The purpose of the guidance is to provide a reprocessing policy for single-used face masks in order to expand the availability of these products in Belgium. The guidance reiterates most of the information provided in Section VI.A. of the FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19).The content of the FDA guidance has been adapted to the Belgian context. The Belgian guidance is available in English.
The guidance provides that reprocessing should be considered as a last resort. It should only be performed if a shortage of surgical masks or FFP2 or FFP3 face masks is confirmed. The guidance also recommends that reprocessing be applied only to CE marked products.
The AFMPS/FAGG will not be actively involved in assessing the reprocessing activities that fall within the scope of this guidance. However, the guidance requests that entities engaging in reprocessing activities notify the AFMPS/FAGG of this activity and provide information regarding reprocessing. This notification should be submitted to email@example.com using the following template.
The guidance provides that the initial manufacturers of reprocessed products will not be held liable for any negative consequences of reprocessed products. It is the legal entity that requests the reprocessing activity that will be legally responsible for conformity with this national guideline.
The guidance provides that the use of sterilization methods for the reprocessing, disinfection and bioburden reduction will not always render the masks or filters sterile after reprocessing. It is, however, necessary to demonstrate that sufficient bioburden reduction has been achieved.
The guidance also includes several recommendations addressed to entities engaging in reprocessing of the products governed by the guidance.
The guidance provides that reprocessing should be accompanied by:
A justification for the selected method or methods used for cleaning, disinfection, and sterilization of the products;
A description of the process for disinfection or sterilization;
Validation of bioburden reduction or disinfection;
Description of a chain of custody and safeguards to prevent inadvertent exposure;
Evidence demonstrating material compatibility;
Evidence that the performance of the surgical masks and respirators is not reduced (after the intended number of times of reprocessing);
Fit test data;
Specific labeling of the product.
The guidance also provides information on how to demonstrate that these different requirements are fulfilled.
Authored by Elisabethann Wright, Hélène Boland, and Vicky Vlontzou