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

BACKGROUND: Due to increased requirement for personal protective equipment during the coronavirus disease 2019 pandemic, many medical centres utilized sterilization systems approved under Food and Drug Administration Emergency Use Authorization for single-use N95 mask re-use. However, few studies have examined the real-world clinical challenges and the role of ongoing quality control measures in successful implementation. AIMS: To demonstrate successful implementation of quality control measures in mask reprocessing, and the importance of continued quality assurance. METHODS: A prospective quality improvement study was conducted at a tertiary care medical centre. In total, 982 3M 1860 masks and 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. Mannequin testing at the National Institute for Occupational Safety and Health (NIOSH) laboratory was used to evaluate 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: In total, 255 N95 masks underwent QFT. Of these, 240 masks underwent post-processing analysis: 205 were 3M 1860 masks and 35 were PFR95 masks. Twenty-five (12.2%) of the 3M masks and 10 (28.5%) of the PFR95 masks 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, three PFR95 masks), and concern about mask shrinkage (N=3, two 3M masks). NIOSH testing demonstrated that while filter efficiency remained >98% after two cycles, mask strap elasticity decreased by 5.6% after reprocessing. CONCLUSIONS: This study demonstrated successful quality control implementation for N95 mask disinfection, and highlights the importance of real-world clinical testing beyond laboratory conditions.

Data and debriefing observations on healthcare simulation to prepare for the COVID-19 pandemic.

We report on data and debriefing observations in the context of an immersive simulation conducted to (a) train clinicians and (b) test new protocols and kits, developed in table-top exercises without prior clinical experience to fit anticipated clinical encounters in the setting of the rapidly expanding COVID-19 pandemic. We simulated scenarios with particular relevance for anesthesiology, perioperative and critical care, including (1) cardiac arrest, (2) emergency airway management, (3) tele-instruction for remote guidance and supervision, and (4) transporting an intubated patient. Using a grounded theory approach, three authors (MHA, DLR, EHS) developed emergent themes. First alone and then together, we sought consensus in uncovering overarching themes and constructs from the debriefings. We thus performed an informal qualitative thematic analysis based in a critical realist epistemological position - the understanding that our findings, while real, are affected by situational variables and the observer's perspective[1,2]. We compared data from videos and triangulated the data by member checking. All participants and course instructors volunteered to participate in this educational project and contributed as co-authors to this manuscript. During debriefing, we applied crisis resource management concepts including situation awareness, prioritization of tasks, and clear communication practices, conducting the debriefing with emphasis on current TeamStepps 2.0 terminology and concepts. [3,4] In addition, we re-evaluated formerly familiar processes, as shortcomings of protocols, kits, and interdisciplinary cooperation became apparent. The data provide detailed observations on how immersive simulation and debriefing among peers mitigated the unfamiliarity of individual clinicians and the organization at large with the demands of an unprecedented healthcare crisis. We also observed and report on the anxiety caused by resource constraints, risk to clinicians in the face of limited personal equipment, and the overall uncertainty surrounding COVID-19. We began to summarize, interpret, critique, and discuss our data and debriefing observations in a rapid co-publication in the Journal of Clinical Anesthesia. [Healthcare Simulation to Prepare for the COVID-19 Pandemic][5].