As a member of the Mass General Hospital’s Biothreats Response Team, Kimberly Whalen, RN, MS, CCRN, is steadfast in applying safety protocols at work, especially when it comes to drawing blood and transferring it from syringes into collection devices. As a pediatric nurse with her entire 26-year career devoted to caring for the tenderest patients, Whalen wondered why adult blood sampling systems were better designed for safety than pediatric ones.
In adult collections, blood is transferred into containers that are part of a closed system, where there is no opportunity for blood to escape, thereby fully protecting health care workers from possible biohazard exposure. However, in pediatric draws, blood is manually squirted from syringes into blood gas syringes or microcontainers but within an open system. In such a system, blood can spill, posing high occupational health concerns, including emotional toll.
Currently, the open system is the only one available for use in pediatrics.
Unlike adult blood sampling, which often require 10 ccs of fluid for testing, pediatric draws require smaller amounts, only .2 cc. Nonetheless, smaller amounts still pose risk, not only when blood is drawn in the PICU, as it is on Whalen’s unit, but also on any unit or in any facility where children are tested by blood.
This troubled Whalen, the nurse director of the pediatric intensive care unit at Mass General for Children.
Whalen traveled often to various biothreat-related meetings throughout the nation in her capacity on the Biothreats Response Team. Frequently, she conferred with experts, like herself, asking if they knew of a way to avoid the exposure to biohazards when drawing pediatric blood. No one did. That became the driving force behind Whalen getting to work, a different kind of work for her—innovating.
Whalen reached out to Ryan Carroll, MD, MPH, an attending physician in the PICU, and the two began collaborating on designing a closed system that would fix the gaping hole in blood sampling. At first, the pair searched frantically for any pieces of equipment around the hospital to fashion a prototype. A medicine cup was a start; glue, vacuum molded forms, and pieces from a vacutainer coupler were added to the mix. This was it—the first prototype.
In 2019, Whalen and Carroll applied for the patient care services IDEA Grant and started working with Hiyam Nadel, MBA, CCG, RN. Nadel is the patient care services director for innovations and care delivery at the hospital. Their innovation, the Blood Shield Transfer device, won the $5,000 grant that propelled them to continue. Nadel also helped navigate the pair through various prototypes, working with engineers and patent attorneys.
Matthew Beatty, a senior research and design engineer at the hospital’s Tearney Lab, helped with fine-tuning the device. In all, it took more than 10 prototypes. One of the last steps: End-user testing among PICU nurses, who said the new device was easily integrated into their current workflow because of the intuitive design.
Whalen had plenty of guidance along the way. She is quick to lend praise for Mass General Brigham Innovation associate director of business development and licensing Dan Currie who helped her file an Innovation Disclosure Form, one of the first steps in the process, and he was also instrumental in filing the provisional patent for the device in 2020. A final patent was filed in fall 2021. Patents protect discovery throughout the process.
Hats off, too, to Nat Sims, MD, a MGfC anesthesiologist and Newbower & Eitan MGH endowed chair in biomedical technology innovation, who provided guidance in the world of innovation. “Working with Kim, Ryan, Hiyam, and Matt has been a highlight of my 40-plus year career at MGH,” said Sims. “Our famous culture of innovation and collegiality in forming self-organizing multidisciplinary teams that strive for improvements in patient and workforce safety is exemplified by this group and assisting with the special needs of pediatric patients is especially rewarding.”
The Blood Shield Transfer was first hatched in September 2018, and after fits and starts (mostly because of coronavirus), it moved from prototypes to the front doors of a device manufacturer this year. The 4-year journey is not atypical for developing an innovation.
“The innovation process is a long road,” Whalen admits. “It’s a roller coaster. You get all excited about something you’re doing and all of a sudden it seems like it (the innovation) does not go forward. But then another opportunity arises, and it does.”
“MGH and Mass General Brigham Innovation are providing support to nurses to explore different avenues, including innovation, which is not available for nurses at other institutions. They provide opportunities to nurses to collaborate with doctors—something nurses were often shut out of. There had never been a path for nurses to innovate. Doctors have always had the natural path to innovation, but nurses never did.”