|Year : 2016 | Volume
| Issue : 1 | Page : 5-21
Retained surgical items: Building on cumulative experience
Brett Styskel1, Brian Wernick2, Ronnie N Mubang2, Steven M Falowski3, Thomas J Papadimos4, Stanislaw P Stawicki2
1 Temple University School of Medicine – St. Luke's University Hospital Campus, Bethlehem, Pennsylvania, USA
2 Department of Surgery, St. Luke's University Health Network, Bethlehem, Pennsylvania, USA
3 Department of Neurosurgery, St. Luke's University Health Network, Bethlehem, Pennsylvania, USA
4 Department of Anesthesiology, The Ohio State University College of Medicine, Columbus, Ohio, USA
|Date of Submission||03-Mar-2016|
|Date of Acceptance||01-Apr-2016|
|Date of Web Publication||2-Jun-2016|
Stanislaw P Stawicki
Department of Research and Innovation, St. Luke's University Health Network, EW-2 Research Administration, Bethlehem, Pennsylvania 18015
Source of Support: None, Conflict of Interest: None
Retained surgical items (RSIs) are much dreaded, preventable complications associated with surgical and other invasive procedures. Despite much effort going into eliminating these “never events” and the associated heavy burden for patients, providers, and institutions, RSIs continue to occur. This manuscript reviews fundamental concepts related to RSI, including risk factors, prevention strategies, technology-assisted detection, team strategies, and pertinent safety education. In addition, we performed a secondary review of a database of all published case reports and series of RSI between 1909 and 2015, focusing on clinical presentation, symptomatology, morbidity, diagnostic workup, pathology findings, and temporal characteristics. Despite a vast body of knowledge regarding RSIs, more needs to be done to help further reduce and prevent these occurrences.
The following core competencies are addressed in this article: Patient care, Medical knowledge, Practice based learning and improvement, Systems based practice, Professionalism, and Interpersonal skills and communication
Keywords: Diagnosis, patient safety, retained surgical items, risk factors, surgical safety, treatment
|How to cite this article:|
Styskel B, Wernick B, Mubang RN, Falowski SM, Papadimos TJ, Stawicki SP. Retained surgical items: Building on cumulative experience. Int J Acad Med 2016;2:5-21
|How to cite this URL:|
Styskel B, Wernick B, Mubang RN, Falowski SM, Papadimos TJ, Stawicki SP. Retained surgical items: Building on cumulative experience. Int J Acad Med [serial online] 2016 [cited 2019 May 24];2:5-21. Available from: http://www.ijam-web.org/text.asp?2016/2/1/5/183316
| Introduction|| |
Retained surgical items (RSIs) are much dreaded, preventable complications associated with surgical and other invasive procedures., RSIs constitute a heterogeneous group of healthcare-related occurrences recognized by the Agency for Healthcare Research and Quality as “never events.” The term “never event” refers to a medical error that optimally should not occur under any circumstance. Unfortunately, despite much energy and effort going into eliminating these events, as well as the associated heavy burden for both patients and providers, RSIs continue to occur. In an attempt to decrease the incidence of RSIs, counting surgical items during surgery have been practiced diligently for decades, but this failed to eliminate unintentional surgical item retentions. Existing data suggest that the occurrence of RSIs is approximately 1–3/10,000 surgical procedures, or 1–2 times in a typical surgeon's career.,,
From the natural history standpoint, majority of RSIs are either immediately “intercepted” or patients develop acute symptoms requiring emergent surgical removal. However, a substantial proportion of RSIs may go unnoticed for long periods of time, only to emerge much later as either incidental findings or masquerade as other entities (e.g., tumors or abscesses), thereby posing a diagnostic challenge when they present. Symptoms and signs associated with RSI's are often vague and most often associated with the anatomic location of the retained item., A study tracking outcomes in over 1100 RSIs events found associations with significant mortality (4.5% cases), permanent (16.3%), or temporary (78.1%) physical injury, as well as psychological sequelae (1.1%). The intent of this manuscript is to provide the reader with a comprehensive overview of up-to-date evidence on RSIs, their natural history, preventive strategies, and a discussion of related topics. Among the latter, the authors discuss clinical presentations, imaging and pathologic characteristics, as well as medicolegal implications and economic impact of RSI. Finally, a collected review of 281 reported RSI cases is provided, focusing on clinical presentation, morbidity, surgical characteristics, and other clinical parameters.
| Methods|| |
A comprehensive search of world literature was performed using Google™ Scholar, EBSCO, and PubMed. The terms searched for included the following terms used alone or in combination: “RSI,” “retained surgical instrument,” “foreign object,” “gossypiboma,” “never event,” “retained surgical foreign bodies (RSFBs),” “laparoscopic,” and “endoscopic.” Cross-referenced sources were subsequently tabulated from primary sources and selected based on content merit. Most current and relevant articles were subsequently selected, reviewed, and included in this manuscript. In addition, a dataset of 281 RSI cases between 1909 and 2015, collected by our study group and previously published in an open access forum, was analyzed for key demographics, item types and locations, clinical and pathologic findings, time to RSI identification/removal, as well as surgical procedure types, and case specialty designations. Descriptive results of subsequent analyses were tabulated and graphically displayed (for details, see section titled “review of collected RSI case reports and series” below).
Definitions and general context
The definition of an RSI is commonly extrapolated from the National Quality Forum's definition, which characterizes RSI as a foreign object that is unintentionally retained within a patient following surgical or other invasive procedure(s), including object(s) deliberately placed by the provider, but subsequently unintentionally left within the patient. It is important to note that the most commonly agreed upon definition of what temporal marker constitutes “final closure” for the purposes of triggering an “RSI event” is the completion of surgical “skin closure.” However, this may need to be modified to reflect “the last step” of the surgical closure process. For example, an operation that conclusively ends with a definitive fascia-only closure (e.g., not a temporary closure) and no formal skin closure is performed (e.g., due to the presence of active infection) should be considered as being “completed” upon the formal closure of the most superficial layer.
