Wednesday, March 21, 2018

UK government regulatory agency for medical devices releases determination letters sent last year re: two anti-choking devices

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

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
United Kingdom