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FDA Updates Information on Respirator Decontamination Systems

The U.S. Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological...

First Patient Treated in Clinical Trial of BCL System

CairnSurgical, Inc., an innovator striving to make breast cancer surgery more precise, announced that the first patient has been treated in its U.S. pivotal trial of the Breast Cancer Locator (BCL) System at Massachusetts General Hospital.

Rush Oak Park Hospital Adopts Surgical Workflow Technology, ExplORer Surgical, Increasing Team Confidence and Reducing OR Challenges

ExplORer Surgical, the only comprehensive intraoperative case support and workflow platform, has reinvented the way surgical support teams prepare and complete effective surgeries with two-way video for case support and remote proctoring to create a digitized playbook.

AORN Releases 2021 Guidelines for Perioperative Practice

The Association of periOperative Registered Nurses (AORN) has published the 2021 Guidelines for Perioperative Practice with six revised guidelines.

Melzi Sharps Finder Ready for Human Use

Melzi Sharps Finder Ready for Human Use

Melzi Corporation has received the U.S. 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 years. 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 20 hospitals use adjunct technology to prevent retained surgical sponges. 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 month.

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.

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