Although any surgical tool can potentially be “forgotten” within a patient, the most common type of RSI is the surgical sponge (followed by other “textile” items).,, Masses formed due to retained textile products are referred to in the literature as gossypibomas (from “gossypium,” Latin term meaning the genus of cotton plants and “boma,” a Swahili term denoting “place of concealment”), gauzoma, and muslinoma (from muslin, a woven cotton textile)., 8, ,,, The term textiloma can refer to a mass caused by any textile material (including hemostatic gauze).,,, Masses caused by RSIs have also been referred to as “pseudotumors” and “foreign body reactions.”, 8, ,, Finally, some authors have advocated the definitional separation between textile and nontextile RSI. Such distinction may indeed be important due to the fact that current technology-based preventive measures focus predominantly on tracking textile objects, thus altering the overall “retention risk profile” by object type and causing a shift in proportional incidence of items from “textile” to “nontextile” as a result.
The terms “retained foreign object” (RFO), “RSFB,” or “retained foreign body” have been used to describe items retained after surgery, as well as objects introduced into the body by any other means (ingestion of foreign object, penetrating wounds, etc.).,, The phrase “unintended retention of a foreign object” or “URFO” has also been used to describe this event, cited as a serious reportable healthcare occurrence., However, for the sake of uniformity, as well as the recent trend in global literature on this topic, the authors will use now generally accepted term “retained surgical item” or RSI as the benchmark for referencing items that were unintentionally “left behind” during surgery.,
Retained surgical items: Risk factors and clinical presentation
It is inherently difficult to study the natural history of RSIs because these events are both rare and underreported., By pooling cases of RSIs, several groups of researchers have attempted to better define specific risk factors for these events, as well as the associated clinical manifestations.,,,, One retrospective study reviewed 54 RSI cases identified via claims/incident reports between 1985 and 2001. The authors compared RSI cases with controls that underwent similar procedures in order to identify risk factors for retained items. The risk of RSI was elevated in the setting of emergent surgeries, unplanned procedural changes, and increasing patient body-mass index (BMI). In another case–control study, Lincourt et al. reviewed 30 RSIs and found that independent risk predictors included “more than 1 procedure” performed during the same operative session and an incorrect sponge count. Finally, the largest study in this category included 59 RSI's in a multicenter case-match design, and found independent risk factors to include longer duration of surgery, the presence of safety variances, and incorrect surgical counts. Interestingly, the latter study found a possible “protective effect” of surgical trainee presence  although this finding has not yet been validated independently.
In 2014, Moffatt-Bruce et al. published a meta-analytic study involving the three source manuscripts presented above, finding that the risk for RSIs may increase when intraoperative blood loss exceeds 500 mL, an incorrect surgical count is present at any point during the procedure, the surgical count is omitted, more than one procedure is performed during the same operative session, or there is an occurrence of unexpected intraoperative factor or factor(s) [Table 1]. The authors also found an additional association between RSI risk and increasing duration of operation. The pooled data also indicated that BMI, emergent procedures, changes in staff, “after hours” operations, and the presence of a surgical trainee did not affect the overall risk. The authors also proposed a risk stratification scheme that was based on pooled data from the above source studies [Figure 1], providing a foundation for future research in this area.
|Table 1: Factors associated with increased risk of retained surgical items, listed according to increasing odds ratio|
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|Figure 1: Risk factors associated with unintentional surgical item retention. Incorrect surgical counts and unexpected events during the operation carry the greatest risk|
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Regarding incorrect surgical counts, there are many covariates involved in the overall risk equation. In one study, greater number of providers involved in a particular case, as well as longer operative times, and correlated with increased likelihood of a count discrepancy. In another study, the sensitivity and specificity of “counting” in coronary artery bypass graft (CABG) cases were 77.2% and 99.2%, respectively; however, the positive predictive value of “counting” was only 1.6%. The same authors reported that the incidence of RSI was 1 in 7000 operations, with discrepant counts being seen in 1 of 70 cases of RSI. It is well-established that significant proportion of RSI cases is characterized by the false reassurance of “correct” final surgical counts. Thus, better methods of cross-checking, verification, technological support, and team coordination are needed to effectively reduce RSI risk in the operating theater., More research on “near-misses”, whether they involve an issue with surgical “counts” or other factors, is needed to improve the overall understanding of what additional factors may be associated with RSI.,
Patients who have experienced RSI and associated complications may present in a variety of ways. Clinical complaints often include abdominal pain, abscesses, nausea and/or vomiting, wound complication, and the finding of a mass while many patients remain completely asymptomatic. Presenting signs and symptoms appear to be significantly correlated with the specific body compartment in which the retained item is located, thus anatomic characteristics must be considered., Finally, one should not discount the possibility of an RSI in cases of atypical “masses” or other delayed presentations of the retained item, even if clinical signs or symptoms appear years or decades after the index operation., For more information regarding clinical presentation, signs, symptoms, procedural characteristics, imaging, and other factors associated with RSI, the reader is referred to subsequent sections of this manuscript.
Several imaging modalities can be used to help diagnose RSIs. Prompt and accurate identification of RSI is important in reducing associated morbidity and facilitating both primary prevention and postretention object identification (e.g., verifying that a mass is a retained sponge and not a malignancy). Some institutions have gone as far as the performance of routine high-resolution radiographs of the surgical field in cases that involve a body cavity. More specifically, patients are taken to a dedicated radiography suite following the departure from the operating room, and prior to arrival in the postoperative recovery area. If RSI(s) is/are identified on such imaging, the patient can be immediately taken back to the operating room a nd the object is retrieved without delays – A process important to reducing any subsequent RSI-related morbidity.
