Ruma Digital-System (Pro) is CE certified as a class I medical device in accordance with MDR. Versions 1.0.x are identified with UDI 111724293144. The current Version 1.1.x is identified with UDI 111820761225. Ruma GmbH is registered as manufacturer at EUDAMED with the SRN DE-MF-000011426.
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Ruma Digital-System (Pro) is applicable in the therapy of mental and behavioural disorders due to psychotropic substances (ICD-10 Code F10-F19) as long as the abstinence control is carried out with urine samples within the necessary therapy-related relapse management.
There are no medical contraindications in accordance with ICD-10 regarding the application Ruma Digital-System (Pro).
Ruma Digital-System (Pro) supports relapse management alongside therapy of addiction patients with mental and behavioural disorders due to psychotropic substances (ICD-10 Code F10-F19).
Ruma Digital-System (Pro) allows urine sample collection for the purpose of abstinence monitoring on the patient's own responsibility and independent of location. Through the intake of a urine marker substance, documented in a video recording, urine samples are positively matched to the patient. The behaviour of the patient during application of the Ruma Digital-System provides additional action-specific parameters such as calm and composure during the process, shaking hands etc. that can be included in the assessment of therapy progress. Support in coping with every-day life and time saving effects increase therapy readiness, motivation and adherence.
Ruma Digital-System (Pro) is structured in two modules that are only functional in combination: Ruma Digital-System (patient module) and Ruma Digital-System Pro (medical office module).
Using the medical office module (Ruma Digital-System Pro) individually labeled urine marker substances are logged and assigned to patients. Through an integrated messaging feature urine sample provision is timed flexibly and in a manner that cannot be anticipated by the patients. Additionally, the app supports the asynchronous validation of the transmitted intake videos.
The patient module (Ruma Digital-System) prompts the patients via the messaging feature to provide a urine sample without prior notice. Afterwards the patient module verifies the security features of the urine marker substance as well as the correct assignment and allows, upon successfull matching, the documentation of intake of the urine marker substance on the patient's own responsibility. The execution is comprehensibly described in the form of an instruction video. The video recording is encrypted and transmitted to the treating physicians. A validation of the regular execution is performed. Validation by laboratory analysis of the urine marker substance can thus verify potential concomitant use.
By avoiding medical office visits for such urine tests additional freedom is created for participation in social and working life, active support is provided for reaching the set therapy goals of adherence and personal responsibility is increased. In the event of pandemics no contact is necessary.