Information from the FAMHP :
- 06.05.2020 - Coronavirus: updated Belgian directive for the reuse of surgical and FFP2/FFP3 face masks during the COVID-19 pandemic
- 04.05.2020 - Coronavirus: good practices when changing consumables used with COVID-19 patient ventilators
- 04.05.2020 - Coronavirus: European Medicines Agency recommends continued use of medicinal products for high blood pressure, heart and kidney disease
- 03.05.2020 - Coronavirus: national guideline for the management of clinical investigations for medical devices during the coronavirus pandemic
- 02.05.2020 - Coronavirus: guidelines for 3D printing of respiratory device accessories
- 30.04.2020 - Coronavirus: how should tests be made available in Belgium?
- 30.04.2020 - Coronavirus: new version of Belgian directive for management of clinical trials during coronavirus pandemic
- 29.04.2020 - Coronavirus: new version of Alternative Test Protocol (ATP) for surgical face masks
- 28.04.2020 - Coronavirus: extension of measures taken by FAMHP to avoid medicinal product shortages
- 24.04.2020 - Coronavirus: reminder of risk of serious adverse effects associated with chloroquine and hydroxychloroquine
- 24.04.2020 - Coronavirus: COVID-19 patients should also report adverse reactions
Directives for medical devices during the COVID-19 pandemic
General information on www.info-coronavirus.be
Information for healthcare professionals via Sciensano
News
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.
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 help healthcare professionals and support hospitals in their processes, the FAMHP is publishing guidelines on changing consumables (filters, etc.) used in the ventilation of COVID-19 patients.
European Medicines Agency (EMA) is aware of reports that certain medicinal products, commonly used to treat high blood pressure, heart failure or kidney disease, may aggravate the coronavirus infection (COVID-19). EMA does not recommend stopping these treatments.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the sale of all ranitidine-based medicinal products be suspended in the European Union. This is due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).
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.
Belgian manufacturers of COVID-19 tests for professional use and Belgian authorised representatives of foreign manufacturers must notify the FAMHP when placing their tests on the market. This notification does not constitute an offer of equipment to the Belgian state. Companies wishing to offer tests to the government must contact the FPS Public Health.
A new version of the national directive is available to supplement the European guidelines (v3) for the management of clinical trials during the coronavirus pandemic.