Pursuant to the Royal Decree of 24 October 2024, the FAMHP has approved a guide explaining in detail all the aspects that actors in the service and technical home assistance (STHA) sector must take into account to correctly set up a self-checking system. This guide includes a set of obligations.
As stipulated in the Royal Decree of 24 October 2024, the FAMHP has approved a first guidance for the implementation of a self-checking system related to the installation, maintenance, and/or removal of medical devices used in the diagnosis and treatment of sleep apnea syndrome outside the hospital. This guide was developed by BeMedtech in consultation with the hospital associations, the NIHDI and the FAMHP.
This guide explains in detail all the aspects STHA actors must consider in order to correctly set up a self-checking system for the installation and maintenance of medical devices intended for the diagnosis and treatment of sleep apnea syndrome. It includes obligations in areas such as quality management system, responsibilities, resources management, services provided, risk analysis, complaint and incident management.
All actors involved should meet these obligations in developing their activities.
The use of this guide and the registration of the activities on the FAMHP's web portal are effective from 16 November 2024.