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Retained surgical sponge (gossypiboma) and other retained surgical items: Prevention and management

Retained surgical sponge (gossypiboma) and other retained surgical items: Prevention and management
Literature review current through: Jan 2024.
This topic last updated: Apr 10, 2023.

INTRODUCTION — The term retained surgical item refers to any surgical sponge, instrument, tool, or device that is unintentionally left in the patient at the completion of a surgery or other procedure. According to the Joint Commission, an item is considered retained if it is discovered any time after completion of the skin closure, even if the patient is still in the operating room (OR) under anesthesia. A vaginal sponge remaining after a vaginal procedure or delivery is also considered a retained surgical item and is a reviewable sentinel event [1]. Retained surgical item is the preferred term (rather than retained foreign body) to distinguish it from other objects that may be found or left in a patient, such as shrapnel [2]. Unintended retention of a foreign object (URFO) is the broadest term and can include other items left in a patient at the time of a procedure, such as catheters, drains, and packing [3]. Surgical sponges are the most common retained item compared with other items used in surgery.

Retained surgical items are rare medical errors that have the potential to cause significant harm to the patient and carry profound professional and medicolegal consequences to physicians and hospitals. In addition, these events and strategies to prevent them increase the cost of health care delivery. Costs associated with retained surgical items include loss of the reimbursement for the procedure itself, those associated with additional hospitalization or readmission to manage the problem, litigation, and malpractice settlements.

Risk factors for this problem are well described and include both patient care processes and working environment issues. Although there are no known measures to completely eliminate the risk, preventive strategies aim primarily to increase awareness. Some newer technologies are available and show promising results but have not been widely adopted. The definition, types, incidence, risk factors, complications, and prevention strategies will be reviewed here.

RETAINED ITEMS

Retained surgical sponge — The most commonly retained surgical item is a woven cotton surgical sponge, which includes both laparotomy pads and smaller sponges (eg, Ray-Tec) [4,5]. Sponges are easily retained because of their ubiquitous use, relatively small size, and because, when soaked in blood, sponges conform to and can be difficult to distinguish from surrounding tissues.

The problem of retained surgical sponge is known as gossypiboma, and also as "textiloma," "gauzoma," or "muslinoma." The word gossypiboma may have been formed from the Latin "gossypium" meaning "cotton" and Swahili "boma" meaning "place of concealment" [6]. Others indicate "-oma" was added to gossypi to indicate a growth, as in the example textiloma [6].

It is estimated that retained surgical items occur in 1 in every 5500 to 18,760 inpatient operations [7-9] but may be as high as 1 of every 1000 to 1500 abdominal cavity operations [10], and even more common during emergency surgery. In a retrospective review from a Level I trauma center, three cases of retained surgical items (all sponges) occurred in 2075 trauma laparotomies over an eight-year period, for an incidence of approximately 1 in 700 [11]. In a study in children, the incidence was 1 in 4713 (413 out of 1,946,831 patients) [12].

The incidence of retained sponge depends, in part, upon the anatomic location of the procedure. Retained sponges in adults occur most commonly in the abdomen (56 percent), pelvis (18 percent), and thorax (11 percent) [13]. However, retained sponge has also been described with vaginal [14], spinal [15], extremity [16], intracranial [17], vascular [18], breast [19], pediatric [12], and even facial plastic surgery procedures [20]. In a review of 319 cases reported to the Joint Commission, the vagina accounted for 24 percent of unintentionally retained sponges; of these, 82 percent occurred following vaginal delivery [14].

Unintended retention of a foreign object — While surgical sponges are the most common retained surgical item, reports of unintended retention of a foreign object (URFO) in the surgical site have proliferated. URFQ includes surgical instruments, needles (image 1), as well as other items that would not be captured in a traditional surgical count, such as central venous catheter guide wires, drain tubes, and the plastic around a hernia repair mesh [21,22]. Clamps and retractors are the most common types of retained instrument, but items such as electrodes, electrocautery scratch pads, drains, and pieces of suction tubing have been described.

One study analyzed 308 cases of URFO sentinel events reported to the Joint Commission between 2012 to 2018 that excluded sponges and guidewires; during this same time period, there were 319 reports of retained sponges and 73 reports of retained guidewires [23]. The largest category of unintentionally retained foreign object was surgical instrument, and the instruments were most frequently retained during orthopedic surgery (35.3 percent) and included a variety of reusable and single-use instruments used in joint arthroplasty (eg, pins, protectors) and other procedures (eg, drill guides, Kirschner wires). The single most frequently retained instrument was part of a uterine manipulator inserted into the vagina during laparoscopic-assisted gynecologic surgeries and thus no longer visible to the surgeon operating transabdominally. The second most common category of retained item were catheters and drains; these included a variety of vascular catheters, epidural and intrathecal catheters, and thoracic catheters. Many (67.9 percent) of the retained catheters were fragments or parts, and the most frequently retained drain was a Penrose. Needles and blades were the third most common category, the majority of which were suture needles. Six reports described retained organs that had been dissected out and were intended to be sent to pathology. A broad variety of other items, most of which were single-use, accounted for nearly one-fourth (23.1 percent) of URFOs. The specialty with the most URFOs was obstetrics and gynecology (25.9 percent), followed by general surgery (19.8 percent), orthopedics (18.7 percent), and cardiothoracic surgery (10.4 percent). At least 156 (50.6 percent) of these events occurred during minimally invasive procedures, highlighting the extent of the problem.

