Comments on the CMDE's "Guideline for Clinical Evaluation of ICU Ventilators"

2016-11-28 | Beijing, Shanghai

The Healthcare Equipment Working Group (HCE) submitted consolidated comments on the Centre for Medical Device Evaluation (CDME) "Guideline on Clinical Evaluation of ICU Ventilators".

The comments focus on the practicability of the regulation. E.g. it is not possible to "hide" a ventilator from a patient, unless he is unsonscious. Therefore it is not reasonable to request a blind trial for ventilators.

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