Recent articles in the media have once again questioned the reliability of the serological tests bought by the government, in particular the DiaSorin test. The FAMHP is clear: on the basis of current scientific knowledge, this test meets all requirements and can be used without any problems.
Coronavirus and the fight led by the FAMHP: solutions implemented by the FAMHP in the face of medical equipment shortages
Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly to support hospitals facing difficulties with supplies of medical devices. Here is an overview of the measures implemented by the FAMHP.
Because medical devices such as medical gloves, surgical masks, intensive care equipment and other medical equipment play a crucial role within the context of the COVID-19 pandemic, on 24 April 2020, the application date of various provisions of the European Regulation (Regulation 2017/745) on medical devices was postponed until 26 May 2021.
Coronavirus: updated Belgian directive for the reuse of surgical and FFP2/FFP3 face masks during the COVID-19 pandemic
The national directive published on 07.04.2020 concerning the reprocessing of surgical and FFP2/3 face masks has been updated. This directive aims to guide the validation of the various initiatives being put in place regarding the reuse of surgical masks and personal facial protection.
In order to assist those offering alternative methods of producing medical devices, the FAMHP has developed guidelines which will help guarantee patient safety and the performance of the products used.
Coronavirus: national guideline for the management of clinical investigations for medical devices during the coronavirus pandemic
The national guideline has been developed to assist sponsors of clinical investigations for medical devices in the management of these investigations in the context of the coronavirus pandemic.
Coronavirus: circular for care institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories
In order to combat shortages of medical devices, care institutions have proceeded to manufacture medical devices and their accessories or to reprocess used medical devices. The FAMHP defines the modalities by means of a circular in order to offer more options to care institutions.
Coronavirus: Belgian directive for the reuse of surgical masks and FFP2/FFP3 masks in the context of the COVID-19 epidemic
A national guideline is available for the reprocessing of surgical masks and FFP2/FFP3 masks which allows reuse by cleaning, disinfecting or sterilising.
The FAMHP issues guidelines for checking the compliance and suitability of surgical face masks The guidelines are for companies not producing in accordance with European standards and for healthcare establishments and authorities ordering the masks.
Following the coronavirus epidemic (COVID-19), experts at FAMHP are actively monitoring the potential impact on the availability of medication and medical devices in Belgium. The FAMHP is also supporting the European Medicines Agency (EMA) in developing COVID-19 vaccines.