Regarding RSI identification, it is important to note that specific findings vary according to the type of retained item, imaging modality, and anatomic location of the item.,, Not infrequently, more than one imaging tool is used. Traditional radiography is the most common imaging modality by which RSIs are diagnosed.,, Here, findings can vary from “very obvious” to “vague and confusing,” depending on object characteristics and overlapping anatomic structures (e.g., it may be more difficult to see a retained sponge that is anterior to the spine and posterior to contrast-filled stomach than same type of sponge in the subcutaneous space). Visualization tends to be easier if the object is radiopaque (e.g., artery forceps, metal retractors) or contains radiopaque markers (e.g., most modern surgical sponges).,, However, it becomes increasingly difficult to visualize smaller, radiolucent, or textile objects which lack radiopaque markers. For example, some plastic objects (e.g., visceral retainer) may be difficult to visualize unless a marker is embedded in the device. Because of the critical importance of embedded radiopaque markers, surgeons should avoid modifying prefabricated surgical tools because radiopaque markers may be inadvertently removed during such maneuvers. Finally, intraoperative use of radiography to detect needles may be ineffective, especially if the lost needle is small.,
Ultrasound may be useful in RSI detection and is commonly used when the pathologic abnormality being assessed is in an anatomic location in which ultrasound is customarily considered to be a primary diagnostic tool such as the breast, neck, pelvis, and right upper quadrant, but also in other areas of the body.,,,, Sonographically, a retained sponge will typically appear as “hyperechoic mass” with an intense acoustic shadow., Although ultrasound may be useful in identification of RSIs, it should not be considered as a primary or definitive diagnostic modality., Finally, one must remember that advanced clinical ultrasound applications require significant operator skills and expert interpretation.
On magnetic resonance imaging (MRI), the typical appearance of a retained surgical sponge consists of a soft-tissue density mass with a thick, well-defined capsule and a whorled pattern on T2 imaging. Kim et al. described MRI findings of 4 patients with abdominopelvic gossypibomas. Their conclusions support a more standardized description of textile RSI characteristics, especially since MRI is commonly used to image the central nervous system, where such knowledge might have greatest impact., Because of inherent image complexity and the fact that MRI is not the first line imaging modality in the setting of suspected RSI, a certain degree of expertise is needed when interpreting MRI images of possible retained sponges and other objects. Finally, one must remember that the performance of MRI in the setting of metallic RSIs may result in serious complications. Consequently, it may be prudent to verify “absence of metallic object(s)” via plain radiography before proceeding with MRI studies in the setting of suspected RSI.
Positron emission tomography (PET) scan findings may be misleading in the setting of a retained surgical sponge. A typical appearance of gossypiboma on PET imaging consists of an intense ring pattern of F-18 fluorodeoxyglucose uptake surrounding a central area of uptake deficiency., This pattern represents the retained surgical sponge surrounded by elevated fibroblast activity secondary to inflammatory response. However, same findings can easily be interpreted by a radiologist to represent a malignant tumor with extensive central necrosis., In this context, an erroneous diagnosis (or even suspicion) of cancer may result in psychological harm and lead to unnecessary or overly aggressive surgical approaches.,,
Computed tomography (CT) is considered to be the confirmatory imaging technique for the diagnosis of RSI, especially when retention is chronic and/or there is diagnostic uncertainty., The “classic” presentation of a retained sponge on CT is a well-circumscribed cystic mass with a whorled, spongiform pattern. One may also see “bubbles” on CT because air/gas can become trapped within the sponge fibers., CT is also useful in detection of nontextile (e.g., plastic or metallic) retained items., At the same time, CT imaging may be misleading under certain circumstances and, thus, lead to erroneous diagnosis. This may be in part due to RSIs being low on the differential diagnosis list in vast majority of CT imaging cases. Examples of “incorrect” preoperative diagnoses of RSIs include gastrointestinal (GI) stromal tumor, intrahepatic cholangiocarcinoma, recurrent aspergilloma, and recurrent hydatid cyst. Conversely, a case of an anastomotic “stapler line” mistaken for an RSI has also been reported.
Radiologist experience is an important aspect of ensuring that rates of radiographic detection and accuracy of imaging interpretation in cases involving actual or suspected RSIs are sufficiently high. After all, the presence of a reliable “safety net” of radiographic detection of RSIs in instances where multiple risk factors for item retention coexist, or when surgical counts are absent or incorrect, constitutes an important component of the “safe surgery” paradigm. At academic institutions, inexperienced radiology trainees are often responsible for the initial interpretation of radiographic images, resulting in a small number of “missed” RSI cases. Consequently, some hospitals have implemented mandatory attending radiologist review for any films labeled as “potential RSI,” with subsequent attending radiologist to attending surgeon direct communication.,, Finally, modules to help train radiology residents in identifying RSIs on imaging are currently being implemented.
Pathology findings: Focus on inflammatory response
Pathology findings associated with RSIs constitute an amalgam of “foreign object confirmations,” inflammatory changes, and findings specific to RSI-related sequelae. One study found that the most common pathologies associated with RSI cases to be localized tissue fibrosis, exudative reaction, purulence/abscess, and other inflammatory changes. The same research group also found that the overall proportion of inflammatory changes increases as the length of time that the item is retained increases. More specifically, pathology findings of RSI cases demonstrated a greater proportion of “inflammation-specific” findings with increasing retained object dwelling time (e.g. 16% specimens with “inflammation” in the group with prompt retrieval, 42% and 50% “inflammation” findings in the intermediate groups, and 68% in the more chronic group).
Because of their proinflammatory characteristics, RSIs can contribute to significant morbidity and mortality. Gawande et al. reported that of 54 patients with RSIs, 1 (2%) died, 32 (59%) required readmission or a prolonged hospital stay, 23 (43%) experienced infection/sepsis, 37 (69%) underwent reoperation, 8 (15%) developed a fistula or bowel obstruction, and 4 (7%) had hollow viscus perforation. Others also found significant morbidity and mortality directly and indirectly attributable to RSIs., In a study by Stawicki et al., RSI-attributable mortality was 1/71 (1.4%), readmission rate was about 41%, and nearly 17% of cases presented to institutions that did not perform the index procedure(s). Although larger studies are needed to help quantify the true extent of harm associated with RSIs, it is clear that any complication or mortality attributable to these theoretically completely preventable events is “too much.” Other than immediate identification and retrieval, there are no known methods of preventing the more severe longer-term sequelae of RSIs.
