Further to my previous on the absurdity that is the administering and receiving of the practice of ear candling, I wondered whether a self-assigned ‘medical device’ classification would be of interest to the Medicines and Healthcare products Regulatory Agency, that is, ‘… the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.’
‘The term ‘medical device’ covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.’
This is followed by a list of devices, which, I note, does not include ear candles (although they do point out that the list is not comprehensive). Below this is a link to information on ‘How we regulate devices’, and I confess that hereafter I become somewhat lost, and unwilling to expend time and effort searching for anything relevant to ear candles. I figured it easier to contact the MHRA, thereby bringing this potentially dubious classification to their attention.
I note that an online provider of Biosun Hopi Ear Candles (at: http://www.hopi-earcandles.co.uk/) claims that:
‘Biosun ear candles are the only ear candles in Europe to have a Medical Device Classification‘
Could you kindly clarify whether the MHRA classifies these ear candles as a bona fide ‘Medical Device’?
The site further states:
‘Our ear candles are… the only ear candles that are certified medical products class IIa according to medical device directive 93/42/EEC.’
I have followed the link from your website to the ‘Council Directive 93/42/EEC of 14 June 1993 concerning medical devices’ document, and note the following:
2. Invasive devices
2.1. Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device:
– are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I,
(my emphasis in bold), but I find no specific mention to these ear candles.
Could you provide comment or information on these statements?
With thanks for your time,
I find confusing the eventual reply:
‘The MHRA view on ear candles is that if medical claims are made on their behalf they should be classified as Class IIa medical devices under Rule IX of the Medical Devices Directive classification rules, covering active therapeutic medical devices.’
And further, it is
‘… unable to confirm whether the Biosun products are the only ear candles in Europe to be CE marked as medical devices as there is no list or register of products CE marked as Class IIa devices.’
I’m not interested in whether they are the only ear candles to be certified medical device. I’m concerned as to the legitimacy of attributing medical claims and medical device classification to ear candles – when there is not an iota of evidence that they have any medical function whatsoever. This seems to read that mere medical claims are sufficient for medical device designation. All that is then necessary for those making such claims, and seeking to persuade the gullible to have them stuck in their ears and set alight, is to give their procedural use a clinical sounding term: Thermal Auricular Therapy.
So, feck it! As I occasionally, erroneously, stick my index finger in my own ear, I figure it will work fine in anybody’s. Henceforth, I declare my (to make it all clever and technical seeming) digitus tertius to be a bona fide medical device, according to ‘Council Directive 93/42/EEC of 14 June 1993 concerning medical devices’. And I make it available for your therapeutic benefit with a manicure-ensured, injury risk-free guarantee. As my device is reusable, the cost of consumable (money-wasting) ear candles is obviated. For a small fee, you can experience an environmentally friendly session of Finger Auricular Therapy. Relax to the background music of your choice (I have a large eclectic collection) as your stubborn cerumen is gently scraped from your ear canal. All I will charge is the time I spend cooing assurances that it will alleviate whatever you want me to assure you it will alleviate. And the more hirsute your ears, the greater the benefit.
TAT is so old hat – get FAT !