Background: Retained surgical items (RSIs), most commonly sponges, are infrequent. Yet despite sponge-counting standards, failure to maintain an accurate count is a common error. To improve counting performance, technology solutions have been developed. A data-matrix-coded sponge (DMS) system was evaluated and implemented in a high-volume academic surgical practice at Mayo Clinic Rochester (MCR). The primary end point was prevention of sponge RSIs after 18 months.
Methods: Two trials were conducted before implementation. A randomized-controlled trial assessed the system's function, efficiency, and ergonomics. The second, larger trial was conducted to validate the prior findings and test product improvements. After the trials, the system was implemented in all 128 operating/procedure rooms across the MCR campus on February 2, 2009. The institutionwide implementation was intended to avoid the possibility of having standard unmarked sponges and DMSs in the operating room suite concurrently.
Results: Before implementation, a retained sponge occurred on average every 64 days. Between February 2009 and July 2010, 87,404 procedures were performed, and 1,862,373 DMSs were used without an RSI (p < .001). After four cases, the average time to count a DMS decreased from 11 to 4 seconds. Total sponge counting time/operation increased without any increase in overall operative time.
Conclusions: After 18 months, a DMS system eliminated sponge RSIs from a high-volume surgical practice. The DMS system caused no work-flow disruption or increases in case duration. Staff satisfaction was acceptable, with a high degree of trust in the system. The DMS system is a reliable and cost-effective technology that improves patient safety.