Retained surgical item prevention: Focus on teams, systems, and technology
It is important to emphasize that prevention of RSIs can take a number of avenues, beginning with passive measures and ending with active, real-time interventions. Passive safety measures include hardwired system-based parameters that are designed to prevent RSI events from occurring by removing as many of the known risk factors as possible out of the overall risk equation before there is even an opportunity for said factors to result in synergistic cooccurrence and thus a “never event.” Active prevention systems are based on various tagging (e.g., barcode, radiofrequency) technologies and are designed to detect any potential RSI before a “never-event” flag is triggered.,, A number of intermediate measures have also been deployed, including routine operative X-rays, item counting, and organized debriefs/checklists.,,
Checklists are valuable but also have important limitations pertaining to design, implementation, as well as the human component (e.g., training and active use) of these preventive tools., Evidence is emerging that the implementation of checklists in the operating theater is both constructive and nondisruptive., However, it is also important to note that checklists may realistically compete with other operating room priorities. Moreover, operative patient safety cannot be viewed as a singular item, but rather as a process that spans from the preoperative appointment and evaluation to the postoperative office visit(s). It is important to remember that patient safety and RSI prevention cannot be effectively implemented without effective communication and team training., In fact, team errors (as opposed to individual errors) were present in > 70% of RSI cases in one study [Table 2].
|Table 2: Safety variances and errors noted in cases of retained surgical items, listed in order of decreasing frequency. The most important take-home message is that lack of safety procedure documentation appears to be associated with safety omissions and variances|
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As mentioned throughout this manuscript, more recent developments in this area include the emergence of various forms of “tagging,” implemented with the intent of reducing, and perhaps even eliminating, RSIs. Although there is evidence to suggest that certain types of RSIs can be virtually eliminated with the proper application/use of such tagging techniques,,, there is also evidence showing that RSI may continue to occur despite the implementation of tagging systems at healthcare institutions. In addition, the introduction of tagging systems into the already complex healthcare systems often results in substantial additional costs, and unless the baseline incidence of RSIs is sufficiently high, there is little to no economic incentive for institutions to alter their patient safety systems simply to introduce a new, expensive piece of technology. Another point of controversy is the choice of tagging/tracking platform and the potential for discontinuation of related product(s) or product line(s) as competition within this limited market niche increases and companies consolidate their product offerings,, leading institutions to carefully reevaluate their investment in such a capital-intensive proposition. Finally, until a universal system is developed that counts all types of surgical items (e.g. sponges, instruments, and miscellaneous objects), there will always be the risk of unintentional retention of a “different type” of item.
Other, more traditional RSI prevention and detection techniques have numerous shortcomings. For example, the performance of preclosure radiography of the surgical field has been associated with both added cost, and a nontrivial risk of failing to detect an RSI., Finally, it is the authors' subjective observation that many healthcare systems have not yet maximized and/or refined their existing safety systems, including optimization of team and human factors, as well as proper implementation and enforcement of simple yet very effective interventions such as the safe surgery checklist.,
Retained surgical item: Anatomic considerations
Anatomic location of RSI may influence both symptomatology and acuity of clinical presentation. In fact, the anatomical location influences numerous aspects of subsequent care, including clinical work up, the differential diagnosis, the choice imaging studies, as well as any potential morbidity and mortality., The overall clinical picture largely depends on what is retained, where it is retained, and how long it has been retained., The subsequent discussion will review our current knowledge of RSIs found in the abdomen, pelvis, retroperitoneum, thorax, breast and subcutaneous tissues, extremities, head, neck, and the intravascular compartment.
Abdomen, pelvis, and retroperitoneum
A previously published retrospective, multi-institutional study analyzing >70 occurrences of RSIs found that the most commonly reported site of surgical item retention is the continuous “space” encompassing the abdomen, pelvis, and retroperitoneum (e.g., approximately two-thirds of all cases). The same study also reported that procedures most commonly associated with RSIs in the abdomen and pelvis include laparotomy and cesarean section. GI complications of RSIs of intraabdominal RSIs can include unexplained abdominal pain, abdominal mass, intestinal obstruction, fistula formation, GI bleeding, intestinal perforation, and transmural migration of the retained object. Retained sponges that undergo transmural migration into the GI tract may adversely affect bowel function and may eventually be passed per rectum.,
Urological complications of RSIs have been described in various case reports., One report presented two cases of gossypiboma associated with urethral stricture following urologic surgery. In another case, a patient presented to the hospital with recurrent lower urinary symptoms a few weeks after an abdominal hysterectomy. She was found to have retention of a surgical hemostat and a sponge, leading to the development of a fistulous tract between the ileum and the dome of the bladder, resulting in fecaluria and the reported acute clinical presentation. Retained surgical sponges may also be found in various retroperitoneal locations as was the case when a surgical sponge was left after a partial nephrectomy, found later on CT during a work-up for bladder outlet obstruction.
Damage control (DC) surgeries have contributed to improved survival in trauma patients. One strategy in DC surgery is to preform aggressive hemostatic maneuvers (including intentional hemostatic packing using surgical sponges) followed by serial laparotomies for definitive hemostasis, repair of injuries, washout(s), and removal of any surgical objects intentionally used for hemostasis during earlier operation(s). However, if surgical hemostatic sponges are left in the abdomen for >4 days, the risk of infection and abscess may be increased. In addition, hemostatic sponges are placed under emergent conditions, and it is highly likely that different surgical teams may be involved in the initial and subsequent operative care episodes., These conditions place patients at risk for RSIs; however, the reported incidence of RSIs in patients who underwent trauma laparotomy continues to be very low (e.g., overall incidence well under 1%).