In an analysis of the root causes of these URFOs, 75.4 percent of the contributing factors fell within the categories of human factors, leadership, and communication, which is like other studies that have examined the root causes of retained sponges and other retained surgical instruments. Clearly, it is not feasible or practical to rely on counting the vast number of reusable and single-use instruments and components of instruments, and these items do not lend themselves to radiofrequency tagging. Some, but not all, are radiopaque. The authors recommend addressing the human factors element through evidence-based team training and leadership that prioritizes a culture of safety. Other specific strategies include verifying the integrity of objects as they are removed from the patient, use of a whiteboard to enhance communication when placing or packing small objects into the surgical wound or the vagina, and collaborating with device manufacturers to improve the safety and design of their products.

RISK FACTORS — Multiple studies have attempted to identify factors associated with retained surgical items [5,8,9,24-26]. The results have not been entirely consistent. Factors that have been implicated as important include the following:

Emergency surgical procedures

Unexpected change in the course of the surgical procedure

Patient obesity

Damage control surgery

Involvement of two or more surgical teams

Procedures involving one or more open body cavities

Prolonged surgical procedures, and the use of an unusually large number of instruments

Absence of the attending surgeon at final closure

In a retrospective study that used malpractice insurance files and identified 61 retained surgical items, a multivariate analysis identified three factors that were associated with a significantly increased risk: an emergency procedure (risk ratio [RR] 8.8, 95% CI 2.4-31.9), unplanned change in the procedure performed (RR 4.1, 95% CI 1.4-12.4), and increased body mass index (RR per one-unit increment 1.1, 95% CI 1.0-1.2) [8]. Other factors that were thought to be important, such as the estimated volume of blood lost, changes in nursing personnel, and duration of the case, were not associated with an increased risk. Intuitively, laparoscopic, endoscopic, and percutaneous procedures are less likely to lead to a retained sponge or instrument, although retained surgical items have been described in these cases as well [2].

A retrospective multicenter case-control study of retained surgical items analyzing 59 distinct events confirmed that body mass index, intraoperative complications and unexpected events, and longer procedure duration are associated with increased risk [25]. Interestingly, on multivariate analysis, the presence of a trainee was associated with significantly lower risk of retained surgical item (odds ratio [OR] 0.30, 95% CI 0.09-1.00).

Pooled data from three retrospective studies identified seven risk factors significantly associated with increased risk for a retained surgical item [26]. These included intraoperative blood loss >500 cc, longer duration of operation, multiple subprocedures, lack of surgical counts, more than one surgical team, unexpected intraoperative factors, and incorrect surgical count. Unexpected intraoperative factors included equipment malfunction, unanticipated change in the operative course, or any other complication that would not be expected during the conduct of a surgical case of a specific type. In this analysis, changes in nursing staff, emergency surgery, body mass index, and operation between 5 PM and 7 AM were not significantly associated with increased risk.

Other risk factors that may have been overlooked in the above studies were highlighted in a retrospective review of 319 cases of retained surgical sponges reported to the Joint Commission in a five-year period [14]. The most common contributing factors identified in root cause analysis were categorized as "human factors," "leadership," and "communication," comprising 79.8 percent of the total. Similarly, in a retrospective study of 34 retained surgical items, the single most important factor was felt to be a breakdown in communication [9]. The two most common communication problems were failure of the surgeon to convey placement of the item within a body cavity to other team members, and failure by the person performing the action to remember that action before closing. In contrast to the data derived from malpractice insurance files, an emergency procedure was not identified as a risk factor in this study.

In addition to faulty care processes in the operating room, the American College of Surgeons (ACS) acknowledges that poor communication among perioperative care personnel plays an important role in retained surgical items. One ACS editorial cites examples of poor communication such as surgeons dismissing reports of a miscount as an error and multiple intraoperative personnel changes without accurate cross-informational reporting [27].

In children, gynecologic surgeries were associated with the highest risk compared with a matched control group [12].

NATIONAL MANDATE — The 2002 National Quality Forum listed retained surgical items among a group of completely preventable medical errors that should never happen to patients, the so-called "never events." Retained surgical materials are also considered "always wrong" by the Leapfrog initiative, mandating acknowledgment, direct apology to the patient, and hospital payment for all costs incurred as a result.

In 2005, the Joint Commission designated retained surgical items as sentinel events requiring immediate root cause analysis investigation and response. As of 2008, the Centers for Medicare and Medicaid Services deny reimbursement to hospitals for the costs associated with objects left in patients during an operation.

PREVENTION STRATEGIES — Strategies for preventing retained surgical items are directed at patient care processes and the work environment in the operating room. Unfortunately, no prevention strategy is entirely foolproof, and each is associated with advantages and disadvantages.

Care processes — Faulty care processes with the potential to cause retained surgical foreign bodies include poorly performed sponge and instrument counts; inadequate or incomplete wound explorations; and incomplete, inadequate, or misinterpreted intraoperative radiographs.

Standardized count protocols — The mainstay of preventing retained sponge is the surgical count. Instruments are also counted. All sponges used during surgical procedures should contain radiopaque indicators, and sponges should never be cut.

The Association of Operating Room Nurses (AORN) publishes a recommended practices policy. This practice policy is widely used and nationally recognized as the gold standard for counting policies in the United States [28-30].

