Melzi Sharps Finder Is Now Listed With FDA and Ready for Human Use

RENO, Nev.--(BUSINESS WIRE)--Melzi Corporation has received the US Food and Drug Administration (FDA) registration and listing confirmation for the Melzi Sharps Finder and it is now listed for human use. The Melzi Sharps Finder is a device designed to help surgeons locate sharps in the surgical area during a lost sharps event. Lost sharps include needles, instruments, broken pieces, and fragments.

While most lost sharps are recovered before wound closure, those remaining are considered unintentional retained foreign objects (URFO) or retained surgical items (RSI). According to the Joint Commission, URFO is the most reported never-event in hospitals for the last 10 years¹. In addition, because URFO are voluntarily reported, the actual number of cases is believed by medical professionals to be much higher. Surgeons understand RSI events could pose significant health issues for patients. Therefore, they usually go through great lengths to ensure a lost sharp is found.

Adjunct technology, such as Medtronic’s Situate™ Detection System, has been used to find soft surgical items. Two-thirds of the country’s top twenty hospitals use adjunct technology to prevent retained surgical sponges². However, a paradigm shift is happening in the RSI cases from soft items (e.g. sponges, towels and packaging) to hard items (e.g. needles, blades, instruments, guidewires, and fragments) reported in an article from Journal of Patient Safety last month³.

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 locating retained surgical sharps, potentially shortening search time and resources during lost sharps events and minimizing risks to hospitals and staff. It is indicated for use in gastroenterology and urology surgeries.

Sources cited:

1. https://www.beckershospitalreview.com/quality/13-statistics-on-never-events.html
2. https://www.medtronic.com/covidien/en-us/products/or-safety/situate-detection-system.html
3. https://journals.lww.com/journalpatientsafety/Citation/9000/Retained_Surgical_Items__A_Changing_Landscape.99101.aspx