Prolonged operative times are associated with significant patient morbidity and mortality, and multiple studies have quantified the degree to which prolonged operative time increases a patient's risk of adverse complications, like infections. Similarly, ineffective asset management in the OR leads to inefficient utilization of resources and may contribute to prolonged operative times. Multiple studies have noted that if surgical teams were more familiar with the procedural equipment and its location thereof, such pre-operative planning could reduce the amount of time spent making critical decisions during operation and allow the anticipation of any additional equipment needed. Unfortunately, there is currently no way to collect the data to quantify pre-operative planning optimization, equipment usage, nor any of the countless metrics that define best practices in the operating room. If the capability to track the location and usage of instrumentation existed, hospitals would be able to optimize their surgical sets based on usage, have quantified metrics behind surgeon preference, and correlate certain techniques with positive patient outcomes. M&S Biotics proprietary RFID scanning technology presents the possibility to passively collect data points related to instrument usage and offer insights into a variety of potential informatics such as surgical set optimization, patient outcomes, instrument longevity, technique variation, operating room throughput, and patient safety. The proposed research in Phase I will focus on (Aim 1) conducing a formative usability study of M&S Biotics' “Biotic System” with surgical experts at The Baylor College of Medicine and (Aim 2) collecting intraoperative data in a pre-clinical setting to inform a larger clinical study. The design of a comprehensive clinical trial using the Biotic System as a means of reducing operative time and quantifying surgical insights would be the next stage following this STTR project.
Public Health Relevance Statement: PROJECT NARRATIVE The proposal aims to test and improve a novel system to passively collect and quantify intraoperative data points related to surgical instrument usage. In doing so it, it will offer insights into a variety of potential informatics such as surgical set optimization, patient outcomes, instrument longevity, technique variation, operating room throughput, and patient safety. State of the art technology that complies with the FDA's Unique Device Identification (UDI) mandate drastically interrupts work-flow and does not perform any intraoperative analytics. The small business partner has developed a surgical instrument tracking and information gathering system that fits seamlessly into any operating room. The academic partner has countless experts in a variety of surgical fields, with a significant track record of success. Together, we are aiming to test and improve the Biotic System as a means of data collection and analytics in order to improve the efficiency of surgical cases for the benefit of both the surgical teams and patients involved.
Project Terms: Accounting; Adopted; Air Movements; Architecture; base; Businesses; Clinical; Clinical Research; Clinical Trials; college; comparative; Computer software; Consumption; cost effective; Custom; Dangerousness; Data; Data Analytics; Data Collection; design; Devices; Documentation; efficacy testing; Equipment; Event; Future; Goals; Hand; Health Personnel; Hospitals; Hour; Human Resources; improved; Individual; Infection; Informatics; information gathering; insight; instrument; instrumentation; Interruption; Legal patent; Location; Longevity; Manuals; Medicine; Meta-Analysis; Metals; Methods; Monitor; Morbidity - disease rate; mortality; novel; Operating Rooms; operation; Operative Surgical Procedures; Patient risk; patient safety; Patient-Focused Outcomes; Patients; Phase; Plastic Surgical Procedures; Porifera; pre-clinical; preference; prevent; Price; Procedures; Process; Prostatectomy; Protocols documentation; Radio Waves; Readability; Reporting; Research; Resources; response; Risk; Savings; Scanning; Signal Transduction; Small Business Technology Transfer Research; Software Design; Sterility; Stress; Structure; success; Surface; Surgeon; Surgical Instruments; Surgical Wound Infection; System; Tablets; Techniques; Technology; Testing; Time; tool; Touch sensation; Training; Training Activity; usability; Variant; Work
