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Vomit Bag a Medical Device?
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Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
Vomit Bag a Medical Device?
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  Post Number #1  
Old 6th December 2017, 02:57 AM
Mor628

 
 
Total Posts: 41
Please Help! Vomit Bag a Medical Device?

Hi guys,

I have what seems to be a very silly question. Please help !!

We manufacture vomit bags and want to know if a vomit bag is a medical device? Can we CE mark a vomit bag?

Last edited by Mor628; 6th December 2017 at 02:59 AM. Reason: sentence error

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  Post Number #2  
Old 6th December 2017, 06:36 AM
pkost

 
 
Total Posts: 824
Re: Vomit Bag a Medical Device?

A medical device is
Quote:
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;
Vomiting is not necessarily the result of a disease, but is a normal bodily function (it can be attributed to a disease though); regardless, a bag does not diagnose, prevent, monitor, treat or alleviate the issue, therefore it is not a medical device

An exception would be if you were intending for the bag to be used to collect the vomit for subsequent analysis, in which case it would probably be an IVD
Thank You to pkost for your informative Post and/or Attachment!
  Post Number #3  
Old 6th December 2017, 06:49 AM
dgrainger's Avatar
dgrainger

 
 
Total Posts: 76
Re: Vomit Bag a Medical Device?

It can be if it has a medical purpose. e.g. prevention of disease. You will have to provide evidence that it does what you claim!!
Thank You to dgrainger for your informative Post and/or Attachment!
  Post Number #4  
Old 6th December 2017, 07:28 AM
pkost

 
 
Total Posts: 824
Re: Vomit Bag a Medical Device?

How does it prevent disease?
  Post Number #5  
Old 6th December 2017, 09:12 AM
dgrainger's Avatar
dgrainger

 
 
Total Posts: 76
Re: Vomit Bag a Medical Device?

Quote:
In Reply to Parent Post by pkost View Post

How does it prevent disease?
That was a hypothetical example of a PPE/MD.

Have a look at the Borderlines manual 1.11-Shoe covers :

"Consequently, shoe covers which are specifically intended by their manufacturer to be used in operating rooms, intensive care units or immunodepressed patients to protect the patient from potential contamination are medical devices. In application of rule 1, they are in class I."

This could apply to a suitably labelled Vomit bag.
Thank You to dgrainger for your informative Post and/or Attachment!
  Post Number #6  
Old 6th December 2017, 09:57 AM
pkost

 
 
Total Posts: 824
Re: Vomit Bag a Medical Device?

You could, if you wanted, come up with a justification that made the product a medical device (I'm not sure PPE could be justified).

What would be the benefit of making a claim such as "reduces risk of transmitted infection in a clinical setting"? Why would anyone buy your product over a standard vomit bag with no claims? It will presumably cost more, or if not your margins will be reduced with the additional work required to CE mark
Thanks to pkost for your informative Post and/or Attachment!
  Post Number #7  
Old 6th December 2017, 09:15 PM
Mor628

 
 
Total Posts: 41
Re: Vomit Bag a Medical Device?

Best answer ever! Thank you so much.

Actually, that works out really well for us, because all our products have infection prevention features. And yes, it does cost more than the regular no frills vomit bag.

Thank you, thank you, thank you!
  Post Number #8  
Old 7th December 2017, 04:57 AM
rob73's Avatar
rob73

 
 
Total Posts: 222
Re: Vomit Bag a Medical Device?

Mor628
I can tell you quite categorically (from past experience) that the MHRA do not classify a sick/vommit bag as a medical device.
Thank You to rob73 for your informative Post and/or Attachment!
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