A Needle Within a Needle
A Needle Within a Needle
A short time ago the Centers for Disease Control and Prevention (CDC) launched the One & Only Campaign, a high profile initiative that seeks to eliminate unsafe medical injections. One needle, one injection, one time. Since 2001, CDC reports over 150,000 US patients have been notified of potential exposure to viruses such as Hepatitis B and C as well as HIV due to healthcare providers reusing syringes. Sterilization is common, but clearly far from perfect.
While attending an ophthalmology meeting three years ago, Dr. Randall Olson, CEO of the John A. Moran Eye Center, picked up on some persistent chatter surrounding eye infections. His colleagues were discussing a recent study revealing roughly 1 in every 2,000 shots in the eye results in an infection. Chances worsen the more you receive shots, particularly for disorders such as glaucoma. Needles being used one time, and one time only, still had to puncture a surface area Dr. Olson pondered. Risk of contamination, albeit lower with a clean needle, was still evident due to bacteria that could be lurking at the point of entry.
XEnd Medical Systems, spearheaded by Dr. Olson’s quest to prevent needle-caused infections, has invented an anti-infective hypodermic needle. Rather than contemplating how to ameliorate a one time, one puncture process, Dr. Olson simply duplicated his efforts. The result – the XEnd Medical Systems needle - a needle within a needle.
The outer XEnd needle is covered with PLGA (an FDA-approved material) that behaves like the other side of a magnet. When it makes contact with the skin it pushes bacteria away from the puncture area. The needle is then inserted, and as this happens, the inner needle (within the outer needle) follows through. Contact with the skin only occurs with the outer needle leaving the inner needle 100% sterile.
“Our proof of concept test was completed on cadavers,” explains XEnd CEO, Andy Raguskus. “Cadavers have a ton of bacteria on them, and as such, are perfect for this kind of test.” The XEnd needle was injected in one arm while a sterile needle was injected in the other. Out of 100 samples, 24 of the standard needles registered infections. XEnd needles by contrast recorded 0% infection rates, a figure that had never been registered prior.
Dr. Olson’s original thought with a needle within a needle was specifically for the eye, but the larger market is blood cultures. There are approximately 25 million blood draws per year in the US. A more interesting side-note however is not related to conventional needles infecting patients with bacteria, but rather, the false positive rate.
“About 5% of US blood draws yield a false positive which means a culture is coming back positive for an infection when the patient really doesn’t have one,” notes Mr. Raguskus. Cutting down these false positives with XEnd needles would save hospitals a considerable amount of money in resources spent to hospitalize and treat patients with unnecessary antibiotics as a result. Moreover, neither insurance companies nor Medicare/Medicaid will pay for infections contracted with a hospital, so the desire to eliminate them is a high priority.
XEnd estimates the value of the blood draw market at US$500 million. The XEnd needle will be more expensive than conventional needles from a point-by-point comparison, but when the cost of false positives is taken into account that is when hospitals will begin to see considerable savings. Next steps for XEnd are to approach two to three of the larger hospital chains, complete a handful of trial programs, and when the results come back positive wait for the ripple effect.
Dr. Olson sees XEnd eventually being acquired. But before that, a milestone on the horizon is developing a version of the needle that can be used with one-hand. Right now two are needed, but this is a small physical price to pay while aiming for perfection.
