01/08/2025
‘’Mild HBO ‘’
Chambers in Ireland
The new ‘’Medical Devises Regulation’’ in the EU
‘’Pressure chambers’’ for ‘’MILD HBO’’are becoming increasingly widespread in Europe.
However, the FDA has nothing to say in Europe.
But for little over 3 years there has been something New and Very effective, at least in the EU:
‘’Medical Devices Regulation’’(MDR).
To the chagrin of medical device manufactures, as it is very difficult to comply with the new regulations ;
Fortunately, in the case of ’’Pressure Chambers for Mild HBO’’
it is very effective in terms of the safety of patients and users.
On closer inspection, hardly any of the pressure designs for ‘’Mild HBO’’are likely to be able to overcome the MDR hurdles.
Various manufacturers of pressure chambers for ‘’Mild HBO’’ have apparently never submitted an application as a class IIb medical device according to the MDR.
What is interesting is that recognition as a medical device has NEVER been attempted for many of these ‘’pressure chambers’’ in the EU.
People like to cover this guise that they only do ‘’Wellness’’ and not ‘’Medicine’’.
This a BIG CHANGE
as the requirements of the old EU Directive MDD had to be transposed into national Law in EACH member state.
In Ireland the MDD was applicable law.
Like all EU ‘’regulations’’ (as opposed to guidelines).
The new MDR is now directly applicable law in all EU member states as of May 26th 2021.
Hyperbaric Treatment or Therapy:
Think of Oxygen as the Prescribed Drug Inhaled and the Hyperbaric Chamber a regulated Dosing Device
THE DELIVERY OF HYPERBARIC MEDICINE IS THE PRACTICE OF MEDICINE:
To Treat a Medical Condition Using a Device (Hyperbaric Chamber) The Device (Hyperbaric Chamber )
must have a CE certification Class IIb
EN 14931/MDR (EU) 2017/745
Pressure Chambers For Wellness ?
The Range of indications which is advertised on various websites for ''Mild HBO'' Is very broad.
The Indication lists partially overlap with recognised Medical Indications for classic HBO Therapy but also mention a significant number of additional indications that cannot be found on any list for classic HBO therapy.
Pressure Chambers as a Medical Product ?
When asked about the medical approval of pressure chambers for ''Mild HBO'' the answer is often
that this type of pressure chamber is designed as a
''Wellness Device and not as a ''Medical Product''
Overall, one can get the impression that, the term
''HBO therapy''
is AVOIDED for the advertised pressure chamber in order
NOT TO BE SUSPECTED OF USING A MEDICAL QUAILITY PRODUCTS -
In which case
MUST MEET THE TESTING STANDARDS, SUCH AS THOSE THROUGHOUT THE EU
IN ACCORDANCE WITH THE MDR.
The Argument that a pressure chamber for ‘’Mild HBO ‘’is not a medical product but a ''Wellness product'' is a protective claim.
In Principle, there is
ALSO A POTENTIAL RISK OF OVERPRESSURE AND INCREASED OXYGEN CONCENTRATION IN PRESSUE CHAMBERS FOR ''MILD HBO'' Exposed to people, users and third parties
Therefore according to the MDR these chambers are to be viewed as Class IIb medical devices and must be tested and operated accordingly.
Examples
Readers are asked to understand that for publication reasons, no example photos of such hyperbaric chambers for ‘’Mild HBO’’ are shown.
Please simply type terms like‘’Mild HBOT’’ into an internet search engine and search for ‘’images’’ to get an insight into the types of hyperbaric chambers in question.
Definition of ‘’HBO’’
Regardless of whether one speaks of
‘’hyperbaric oxygenation’’,
‘’hyperbaric oxygen therapy’’, ‘
’mild hyperbaric oxygen
‘’mild HBO’’:
In principle it is about the breathing of oxygen or oxygen enriched respiratory gases by people under increased ambient pressure in a pressurized room = (Pressure Chamber)
Reference - ‘’A European Code of Good Practice for Hyperbaric Oxygen Therapy ‘’ECHM [10].
Similar definitions can be found in other recognised publications.
According to the MDR, pressure chambers are classified as Class IIb medical devices.
This classification is based on the potential risks posed by human exposure to these pressure chambers. The increased pressure and breathing Oxygen in higher concentrations can endanger patients, users and bystanders-
FOR EXAMPLE,
THROUGH A FIRE IN THE CHAMBER.
Tragic accidents
Recently and in the past there have been explosion in pressure
Chambers with Fatalities
Do not Be Misled
Get & Check the Facts
Stay safe in choosing an accredited Centre
or Hospital based facility
Independently Audited by a third party
for the Delivery of HBOT
