the Science Behind PoSitive Patient outcomeS

Using the Situate™ Detection System for the Prevention of Retained Surgical Sponges

IntroductionRetained surgical instruments (RSis) or retained surgical sponges

(RSS) can have a profound effect on surgical outcomes, health care costs, and provider and institutional reputations.1-3 Because of the infrequency of such events, the extent and consequences of this prob-lem are often unrecognized by hospital administrators.3,4 traditional methods of accounting for instruments and sponges, such as manual counting and intraoperative radiography, are unreliable and prone to errors, and have been deemed insufficient to prevent retained surgi-cal items.1,2,5-8

a representative sample of operating room (oR) count discrep-ancy data suggests that the RSi rate is as high as 1 per 7,000 surgi-cal admissions, with surgical sponges comprising 69% of all cases of RSis.3,8 this problem is magnified in the setting of urgent/emergent procedures, including trauma cases, in which rapid efforts made to sustain the patient’s life often do not allow for orderly counting pro-cedures and in which the complicated surgical field and need for wound packing performed by different teams may be more prone to “mask” an RSi.4,9,10

although some patients with RSS develop pain or signs and symptoms of abscess formation or sepsis, others may be asymp-tomatic for many years.1,11 the risk for RSS-related infection, sep-sis, or death increases with the possibility of sponges migrating transmurally and entering nonsterile compartments, such as the intestine, stomach, and airway.11 Recent findings indicate that the mortality rate associated with RSis is much higher, ranging from 11% to 35%.12

complications of RSis increase health care costs significantly. the average per-incident costs for RSis is approximately $63,631 for unreimbursed procedural costs and an additional $25,000 for associated secondary infections that are not otherwise reimbursed by the centers for medicare & medicaid Services (cmS).13,14 Legal costs, including legal defense fees and malprac-tice settlements, are estimated at $370,000 per incident.15,16 RSi-related complications may affect the patient’s emotional health and trust in the health care system, as well as jeopardize rep-utations and cause distress for the providers and institutions involved.3,17,18

Current Prevention Strategies Against RSSaccording to the Joint commission, a standardized counting sys-

tem can be implemented to account for all surgical items.2 however, the use of “cavity sweeps” and manual counting protocols to prevent RSS has a 10% to 15% error rate.2,19 also, nearly 88% of all RSS occur when the counts are thought to be correct.3

the association of perioperative Registered nurses (aoRn) rec-ommends that perioperative staff should consider using adjunct technologies to supplement manual count procedures, and has deemed reliance only on manual counting and x-ray to be insuffi-cient.7 Radiography is the current standard counting supplement, and has been the primary method of screening for RSis when manual counts are not correct.20 in procedures such as trauma,

Supported by Reprinted from September 2017

Glenn T. Ault, MD, MSEd, FACS, FASCRS

Senior Associate Dean of Clinical AdministrationChief, Colorectal Surgery LAC+USC Medical CenterAssociate Professor of SurgeryResidency Program DirectorDivision of Colorectal SurgeryKeck School of Medicine of the University of Southern CaliforniaLos Angeles, California

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the Science Behind PoSitive Patient outcomeS

in their cost–benefit analysis of adopting RF technology, Williams and colleagues reported a 93% reduction in the rate of reported RSS across 5 organizations that implemented RF technology com-pared to a 77% reduction in the rate reported across 5 organiza-tions not using it over a 2-year period.20 institutions that used the RF technology showed a significant reduction in oR time per case (16 minutes per procedure).20 Furthermore, the cost–benefit analysis showed that the savings in x-rays and time spent in the oR, as well as the medical and legal costs (estimated at $598,558 annually), out-weighed the cost of using RF technology ($191,352).20

