An Easier Scrub for the Hub
Central lines are lifesavers — literally. They’re used to draw blood or give medication to critically ill patients, both adult and pediatric, in hospitals. Inserted into a major vein near the heart, they may need to stay operational for weeks or longer. But they can also be the source of life-threatening infections, called central line-associated bloodstream infections (CLABSI).
To avoid this deadly problem, the catheter hubs, luer locks, and needleless intravenous (IV) connectors must be kept clean. Doctors and nurses are supposed to follow the “scrub the hub” protocol that requires scrubbing the access port for 15 seconds with an isopropyl alcohol-saturated prep pad, and then letting it dry for 30 seconds. But the hub has tiny threads and other small orifices that are hard to clean, and the protocol is rarely followed because of the amount of time and effort it takes. Hundreds of thousands of patients in the U.S. die each year because of CLABSIs.
Jud Ready, deputy director of Innovation Initiatives at Georgia Tech’s Institute for Materials, and his team came up with an invention that can reduce those numbers. Called easySCRUB, it’s a micro-abrasive melamine foam sponge that’s saturated with isopropyl alcohol. About the size of a sugar cube, it can be used to more effectively “scrub the hub” because the foam conforms to the spaces between the threads to lift and trap bacteria that cause infection.
It doesn’t require any additional training for clinicians to use and it’s thrown away after a single use to prevent contamination. It even makes a noise — Ready described it as a squeak — when used properly, so the clinician has confirmation.
Researcher Jud Ready demonstrates how easySCRUB would be used to clean a catheter hub connector. The hubs must be kept clean to help prevent central line infections. Photo by Rob Felt.
The secret is in the material used in the sponge. Initial proof-of-concept tests against two types of bacteria (Staphylococcus aureus and Pseudomonas aeruginosa) that often cause pediatric hospital-acquired infections showed that the microabrasive makeup of the melamine foam removed orders of magnitude more bacteria colony forming units from the luer lock threads on the needleless IV connector compared to the traditional prep pad. (Luer locks are industry standard in medicine.)
Ready said the team looked at a wide variety of materials. “To be commercially viable, we need to make hundreds of millions of these cubes per year for pennies each. The melamine foam is commercially available at the right price and made in huge quantities,” he said. “Its original purpose, from the 1980s, is to be used as acoustic tiles.”
The project had its genesis through a friendship: Ready and his childhood pal Ned Frisbee have known each other since they played soccer together as kids. When Frisbee’s wife, a nurse in North Carolina, was talking about CLASBI, Frisbee suggested he call “his friend at Georgia Tech who knows materials,” as Ready put it. That got Ready started, and he investigated a number of prototypes through the years before working with an interdisciplinary design team to come up with easySCRUB in 2016. Students who participated were from biomedical engineering, mechanical engineering, and materials science and engineering.
In 2016, the team won the $5,000 first prize at Georgia Tech’s spring Capstone Design Expo, then in 2017 received a $50,000 first prize from the “Make Your Medical Device Pitch for Kids!” competition sponsored by the National Capital Consortium for Pediatric Device Innovation, which is funded by the Food and Drug Administration (FDA). Now incorporated as a biotech startup called Hub Hygiene, things have moved even faster. The team partnered in 2018 with BASF, which manufactures the melamine foam in commercial quantities. FDA clearance activities are underway, and are expected to conclude this year.
Hub Hygiene recently received a patent for the device (#10,166,085), with more on the way. The company is currently doing packaging, sterility, and biocompatibility testing prior to filing a 510K for FDA clearance for use on humans. Once that clearance is received, clinical trials will follow.
“It’s been a whirlwind,” said Ready, who is also a principal research engineer at the Georgia Tech Research Institute and an adjunct professor in the School of Materials Science and Engineering. “To go from college seniors doing a paper study in 2016 to a life-saving, FDA-cleared medical device in 2019 is incredibly fast and virtually unheard of in the medical product space.”
If easySCRUB gains traction, it could also be evaluated for use with PICC (peripherally inserted central catheter) lines, which are also prone to infection, as well as for maintenance of IVs used in dialysis, chemotherapy, and anesthesia, among other health care applications. Ready hopes Hub Hygiene goes from startup to successful company, but he knows there’s more at stake. “Hopefully two kids playing soccer can end up saving thousands of lives four decades later,” he said.
The research has received funding from Children’s National Health System and BASF.