XEnd

Blood cultures

Ending Needle-Caused Infections

While attending an ophthalmology meeting in New Orleans five years ago, Randall Olson, M.D., CEO of the John A. Moran Eye Center and professor and chair of the Department of Ophthalmology and Visual Sciences, was intrigued by the persistent chatter surrounding eye infections. His colleagues were discussing the fact that roughly 1 in every 2,000 eye injections results in an infection, with total loss of vision an all-too-common outcome. Chances worsen the more one receives shots, particularly if they have a complex retinal disease such as age-related macular degeneration that routinely requires them.

The risk of contamination from injections is lowered when proper procedures are followed but can never be completely eliminated due to bacteria that lurk at the point of needle entry. “Antiseptics simply do not kill all of the surface bacteria present,” explains Olson. “There are many microscopic cracks and crevices for harmful bacteria to hide in, such as on the skin or on the surface of the eye. It’s not as smooth as you might think.”

Removing harmful bacteria from the skin prior to an injection is vital because when needles puncture the surface they take a small amount of that tissue with them into the patient. The bacteria not removed on this skin-core with an antiseptic or anesthetic enter the bloodstream. If the injection is made in areas more susceptible to infections such as the eye, spine, or joint spaces—or if the patient has a weak immune system—there is an increased risk of that patient acquiring a needle-caused infection.

T

he XEnd Needle

After returning home from the New Orleans conference, Olson searched for potential solutions to this problem. He was surprised to find very little on the market or in development. This absence led him to develop his own solution: an anti-infective hypodermic needle. In 2011, U-spinout XEnd was established to commercialize this new medical device. The needle, which has undergone significant iteration, promises to greatly reduce needle-caused contamination.

Randall Olson, founder, XEnd and CEO, John A. Moran Eye Center

Olson’s device is actually made up of two needles, an outer and inner one. Unlike standard needles, the outer needle does not take skin-cores with it as it penetrates the skin. It is also covered with a key anti-infective film made up of FDA-approved materials that repel bacteria from puncture areas rather than kill or inhibit them. Once inside the skin, the inner needle follows through, allowing the healthcare worker to either inject medicine or draw blood. The only contact with the skin comes from the outer needle; the inner needle remains 100 percent free from surface contact.

Proof of Concept

To test the needle’s effectiveness a proof of concept test was recently completed on cadavers. “Cadavers have a large amount of bacteria on them and were perfect for this kind of test,” explains Andy Raguskus, XEnd’s CEO. In the study, the XEnd needle was injected in one unsterilized arm while a standard, sterile needle was injected in the other unsterilized arm. Out of 100 samples, 24 of the standard needles registered bacterial contamination. XEnd needles recorded zero percent contamination rates, a result that astounded both Olson and Raguskus.

Targeting False Positives

Although Dr. Olson originally designed the XEnd needle for intraocular injections, later research showed that its impact could be multiplied if it were also used in blood cultures. Roughly 18-million blood culture tests are ordered annually in the U.S.[10] Of these, approximately three percent yield a false positive, meaning that bacteria not present in the patient’s blood were identified in a grown culture.[11]

Patients with false positive blood cultures often undergo unnecessary and expensive antibiotic treatments, lab tests, and hospitalizations.[12] Studies have estimated the cost of an inpatient stay stemming from a false positive at between $2,889 and $8,720.[13] Altogether, false positive blood cultures cost the U.S. healthcare system approximately $4 billion each year.[14] The treatment procedures also lead to an increase in antibiotic resistance and even patient morbidity.[15]

The XEnd needle

According to the College of American Pathologists Today, reducing false positives from five percent to one percent would save individual hospitals anywhere from $400,000 to $4.1 million, depending on the institution’s size and current false positive rate. Moreover, neither insurance companies nor Medicare/Medicaid pay for infections contracted within a hospital, so the need to eliminate them has become a high priority.

A Veteran CEO to Lead the Company

To satisfy this need and move the needle to market more rapidly, Olson brought on serial entrepreneur and veteran CEO Andy Raguskus to lead the company. Raguskus successfully led Sonic Innovations, a hearing aid company, as it became the 17th largest company in Utah and the sixth largest global hearing company in the world. He was also named “Utah Entrepreneur of the Year” in 2001 by Ernst & Young, CNN, USA Today, and NASDAQ.

Next steps for XEnd are to conduct live human trials in conjunction with ARUP as part of its process to obtain approval from the FDA. They will then approach two or three of the larger hospital chains and conduct a trial program. “Every needle puncture carries risk of infection,” Raguskus explains. “If live human trials are as successful as our cadaver study, XEnd will likely experience rapid growth.”

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[10] Shramik Sengupta and John Pardalos, “Electrical System for the Rapid Detection of Viable Bacteria in Blood Cultures,” Coulter Translational Partnership Program, University of Missouri, accessed September 14, 2015, http://coulter.missouri.edu/2013/sengupta-pardalos.php.

[11] Keri K. Hall and Jason A. Lyman, “Updated Review of Blood Culture Contamination,” Clinical Microbiology Reviews 19, no. 4 (October 2006): 788-802.

[12] Wesley H. Self, Theodore Speroff, Carlos G. Grijalva, Candace D. McNaughton, Jacki Ashburn, Dandan Liu, Patrick G. Arbogast, Stephan Russ, Alan B. Storrow and Thomas R. Talbot, “Reducing Blood Culture Contamination in the Emergency Department: An Interrupted Time Series Quality Improvement Study,” Academic Emergency Medicine 20, no. 1 (January 2013): 89-97.

[13] Anne Paxton, “Contaminated Blood Cultures: Taking Bold Steps to Lower Rates,” College of American Pathologists Today, accessed September 14, 2015, http://tinyurl.com/qg3xc6a.

[14] Arjun Gupta, “Being Cultured While Culturing,” Southern Medical Journal 108, no. 8 (August 2015): 482.

[15] A. Roth, A. E. Wiklund, A. S. Pålsson, E. Z. Melander, M. Wullt, J. Cronqvist, M. Walder and E. Sturegård, “Reducing Blood Culture Contamination by a Simple Informational Intervention,” Journal of Clinical Microbiology 48, no. 12 (December 2010): 4552-4558.