inaba and colleagues performed a prospective study to evalu-ate the ability of Situate detection system–embedded sponges to mitigate the incidence of RSS after emergency surgery at the Los angeles county + university of Southern california (Lac+uSc) medical center.10 among 2,148 operations, the sponge count was incorrect in 36.4%, not performed due to time constraints in 45.5%, and correct in 18.2% cases.10 additionally, the Situate detection system detected retained sponges in 11 (0.5%) patients, includ-ing 2 retained sponges that were not detected when counting was thought to be correct.10 using the Situate detection system resulted in 100% sensitivity and specificity—there were no missed retained sponges.10 in terms of costs, use of the Situate detection system–embedded disposables costs an additional $0.17 for a 4-in × 18-in laparotomy sponge and $0.46 for a 10-pack of 12 ply, 4 in × 8 in.10 as a result of these data and use of the Situate detection system, the Lac+uSc medical center is no longer requiring mandatory x-rays during trauma procedures; instead, the oR staff routinely scan the patient with the Situate detection system at the end of the case, regardless of the sponge count.10

Conclusionan RSS is an uncommon but serious medical error associated

with significant complications and high health care costs. this phe-nomenon is entirely preventable, but avoidance of RSS through manual counts, intraoperative x-rays, and technologies with the inability to detect the surgical sponges is labor-intensive, time-consuming, costly, and prone to errors.

By contrast, the use of RF-based technology to detect RSS is quick, cost-effective, and associated with very high sensitivity and specificity (~100%) without adding a workload burden com-pared with manual counts (~77%) or radiography (~67%). as rec-ommended by the Joint commission and aoRn,2,7 manual counts and x-ray are insufficient to prevent RSis and institutions should

some hospitals advocate mandatory x-ray protocols due to “no time to count.”21 there are, however, several drawbacks in rely-ing on x-ray. in addition to its high cost, radiography exposes the patient to radiation; is not always reliable, especially for sponges and needles; and can be time-consuming.5,6,22 indeed, the sensi-tivity of intraoperative radiographs for detecting a retained item has been found to be 67%, while its use can extend oR time by an estimated 30 minutes.3,23 these consequences are not ideal, partic-ularly when managing trauma cases. in terms of costs, a key clini-cal study assessing the probability of detecting RSis found the cost of performing routine intraoperative radiography to prevent RSis was estimated to be $11.5 million per harmful object detected.6,24

The Situate Detection Systemthe challenges associated with counting and radiography have led

to the development of technologies to help detect RSS more accu-rately and in a cost-effective, rapid manner. the Situate detection sys-tem uses a low-energy radiofrequency (RF) signal designed to detect misplaced surgical sponges and gauzes that have been embedded with a proprietary RF tag both in the patient and in the surrounding suite.25 the technology is used at the end of the procedure before clo-sure to supplement manual counts to determine whether a sponge has been retained inside the patient and assist in efficient miscount reconciliation. visual proximity is not required with RF systems, and sponges with the passive RF tag can be detected when a receiver is within 16 in of the tag.25 in addition to an automated body scanner that is placed under the patient, an extremity scanner and room scan-ner can be used to detect RSS in surgical sites beyond the torso (eg, extremities, head, neck, spine) or in the surrounding oR suite (eg, lin-ens, trash) to help locate missing sponges outside of the patient.25

Several studies have investigated the clinical utility, time and resource utilization, and cost-effectiveness of this RF-based approach. Steelman and colleagues reported a sensitivity and specificity of the RF technology of 100% and noted that the RF scanning procedure to detect the presence of a sponge took less than 1 minute.22,23 Further-more, Rupp and colleagues reported that the incorporation of the RF-based sponge detection technology resulted in the complete pre-vention of RSS over a 10-month period in a large surgical population.26 in a survey component of the study (n=2,285), 83% agreed that the RF system improved the time to resolve a count discrepancy, 97% agreed that the RF system was easy to use, and 99.5% agreed that the process of body cavity closure/operative conclusion was not prolonged by the use of the RF system.26

consider integrating the use of adjunct technologies, such as the RF-based system, as part of their standard retained sponge pre-vention protocol. the Situate detection system has clinically dem-onstrated positive results, and instills the level of confidence in its

users to empower clinicians to use this adjunct instead of radiogra-phy in their RSi prevention protocol—especially in scenarios with high RSi risk, such as trauma cases.