RSIs should be considered on the differential diagnosis for any patient presenting with an “atypical” abodominal, pelvic, or retroperitoneal mass and previous history of previous surgery involving corresponding anatomic location(s). To help assist with more accurate diagnosis and avoid misdiagnosis, efforts are focusing on better detection and identification of RSIs through imaging. Shaish et al. presented imaging findings from various RSIs, including surgical items left in place both intentionally and unintentionally, as well as normal findings that may appear similar to RSIs. Such resources provide significant value to radiologists (and other clinicians) who most likely see RSIs very rarely, yet cannot afford to “miss” these critical findings. Along the same lines, O'Connor et al. outline key imaging characteristics of abdominal and pelvic RSIs.
Intrathoracic RSIs are well-described in the literature, accounting for 7–8% of RSI cases in two large series., Thoracic RSIs have been reported following a broad range of procedures including CABG, thoracotomy, cardiac valve replacement, and bilobectomy. Presenting symptoms of thoracic RSIs, especially if adjacent to the lung, may include dyspnea, cough with sputum production, and respiratory distress.,, At the same time, some cases may be completely asymptomatic., CT of a retained intrathoracic sponge will likely detect the radiopaque marker embedded into the sponge. In addition, a retained sponge may produce a “whorled” pattern on CT, similar to similar finding in the abdomen. Surgical sponges left behind in the thoracic cavity have been misdiagnosed as aspergillomas and malignancies., Cardiothoracic cases may be complicated by surgical item retention in the pericardium and may be associated with potentially life-threatening sequelae.
Skin and soft tissues
Subcutaneous tissues are among the most common locations of RSIs, especially when one considers items retained during the final skin closure. In response, some have proposed that only a limited number of instruments and sponges be allowed on the surgical field for the final closure portion of the operation, and that additional instrument accounting is needed to prevent retention of items used during the wound closure process. Deeper soft tissues of the extremities may also provide an environment conducive to surgical item retention, especially in cases that involve morbidly obese individuals and/or deep exposures. Implantable defibrillator and other subcutaneous device “pockets” have also been reported to harbor RSIs.,
Breast surgery is an area of special consideration because of the large volume of operations performed to treat benign and malignant pathologic conditions, as well as esthetic procedures., In addition, RSIs in this general anatomic location may mimic a neoplasm, abscess, or hematoma on both clinical exam and imaging. Ultrasound of retained sponges may show nonspecific cystic, hypoechoic, and complex masses. Contrast-enhanced CT may demonstrate a ring enhancing round mass while MRI may show a “wavy,” low-intensity T1 signal and high intensity signal on T2-weighted images. Consequently, in a patient with a history of breast surgery, if the above described features are found on imaging, a retained sponge should be considered in the differential diagnosis.
Numerous literature sources report on various types of surgical items retained in the extremities.,, Extremity RSIs constitute approximately 8% of all cases of unintentional surgical item retention. In one case report, a young man presented with a right lower extremity mass. Five years prior to presentation, he had undergone an anterior cruciate ligament repair for an avulsion fracture. Imaging studies revealed an unusual soft tissue tumor and surgery ultimately demonstrated a well-encapsulated brownish soft tissue mass. Final pathology showed gauze fibers with granulomatous inflammation. Many of the chronic extremity RSI cases follow a similar pattern where the presentation involves a mass suspicious for a sarcoma or other type of malignancy.
Imaging can be helpful in clarifying the diagnosis of extremity RSI, provided that the possibility of retained surgical object is on the differential list. Radiography is useful to detect radiopaque markers characteristic of most textile items used in surgery. Ultrasound may reveal hyperechoic stripes with acoustic shadowing secondary to the presence of gauze fibers. MRI is frequently obtained to evaluate for a suspected “soft tissue mass.” The MRI signal intensity of a gossypiboma can vary based on the fluid content, composition, and stage of tumor. Surgical exploration is often required, however, to make the final diagnosis of a retained surgical body. Pathologic findings consistent with foreign body include giant cells infiltration and surrounding gauze fibers. In addition to strictly (and critically) following established safety protocols and checklists, liberal use of plain radiography in the operating room is recommended to ensure that no foreign objects are left behind, particularly in cases where the sponge count is in doubt (e.g., has not been performed due to emergency, has been repeated due to discrepancies, or was persistently incorrect).
Head and neck
There are relatively few cases of RSIs involving the head and neck region. This may be a reflection of relatively smaller surgical field dimensions in head and neck cases, as well as a more limited instrument set used in these more highly specialized operations. Symptoms in the anatomic areas involved are heavily dependent on the location of the RSI in relation to surrounding structures (e.g., proximity to important neurologic, vascular, or aero-digestive structures may result in presentation related to each respective anatomic consideration). The types (and distribution) of retained objects may also differ from other anatomic locations, mainly due to space limitations within the head and neck region. Due to the use of smaller size needles, to a variety of small textile objects, and cavitary packing gauzes, surgeons and their teams need increased vigilance when operating in the head and neck region. In a review of over 150 malpractice claims related to tonsillectomies and adenoidectomies, three cases involved RSI, including one nasopharyngeal packing and one suture needle.
In neurosurgery, retention of textile and various nonreabsorbable hemostatic materials has been reported. In one series, five textilomas prompted the performance of MRI studies to rule out the possibility of recurrent tumor. Authors of the same report suggest that unless RSIs are immediately detected, the most likely temporal marker at which detection occurs is within 6 months of the index surgery, or the time at which routine follow-up imaging is usually obtained and the acute inflammatory response may be heightened. In another case, a gossypiboma was found to be mimicking a recurrent intracranial tumor. Despite the rarity of these “never events,” the differential diagnosis in such circumstances should not exclude the possibility of an RSI, especially when a contrast-enhancing mass or an atypical lesion is present on advanced imaging following a tumor resection.
