The FAMHP is keeping a close eye on the situation on the ground. Consequently, the Alternative Test Protocol (ATP) is being adapted. From now on, it will no longer be possible to sell surgical masks which do not comply with the ATP as comfort masks. One of the parameters has also been refined based on an evaluation of the new test results. Furthermore, masks that have been subject to the ATP must carry a warning on the packaging. The third version of the ATP is applicable from 04.06.2020.
Coronavirus: newly updated guidelines for verifying the compliance and suitability of surgical face masks
The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. These guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
The FAMHP reminds hospitals of the recommendations for replacing closed suction systems and offers temporary practical advice to help healthcare professionals waiting on a new stock of suction systems.
In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
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 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.
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.
The FAMHP no longer provides specific validation or verification procedures for COVID-19 tests, nor are there any restrictions for making these tests available on the Belgian market.