Sunday, September 23, 2018

Is a UK nursing home chain using unwitting residents to test a controversial, experimental anti-choking device? I've asked two government agencies to investigate [UPDATED 9/27/18]

Screenshot of an article by staff reporter Carly Roberts published June 15, 2018 in the Northampton Chronicle & Echo about the problematic case discussed in my investigation request. The article has since been removed from the paper's website and the article's URL https://www.northamptonchron.co.uk/news/northampton-care-home-staff-save-residents-life-after-he-started-choking-1-8536207 now leads to the paper's home page. Click here to read the article via The Wayback Machine.

UK's Care Quality Commission "(makes) sure health and social care services provide people with safe, effective, compassionate, high-quality care and we encourage care services to improve." The Medicines and Healthcare products Regulatory Agency "regulates medicines, medical devices and blood components for transfusion in the UK.:

See below the hash marks for the first page of a five-page investigations request I sent to those agencies today. Click here to download the complete pdf. Click here to view on Scribd.

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Care Quality Commission (CQC)
151 Buckingham Palace Road
London SW1W 9SZ UK
e-mailed to enquiries@cqc.org.uk

Corporate Governance and Accountability
Medicines and Healthcare products Regulatory Agency (MHRA)
10 South Colonnade
London E14 4PU UK
e-mailed to info@mhra.gov.uk

To whom it may concern:

1) According to the CQC website, Timken Grange, Timken Way South, Duston, Northampton NN5 6FR, “provides accommodation for persons who require nursing or personal care, Dementia, Caring for adults over 65 yrs.” According to Timken Grange’s website, the residence is operated and presumably owned by Oakdale Care Group, Oakdale House, Devonshire Avenue, Amersham, Buckinghamshire HP6 5JE.

According to information published by Oakdale Care Group, Timken Grange staff recently used a medical device called the Dechoker on 87-year-old resident Bryan Kett in violation of a 30 August 2017 directive issued by the MHRA re: the recommended use of the device.

2) According to an investigative report aired on 21 May 2018 by ABC Action News (Tampa, Florida), the Dechoker has never been tested on humans and a keyword search of PubMed for Dechoker produced no results. Therefore it appears the device has never been the subject of any research published in the literature.

Further, in a 17 September 2018 e-mail, a representative of the European Resuscitation Council (whose member organizations include the UK Resuscitation Council) wrote me that their organization does not recommend the Dechoker. Other medical experts and organizations including the MHRA have reportedly raised concerns that the device is of unproven effectiveness and safety.

According to information published by Oakdale Care Group, in addition to Timken Grange, the company has installed Dechokers at three other other care homes which they operate and presumably own.[Kingfisher Court (Sutton in Ashfield), Layston Grove (Buntingford), and Westhill Park (Kettering)] Therefore, Oakdale Care Group appears to be using residents at all of their properties as research subjects to test an experimental medical device.

Further, I’m unaware of any evidence that the research being conducted on residents in the four care homes is being overseen by an Institutional Review Board or that residents and/or their legal guardians have provided informed consent. Therefore, Oakdale Care Group may be in violation of UK and international laws protecting vulnerable human subjects used in medical research.

3) This month I sent multiple e-mail inquiries to an Oakdale Care Group executive in which I requested the names of the attending physician(s) at Timken Grange. I also asked how I could relay messages to residents and/or their legal guardians. Despite receiving multiple confirmations of receipt, I received no further communications, therefore I’m concerned that the company is trying to avoid scrutiny of the research and may be holding residents incommunicado.

Therefore I’m requesting that your agencies review these matters and provide me with a determination whether or not Timken Grange and the three other Oakdale Care Group facilities conducting the research on residents are in compliance with all applicable statues and guidelines. Further, this is to request that your agencies contact resident Bryan Kett, his legal guardian, and his attending physician and that you provide each of them with a copy of this letter.

Finally, would you please provide me with the names and contact information of UK government agencies responsible for oversight of medical research using human subjects?

[pages 2-5]

Thank you for your consideration 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
e-mail: Peter.Heimlich@gmail.com
website: http://medfraud.info
blog: http://the-sidebar.com

UPDATES

9/24/18: Hat tip to a prominent UK medical professional who sent me this February 2018 statement by the Resuscitation Council (UK), Does the Resuscitation Council (UK) recommend the use of airway clearance devices (ACD) in the treatment of the choking victim? which I hadn't seen before. I've asked the CQC & MHRA to append my request with the statement.

I also asked both agencies to determine if the Timken Grange care home staffers that used the Dechoker on resident Bryan Kett (according to parent company Oakdale Care Group, Buckinghamshire) possessed the requisite credentials to use the device on him.

9/27/18: I came across this information posted on 25 September 2018 on the website of Dechoker UK https://www.dechokeruk.com/news/6livessaved/
Dechoker prevents 6th Care Home choking death
I've appended my request to the CQC & MHRA and asked them to review the six cases in order to determine if the use of the Dechoker was in compliance with their agencies' guidelines.

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Choking gadgets to suck out the obstruction - a good idea or not?, an April 24, 2018 commentary featuring the Dechoker by first aid trainer and author/speaker Emma Hammett of First Aid For Life.