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.
Contact point for requests for medical devices experiencing a shortage
Faced with a lack of medical equipment in hospitals, the FAMHP quickly set up a contact address and a tool allowing healthcare establishments to report any equipment problems they encountered.
Our experts have processed around a hundred requests concerning the lack of equipment in hospitals. Solutions were found either through the redistribution of centrally-acquired stock, or thanks to solidarity between hospitals.
Reprocessing of medical equipment or alternative production
To address the shortage of medical devices due to the coronavirus crisis, healthcare facilities have started to manufacture medical devices and their accessories, and to reprocess used medical devices. To support this approach, FAMHP experts have drawn up guidelines offering healthcare establishments more possibilities for collaborating with external firms to work on alternative solutions to overcome the lack of essential equipment. In this context, the FAMHP has published a document as guidance for the validation of a decontamination procedure for surgical masks and FFP2/3 which includes services offered by companies that have approached the authorities, with the aim of facilitating interactions between healthcare facilities and private companies.
Ventilators, oxygen, etc.: guidelines
In order to help healthcare professionals and support hospitals, the FAMHP has published guidelines on changing consumables (filters, etc.) used for the ventilation of COVID-19 patients.
Additionally, in order to guarantee oxygen supply in healthcare facilities, FAMHP experts have worked alongside numerous organisations to establish national recommendations for hospitalised patients and ambulatory patients.
Guidelines for 3D printing of breathing apparatus accessories
In order to help actors offering alternative methods of producing medical devices, the FAMHP has developedguidelines, in collaboration with experts in the field, which help guarantee patient safety and the performance of the products used.
Face masks: Alternative Test Protocol
The FAMHP has followed the European Commission’s recommendation and published guidelines for verifying the compliance and suitability of surgical face masks used during the COVID-19 crisis.
As of 3 June 2020, 279 customs files had been opened for face masks. The FAMHP inspection departments have noted, during spot checks in collaboration with customs, that the (imported) surgical face masks offered often did not have the declarations, certificates and test reports necessary to demonstrate unequivocally that they met the requirements of applicable and acceptable standards during the COVID-19 crisis. Consequently, our experts have developed an Alternative Test Protocol (ATP). The ATP is a dynamic protocol that can be adapted if necessary to reflect developments observed in the field. The third version, version 3, is the one currently in use.
The FAMHP then published the results of the face mask tests to allow end users to check information relating to the masks tested and released by the FAMHP on the basis of this protocol. The list of lots released is regularly updated on the FAMHP website.
Tests: quality criteria
To avoid misinterpretation of negative results, the FAMHP has banned the use of rapid coronavirus (COVID-19) self-diagnostic tests for six months.
To help healthcare professionals and companies in the use and development of COVID-19 tests, the FAMHP has provided information on the different types of tests available.
The reliability of the professional tests on offer is not always clearly proven and documented. This is why the FAMHP and Sciensano have drawn up a list of tests which meet certain minimum criteria, as well as a procedure and qualification criteria for the manufacturers of these tests who wish to appear on this list.
To make up for the shortages noted, the FAMHP has also issued derogations to local and international companies to ensure that certain essential health products are commercialised on the local market during the COVID-19 period (swabs, sample containers, surgical masks, etc).
Success through extensive collaboration
None of the work carried out by the FAMHP would have been possible without the support and hard work of all the actors in the field. The FAMHP teams would like to thank all of these partners for their indispensable cooperation in managing the COVID-19 crisis.
You can find all information from the FAMHP concerning the measures taken during COVID-19 on our website.