Pressure energy - Essential Requirements (MDD/MDR)

Rincewind

Involved In Discussions
#1
Hello,

I was wondering if a device that puts pressure on a patients limb, for example would have to be considered under Annex I MDD (12.8.1.) or respective Annex I MDR (21.1.)

"21.1. Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user." (MDR, Annex I, p. 102).

As the device is non active and class I, no electrical energy is involved, this was discussed.

I am leaning towards: Yes, this clause should be applicable as pressure is still a form of kinetic energy and the regulation does not differentiate between thermic, electrical, light and so on.

Any opinions on this? :)
 
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planB

Super Moderator
#2
From a purely physical perspective and in terms of SI basic physical quantities:

Pressure = Force / Area

Energy (expressed as Work) = Force X Distance

So pressure is not a form of any kind of energy. Pressure and energy are two distinctly different physical quantities.

HTH,

Gerhard
 

dgrainger

Trusted Information Resource
#3
Not strictly applicable, but MEDDEV 2. 1/2 rev 2 has guidance on being an active device and pressure:


2.1.2. For the purpose of the Directive 90/385/EEC a medical device is active if it "relies for its​
functioning on a source of electrical energy or any source of power other than that directly​
generated by the human body or gravity. This includes, for instance, devices activated by​
means of pressure unless this effect is achieved by energy resulting from the body of the​
patient. The definition implies that the function of the device involves using the source of​
power to perform useful work. The mere transmission of heat, light, pressure or vibration​
does not mean that a device is active.​
Examples :​
- a hydrocephalus pressure relief allowing release of cerebro-spinal fluid when a spring
is overcome is not "active". Even where the setting of the spring can be adjusted by
electro-magnetic means, it remains non-active as the medical function of the device is
to relieve pressure, not to be adjusted,
- a drug delivery device in which the drug is driven from a reservoir by means of a stored
energy source (spring, fluid, gas, etc...) is "active"
- an intravascular cathether containing a fibre-optic bundle connected to an external light
source may be used to measure pressure or other characteristics of blood if some
quality of the light can be changed by the blood characteristic and detected. Although
the system as a whole depends on a power source to achieve its medical function (the
measurement of a blood characteristic) the invasive element is not "active" as it does
no more than transmit light
- a cochlear implant activated by an external power transmitter is regarded as "active"
as the implanted component clearly depends on a power source for its function and its
purpose is to convert the power it receives into electrical signals which trigger
appropriate sensory channels in the brain, i.e. it performs useful work.
 
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