Your browser doesn't support javascript.
The need for systematic quality controls in implementing N95 reprocessing and sterilization.
Goyal, N; Goldrich, D; Hazard, W; Stewart, W; Ulinfun, C; Soulier, J; Fink, G; Urich, T; Bascom, R.
  • Goyal N; Department of Otolaryngology - Head and Neck Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA, USA. Electronic address: ngoyal1@pennstatehealth.psu.edu.
  • Goldrich D; Department of Otolaryngology - Head and Neck Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Hazard W; Department of Anesthesiology and Perioperative Medicine and Neurosurgery, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Stewart W; Operational Excellence Program, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Ulinfun C; Department of Facilities, Administration, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Soulier J; Department of Nursing, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Fink G; Facilities Infrastructure and Energy, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Urich T; Department of Environmental Systems, Facilities Maintenance, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
  • Bascom R; Department of Pulmonary Medicine, The Pennsylvania State University, College of Medicine, Hershey, PA, USA.
J Hosp Infect ; 133: 38-45, 2023 Mar.
Article in English | MEDLINE | ID: covidwho-2241095
ABSTRACT

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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Systematic review/Meta Analysis Limits: Humans Language: English Journal: J Hosp Infect Year: 2023 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Qualitative research / Systematic review/Meta Analysis Limits: Humans Language: English Journal: J Hosp Infect Year: 2023 Document Type: Article