Specifically, counts of "soft goods" (ie, textiles including sponges) are performed at the following points during the procedure:

Before the procedure begins (ie, initial count; number of sponge packs and verification of the reported number of sponges per pack)

Whenever new items are added to the sterile field

Before closure of a cavity within a cavity (ie, the uterus)

When wound closure begins

At skin closure or end of the procedure (final count)

At the time of permanent relief of either the scrub nurse or circulating nurse

Sponges should be separated, audibly counted, and concurrently viewed during the count procedure by two individuals, typically the scrub nurse and circulating nurse. If a discrepancy in any of the counts is identified, the entire surgical team is responsible for carrying out appropriate steps to locate the missing item. The odds of a retained foreign body are increased 100-fold if there is a persistent discrepancy between the initial and final sponge counts [8,31]. If the item cannot be found with manual exploration of the surgical site by the surgeon or cannot be located elsewhere in the room (eg, trash), an intraoperative radiograph should be taken before final closure of the body cavity. The film should be read by a staff radiologist who has been specifically alerted that the purpose of the film is to "rule out retained foreign body." Before anesthesia is reversed, the radiologist should communicate the results of the film reading to the responsible surgeon and confirm that the entire surgical field (abdominal, pelvic, or other body cavity) has been included in the film [32]. (See 'Radiographic screening' below.)

Despite widespread compliance with the convention of the surgical count, data are inconclusive regarding its effectiveness in reducing the risk of a retained surgical foreign body. Unfortunately, an incorrect count does not mean that a retained foreign body is present, and more importantly, a correct count may be erroneous and is therefore not a guarantee of the absence of a retained foreign body. (See 'Count discrepancies' below.)

The Sponge ACCOUNTing System, which consists of structural elements, medical personnel training, and specific equipment (ie, sponge holder racks), was developed as part of a United States national surgical patient safety project (the NoThingLeftBehind project) to facilitate accurate accounting of sponges and other "soft goods," thus preventing retained surgical items [33]. Among hospitals that have implemented the system, 97 percent have had no retained sponges for at least one year.

Count discrepancies — The Joint Commission requires investigation of retained surgical items after surgery and defines "after surgery" as "any time after completion of the skin closure; even if the patient is still in the operating room under anesthesia" [1]. This definition incentivizes the surgical team to stop the operation while searching for the sponge, obtain a radiograph to look for a missing sponge, and wait for the radiograph to be read. Count discrepancies are common and consume time and resources to reconcile. One study observed that the operating room time associated with obtaining an intraoperative radiograph alone averaged approximately 30 minutes [34]. A multicenter study found that most cases (50 of 71) involved team/system errors involving more than one safety omission errors or variances, rather than individual errors [35].

The counting process relies almost exclusively on human factors. Up to 88 percent of retained surgical item cases occur in the face of sponge and instrument counts that were declared "correct" [8]. One study identified a total of 57 potential points of failure in the surgical count associated with room preparation, the initial count, adding sponges, removing sponges, the first closing count, and the final closing count [36]. An interim count may have been rushed while nursing teams were changing shifts, or in some cases the count is omitted altogether as may occur during emergency laparotomy. The most frequently identified causes of failures included distraction, multitasking, not following procedure, and time pressure. Other factors related to the operating room environment that contribute to count discrepancy include incomplete, interrupted, or absent sponge counts; absence of a clear standardized count policy; and using nonradiopaque sponges [13,24]. Nevertheless, count discrepancies should never be dismissed as human error but should instead prompt a thorough search for the missing items and count reconciliation.

The frequency of count discrepancies has been evaluated in several studies:

One study at a major academic medical center examined the frequency of disparities in the final surgical count over a four-year period [37]. Count discrepancies were found in 1062 of 153,263 surgical procedures for a counting error rate of 0.7 percent. Among the discrepancies, the missing item was found in 51 of the 1062 cases with 34 found in the operating room and 17 found in the patient. The positive predictive value of a discrepant count leading to a retained foreign body was only 1.6 percent. The authors noted that the frequency of "false positive" discrepant counts may be the fundamental source of surgeon skepticism of sponge and instrument counts, thereby reducing the impact of what should be an alarm signal when an incorrect count occurs.

In another report, at least one count discrepancy occurred in 12.8 percent of 148 operations (approximately one of eight operations); 41 percent of the discrepancies were due to process errors, including miscounts, mathematical errors, or documentation problems, and 59 percent due to a misplaced sponge or instrument [38].

A common concern is that the counting protocol itself may pose a threat to patient safety by distracting the surgical team from primary activities, particularly during more complex procedures. During interim counts, the surgical procedure is ongoing, and the scrub nurse and circulating nurse must perform the count while carrying out other duties.

In a study that detailed activities during nine complex general surgery cases performed in an academic hospital, counting was an auxiliary task that was in direct competition with primary patient-centered activities [39]. An average of 35 minutes per case was dedicated to counting, representing 14.5 percent of the nursing time during the operation. In spite of the time involved, 17 count discrepancies were observed, 11 of which disrupted the activities of the surgical team. The observational team identified two events labeled as "safety compromising" that occurred when attempts were being made to reconcile an inconsistent count.

Radiographic screening — The limitations of the surgical count in preventing retained items have necessitated the use of radiography to identify surgical sponges. The diagnostic features of retained surgical sponges on plain radiography are discussed below. (See 'Count discrepancies' above and 'Imaging' below.)

