As COVID-19 spread through Europe and into the United States, Cleveland Clinic’s Supply Chain identified N95 masks as a critical piece of personal protective equipment (PPE) quickly becoming difficult to purchase. As part of the enterprise’s MAKE workstream response, Innovations’ Jon Sakai and Suguna Rachakonda, PhD, were tasked to recreate what they refer to as the “deceptively complex” mask and open a secondary source for Supply Chain’s needs.
Across the country, hospital systems were identifying designs and materials that qualified as fabric to make N95 masks. Understanding time was of the essence, Sakai and Dr. Rachakonda joined the pursuit. The pair spent approximately six weeks designing and redesigning the construct of the material in hopes of successfully passing a fit test – the trial which validates a mask by measuring the amount and type of particles that are able to penetrate the material while being worn. Although the Occupational Safety and Health Administration (OSHA) waived the requirement for fit testing during COVID-19, Cleveland Clinic recognized the potential risk to caregivers in bypassing this critical step. Sakai and Dr. Rachakonda continued testing prototype after prototype. Following several trips to campus and dozens of failed tests, they identified the error was not in their designs, but in the material – the fabric’s filtration qualities would not meet N95 standards.
The team took a step back and re-evaluated their approach. With renewed energy, Sakai and Dr. Rachakonda sought design and manufacturing partners to bring additional perspective. They qualified a new material, sourced the raw goods, and conducted final tests of the design. With material and design on hand and approved, Supply Chain is equipped to begin manufacturing alternative N95 masks if or when inventory is needed. Though a painstaking project, the team’s perseverance has provided reassurance of protection for caregivers and patients amid COVID-19.