News FAMHP

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.

An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.

The FAMHP inspection services have noted that the surgical face masks offered do not have the declarations, certificates and test reports necessary according to European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed to ensure they can still be permitted for use as a surgical mask or comfort mask.

Due to the COVID-19 pandemic, there is an increased need for oxygen in Belgium for patients with respiratory problems. The FAMHP and its relevant partners, assembled as part of the Task Force in charge of the management of medical devices and medicinal products, are taking measures to guarantee supply.

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.

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.

The FAMHP, in collaboration with Belgian customs, took part in the international Operation PANGEA XIII from 3 to 10 March 2020. This operation, coordinated by INTERPOL, specifically targets the interception of illicit and counterfeit medicinal products and devices. In Belgium, inspections were performed at the Zaventem and Bierset control points.

In order to avoid misinterpretation of negative results, the FAMHP has banned the use of rapid coronavirus (COVID-19) diagnostic tests for six months.

Afin de lutter contre le Covid-19, nos prestataires de soins ont besoin d'équipements de protection de qualité (masques buccaux, gants, tabliers, etc.), d'équipements médicaux et de pièces de rechange (p. ex. les respirateurs). C'est important pour pouvoir traiter leurs patients dans des conditions sûres.