Plain abdominal films can be obtained in all patients, independent of the results of the surgical count, or selectively obtained based upon the persistence of an incorrect count.

In a study that involved 191,168 surgical patients, the protocol included a high-resolution survey radiograph performed in a dedicated radiology suite after the patient left the operating room (but before transport to the recovery room) regardless of whether a radiograph was performed by a portable machine in the operating room [9]. A retained surgical item was found in 34 of the patients (0.02 percent), 20 of whom had a count that was deemed correct. Of the 34 patients, 18 had undergone intraoperative radiography with a portable machine that did not demonstrate the surgical item in six of the patients, stressing the importance of high-resolution radiography. On the other hand, the cost of routine high-resolution radiographs may be prohibitive, and radiation exposure is also a concern [37].

One trauma center's experience with retained sponges highlights the experience at one institution with sponge counts and screening for retained surgical items using intraoperative radiography (or lack thereof). Three cases of retained sponge occurred over a two-year period [40].

Case 1: During open abdominal exploration, the abdomen was packed to control bleeding followed by multiple returns to the operating room by different surgical teams. The institution had no policy for documenting and accounting for abdominal packs intentionally left in the abdomen during damage control surgery. The patient's abdominal wound healed by secondary intention. The patient returned six weeks after discharge with wound drainage that was found on computed tomography (CT) scan to have a retained sponge. The policy was revised to require radiography after every procedure and reading of the film by a physician trained to recognize the characteristics of a retained sponge.

Case 2: A little more than one year later, a patient with hemoperitoneum from an abdominal crush injury underwent emergent laparotomy and packing. The bleeding was controlled, sponge counts were correct, and the mandatory abdominal radiograph was performed and was negative for a retained foreign body. CT scan performed for another reason identified a retained sponge near the spleen. It was evident upon review of the intraoperative radiograph that the left side of the patient's abdomen was only partially imaged due to a misplaced film cartridge. This incident prompted revision of the policy to include immediate notification of the operating surgeon if the intraoperative radiograph did not cover the entire surgical field.

Case 3: Four months later, a young blunt trauma victim required emergent laparotomy and damage control packing. The patient was returned to the operating room two days later for re-exploration, removal of the packs, and fascial closure. The sponge counts were correct, and the abdominal radiography was judged to be adequate and negative for retained sponge by the attending surgeon. Nevertheless, a sponge was identified in the left upper quadrant on a subsequent plain abdominal film. The tip of the retained sponge was visible on the original plain film and the film "clipped" only slightly. This finding was missed by multiple subsequent reviewers.

Novel computer-aided software has been described to aid in the detection of retained sponges on plain radiography [41]. The creation of this software involved deep learning for development and validation. The use of the software on radiographs from cadavers demonstrated 97 percent sensitivity and 83 percent specificity for retained surgical sponges. Further study is needed to assess clinical validity and impact.

Technological adjuncts — Several technological adjuncts are commercially available to help prevent retained surgical items.

The Association of periOperative Registered Nurses (AORN) guideline for the prevention of retained surgical items noted that a multidisciplinary team may evaluate adjunct technologies for use as a supplement to manual counting procedures [28-30]. However, that research has not confirmed the benefit of widespread implementation of adjunct technology as part of retained surgical items prevention protocol. Further research is needed to validate the efficacy, safety, and cost effectiveness of adjunct technology systems.

The three main approaches include systems that count surgical items, those that detect the items, and those that count and detect the items. These adjuncts were developed as a result of recognizing that surgical counts are an inherently error-prone process and that retained surgical items occur as a result of a series of events that lead to a system failure, rather than simply the mistake of a single person. As such, traditional approaches like disciplinary or educational intervention are unlikely to eliminate the problem of retained surgical items entirely. The hope is that these technologies will more reliably identify retained surgical items, thereby eliminating the need for radiographs. However, any additional technology is likely to be associated with an increased cost. (See 'Cost' below.)

Counting devices — Counting devices are an approach to materials management that involves tagging items used in cavitary surgery. Bar codes or data-matrix-coded sponges are used primarily to assist with counting. The technology does not evaluate the presence of a retained sponge, and in the event of a missing sponge, a radiograph must still be used to determine if the item has been retained within the patient. One trial randomly assigned 300 patients undergoing a general surgical procedure to a bar-coded sponge counting system or traditional counting [42]. In the bar-coded arm, sponges were scanned as they were added to the sterile field and again as they were removed. The bar-code system detected significantly more counting discrepancies than the traditional counting (32 versus 13 sponges). Although the bar-code system improved the recognition of missing sponges, the amount of time required to resolve discrepancies and the need for a radiograph to resolve a discrepancy was not changed. Disadvantages of the bar-coded sponge system were a significantly greater amount of time spent counting sponges compared with the traditionally counted sponges, and increased cost. Another study found through implementing a data-matrix-coded sponge system that all (known) retained surgical sponges were eliminated in a high-volume practice over 18 months [43].

Detection devices — Another approach uses sponges embedded with a radiofrequency tag or microchip that can be detected inside the patient with a handheld wand or mat that contains the detection system [44]. This system does not count the sponges. At the completion of the procedure but prior to closure, a handheld radio wand connected to a detection console is passed over the patient, and, if the chip on a tagged item is detected during the radio query, a digital or audio alarm is triggered. The system does not distinguish between sponge types or the number of sponges. In the event of a missing sponge, the wand can also be used to scan the trash and linen bins to find the sponge.

