Clinical Study of RFID Tagged Surgical Sponges
Small Business Information
SURGICAL RESOURCES, LLC, 71157 SLOOPE PL, ABITA SPRINGS, LA, 70420
AbstractDESCRIPTION (provided by applicant): The long-term objective of this project is the commercialization of Surgical Identification Systems for use in operating rooms worldwide. These systems, based on radio frequency identification technology (RFID), will be used to automatically identify, track and manage surgical implements such as sponges, instruments and all other foreign bodies that are introduced into patient's body during surgery. Current methods used to account for these items rely on manual counting by the RN nursing staff. These methods require a large amount of manpower, they unnecessarily expose staff to blood and are subject to human errors, which can lead to a retained item and repeat surgeries. Retained foreign bodies are the 2nd leading cause of lawsuits following inpatient surgery in the United States. Through automation, surgery departments can improve safety for both patients and staff and increase RN productivity. The devices described in this application will address some of the most pressing issues in healthcare today: Medical Errors, Nursing Shortage, Skyrocketing Malpractice Premiums and the Efficient Delivery of High Quality Healthcare. The applicant respectfully requests funding in Phase I for development of a beta version of Surgical Resources, LLC's SD-2000 WAND, Hand Held Surgical Sponge and Implement Detection System or "SD-2000" and initial clinical evaluation of the SD-2000 at Stanford University School of Medicine in Stanford, California. The specific aims of the proposed investigation are to: 1) Quantify the success rate for using the SD-2000 system to correctly detect a radio-frequency tagged surgical sponge placed in the abdomen of general surgery patients. 2) Determine the ease-of-use of the SD-2000 system device as perceived by the surgeon and nurse end-user. This pilot clinical study will lead to future studies, under follow-on funding in Phase II, to study implementation and economic effects of the SD-2000 and its complimentary device, the SC-1000, Sponge Management and Blood Loss Determination System. These studies are essential for eventual FDA approval of these systems and eventual commercialization over a 24-month period.
* information listed above is at the time of submission.