Early in 2020, in support of the organization’s COVID-19 response, Innovation at Cleveland Clinic collaborated across the enterprise to source and develop alternative personal protective equipment (PPE) to help ensure the safety of our caregivers, patients and communities. As the organization began to see COVID-19 cases, our supply chain department faced disruptions to traditional purchasing channels. Caregivers from supply chain, Innovation at Cleveland Clinic and the Philanthropy Institute collaborated to purchase and produce supplies, as well as raise funds to support these activities. Innovation at Cleveland Clinic formed strategic partnerships with internal and external groups to design, validate and manufacture PPE and clinical accessories through alternate avenues.
Nearly every member of the team supported the “MAKE Workstream,” making phone calls; reviewing COVID-19-related invention disclosures; sorting, sourcing and transporting materials; reverse engineering on-hand supplies; identifying manufacturers and validating new designs. These efforts resulted in many notable deliveries of face shields, cotton masks, isolation gowns, nasopharyngeal swabs and other high-demand products.
Innovation at Cleveland Clinic rapidly built a network for isolation gown fabric supply by leveraging medical material manufacturers, industrial sellers, fabric distributors, large retail organizations and local fashion schools. After home experiments on received fabric samples, lab-confirmation of superior fit and water penetration qualities, verified sewer capacity and distribution of design specs, official orders for isolation gowns were placed by Cleveland Clinic with three main suppliers: commercial sewing company Stitches USA, non-healthcare PPE supplier National Safety Apparel and cold-weather sportswear manufacturer WSI Sports. Together, the groups were able to produce 40,000 isolation gowns for Cleveland Clinic’s supply in less than two months. Additional supplies of about 7,000 gowns were produced over the following few months. Read more on isolation gown production.
Face Masks – N95 & Community
Innovation at Cleveland Clinic spent six weeks designing and redesigning the construct of alternative fabrics to make N95 masks and opened a secondary source for the product. After several prototypes, the team landed and acquired an approved material and design, and Cleveland Clinic became equipped to manufacture alternative N95 masks should inventory be needed. Read more on re-engineering the N95.
In addition to N95 masks, Innovation at Cleveland Clinic engaged the local Amish community, as well as Stitches USA, Keim, Berlin Gardens, Superb Industries and groups of local volunteers to create 570,000 cloth masks to help protect the community.
Nasopharyngeal swabs were also in short supply at the height of COVID-19 testing. With the gold-standard nasal swab manufacturers overseas or across the country and already running at full capacity, nasopharyngeal swabs were established as a MAKE initiative. Containing two parts – the shaft and the flocked end – manufacturing the swabs became a team effort within industry. Connecting with Cincinnati-based Procter & Gamble iMFLUX, Innovation at Cleveland Clinic secured a donation of the tooling for an injection mold that would produce 50 swab shafts every 15 seconds. Flocking ability came via introduction to specialty manufacturer of dental brushes, Microbrush, which possessed the machinery to properly flock the molded shaft. Cleveland Clinic supported product testing through initial prototype tests in-house and further testing at an outside lab location. On July 1 2020, the Microbrush test swabs were FDA-listed and are now available for immediate purchase. From this endeavor, Cleveland Clinic received a donation of 63,000 swabs for its inventory. The benefit of the project, however, reaches far beyond Northeast Ohio, with an alternate source of nasal swabs established for providers nationwide. Read more on nasopharyngeal swab production.
Members of Innovation at Cleveland Clinic also contributed to the enterprise’s collaboration with Procter & Gamble (P&G) for the production of protective face shields. Alongside Cleveland Clinic, P&G evaluated an open-source design and expedited the production of a detachable, refillable face shield with its Cincinnati location’s unique manufacturing capabilities. In their first shipment, Cleveland Clinic received 18,000 face shields just two weeks after the initial phone call between the organizations. Face shield deliveries from P&G would eventually total 350,000. Read more on the collaboration for face shield production.