Radiofrequency (RF) scanning is superior to abdominal radiography for the detection of retained surgical foreign bodies with sensitivity and specificities that are reliably 100 percent when the system is properly used, even in patients who are obese [45-47]. However, incidents can occur if the wand is not used in all cases, if radiofrequency sponges are not used, or if the wand is not used properly. Radiofrequency sponge detection is rapid; in one study, intentionally placed sponges were detected in an average of less than 3 seconds [45]. Despite early concerns that radiofrequency scanning may potentially compromise medical device function (eg, pacemaker, infusion pump, mechanical ventilator) due to electromagnetic interference (EMI) from the radio waves [48], radiofrequency energy at wavelengths used by this technology has not been shown to cause any deleterious effects [49], and there have been no incident reports to the US Food and Drug Administration (FDA) of clinically significant interference with pacemaker or implantable cardioverter-defibrillator devices [50]. In a study examining use of RF technology in patients with cardiac implantable electronic devices (CIEDs), pacing inhibition was detected only in patients with temporary pacing systems programmed to synchronous mode [51]. The authors concluded that RF detection technology can safely be used to scan for retained sponges in patients with permanent CIEDs and temporary pacemakers set to asynchronous mode. In an observational study that included 2285 patients, implementation of a radiofrequency detection system assisted in the resolution of one near-miss event not detected by conventional counting protocols and assisted in the resolution of 35 surgical sponge miscounts [49]. In a retrospective review of nearly a million procedures performed at five New York teaching hospitals over a 10-year period, the dual intervention of mandatory RF scanning for surgical sponges along with the introduction of Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) training was associated with a reduction in the incidence of retained surgical item from 11.66 to 5.80 events per 100,000 operations [52]. The frequency of retained surgical items involving RF-detectable items decreased from 5.21 to 1.35 events per 100,000 over this interval.

Dual counting and detection systems — Radiofrequency identification (RFID), which includes a unique radiofrequency identification chip sewn into each sponge, and a separate computer console, is a hybrid of the counting and radiofrequency detection systems discussed above. Unopened packages of sponges are placed on a front panel of the console to be electronically counted, and after they are used, sponges are placed into a scanning bucket. If there is a missing sponge, it is detected using a wand. Few prospective studies are available evaluating the effectiveness associated with this system.

Among 319 cases of retained surgical sponge reported to the Joint Commission, RF or RFID sponge detection technology was used in 9 instances [14]. In six of these, the technology was used after the incision was closed and the retained sponge was removed during the same procedure. In one event, the sponge count was reported as correct; the technology identified a retained sponge and alarmed, but the detection was ignored. In another, the scan was not performed until the patient was in the postanesthesia care unit. In the only report in which the technology was used and did not detect a retained sponge, the retained sponge in question was a Kerlix, which does not contain an RF chip. Of the eight cases in which the RF or RFID sponge detection identified a sponge, the sponge count was reported as correct in six (75 percent). In a study of RFID during emergency trauma surgery, the sponge count was incorrect in 36.4 percent and not performed due to time constraints in 45.5 percent. All RFID sponges were found [53].

A Veteran's Administration study that compared the rates of retained surgical items in 46 programs with and without surgical technology systems that included both RFID and RF technology systems over a seven-year period reported that the retained surgical item rates were lower in the programs that did not have the technology. In two cases of retained surgical sponges, the technology malfunctioned in one case and was not used in another despite being available. In reviewing the root cause analyses of the 124 events, it was determined that the three main causes were human factors, failure to follow policy/procedures, and communication failures [54]. It is clear that technology-based solutions alone are not the answer to retained surgical items, as any technologic approach will only be beneficial if it is embedded into a larger multi-pronged culture of safety in the operating room. Indeed, a comprehensive review of the history of the problem of retained surgical items noted the same themes related to the reasons for retained sponges identified at the dawn of the modern surgical era nearly 150 years ago, namely: deviation from standard processes, poor communication, poor situational awareness, team dynamics, and a belief in correct counts at the end of the case [55].

Cost — The choice of preventive strategy depends upon the resources of the facility, ease of use, workflow issues, priorities, and perception of the consequences of retained surgical items, which all have a bearing on cost [56]. The cost of reconciling incorrect sponge counts is nontrivial. Using an estimate of $62 USD per minute of operating room time, one study estimated the total annualized cost of operating room time spent searching for sponges and ruling out the presence of potentially retained sponges at a busy level I trauma center hospital at $219,056 USD [34].

A cost-effectiveness study of emergent open cavity surgery found that routine intraoperative radiography was the preferred strategy compared with standard surgical counts alone provided that the sensitivity of standard counting is less than 98 percent and that legal fees are more than $44,000 USD per case of retained sponge [57]. However, this model requires accurate radiography performance and interpretation. (See 'Count discrepancies' above and 'Radiographic screening' above.)

Another approach used a decision analysis simulation to model the predicted incidence of retained sponge and the incremental costs associated with various prevention strategies [56]. For a sponge tracking strategy to be cost effective, it must come very close to eliminating retained sponges while keeping incremental costs low given that retained surgical items are rare. The authors estimated the average cost of a retained sponge at $200,000 USD per event. The baseline incidence of retained sponge associated with a standard counting protocol alone was estimated to be 12 per 100,000 cases. To be cost saving when compared with the expected losses, a strategy that completely eliminates the incidence of retained sponge would need to cost less than $24 USD per operation.

