Dekontaminering av åndedrettsvern for gjenbruk i spesialisthelsetjenesten i Norge – etablering av nasjonal kapasitet for dekontaminering med hydrogenperoksiddamp

The COVID-19 pandemic has affected the supply and consumption of personal protective equipment in Norway. In the spring of 2020, the situation was demanding and it was difficult to meet the increased need in Norway. The situation was particularly challenging for respiratory protection equipment since the pandemic led to a global shortage. Decontamination of used respirators and reuse is a possible solution to increase the availability of respirators. Several countries have during the pandemic introduced systems for decontamination of used respirators with hydrogen peroxide vapour. In the United States, Battelle has provided a high capacity system that can decontaminate up to 5000 respirators simultaneously. Respirators are personal protective equipment and must be Conformité Européenne (CE)- marked. A temporary national regulation from March 2020 conditionally allow for the use of non- CE-marked respirators. In June 2020, the Norwegian Directorate of Health decided that reuse of decontaminated respirators intended for single-use can be approved if all the specified criteria are met. The decision concluded that there are no national regulations for the approval of decontamination systems for personal protective equipment, and made it possible to establish and validate a system for decontamination of respirators for reuse in Norway. This report describes the development of a national capacity for decontamination of respirators for reuse in the specialist health service in Norway. The national capacity is a system solution consisting of a number of sub-processes - collection, labelling, packaging, transport, decontamination, return and reuse - all of which work together. A centralised national unit for decontamination has been established at the Norwegian Defence Research Establishment FFI. The national unit is a container-based solution that uses a BQ-50 decontamination system from Bioquell to decontaminate respirators with hydrogen peroxide vapour. Routines/procedures have been established for all sub-processes associated with national capacity and national unit. Validation carried out at the national unit shows that FFP2/FFP3 type respirators can be decontaminated. This is documented by a ≥6-log reduction in Geobacillus stearothermophilus spores, which is a highly persistent and commonly used biological indicator. Measurements of total inward leakage (TIL) documents that the respirators maintain the necessary quality and performance in terms of their filtration properties, adaptability and functionality after one, two and five rounds of decontamination. The validation shows that the national unit can decontaminate up to 1400 respirators simultaneously, with an estimated treatment time (loading, decontamination, ventilation, and unloading) of 5–6 hours. The process shall only be used for respirators that do not contain cellulose or have an exhalation valve. Decontamination of respirators for reuse within the national capacity framework shall exclusively be carried out at the national unit according to the validated solution. Based on the overall technical documentation presented, FFI recommends that the national capacity and national unit for decontamination of respiratory protection for reuse in the specialist health service in Norway be considered established and ready for operations upon publication of this report.