About our project
Help in the fight against bloodstream infection with HomeClean™ and RunClean™, novel medical devices designed to provide a quick, efficient and economical solution to Catheter Related Contamination and Bloodstream Infection.
Catheter Related Bloodstream Infection (CRBSI) is a growing global issue. With a large aging population coupled with the shortage of qualified medical staff at hospitals, CRBSI-related incidents are projected to increase and potentially cause a serious global crisis. As a result, multifaceted approaches to prevention are needed immediately.
Luckily, Davis Medical’s frontline experts in disease treatment are well positioned to make a large impact on the looming CRBSI pandemic through the company’s main product lines as well as other bodily catheters. Additionally, Davis Medical’s products are not limited to human use as veterinary markets suffer the same fate from these deadly but preventable infections. While the ultimate cost from an infection of this magnitude is death, the secondary costs associated with treatment reach billions of dollars annually. Moreover, loss of work, permanent damage, and antibiotic resistance are all directly associated with CRBSI.
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Inventor and founder of Davis Medical, Nic Davis, was a nurse who experienced firsthand how serious CRBSI can be. One day while lying in a hospital bed fighting for his life due to complications from a surgery, Nic had an epiphany. The PICC line that was designed to deliver lifesaving medications became infected causing a secondary CRBSI. What Nic noticed was, not one nurse used the same “sterile” technique when interacting with the catheter. As a result, the vision to automate the process began, and to date the concept has received tremendous positive feedback from the medical community. Now, we need your help to make this happen! Join the Davis Medical team in our fight to making healthcare safer!
Stop Bloodstream Infection at the Source
Davis Medical designs, manufactures, markets, and sells novel lines of infection prevention devices positioned to reduce global Catheter Related Bloodstream Infections. Our products will save lives while reducing costs in healthcare.
Automating Catheter Tube & Port Cleaning through Aseptic Enclosure Housing
Davis Medical’s product suite prevents CRBSIs by preventing microorgansims from entering the main portals of the catheter.
HomeClean™ and RunClean™ are barrier devices against outside contaminants. These small, light-weight, air tight clam shells house an antiseptic fluid and a medical sponge. When the fluid pouch is ruptured in the sealed clam shell, the port ends of the catheter are contained in an aseptic environment.
HomeClean™: nurses or technicians no longer have to clean the catheter ports prior to accessing them, as HomeClean™ automates the cleaning process. The device is worn between treatments, so to begin treatment, the caregiver simply removes the HomeClean™ device. This simplified process will save time in busy clinical settings and reduce the risk of human error.
RunClean™: similar to HomeClean™ in function but is used during treatments. Often during a dialysis treatment involving a catheter, the arterial and venous lines need to be reversed to achieve a therapeutic blood flow rate. Without such a flow rate, the bloodlines eventually clot. This risk is exacerbated due to the intensiveness of the dialysis process for the technician. Given the importance of maintaining therapeutic blood flow rate, the technician may forget the important but time consuming cleaning steps prior to accessing the lines to reverse them. The RunClean™ device automates this important cleaning process and saves time.
Shower Clean™: a biocompatible plastic bag with an adhesive ring. This device will be placed over the entire catheter and adhered to the skin during bathing. This will prevent exposure to contamination at the insertion site.
Clinical Proof to Date
HomeClean™ and RunClean™ are barrier devices designed to reduce the risk of catheter related bloodstream infections. Bacterial infections, including E. coli cross infection, are a common cause of secondary illness in hospitals. To assess the efficacy of HomeClean™, a series of preliminary experiments were conducted using E. coli, while future experiments will use a variety of other bacterias. E. coli was grown through log phase growth as per standard protocols. Three sterile loops were then incubated in the E.coli broth for 5 minutes and were allowed to dry at room temperature. One loop was immediately placed in 5 ml’s millipore H2O, vortexed, sonicated, and inoculated onto a LB agar plate and incubated at 37 degrees celsius for 24 hrs as control. The remaining loops were placed within the HomeClean™ device containing a 4% chlorhexidine gluconate solution and incubated at 30 degrees celsius for 5 minutes and 24 hrs, respectively, to simulate the ambient temperature of the device against the skin. Again, the loops were removed, placed in 5 ml’s millipore H2O, vortexed, sonicated, and inoculated onto a LB agar plate and incubated at 37 degrees celsius for 24 hrs. The experiments were repeated in triplicate and showed positive results. All untreated, positive controls showed colonial growth by 24 hrs. The 5 minute, short exposure, and 24 hr, prolonged exposure, showed no bacterial growth at 24, 48, and 72 hrs incubation.
FDA Status
We have engaged a regulatory veteran as a consultant to assist with our strategy and filings. The current path identified is a class 2 medical device with a 510(k) exempt status. Once the design is complete, we will register with the FDA as a manufacturer and develop our ISO 13485 quality system. Furthermore, we will initiate clinical studies designed to publish journal articles, obtain reimbursement, and early adoption.
How Our Project Will Help Reduce Cardiovascular Disease and Stroke by 20% by 2020
According to the World Health Organization, Catheter-related bloodstream infections (CRBSI) are the most common cause of healthcare-associated infection to the bloodstream. In the United States, the number of Central Venous Catheter-days for patients in the ICU has been estimated at 15 million. The average rate of central venous catheter related blood stream infections (CRBSI) is approximately 5 per 1000 catheter-days in the ICU. This amounts to a total of around 80,000 CRBSI each year, with a mortality rate of up to 35%. Those who recover face increased lengths of hospitalization, increased cost of treatment, and increased morbidity due to complications of their infection. CRBSI are associated with many serious complications such as infective endocarditis, hemorrhage, and stroke. RunClean™ and HomeClean™ form a direct barrier to contamination and prevent the spread of bacterial, fungal, and viral infection and will thus decrease the number of cases of infective endocarditis and cerebrovascular diseases.
How We Will Spend Your Contributions
All proceeds will be used in the continued development of the final designs geared to making the device safe, comfortable, and stealthy for patients. In concert with development efforts our final regulatory strategy and filings will be completed. This will be achieved by finishing our preclinical studies and collecting benchtop data.
Who We Are
Nic Davis, LPN, Inventor, Founder & President
Ryan Yoakum, Ph.D., VP Business Development & Scientific Studies
Laura Green, Regulatory Affairs
Allon Friedman, MD, Medical Advisor
Collaborators: Wright State University, Dayton Development Coalition, Wright State Research Institution
Legal IP & Business: Ice Miller, LLP
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Have a question?
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