Using this model, the following findings were noted:

Universal and selective use of radiographs were each estimated to cost more than $1,000,000 USD per event prevented compared with standard counting protocols.

The radiofrequency-tagged sponge system, even under the assumption that it would prevent 100 percent of retained sponge events, was estimated to cost $620,000 USD per event prevented. In one study, the cost of RFID disposables was $0.46 for a 10-pack (12 ply, 4X8 inches) [53].

Using a bar-coded sponge system and assuming the incidence of retained sponge using bar coding would be no more than 1.7 per 100,000, the cost was approximately $95,000 USD per event prevented.

Another study compared rates of retained sponges and costs between organizations that used radiofrequency technology in addition to standard methods compared with those who only used standard methods [58]. For organizations that used radiofrequency devices, there was a 16 percent greater reduction of the rate of retained sponges over the study period compared with organizations that did not use radiofrequency devices. The additional cost to transition to radiofrequency technology was estimated at approximately $17 USD per case, which was offset by cost savings in X-ray machine usage and operating room time. The benefits of radiofrequency technology were even greater when avoidance of legal incidents was included in the cost analysis.

Work environment — As has been noted, communication in the operating room (OR) is particularly relevant to the problem of retained surgical items, and the American College of Surgeons emphasizes team development and team performance in promoting a culture of patient safety [27,59]. (See 'Risk factors' above.)

The maintenance of an "optimal OR environment" should "allow focused performance of operative tasks" [59]. Distractions including interruptions, noise, conversation, and traffic in the operating room should be limited. When personnel changes occur during a procedure, complete and accurate transmission of relevant information about the surgical field and its contents needs to be conveyed. Focused time for these tasks, and particularly the surgical count, should reduce errors.

CLINICAL PRESENTATION — Retained surgical sponge results in a broad spectrum of clinical presentations [60]. The reported time to diagnosis ranges from 1 day to 40 years [13,61]. In a series of 14 cases of retained surgical foreign body in the abdomen at a single institution over a six-year period, all but one patient were symptomatic at presentation; abdominal pain was the most common symptom [61]. In general, two distinct clinical patterns of retained surgical sponge are described: exudative and fibrinous [61-63].

Exudative — The early or exudative pattern usually presents in the postoperative period as a result of local inflammation as a response to the foreign body [35].

The most common clinical sign associated with retained surgical sponge in the immediate postoperative period is surgical site infection [64]. Although sponges themselves are sterile, any inoculation (skin, gastrointestinal flora) permits bacteria to reproduce in the interstices of the sponge (inaccessible to immune mechanisms), which may result in wound infection, abscess, fistula formation, or sepsis. Approximately 10 to 15 percent of cases of retained surgical sponge are complicated by acute intra-abdominal sepsis, which is associated with high morbidity [64,65]. Longer retention times increase the risk of bowel fistulization.

Retained vaginal sponges can lead to pain and infection, increased health care costs, and have even led to maternal deaths related to systemic infection [14].

Other clinical presentations involve extrusion of the sponge, which can occur externally through the wound or by fistulization into the rectum, vagina, or bladder. Sponge erosion and migration internally can lead to intestinal obstruction, malabsorption, or gastrointestinal hemorrhage.

Fibrinous — A fibrinous pattern refers to the encapsulation of the retained foreign object within scar tissue, which presents in a delayed fashion (>60 days) representing approximately 25 percent of all cases. Delayed presentations months, years, or, in some cases, decades later following the index surgical procedure have been reported [65].

The fibrinous clinical pattern presents as a soft tissue mass in approximately 27 percent of patients [13], or as an aseptic foreign body granuloma with adhesions and encapsulation with "pseudotumor" formation. Some may mimic carcinoma, leading to ill-advised attempts at biopsy or radical excision of involved organs en bloc.

Patients with an abdominal or pelvic retained surgical sponge may have nonspecific symptoms such as chronic abdominal pain, nausea, dyspepsia, constipation, weight loss, and pelvic pressure. A pulmonary retained surgical sponge may cause shoulder pain, cough, hemoptysis, or chest pain [62].

The most common presentation of a retained surgical sponge in an extremity is a soft tissue mass that can be mistaken for a sarcoma.

DIAGNOSIS — For patients in whom a retained surgical item is suspected (early or late postoperative), the diagnosis is based upon imaging studies that demonstrate the object.

If retained surgical item is suspected in the early postoperative period, plain radiographs of the surgical field should be performed. Radiopaque surgical instruments and devices should be immediately apparent on plain film, and the characteristic appearance of radiopaque tape or wires of laparotomy pads and surgical sponges, respectively, should indicate their presence. However, over time, radiopaque markers may fragment or disintegrate altogether [66]. Thus, for patients with symptoms potentially due to retained sponge from a past surgery, we prefer computed tomography as the initial study. (See 'Computed tomography' below.)

Of asymptomatic retained sponges, approximately 6 percent are discovered on routine imaging studies performed for other reasons. Many modalities have identified retained sponges incidentally, including mammography, ultrasound, magnetic resonance imaging, and fluorodeoxyglucose positron emission tomography.

