TRACKING OF SURGICAL SPONGES IN THE OPERATING ROOM: DESIGN AND VALIDATION OF AN INNOVATIVE MEDICAL DEVICE

10^th World Congress on HEALTHCARE & TECHNOLOGIES

July 17-18, 2017 | Lisbon, Portugal

Sergio Sbrenni, Alessandra Lazzaro, Silvia Quaresima, Luca Armisi, Eng, Carlo Maria Medaglia, Nicola Rosato and Nicola Di Lorenzo

Istituto Superiore di Sanit� , Italy
University of Tor Vergata, Italy
University of Tor Vergata, Italy

Posters & Accepted Abstracts: J Health Med Informat

Abstract :

During surgical procedures in operating room about 300 surgical tools (including needles, sponges, and instruments) are used. Previous studies stated that a retained surgical item in patients (gossypiboma) is one of a most critical adverse events. For the possible negative effects on patients, doctors and healthcare facilities, this event is classified as "Sentinel Event" by the Italian Ministry of Health. In hospital facilities, there are rigorous procedures and protocols for the management of instrumentation and surgical sponges during surgery. For the surgical sponges, these protocols require the recording of the initial number and the cross-counting of the sponges used and those removed by the patient at the end of surgery, in order to ensure traceability of the devices at any times. In order to provide a valuable support to this activity, a study was developed to design, implementation and testing of an automatic surgical sponges management system during surgery. The system is based on Radio Frequency Identification Technology (RFId). It�s a complex hardware and software architecture that, for its intended use, is classified as a Medical Device, according to Council Directive 93/42/EEC as amended by Directive 2007/47/EC. Results obtained after in vitro and in vivo testing, has demonstrate that the system developed allows a significant reduction of the clinical risk in surgical practice. Hundred percent retained sponges were detected correctly, even when they were overlapped. No false positive or false negative was recorded. It was demonstrate also a reduction of the surgery times into the operating room.