In order to assist those offering alternative methods of producing medical devices, the FAMHP has developed guidelines which will help guarantee patient safety and the performance of the products used.
The COVID-19 pandemic has put pressure on the availability of medical devices at both hospital and national level. In order to address shortages of medical devices, healthcare facilities have arranged for the manufacture of medical devices that would otherwise not be available in time for the treatment of a patient, or the reprocessing of used medical devices.
The FAMHP had already previously released a circular, in which it set out the terms for providing healthcare facilities with more options when subcontracting the production of said medical devices to third parties. The role of healthcare providers and health facilities remains essential to enable the rational deployment and continuous assessment of these crisis solutions.
In recent weeks, many companies, universities, Fab Labs and citizens have contributed to the production of some of these missing devices or accessories. Although the FAMHP understands that in times of crisis, risk/benefit ratios can be temporarily redefined, this needs to be based on the existing regulatory framework.
The new guidelines developed for the 3D printing of accessories for respiratory devices must guarantee patient safety when using these products. As a reminder, the criteria set out in the circular remain applicable.
A list of organisations undertaking to comply with these guidelines in order to guarantee a certain level of production quality has also been published.
Directives for medical devices during the COVID-19 pandemic