Value based healthcare: Maximizing efficacy and managing risk with spinal implant technology

Abstract Objective The aim of this work is to investigate the efficiency of the perioperative processing of pedicle screw systems (PSS) prior to and after fusion surgery for conventional systems compared to an innovative value-based system. Methods This literature and application-based evaluation of efficacy compares a single-use PSS to conventional systems which require re-sterilization. The literature review focuses on sterilization factors, perioperative factors and surgical site infection (SSI) with particular consideration of liability, logistics and costs. An economic benefit simulation considers operating room (OR) time savings and resulting costs regarding preoperative OR preparation, intraoperative OR handling and postoperative OR disposal, and sterilization costs. Results According to literature, re-sterilizable surgical instruments shows severe contamination after sterilization and reprocessed pedicle screws foreseen may demonstrate corrosion, contamination, deterioration and damage. In addition to the reprocessing costs, the re-sterilization of devices causes indirect expenses due to surgery delays, cancellations and infection treatments. Economic simulation shows average savings per case of 1.167€ for percutaneous and 983€ for open surgery, and of 21 min OR time for a terminally sterilized PSS. Considering also tray sterilization, the average cost savings amount 1.415€ per case. Conclusions To evaluate the benefits of disposable instruments compared to re-sterilizable systems, process-oriented comparative analyses are required. For the specific setting of spinal fusion surgery, single-use implants and instruments, streamlined instrumentation and optimized operative techniques have the potential to save costs due to significantly decreased expenses for processing, logistics, decreased rates of contaminated instruments, less OR delays, and potentially lower revision and SSI rates.