciate your answers to some quick questions for a follow-up item I'm reporting.

1) Would you please provide me with copies of the documentation on which your district relied to determine that the Dechoker was an effective and safe treatment response to a choking emergency?

2) Did any district officials obtain opinions from any medical experts or first aid organizations, and/or an opinion from the school district's risk manager? If so, would you please provide me with details and documentation?

3) To my knowledge the Dechoker is not recommended by any established first aid organizations, therefore some might consider it to be an experimental medical device. With that in mind, have parents and guardians of students been provided the opportunity to approve or deny its use on their children? If so, would you please provide details and documentation? 

Thanks for your time/consideration and I look forward to receiving your answers. And if you have any questions for me, please don't hesitate to ask.

Sincerely,

Peter M. Heimlich
Peachtree Corners, Georgia 30096 USA
ph: (208)474-7283
website: http://medfraud.info
blog: http://the-sidebar.com
e-mail: peter.heimlich@gmail.com
https://twitter.com/medfraud_pmh

cc: Ryan Wise