The need for systematic quality controls in implementing N95 reprocessing and sterilization

Source avec lien : Journal of Hospital Infection, 133(March 2023). 10.1016/j.jhin.2022.11.023

L’objectif de cette étude était de démontrer la mise en œuvre réussie des mesures de contrôle de la qualité dans le retraitement des masques et l’importance de l’assurance qualité continue.

Summary Background Due to increased requirement for personal protective equipment during the COVID-19 pandemic, many medical centres utilized sterilization systems approved under FDA Emergency Use Authorization for single-use N95 respirators reuse. However, few studies have examined the real-world clinical challenges and role of ongoing quality control measures in successful implementation. Aims To demonstrate successful implementation of quality control measures in mask reprocessing and importance of continued quality assurance. Methods A prospective quality improvement study was conducted at a tertiary-care medical centre. 982 3M 1860 or Kimberly-Clark Tecnol PFR95 masks worn by healthcare workers underwent sterilization using a vaporized hydrogen peroxide gas plasma-based reprocessing system. Post-processing qualitative fit testing (QFT) was performed on 265 masks. NIOSH laboratory mannequin testing evaluated the impact of repeated sterilization on mask filtration efficacy and fit. A locally designed platform evaluated the filtration efficiency of clinically used and reprocessed masks. Findings 255 N95 masks underwent QFT. 240 underwent post-processing analysis. 205 were 3M 1860 masks and 35 were PFR95s. 25 (12.2%) of the 3M masks and 10 (28.5%) of the PFR95s failed post-processing QFT. Characteristics of the failed masks included mask deformation (n=3, all 3M masks), soiled masks (n=3), weakened elastic bands (n=5, 3 PFR95), and concern for mask shrinkage (n=3, 2 3M masks). NIOSH testing demonstrated that while filter efficiency remained >98% after 2 cycles, mask strap elasticity decreased 5.6% after reprocessing. Conclusions This study demonstrates the successful quality control implementation for N95 disinfection and highlights the importance of real-world clinical testing beyond laboratory conditions.

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