image source: © Uniklinik RWTH Aachen/OIM

ASIC App obtains CE marking as medical device

Data-based early detection of acute lung failure

The early detection app for the clinical Use Case ASIC of the SMITH Consortium has obtained the CE certification. The application is therefore considered a class 1 medical device and can contribute to the early detection of acute lung failure.

Intensive care medicine is a medical field in which the largest amounts of patient care data is generated and usually saved digitally. The usage of this existing clinical routine data and its structured, systematic analysis can improve patient care. This is demonstrated by the clinical Use Case ASIC (Algorithmic Surveillance on ICU Patients) implemented by the SMITH Consortium. In ASIC the value of big data analysis is shown by the therapy of patients suffering from Acute Respiratory Distress Syndrome (ARDS).

Although there are clear criteria for the existence of an ARDS, it is often difficult to diagnose. In order to support physicians in early detection, the ASIC App was developed for iOS and Android-based devices within the scope of the use case. The mobile application ensures continuous electronic monitoring of the relevant ventilation parameters of intensive care patients. In the case of clinical deterioration, the app provides the relevant data for all affected patients and enables a patient-related, process-controlled, actual determination of ARDS based on guideline-compliant criteria and subsequent therapy recommendations. The obedience of these recommendations can significantly improve the outcome of the treatment of these patients.

After a development and test phase of two years, the app now officially bears the legal CE mark, making it the first successfully certified Class I medical device in the medical informatics initiative. A technical connection to already existing clinical and administrative systems in patient data management and thus the integration into clinical routine is planned at eight university medical locations within the SMITH Consortium.