16400 - Celox Haemostatic Gauze

I represent a Medical device manufacturer that produces Celox Haemostatic Gauze, dressings that are used to stop life-threatening bleeding in traumatic injuries. I believe that Celox may be in use with the East of England Ambulance Service. As part of a freedom of information request I wish to receive clinical data on the usage of Celox by the East of England Ambulance Service.

 

  • Reference:
    16400
  • Response:

    I represent a Medical device manufacturer that produces Celox Haemostatic Gauze, dressings that are used to stop life-threatening bleeding in traumatic injuries. I believe that Celox may be in use with the East of England Ambulance Service. As part of a freedom of information request I wish to receive clinical data on the usage of Celox by the East of England Ambulance Service.

    This is a legal obligation as the regulatory requirements for medical devices are becoming ever more stringent, including an increasing necessity to proactively collect post-market clinical data. Clinical data is the safety and/or performance information that is generated from the human clinical use of a device. It is required to perform a Clinical Evaluation to comply with the essential requirements of the current Medical Devices Directive. The new Medical Devices Regulation also has more stringent clinical data requirements, with it expected clinical data will be required to enable certification to the new regulation.

  • Area:
    Trust wide
  • Category:
    Clinical
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  • Year: