New guidelines from FAMHP for in-house fabrication of respiratory devices accessories using 3D printing
News for our Belgian members active in the production of respiratory devices: the FAMHP has drawn up guidelines that will “help to guarantee patient safety and the performance of the products used”. These guidelines apply specifically to 3D printing. You can find them here.
Feedback or input on this guideline is also welcome: “You can send your questions or comments about this document to email@example.com with the following subject: comments/questions”. We ask our members to (also) send this input to us so that we can centralise and strengthen this – a common position results in a stronger signal.
We recommend that our members, who wish to participate in the development of respiratory devices, apply for publication on the list of “organisations that undertake to comply with these guidelines in order to guarantee a certain production quality”. This can be done via this mail address: firstname.lastname@example.org with the subject: “Guidelines 3D”. Please note that guarantees are requested with regard to the quality and quality assurance of the companies in question.
Note that there is a distinction between the guidelines and conditions for the production of respiratory devices and the other applications of 3D printing. To this end, there is the more general “Circular for care institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories”: to be found on this site. Via the site you will also find “Notification forms” that hospitals and manufacturers are required to fill in. These can be submitted at email@example.com.
For more information, questions and/or feedback, please contact Flam3D.