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

Introduction: The ProximaTM 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 ProximaTM versus a standard ABG sampling system. Twenty patients were randomized to ABG sampling using ProximaTM, or a standard ABG system. Nurses were observed performing all ABG sampling episodes for a minimum of 24 hours and no more than 72 hours. Results: The mean time taken to obtain a result using ProximaTM was 4:56 (SD = 1:40) minutes compared to 6:31 (SD = 1:53) minutes for the standard ABG technique (p < 0.001). Mean time away from the patient's bedside was 3.07 (SD = 1:17) minutes using the standard system and 0 minutes using ProximaTM (p < 0.001). Conclusions: Reduced time for blood gas sampling and avoidance of time away from patients may have significant patient safety and resource management implications, but the clinical and financial significance were not evaluated.

[Medical devices industry: the problem of clinical evaluation reports]. / L'industrie des dispositifs médicaux : la problématique des rapports d'évaluation clinique.

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. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.