Imaging

Plain radiographs — Plain radiographs are the most common imaging technique used to detect retained sponges. The accuracy of plain radiography in detecting retained sponge is not very high, and it is important to keep in mind that most missed retained sponges are at the edges of the film. Known causes of false-negative radiographs include poor film quality, multiple other radiopaque densities, and a lack of awareness on the radiologist's part that there was a concern for retained foreign body [57]. These issues are discussed above. (See 'Radiographic screening' above.)

A retained sponge appears opaque on plain radiograph with mottled small air densities (image 2). If the sponge still contains a radiopaque marker, the diagnosis may be made based upon the characteristic appearance of wavy striped lines. On chest radiograph, intrathoracic retained surgical sponge may mimic intrapulmonary abscess, aspergilloma, or tumor. Retained surgical sponge adjacent to bone may show a periosteal reaction [62].

Radiopaque surgical needles can also be seen on plain film (image 1). Two views (anteroposterior and lateral) should be obtained to ensure that the needle is intra-abdominal and not lying anterior or posterior to the patient within the drapes.

Gastrointestinal contrast studies — Although computed tomography is the test of choice to evaluate suspected retained surgical foreign body, gastrointestinal studies performed to evaluate abdominal symptoms may show the retained object as the source of obstruction or fistula formation. Intraluminal retained sponges will appear as a whorl-like hypodense mass with a thick rim (image 3).

Computed tomography — Computed tomography (CT) scan is superior to plain radiograph for evaluating the source of symptoms and detecting retained surgical sponge [62]. The most characteristic appearance of retained sponge is a low-density heterogeneous mass with a spongiform pattern that contains gas bubbles (image 4). The mass may contain wavy, striped, high-density areas that represent the markers (image 5). Very long-standing retained surgical sponge on CT is associated with calcification due to gradual calcium deposition along the fiber network of the surgical gauze, also known as the calcified reticulate rind sign (image 6) [62].

Other modalities — Depending upon the nature of the surgical intervention, a retained surgical item may be identified using other modalities, including mammography (eg, breast surgery (image 7)), ultrasound (eg, extremity surgery), and magnetic resonance (MR) imaging (eg, spinal surgery).

The ultrasound appearance of a retained sponge may result in a cystic, solid, or combined appearance. Ultrasound typically demonstrates a well-delineated mass with wavy internal echoes and dense acoustic shadowing behind the object (image 8) [62]. Prolonged retention is characterized by an encapsulating hypoechoic complex pseudotumor, with both cystic and solid components.

Magnetic resonance imaging of a retained sponge appears as a soft-tissue-density mass with a thick, well-defined capsule (image 9); the signal intensity varies according to histologic composition, stage, and fluid content of the retained surgical sponge [62]. A whorled internal configuration is seen on T2-weighted imaging. In general, most lesions caused by foreign bodies are hypointense on T1-weighted images and hyperintense on T2-weighted images [67].

Uptake on fluorodeoxyglucose positron emission tomography (FDG-PET) imaging corresponds to the fibroblastic reaction and encapsulation of the sponge and appears as a characteristic rim-shaped uptake with a central region with no uptake (image 10) [65,66].

MANAGEMENT — Once a retained sponge is identified in the symptomatic patient, it should be removed [8,27,68]. In one multicenter review, the median time from index case to removal was two days (range: <1 day to >3600 days, n = 63) [35]. However, operative removal of retained sponges, particularly those present for a prolonged time, can be difficult and is associated with high complication rates. The mortality associated with retained sponges ranges from 11 to 35 percent [69]. Most intra-abdominal retained foreign bodies require laparotomy for removal; however, laparoscopic removal has been described for both retained instruments and sponges [2,70,71].

In a review of 14 cases of retained surgical sponge at a single institution over a six-year period, four of the patients required urgent surgery due to symptoms of intestinal obstruction or intra-abdominal sepsis [61]. Following removal of the sponge, 5 of the 14 patients developed postoperative complications.

Although removal of the retained surgical object should be pursued in symptomatic patients, there may be a role for watchful waiting in selected asymptomatic patients, particularly if there has been a prolonged retention time [22]. In one case series, a decision was made not to attempt removal of 6 out of 34 asymptomatic retained surgical foreign bodies, primarily because it was felt that the procedure to remove the object would pose a greater risk than leaving it in place [9]. The authors did not report on the long-term outcomes of the patients or the character or location of the items left behind.

MEDICOLEGAL IMPLICATIONS — Retained surgical items are considered "always wrong," mandating acknowledgment, direct apology to the patient, and hospital payment for all costs incurred as a result. Nevertheless, retained surgical items continue to be one of the most frequent sentinel events reported to the Joint Commission in recent years [72]. (See 'National mandate' above.)

In a retrospective analysis of surgery-related malpractice payments using the National Practitioner Data Bank (NPDB) over a 16 year period, "retained foreign body" was the third most commonly cited malpractice allegation at 6 percent [73]. In another review of NPDB paid malpractice claims, "retained foreign body" accounted for approximately 50 percent of surgical "never events" and was the most common [74].

The ramifications for surgical team members include malpractice lawsuits and adverse reports to the state licensing boards or National Practitioner Data Bank. In most jurisdictions, the legal doctrine applied to the problem of a retained surgical sponge is res ipsa loquitor, "the thing speaks for itself." The fact that a surgical item has been retained is, in itself, proof that malpractice has occurred. It is also important to note that the statutes of limitations for retained surgical item in most jurisdictions are generally extended indefinitely, rather than fixed to a two- or three-year term as in other cases of medical malpractice. Thus, a patient may be able to sue 20 years later for a surgical item that was undiscovered.

