Can distilled water be certified as a medical device?

#1
I was wondering whether distilled water which is intended to be used for all general irrigation, washing and rinsing procedures; especially in surgical field (to be specific it will be used to rinse and wash surgical instruments).

Thanks a lot :)
 
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shimonv

Trusted Information Resource
#2
Hi lyannastark,
Below is the definition of medical device from the European directive:

"‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means;"


As you can see - distilled water by itself is not a medical device.

Cheers,
Shimon
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Not my field, but curious - What would water for this type of use be classified as?
 

shimonv

Trusted Information Resource
#4
Good question. It's not a device by itself; it's not a drug; and it's not a cleaning & disinfetion agent per se. But often it is used as part of a cleaning procedure. To my knowledge there is no specific classification for it.


-Shimon
 

Ajit Basrur

Staff member
Admin
#5
Not my field, but curious - What would water for this type of use be classified as?
Water for Injection and Purified Water are called as "excipients".

Distilled Water is produced by vaporizing liquid water and condensing it in a purer state. It is used as "solvent" for reagent preparation, or calibration standard or analytical blank, and for test apparatus cleaning. It is also used as a starting point for making High Purity Water.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Yeah - I was mainly interested in
...especially in surgical field (to be specific it will be used to rinse and wash surgical instruments)...
which obviously has to be sterile water. I do know distilling water using heat will clean it of *most* impurities and should sterilize it.

I hadn't thought of distilled water as an excipient, but that makes sense now that I think about it.

In part I asked because since the question was asked here I *assumed* that a company was selling / distributing it (as opposed to, say, a hospital or doctor's office producing it in-house) and as such there would have to be some type of regulation applied to producing and selling it.

I am aware of High Purity Water. In college chemistry (Westminster College in Fulton, MO.), oh so many years ago, our laboratory water was deionized and "double distilled". In fact, I got into salt water fish tanks back then and used water from the lab to mix up what was then (and still is, I see) named "Instant Ocean" synthetic seawater salt - Saltwater Aquarium Fish Supplies | Instant Ocean - This was about 1975 and synthetic seawater was relatively new.

I have also read Guide To Inspections Of High Purity Water Systems.

Anyway, like I said - I was just curious in a general sense. Obviously, water used to rinse and wash surgical instruments has to be very pure and sterile.
 

Pads38

Trusted Information Resource
#8
Purified water is regarded as a pharmaceutical product. See here:

The European Pharmacopoeia (Ph Eur) contains standards for grades of water for pharmaceutical use including water for injections (WFI) and purified water.
This covers use as an excipient, reconstitution of products and as a cleaning/rinsing agent.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Good morning!

Sterile water for Inhalation is CE-marked, ergo a medical device - not sure how it is classified, though...
I’m not saying that it’s not a medical device, but the fact that it’s CE-marked is insufficient for such a determination. For instance, a liquid could be CE-marked as a medicinal product under the releveant directive.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Purified water is regarded as a pharmaceutical product.
In some cases - it depends on the intended use. From the regulatory (EU directives) perspective, to be considered “a pharmaceutical” (a Medicinal Product in the directives terminology) it must achieve its intended purpose metabolically, pharmacologically or immunologically.
 
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