Shortly after the pandemic’s onset, providers found that treating patients with COVID-19 required an extra level of precaution due to its transmission via respiratory droplets. Anesthesiologists, in particular, needed to remain vigilant while performing Aerosol Generating Medical Procedures (AGMPs) such as intubations. This need heightened demand for Cleveland Clinic cardiothoracic anesthesiologist Sergio Bustamante, MD, to develop the CT Airway Bag – a large, fully-disposable, non-sterile, transparent plastic bag with four circular openings to be accessed through zippers. The bag creates a “cavity” to surround the head, neck and upper chest of a patient to maximize caregiver protection during AGMPs. Early designs of the intubation bags were made possible by the Polymer Core in Lerner Research Institute and think[box] at Case Western Reserve University. About 100 prototypes were put together by Innovation at Cleveland Clinic members before the design was sent to Parker Hannifin to improve the manufacturing processes and streamline production. One hundred bags were stocked in COVID-19 operating rooms throughout Cleveland Clinic. Dr. Bustamante is collecting feedback from users with the intent to design a next-generation bag. Both a provisional patent and FDA Emergency Use Authorization were filed for the device. Read more about the development of intubation bags.
Moving intravenous (IV) pumps outside of patient isolation rooms at Cleveland Clinic allowed for preservation of PPE and reduction in potential exposure for critical care unit medical staff during COVID-19’s peak. However, issues with effective management of the tangled web of lines connected to these pumps quickly emerged. To increase patient and caregiver safety around these lines, inventors Jane Hartman, APRN-PNP-BC, Nancy Albert, PhD, ACNO, and Innovation at Cleveland Clinic developed and produced a solution known as the HighLine™. Initially conceived to allow hospitalized children more freedom of movement by preventing IV lines from dragging on the ground, the innovation was quickly reimagined as an easy-to-use system that enables pumps to be placed outside ICU rooms. Working with Lerner Research Institute’s Medical Device Solutions, Case Western Reserve University’s think[box] and prototyping partner Protolabs, HighLine™ devices (~500 stems/~30,000 cradles) are now in use in COVID-19 ICUs across the enterprise. Read more on the HighLine™ solution.
Adjustable Flow Distributors
With inpatient volumes swelling in early 2020, hospitals nationwide faced the threat of insufficient supplies of ventilators. While it is possible to stretch ventilator usage to treat more than one patient, guidelines posted in April 2020 maintained it would be unsafe to do so with current equipment. To help address this potentially grave situation, caregivers Marc Petre, PhD; Umur Hatipoglu, MD and Rob Chatburn designed a safer approach to multiplex ventilation – a splitter valve that would allow clinicians to share the airflow between two patients in a safer, more controlled manner. Initial sketches of the splitter valve were shared with Parker Hannifin, and within days a working prototype was 3D-printed and hand-delivered to Cleveland Clinic for testing. After many rounds of iteration by Parker Hannifin and Cleveland Clinic staff, a final design was reached by April 15. Currently, Cleveland Clinic has nearly 200 Adjustable Flow Distributors in stock for internal use, and the solution was submitted for an FDA Emergency Use Authorization, should other hospitals wish to use them. Read more about the Adjustable Flow Distributors – a safer approach to multiplex ventilation.
COVID-19 Invention Disclosure
As scientists around the world put their heads together to find innovative solutions to worldwide PPE shortages and viral transmission issues, our internal inventor base also brainstormed several lifesaving technologies for COVID-19. From new mask prototypes to solutions for safer public transit, Cleveland Clinic caregivers submitted COVID-19-related Invention Disclosure Forms (IDFs) with the intent to rapidly and scalably provide protection for caregivers, patients and community members. Read descriptions of select submissions finding adoption within the healthcare community.
COVID-19 Call Center
With increasing availability and necessity of COVID-19 testing, provider systems were challenged to balance patient and supply volumes – effectively screening the community while ensuring the availability of tests for those who desperately needed them. After establishing a set of eligibility guidelines for COVID-19 tests, Cleveland Clinic’s operations team created a workflow to ensure that the guidelines were followed for all caregivers and patients of the enterprise. Adoption of this workflow required the establishment of a headquarters. Innovation at Cleveland Clinic team members were proud to take on this task. They routed the existing hotline number to the new headquarters, spread awareness of the initiative, staffed the terminals, implemented a scheduling system, trained new caregivers and occasionally operated the phone lines themselves. The team staffing Cleveland Clinic’s call center was instrumental in the enterprise’s successful distribution of COVID-19 tests. Read more about the establishment of the COVID-19 call center.