In a review of closed case files in Massachusetts, 40 patients were found to have retained sponges over a seven-year period representing approximately one half of the claims of retained foreign bodies during that period [75]. Eleven were vaginal sponges retained after vaginal delivery, and these were presumably removed at the bedside, without requiring laparotomy. Total compensatory damage awards for the 40 actions were $2,072,318 USD, with $1,762,163 USD (85 percent) made on behalf of the surgeon and $909,705 USD (15 percent) on behalf of the health care institution. Five cases (10 percent) went to trial. A median of $68,857 USD and a mean of $32,500 USD were spent on claims involving abdominal procedures. The time period between discovery of the sponge and the original procedure was significantly related to the case payment, with higher payments reflecting delayed discovery and difficulties and complications associated with surgical removal. Two patients declined removal of the retained sponge because they were asymptomatic but filed claims for damages anyway.

In several cases, a verdict has been returned against the surgeon in spite of a correct sponge count [76]. The surgeon can be held responsible for his or her own failure to examine the field and look and/or feel for foreign bodies independent of the staff's responsibility to perform accurate counts. The duties are parallel, and one responsibility does not relieve the other.

Payments for claims for retained sponges may be greater in jurisdictions where no cap on noneconomic damages exists. Among three studies, the average payment for retained surgical foreign body was estimated at $95,000 USD, a figure that included $14,701 USD for readmission and reoperation and the remainder in lost wages and pain/suffering. In a review of over 1000 cases reported to the National Practitioner Data Bank over a seven-year period, retained surgical foreign body resulted in a mean compensation of $77,175 USD. The maximum payment was $2,350,000 USD [24].

SUMMARY AND RECOMMENDATIONS

Retained surgical items – The most common retained surgical item is a surgical sponge, also known as gossypiboma. Retained surgical sponges and other foreign objects unintentionally left at surgical sites are rare medical errors that have the potential to cause significant harm to the patient. Retained items are among a group of completely preventable medical errors that are always considered wrong. (See 'Introduction' above and 'National mandate' above.)

Risk factors – A retained surgical item is related to the patient care processes and the work environment in the operating room. Many factors have been associated with retained surgical item. Factors identified as significantly contributing to increased risk include the following (see 'Risk factors' above):

Emergency surgical procedures (risk ratio [RR] 8.8, 95% CI 2.4-31.9)

Unexpected change in the course of a surgical procedure (RR 4.1, 95% CI 1.4-12.4)

Increased patient body mass index (RR per one-unit increment 1.1, 95% CI 1.0-1.2)

Prevention – Strategies for preventing a retained surgical item are directed at patient care processes in the operating room, including improving the accuracy of surgical counts and improving communication between the members of the surgical team. (See 'Prevention strategies' above.)

Tracking devices that use electronic tagging increase the accuracy of sponge counts (bar coding) and reliably identify retained sponges (radiofrequency identification), but these technologies are costly, and have not been widely adopted. (See 'Technological adjuncts' above.)

Given the limitations of the surgical count, particularly under emergency circumstances, we prefer to obtain a radiograph of the operative field (open cavity surgery) prior to patient transport in high-risk patients. In patients with a low risk for retained surgical item, we use selective radiographic screening. The best strategy to prevent retained surgical item depends upon institutional resources, operating room workflow, and perception of the consequences of retained surgical items relative to cost. (See 'Radiographic screening' above.)

Clinical presentation – Two distinct clinical patterns of retained surgical sponges are described. An exudative pattern, characterized by wound complications including infection, abscess, or fistula formation, usually presents early in the postoperative period. Expulsion of the sponge can occur externally, through the wound or fistula tract to the rectum, vagina, bladder, or internally, leading to intestinal obstruction, malabsorption, or gastrointestinal hemorrhage. A delayed or fibrinous clinical pattern usually presents with nonspecific symptoms and findings of a soft tissue mass or aseptic foreign body granuloma with adhesions and encapsulation of the sponge. (See 'Clinical presentation' above.)

Diagnosis – The diagnosis of a retained surgical item is based upon imaging studies that demonstrate the object. Steel surgical instruments are readily apparent on imaging studies. The appearance of retained surgical sponge on imaging depends upon the retention time and modality chosen. In the majority of patients, symptoms indicate the need for imaging, but in approximately 6 percent of patients, the retained sponge is discovered incidentally. Very long-standing retained surgical sponge is associated with a particular pattern of calcification termed the reticulate rind sign [1]. (See 'Diagnosis' above.)

Management – We remove all symptomatic retained surgical items. There may be a role for observational management in asymptomatic patients, particularly if the retention time has been prolonged, given that operative removal of retained sponges can be difficult and is associated with significant morbidity and mortality. (See 'Management' above.)

Medicolegal implications – The medicolegal ramifications of retained surgical item for the surgeon can be significant. The fact that an instrument or sponge has been left behind is considered proof that malpractice has occurred. Compensatory damage awards are commonly assigned to the surgeon as well as the hospital that is the employer of the operating room staff. (See 'Medicolegal implications' above.)

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Topic 15699 Version 23.0

References

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