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Discussion Thread Title: Vomit Bag a Medical Device?
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Old 6th December 2017, 06:36 AM
pkost

 
 
Total Posts: 809
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!

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