Whenever surgical counts are incorrect or any other indication(s) exist to suggest the possibility of RSI, additional verification procedures using standard radiographs are appropriate. However, this may not be as helpful in neurosurgical (or head and neck) cases compared to other types of surgeries. Smaller instruments and needles that are routinely used in such cases can be very difficult to locate once misplaced. Moreover, a cadaveric study by Luo et al. showed that plain radiographs did not reliably detect small (e.g., ¼–½ inch) surgical sponges. This, in turn, emphasizes the importance of an accurate sponge counting and careful tracking of sponges during head and neck cases, and also stresses the need for CT imaging in cases where smaller sponges may have been left behind.
Intravascular retained objects
A report on multicenter experience with intravascular RSIs described a variety of objects left behind including guide wires, catheters, catheter fragments, and coils. Unexpected procedural factors and equipment failures were significantly associated with increased risk of intravascular retained instruments. Of note, nearly 54% of cases were missed on initial postoperative imaging, highlighting the need for standardized communication, equipment and procedure training, as well as the establishment and enforcement of procedural safety systems.,, One unusual case of an intravascular RSI involved surgery for a lumbar spinal pseudarthrosis, during which the common iliac vein was inadvertently entered and profuse bleeding ensued, requiring hemostatic packing. Postoperatively the patient developed dyspnea and shortness of breath, and chest X-ray revealed radiopaque material around the left lobar artery, later confirmed on CT scan. Months later, the patient underwent a thoracotomy for persistent symptoms and removal of the intraarterial object (e.g., a cotton sponge with surrounding thrombus was retrieved). Embolization of intravascular retained items has also been reported by others.
Retained surgical items: Laparoscopy cases
Despite the use of fewer instruments and smaller incisions, laparoscopic surgery is not immune from the problem of RSI, with a number of reported cases in this surgical patient population.,,, One general characteristic of RSIs associated with minimally invasive cases is that they are often “atypical” and may not be readily or intuitively identifiable.,, Operating room culture must change to prevent RSI in all types of surgical procedures, regardless of their invasiveness. This applies especially to laparoscopic and endoluminal surgery where it should theoretically be easier to keep track of instrument counts as fewer instruments are used during minimally invasive procedures., Yet, the false “sense of security” associated with laparoscopy can be used to justify potentially unsafe practices in the operating room (e.g., omitting surgical counts, poor checklist execution, taking shortcuts, etc.).
Gibbs discussed four case examples involving RSI occurrences following laparoscopic surgery. In all four cases, surgical sponge counts were correct at the end of the case. This is not surprising. In fact, in the study by Stawicki et al., majority of RSI cases had “correct” surgical counts. Consequently, Gibbs author argues that even though the sponges were counted, they were not “accounted for,” thereby necessitating a move beyond simple counting. For instance, operating room nurses at many institutions now routinely use hanging “sponge counters” made from transparent plastic materials. In such scenarios, the failure to account for a missing sponge may be directly or indirectly attributed to the failure to “see, separate, and say” when depositing used sponges. Consequently, the risk of surgical sponge retention may be reduced by employing strict procedures for sponge “accounting” that mandate each item to be placed in its designated, individual holder, and clear verbal team communication to that effect. Surgical teams are also encouraged to employ additional methods during laparoscopic (and nonlaparoscopic) procedures, include placing only surgical items with radiopaque markers intracorporeally, a thorough cavitary exploration prior to removal of the laparoscopic camera, empowering the surgical technologist (and other team members) to account for the instruments, directly communicating with radiology about the potential location and exact type of surgical item that is unaccounted.,,
At times, laparoscopy presents an attractive option for minimally invasive retrieval of a retained item. In such cases, significant morbidity associated with an open procedure can be potentially avoided. When approaching the question of RSI retrieval, surgeons must consider a broad range of factors, including the chronicity of object retention, object characteristics (e.g., location, size, and composition), the general status of the patient, and many other surgical factors (e.g., anticipated adhesions, RSI erosion into surrounding tissues, associated abscess) before proceeding with the operative intervention., Patients must understand that the risk of associated mortality and morbidity is substantial.,,
Retained surgical items: Pediatric population
Although RSIs should be regarded as “never events” in all patients, this is especially so in the pediatric population. Despite that, our knowledge of risks associated with RSIs is largely derived from the adult patient population,,, with available data from pediatric surgery remaining very scarce.,,, A 2009 study by Shah and Lander reported on 103 pediatric patients with RSI, demonstrating an overall incidence of 1 in 32,672 cases. The associated upcharge was approximately $42,000 per case. In 2015 Wang et al. reported that the incidence of RSI in children was approximately 2.2/100,000 admissions, with an average patient age of 8.3 years, an attributable length of stay of approximately 13 days, and associated total charges of around $91,000 per event. The World Health Organization's “Guidelines for Safe Surgery” implemented in 2008 have resulted in a decreased incidence of RSI in children in the USA.
The difficulty finding small instruments and needles that may become lost intraoperatively, especially in cases of equipment breakage, may contribute to the overall RSI risk in the pediatric surgical patient. Inherently smaller, pediatric instruments, and needles may break more easily, and while retained fragments <13 mm in size rarely cause problems in adult patients, the same may not hold true in terms of adverse clinical events in children., It is important to note that smaller instrument fragments, needles, and sponges are very difficult to visualize on X-ray imaging.,
As with RSIs in the adult population, some cases of retained items in pediatric patients may not manifest clinically until years or even decades following the index operation., In one example, a malleable retractor was incidentally found in a 29-year-old male following abdominal radiography. The large (5 cm × 33 cm) object was left in place during a staging laparotomy for Hodgkin's lymphoma when the patient was only 15-year-old. Throughout the entire period of 14 years, the patient remained asymptomatic.
