Melzi Sharps Finder™ Demonstrates Improved Ability to Locate Retained Surgical Sharps (RSS)
Sharps Finder shows detection of 13mm, 17mm, and 26mm needles with a 95% reliability rate
This device addresses the standard surgical issues of poor visualization, narrow optics, large heterogenous space and increases the probability of successfully identifying RSS
Data presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2021 Annual Meeting
RENO, Nev.–(BUSINESS WIRE)–November 8, 2021 – Melzi Surgical (“Melzi” or the “Company”), a surgical device company dedicated to creating innovative technologies that improve patient outcomes while reducing hospital expenses, today announced a report evaluating the Company’s lead product, the Sharps Finder™. The report, titled “Finding A Needle in a Haystack: Evaluation of New Medical Device to Find Lost Surgical Sharps,” was presented by Hae Sung Kang, MD; Dielle Meyer, MD; Jad Koak, MD; Susan Haynes, MD; Martin Mangino, PhD; Levi Procter, MD, at the recently held Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2021 Annual Meeting in Las Vegas, NV.
Over 390,000 sharp objects are lost during surgery each year in the United States. The Melzi Sharps Finder is a sterile, single-use sharps detection device and can be used in robotic, laparoscopic, and open procedures. When a sharp is lost or miscount is identified, surgeons can activate the Sharps Finder to assist with the search in the surgical area. The use of the Melzi Sharps Finder is intended for preventing retained surgical sharps, reducing search time and resources during lost sharps events and minimizing risks to patients, hospitals and staff.
“There is an urgent and growing need for prevention of retained surgical item incidences and surgical safety. At Melzi, we have developed an easy-to-use device that can be implemented seamlessly in the operating room to resolve lost surgical sharp events. The Sharps Finder, has continued to demonstrate its ability to improve RSS incidents and we remain encouraged by the feedback we are receiving from surgeons using the device. We are committed to driving distribution and adoption in facilities around the country. I believe Melzi is well-positioned to be a leader in helping surgeons locate these foreign bodies and therefore improve patient outcomes,” commented Reid Rutherford, MBA, President of Melzi.
As part of the Sharps Finder evaluation, two tests were conducted. Test one had a small (13mm) needle hidden within a 5”x5”x2″ container of hay and placed in a laparoscopic trainer box. Users were randomized to the control (laparoscopic grasper) or device group and given up to 5 minutes to locate the needle. Time to locate (TTL) was recorded. For the second test conducted, using the same apparatus, users were blinded to the presence or absence of the needle in the container. Users were randomized to the control or device group and given up to 5 minutes to decide if a needle was present. Reporter accuracy and the time to decide (TTD) were recorded. All results were statistically significant and are summarized below:
“Most surgeons in this day and age would say that good surgery results from a million little things done well. So, any tool we could use to our advantage to help incrementally make the ultimate outcome as good as possible is welcome,” added Dr. Jay Shah, Vice Chair of Medical Staff, Stanford Health.
About Melzi Surgical
Melzi is a surgical device company dedicated to creating innovative technologies that improve patient outcomes while reducing hospital expenses. The Company’s lead product, the Melzi Sharps Finder, is a U.S. FDA registered device designed to locate instruments, needles, broken pieces and fragments, or sharp objects (“sharps”) that have been lost inside a patient during surgery. The Melzi Sharps Finder is an easy-to-use hand tool capable of working in a 5mm trocar for laparoscopic and robotic surgeries and can also be used in open surgery. In a lab study, testing results with the Melzi Sharps Finder show detection of 13mm, 17mm, and 26mm needles with a 95% reliability rate.
The use of an adjunct technology, like the Melzi Sharps Finder, can bring patient safety, time, financial, and risk benefits. The Melzi Sharps Finder is currently indicated for use in gastroenterology and urology surgeries.
For more information about the Company, please visit melzisurgical.com
Jenene Thomas, JTC Team
T: (US): +1 (833) 475-8247
Business Development Contact:
Allen McClinton, Melzi Surgical