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Coronavirus: the FAMHP again calls for rational use of oxygen

Due to the second wave of the COVID-19 pandemic, there is an increased need for oxygen in Belgium for patients with respiratory problems. The FAMHP asks all actors and users not to stockpile and return unused or empty material to the supplier as soon as possible.

Central traceability register: the traceability of certain implants to become compulsory

From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.

Coronavirus – a new validation procedure for serological tests

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

The COVID-19 serological tests bought by the government are reliable

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.

Coronavirus: third version of the Alternative Test Protocol (ATP) for surgical face masks

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.

Coronavirus: 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. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.

Coronavirus: recommendations for replacing closed suction systems

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.

Web portal - updates to the “My company” and “My activities” applications

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.

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