While RSIs in body cavities are a major focus of patient safety initiatives, there are other types of items that can become unintentionally retained and have the potential to cause complications if unnoticed. Specific examples reported in pediatric patients include broken insulin infusion pump needles  and reusable lens introducers used to retain viscoelastic material in ophthalmologic surgery. In addition, children in the USA are becoming increasingly obese,, which may both increase the risk of RSI and make the diagnosis/detection more difficult.,, It is important to note that large institutions, children's hospitals, and teaching and public hospitals may have higher RSI rates than other health care organizations. However, this observation should be viewed with caution. For example, the role of trainee presence has not been shown to increase the risk of RSI in at least two reports., Although, in general, RSIs are very rare in the pediatric population, rates vary significantly between localities. While the number of factors that potentially contribute to the observed trends, rates, and outcomes is vast, one key parameter to scrutinize should be the degree of adherence to established “best practices” across different institutions and geographic locations. More research is warranted to better quantify the impact of RSI in pediatric surgical patients.
Economic and medicolegal impact of retained surgical items: Focus on system-based interventions
In addition to direct patient harm, RSIs are associated with potentially serious damage to the surgeon's and the institution's reputation.,,, In addition, the entire healthcare system is affected because of the associated loss of trust and significant attributable expenditures.,,, Looking beyond direct injury and the need for reoperation, RSIs result in medicolegal liability and negative public opinion toward the involved surgical personnel and the healthcare system. As outlined in earlier sections of this manuscript, retention of any surgical item is classified as one of the 28 types of “never event” that are subject to mandatory reporting in the USA., The Center for Medicare and Medicaid Services has now implemented rules which effectively eliminate any reimbursements for costs associated with RSIs and other “never events.” In response, initiatives have been developed by hospitals and health systems to reduce and/or eliminate the incidence of RSI. Such initiatives include the introduction of new technology-based solutions (e.g., radiofrequency or barcode identification and tracking of surgical sponges) and team-based approaches.,,, The expense related to sponge identification, and tracking systems is likely offset by the decrease in nursing labor previously dedicated to counting sponges. Other methods employed include routine X-rays performed in the operating room before definitive wound closure, the use of traditional counting bags, and better communication strategies within the surgical team.,,
In addition, dedicated quality and safety networks and organizations have been created to address the issue of RSI. For example, “nothing left behind” is a consulting organization that specializes in RSI prevention strategies. Likewise, the Association of Perioperative Registered Nursing fosters an anonymous safety reporting system to better track “near misses” and disseminate the associated knowledge and experience so that future healthcare-associated adverse events can be prevented. Finally, many hospitals realize that lack of knowledge and education regarding RSIs plays an important role in the incidence of these “never events.”, In response, educational programs have been successfully implemented to reduce the incidence of RSIs and other “never events.”,, Team training is essential within this general context, including the ability for any team member to voice their concern about any potential patient safety issue, at any time during the operation.,
Surgical objects that are unintentionally left in patients often to lead to civil lawsuits. Historically, individuals were accountable for such “never events.” However, more recently the legal system increasingly recognizes the culpability of “the system” as opposed to “the person” due to systemic complexities and the combination of human and team factors that usually lead to the occurrence of RSI [Table 2]., The average cost of RSI-related medicolegal expense ranges from $37,000 to $2,350,000 per incidence and does not always correspond to the degree of actual patient harm.,,, It has been shown that the length of intracorporeal retention of a surgical item correlates with inflammatory changes and symptoms. Consequently, prompt identification and removal of an RSI may be the best strategy to reduce associated morbidity and the risk of subsequent civil legal action. As always, an honest and apologetic admission to the patient that an error has been made is a critical component of rebuilding patient-surgeon trust and medicolegal risk containment.
Review of collected retained surgical items case reports and series
To further increase our current understanding of RSIs, their natural history, as well as various associated clinical findings, we performed an exhaustive literature search using PubMed and Google™ Scholar that identified a total of 281 reported cases of surgical object retention between 1909 and 2015. All available details regarding each reported case were abstracted, standardized, and tabulated into the following categories: (a) Demographics, (b) anatomic location of the retained object, (c) type of retained item, (d) time to identification/removal, (e) associated complications, (f) operation characteristics, and (g) pathology findings. The resulting dataset was previously published by our group. The methodology and rationale behind the performance of the current secondary analysis of reported cases and series is based on previously published guidance and consensus recommendations., Due to inherent shortcomings within the collected data, results are limited to descriptive statistics (means, medians, ranges, and frequencies).
The current analysis of the collected RSI series  is intended to provide an important glimpse into the natural history and patterns of occurrence of these “never events.” A total of 299 RSI instances were tabulated, involving 281 cases. Among reported instances, there were 107 (38.1%) males. Median patient age was 47 years. The overall distribution of item locations is shown in [Figure 2] and [Figure 3]. The most commonly reported anatomic locations involved the abdomen/pelvis, followed by the thorax, and then more peripheral locations. Of note, 12/299 RSIs involved a natural orifice as the location at the time of discovery. Consistent with the general assumptions used in the current analytical approach,, the overall distribution of anatomic locations in the collected literature review approximates the cumulative distribution of RSIs in previous reports.,,
|Figure 2: Retained surgical item locations in the current review series, presented as percent of cases involving each general anatomic location|
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|Figure 3: Detailed representation of retained surgical item locations in the current review series, presented as percent of cases involving a specific anatomic location|
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Types of RSI in this review series are shown in [Figure 4]. Surgical sponge was the most common RSI type, followed by other types of gauze, various plastic items/tubing, surgical instrument/retractor, needle, surgical suture material, or surgical specimen unintentionally left in place. Again, consistent with the current analytical model's assumptions,, the general distribution of various item types approximates the overall RSI distribution reported in other major series.,, Diagnostically, the most commonly used modalities include CT (56% cases) and plain X-rays (43% cases), with other radiographic modalities being utilized less commonly [Figure 5].
