Result card

  • CUR15: What is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?
English

What is the marketing authorisation status of Structured telephone support (STS) for adult patients with chronic heart failure?

Authors: Ingrid Wilbacher, Nadine Berndt, Francesca Gillespie

Internal reviewers: Alessandra Lo Scalzo, Christian Vladescu, Christina Mototolea, Kristina Lampe, Maria Camerlingo

The listed devices in the included studies were searched for their CE status using google and the device-specific websites.

European Commission at http://ec.europa.eu/growth/index_en.htm

The database for medical devices within the EU (http://ec.europa.eu/health/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm) is access-restricted. And could not be consulted

Italy has a comprehensive national database for medical devices which is in Italian and is accessed only by authorized operators. An open access classification of medical devices in Italian language only (http://www.salute.gov.it/imgs/C_17_pubblicazioni_1687_allegato.pdf) is needed for the research in the database itself, so no results can be provided.

There is also a medical devices registration database for medical devices in Austria, but the access is closed. (http://www.medizinprodukteregister.at/de/start).

An Austrian expert was asked for information.

For equipment used within structured telephone support in a (community-)setting and/or within a disease management programme the devices seem to be individually created for the local need and based on a software for data-collection via App, internet or as a database where data are written in while telephone interviews.

Different related devices like mobile phone applications, bluetooth adaptations (sending data from the scale or bloodpressure device, etc., via telephone to the healthcare center), are used within structured telephone support.

Usually a telephone does not need to be registered as a healthcare device, but any related medical device as regulated within the European Commission at http://ec.europa.eu/growth/index_en.htm

The information from the expert consultation in Austria lead to two homepage information-links which give information about the status of authorisation, another two systems were not found. It is not known whether these systems are used elsewhere than in Austria:

-The AIT Telemonitoringsystem of the Medical University of Graz provides a DMP monitoring device named TMScardio which is used in hospitals and a healtnetwork in Tyrol. There is some official information at http://www.meduni-graz.at/cms.php?pageName=301&year=2013&newsId=25852 (last check on 2.7.2015) and on http://www.ait.ac.at/research-services/research-services-digital-safety-security/health-information-systems/telemonitoring-and-therapy-management/heart-failure/?L=1 (last check 6.7.2015), but not about CE registration (needed ?).

-ELICARD Heart Telemonitoring System, DMP monitoring system, which uses the TMScardio. Information is avaliable at http://bmg.gv.at/cms/home/attachments/4/5/9/CH1417/CMS1423479059781/9_ait_factsheet_telemonitoring_herzinsuffizienz.pdf (last check 6.7.2015), includes the same technical product AIT as mentioned above, we did not find any information about CE mark.

-Two further systems were mentioned, a telerehabilitation discharge-home training-monitoring and a bloodpressure SMS, but with no further information and no hint to a CE mark.

Important
Partially
Wilbacher I et al. Result Card CUR15 In: Wilbacher I et al. Health Problem and Current Use of the Technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Structured telephone support (STS) for adult patients with chronic heart failure [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=305