A 28-Year-Old Man With Multiple Gunshot Wounds With a Retained Surgical Sponge

the patient presented to the emergency room at 3:10 am with multiple gunshot wounds to the abdomen. Secondary to his

vital signs en route to the hospital, the trauma team was activated and present on his arrival. on presentation, the primary survey was conducted and determined that his airway and his breathing were intact, and the patient was talking with the trauma team. his respi-ratory rate was 28 breaths per minute, blood pressure was 82/58 mm hg, and he was experiencing tachycardia at 136 beats per min-ute. Resuscitation was started.

on secondary survey, the pertinent findings were multiple gun-shot wounds to the anterior and right lateral abdominal wall. the patient’s abdomen was distended, and he had peritoneal signs. his lungs were clear, and there were no other injuries found on his extremities, torso, or head and neck. a focused assessment with sonography in trauma exam was found to be positive in the abdo-men and negative elsewhere. a chest x-ray also was negative. an abdominal film was completed and demonstrated 3 retained bul-lets in the midabdomen. due to the findings on clinical presenta-tion, the patient was emergently taken to the operating room (oR).

Because of the advance notification, the oR team had the trauma oR prepared with open trays, and instruments as well as sponges counted. our oR uses the Situate detection system (medtronic) that has a low-energy RF tag embedded in all of our sponges and tow-els used for surgery. upon entering the oR, the patient underwent rapid sequence intubation, and an exploratory laparotomy was con-ducted. there was a large volume of blood inside the abdomen, and the surgical team packed all 4 quadrants with multiple laparotomy sponges. transfusion and resuscitation were ongoing.

multiple injuries were found in the abdomen, including a small-bowel and mesentery injury that was actively bleeding. this neces-sitated a small-bowel resection. a segment of the small bowel had multiple injuries that required resection as well, while a single injury to the ascending colon was primarily repaired. the abdomen was then thoroughly inspected for other injuries, while the packs were removed and abdominal irrigation was performed.

the surgical team notified the oR team of the commence-ment of the closing process. the scrub and circulator completed the counts of sponges, needles, and instruments. closing counts were reported to the surgical team as all correct. Per our oR policy, the Situate detection system was activated using the body scan-ner pad. the console reported to the team the presence of an RSS within the abdomen. the team once again inspected the abdo-men, and a laparotomy pad was found in the left upper quadrant above the spleen, despite the report of correct counts. the Situate detection system was activated a second time and reported that the scan was now free of any sponges. once the team had com-pleted the abdominal closure, the patient was extubated and trans-ferred to the icu.

this case study demonstrates the benefit of the Situate detection system, a case in which the counts were reported to the surgical team as correct, but the detection system alerted the team to an RSS that was located and subsequently removed. it has been reported that 69% of RSis are sponges, and 88% of RSis occur when the counts are reported as correct.3 multiple studies have demonstrated a higher risk for RSS in trauma. Because of the unplanned and rapid pace of these emergency surgical procedures, counts are frequently unable to be performed before the start of the operation, and often intentional wound packing is performed by multiple teams in dam-age control situations that set up the team for this devastating com-plication. in the event of an RSi, 59% result in readmission, and 83% require further surgery for removal and potential repair of damage caused by the retained item.3,27

in this case, the Situate detection system potentially protected our institution from RSi-related malpractice costs; avoided the neg-ative effect on nationally reported safety scores, as well as regu-latory surveys initiated by the report of an RSi; and preserved our hospital’s reputation. Since initiation of the detection system in all of our emergency and elective surgical cases, we have not had a sin-gle RSS and have experienced a high level of satisfaction and confi-dence in the system reported by our oR team.McM

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disclosure: dr. ault reported that he is a consultant for olympus corporation.

disclaimer: this article is designed to be a summary of information. While it is detailed, it is not an exhaustive review. mcmahon Publishing, medtronic, and the author neither affirm nor deny the accuracy of the information contained herein. no liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literatuve.

copyright © 2017, mcmahon Publishing, 545 West 45th Street, new York, nY 10036. Printed in the uSa. all rights reserved, including the right of reproduction, in whole or in part, in any form.

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