|Figure 4: Types of retained surgical items, presented as the percentage of the total number of cases in the collected series of 299 items unintentionally left in place|
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|Figure 5: Most frequently reported imaging modality associated with the identification/diagnosis of retained surgical items|
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A majority of RSIs in this series were recognized and removed within 2 years of index operation, with the remainder either remaining asymptomatic and being discovered incidentally at a later time, or becoming symptomatic after a longer period of dormancy. Symptoms associated with RSIs in the collected series are shown in [Figure 6]. Median time to retained item retrieval was 365 days [range, 0–16,790 days, 25–75% inter-quartile range of 60–1825 days, [Figure 7]. Only one previous report provides sufficient data reporting to ascertain temporal RSI retrieval patterns, albeit with a smaller sample size than the current review. In that report, median time to retrieval was 1 day, with a range anywhere from “immediate” retrieval to >3600 days postretention. Of note, patient population characteristics in the current collected review are different from those in the above-mentioned study of natural history of RSIs, with focus of the latter being on the shorter-term behavior of retained items. Further analysis of the current dataset  offers an important glimpse into the timing of RSI retrieval in relation to the location of the retained item. More specifically, median times to object retrieval, from shortest to longest were natural orifice/intraluminal (15 days), subcutaneous/soft tissue (121 days), spine/paraspinal (244 days), abdomen (377.5 days), thorax/mediastinum (455 days), head/neck (540 days), retroperitoneum (902.5 days), and extremity (3285 days).
|Figure 6: Symptoms associated with retained surgical item in the current cumulative review series|
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|Figure 7: Time to removal of retained surgical items in the current collective review. Approximate intervals between presumed item retention and removal are plotted using the Kaplan–Meier curve|
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In terms of the presence and severity of symptoms (categorized by total number of symptoms present) associated with RSI, we noted a pattern of escalation associated with increasing duration of retention. More specifically, patients with no symptoms reported had a median duration of time to retrieval of only 75 days. For those with one reported symptom, the median duration was 365 days. Retrieval of retained item for patients with 2 reported symptoms was performed at the median temporal marker of 544 days following the index operation. Finally, for patients with 3 or more reported symptoms, the median time to retrieval was 570 days. These findings and trends are generally consistent with previous data showing that the longer the duration of retention, the more likely it is for symptoms to appear and/or worsen.
In the current series, surgical counts were mentioned in only 23 reports. Despite this limitation, potentially useful information was derived from our secondary analysis, with 13/23 (56.5%) surgical counts reported as being “correct.” This is generally consistent with previously reported data. Furthermore, safety procedures and compliance-related details in the collected RSI dataset  were reported in 18 cases, of which 17 were determined to have at least one safety variance. This is also in agreement with data reported by others., Of interest, published data suggest that over half of all RSI incidents involved more than one safety omission or variance, and majority of retained items were associated with system and/or team errors.
Information on whether cases in the current collected review were emergent or elective was provided in 144 reports. Emergency surgery was performed in 33 of 144 cases (22.9%). This percentage is consistent with other published data (e.g., reported “emergency surgery” range of 13.3–37.3%).,, More than 1 subprocedure was performed in 24/144 reports (15.3%), with 24 reports (8%) describing 2 or more procedures. Again, these percentages are consistent with previously published data regarding the association between RSI and multiple procedures (16.7–49.2%)., In another study, an average of 2.8 subprocedures was performed in a sample of 30 surgeries complicated by RSI.
Early removal of RSIs has been associated with fewer complications and better clinical outcomes. In the current collected review, vast majority (281/299, or 94%) of objects were eventually removed, with the time to removal as shown in [Figure 7]. Of note, approximately 16% of RSI retrieval operations in this series were associated with “difficult procedure” as stated in individual reports. Depending on chronicity of surgical item retention, removal of the object(s) required associated tissue resection in 52 (17%) instances. Significant complications were reported in 93/299 (31%) cases, which highlights the high overall degree of morbidity associated with RSIs. A more detailed summary of complications associated with RSI-related procedures is presented in [Figure 8]. The complication profile noted in the current report is similar to complication profiles reported in other studies.,,
|Figure 8: Complications attributable to retained surgical item-related procedure(s); mortality was reported in approximately 4% of cases|
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In terms of gross specimen appearance and pathology data [Figure 9], this review found a heterogeneous collection of findings that approximates previous reports. Other than the general description of the retained item type, common findings included fibrosis, inflammation, tissue capsule formation, mass, and inflammatory changes [Figure 9]. It was previously reported that the chronicity of surgical item retention corresponds to the increase in “inflammation-related” findings on formal pathologic evaluation. Although the current review is not able to confirm such observation scientifically, it logically follows that the longer an object is retained, the more likely it is to cause an associated inflammatory and fibrotic response.
|Figure 9: Combined data on gross and microscopic pathology findings in the current series|
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RSIs are inherently associated with increased health care resource utilization. In the current review, median RSI-attributable hospital length of stay was 7 days (mean, 7.29 days; cumulative attributable length of stay, 481 days). In another study, readmissions were required in nearly 41% of RSI cases, with a second readmission needed in an additional 3% of cases. In that study, the median length of stay for readmissions was 3 days (range, 1–80 days).
| Conclusions|| |
Detailed knowledge of risk factors associated with RSI is critical to effective preventive efforts. RSIs are associated with substantial patient harm, significant professional consequences to practitioners, as well as major legal and reputational sequelae to hospitals and health care systems. In addition to aggressive preventive measures, early detection and retrieval of RSIs may be associated with better clinical outcomes (e.g., fewer symptoms). Technological advances are increasingly utilized in an attempt to reduce the occurrence of RSIs. System-based prevention methods, including staff training and hard-wired safety procedures, must be implemented and embraced by all stakeholders to decrease the frequency of these and other “never events.” The ultimate goal in this domain is to develop system-based solutions and technological capabilities that go hand in hand with team training so that complete elimination of RSIs moves “from possibility to reality.” The accomplishment of this goal will require continued efforts of physicians, nurses, allied health care providers, scientists, engineers, and information technology specialists. Cumulatively, the findings of our review corroborate and highlight the need for a national RSI registry.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9]
[Table 1], [Table 2]