Clinical study of RFID Tagged Surgical Sponges and Instruments

DESCRIPTION (provided by applicant): The objective of this project is the commercialization of a surgical sponge and instrument detection and identification system for use in operating rooms worldwide. The success of this project promises to reduce the current dependency on the error-prone and labor intensive manual procedures currently practiced to manage sponge and instrument counts in surgery. Current counting practices require a large amount of manpower, unnecessarily expose staff to hazardous materials, and leave an estimated 1,500 foreign bodies behind in patients each year in the U.S. alone. ClearCount Medical Solutions, Inc. (formerly Surgical Resources, LLC) is currently commercializing a system based on radio frequency identification (RFID) which can automatically detect, identify, and count surgical sponges that are introduced into the patient's body during surgery. RFID offers an ideal solution to the problem of tracking potential retained foreign bodies, in that it is fast, accurate, and can detect, identify, and count items even if they are obscured inside a body cavity. The initial feasibility of this device was validated with support from a successful Phase I grant from the NIH. ClearCount has been and will be working over the next year with support of public and private investors to commercialize its surgical sponge tracking system. ClearCount respectfully requests funding in order to further develop the surgical tracking device into a system which can count not only sponges, but surgical instruments as well. Several major technological challenges must be overcome in order to achieve this goal. This specific aims of this study will focus on developing RFID tags for surgical instruments which can withstand the rigors of the operating room environment, including sterilization. The study will also address the challenges of creating a reliable RFID system for use in tracking metal objects, which tend to distort RFID signals. Successful completion of these goals will be validated by simulated surgical trials as well as a human clinical trial. The proposed system is the only one in the field that can simultaneously count surgical items as well as scan the patient's body as a final safety check for retained foreign bodies. The implications for each of nearly 40 million surgical procedures each year in terms of patient safety, operating room productivity, and better allocation of healthcare resources make the successful completion of this project extremely beneficial to public health worldwide.