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An infection prevention officer at the hospital along with key clinical personnel and administrators had to give the OK for the prototype mask to be manufactured.
“To match steps with crisis is to dance with uncertainty,” say investigators with the University of Colorado in a study in the American Journal of Infection Control. “A structure for decision making and executive sponsorship is necessary to allow available information to be rapidly assembled and then decisively acted upon.”
The decision-making necessary to pull off the manufacturing of a new type of mask using entities that don’t often work together was facilitated by an Incident Command Center.
And the uncertainty that the study focuses on will be all too familiar to infection preventionists (IPs) and other health care professionals on the frontlines of the COVID-19 pandemic, especially in the early months of 2020. That’s the uncertainty about the supply of personal protective equipment (PPE), particularly masks.
The investigators set out to determine whether it’s best for hospitals and other health care facilities to put their efforts into shoring up existing medical supply lines or into inventing alternative methods—and novel designs for masks—to meet the need during COVID-19 surges.
“Based on the vital importance of being able to deliver PPE in preserving the health and trust of the medical workforce, our academic medical center elected to pursue this avenue to meet what was potentially going to be an unmet need based on the information available early in the pandemic,” the study states. “As of this point, these novel masks, and the manufacturing capability to create more, remain in reserve. However, based on our experience, the iterative process from design to production required several months and subsequent waves of COVID-19 have demonstrated that regional supplies of equipment can be strained long after the initial surge has passed.”
The University of Colorado investigators work in 2 different departments: the school of medicine, and the college of engineering, design and computing. The idea was to “design and manufacture a novel, re-usable, half-face respirator in case conventional medical supply chain failed to meet demand.”
Investigators had 3 major concerns. The first was to not let the new masks foster a false sense of security among clinicians who’d be wearing them. Clinicians were taught just what the new masks could and couldn’t do. Another concern was that clinicians and the public might become anxious knowing that a new mask was being manufactured because supply lines could run dry. The investigators and hospital administrators decided to keep the project secret.
Then, there was the question of legal liability if the hospital used masks that had not been approved by the National Institute for Occupational Safety and Health (NIOSH). “To address this, the decision was made that [Colorado Gov. Jared Polis] would need to declare crisis standards of care and the conventional PPE options available to the hospital would have to be exhausted before they would see use,” the study states.
They wanted to design a mask that afforded the same protection as an N95 respirator. It would need to be able to be decontaminated and reused and be able to fit inside a face shield without causing fogging.
“Via the Incident Command Center, our Infection Prevention Officer reviewed the prototype with key clinical and executive leadership for input and to establish buy-in during the iterative design phase,” the study states. “The center was also critical in approving simulated fit testing of the novel design through Employee Health.”
The industries needed to help in the manufacturing process were not the types of industries that usually work with health care organizations, the study states. The University of Colorado’s college of engineering, design and computing facilitated the manufacturing process.
“An original mask design was developed, and the University Hospital had an initial batch of this novel mask manufactured during the first wave of the SARS-COV-2 pandemic,” the study states. “These masks, and the die necessary to produce more, is in reserve in case of depletion of stores of conventionally sourced PPE.”
The study concludes: “Healthcare organizations facing similar crisis in the future need to make this decision early. One way or another, by the time the surge peaks, or next pandemic wave arrives, the die is cast.”
SOURCE FOR ILLUSTRATION: Cumbler E, Wittig M, Jacobson N, et al. Contingency planning for healthcare worker masks in case of medical supply chain failure: Lessons learned in novel mask manufacturing from COVID-19 Pandemic. Am J Infect Control. Published online August 4, 2021. Accessed August 7, 2021. doi:https://doi.org/10.1016/j.ajic.2021.07.018