FAMHP defines modalities with regard to the use of 3D printing in the fight against COVID-19 in Belgium
In order to fight medical device shortages, healthcare 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 increase the options available to healthcare institutions. Please note that this circular only covers the production of medical devices, not personal protective equipment, and only applies to Belgium.
The COVID-19 pandemic poses a challenge to the usual production and distribution channels of medical devices. For this reason, healthcare institutions are looking for new possibilities to obtain medical devices, their accessories and used medical devices that have been reprocessed. 3D printing can certainly contribute to this.
A circular from the FAMHP (Federal Agency for Medicines and Health Products) now lays down the framework to offer healthcare institutions more opportunities to work with external companies on alternative solutions. In this way they want to tackle the shown shortages of necessary materials. This can be done, on the one hand, by producing certain medical devices “in-house” and, on the other hand, by reprocessing single-use medical devices. This circular sets out the conditions and modalities under which this can be allowed to respond to the emergency situation.
The various guidelines published by the FAMHP can be found on their Guidance COVID-19 page, including the two notification forms requested in the above circular.