Comparison of time taken to obtain an arterial blood gas result at the bedside using the Proxima point of care machine vs. a standard remote arterial blood gas analyser: A randomized controlled trial.

Introduction: The Proxima point of care (POC) device enables arterial blood gas (ABG) samples to be analysed without the nurse leaving the patient. The benefits of this for work efficiency have not been evaluated.

Methods: We compared the time taken to obtain an ABG result using Proxima versus a standard ABG sampling system.

[Medical devices industry: the problem of clinical evaluation reports].

In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017.