KEY POINTS
■ The unintended retention of surgical objects is a medical error that causes harm to patients, providers, hospitals, communities, and the health care system.
■ Current methods used alone or in combination are ineffective in preventing the retention of surgical objects.
■ New technologies developed to prevent the retention of surgical objects cannot solve the problem entirely.
■ Hospital and surgery centers should develop policies and procedures aimed at improving patient safety and provide support in the form of personnel and equipment, including new RSO detection devices to prevent the retention of surgical objects.
The National Quality Forum, a nonprofit organization that sets national priorities and goals for health care quality and safety, lists the unintended retention of foreign objects in patients following surgical procedures as one of the 28 events that should never occur.1 Despite recognition of the problem, the unintended retention of foreign objects ranked fourth among the most common sentinel events reported in 2008 (with wrong-site surgery ranking first) by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).2 While the exact number cannot be determined, a recent study estimated that needles, sponges, or other surgical objects are inadvertently left in a patient's body once in every 7,000 surgical procedures (Figure 1).3 The estimate is significantly higher for abdominal procedures, representing 1 in every 1,000 to 1,500 operations.4 Gawande and colleagues estimate that more than 1,500 cases of retained surgical objects (RSOs) occur annually.5
The most common type of RSO is the sponge, which may also be referred to as a gossypiboma, textiloma, gauzoma, or muslinoma.6-8 Gawande and colleagues found that of the 61 RSOs identified in their study, 69% were sponges and 31% were instruments.5 Most were left in the abdominal/pelvic cavity (54%), while the remaining foreign bodies were left in the vagina (22%), thorax (7.4%), and other locations (17%), including the spinal canal, brain, face, and extremities.
Wan and colleagues reviewed 147 reports from 1963 to 2008 involving retained surgical sponges and found that 74% were in the abdomen/pelvis and 11% in the thorax.8 Their review noted an average discovery time of 6.9 years and a median discovery time of 2.2 years. The majority of objects were detected via CT (61%), but many were found with the aid of radiographs (35%) and ultrasound (34%) as well. The most common signs and symptoms were pain/irritation (42%), palpable mass (27%), and fever (12%). Approximately 6% of cases were asymptomatic and found incidentally.8
Gawande and colleagues reviewed malpractice insurance claims and incident reports for a 6-year period in Massachusetts.5 The consequences of retained surgical objects were deemed serious, with 69% requiring reoperation and management of complications; 22% resulting in small bowel fistulae, obstruction, or visceral perforations; and one case resulting in death. Of the 56 cases, 47 of them prompted litigation. The 47 claims averaged $52,581 in costs for compensation and legal expenses. The incidence for this study was 1 in 8,801 to 1 in 18,760 operative procedures. This rate corresponds to at least one case each year for every large hospital, although the actual number is likely higher.5
The consequences of iatrogenic retention of surgical objects are significant for patients, providers, and health care institutions5,8-12 (Table 1). On October 1, 2008, the Centers for Medicare and Medicaid Services (CMS) initiated a new payment policy for certain hospital-acquired conditions (HACs). The CMS has identified the unintended retention of surgical objects as 1 of the 10 HACs that they consider "reasonably preventable." As such, Medicare has refused to pay hospitals for the increased cost of care that result from an HAC, such as the unintended retention of surgical objects.12 Twelve commercial insurance companies are expected to follow suit, thus placing further restrictions on the reimbursement of services that result from this type of HAC.
The retention of surgical objects is a widely recognized problem within the health care system. It causes harm to patients, providers, hospitals, communities, and to the health care system as a whole. It also results in needless expense. The RSO is a problem that has existed since the first surgery was performed, and it is completely preventable. This article reviews the risk factors for RSOs, examines the current methods of prevention, and surveys the new technologies that have been developed to prevent this medical error.
RISK FACTORS
Although the unintended retention of surgical objects can occur in nearly any procedure and under any circumstance, some conditions put patients at increased risk. JCAHO has identified the following high-risk categories for the unintended retention of surgical objects: emergency procedures, deviations from planned procedures, type of procedure, patient's body mass index, and failure to count or count accurately.13 Other potential risk factors include shift or personnel changes, lengthy procedures, excessive blood loss, poor communication, lack of cooperation, fatigue of the surgical team, lateness in the day, performance of more than one major procedure at a time, incomplete counts, absence of a counting policy, and use of nonradiopaque sponges.5,8,14,15
CURRENT METHODS OF PREVENTION
Manual counting The current approach to preventing retention of surgical objects is manual surgical counts performed by the operating room (OR) team. JCAHO reports that standard practices in the operating room include surgical sponge and sharps count prior to incision and twice at the end of the operation.13 The Association of periOperative Registered Nurses (AORN) currently recommends four separate counts during each operative procedure.16 In addition, instruments should be counted in all procedures involving open cavities. If counts are not reconciled at the conclusion of a procedure, radiography or manual exploration must take place.
Although fewer RSO incidents occur when sponges and instruments are counted, the system is widely regarded as being prone to human error.17 Counting alone does not prevent the retention of surgical objects.15 Greenburg and colleagues argue that current counting protocols are laborious and have the potential to increase team workload, thus hindering more patient-centered activities.18 Their study found that 1 in 8 surgical cases involved a discrepancy in surgical counts during the procedure. In addition, a count discrepancy occurred once in every 14 hours of operating time or once every 85 counts, and an average of 13 minutes was spent reconciling the count. Counts involving a personnel change were three times as likely to involve a discrepancy. Most discrepancies involved sponges (45%), instruments (34%), and needles (21%), and the majority of incorrect counts were due to misplacement (59%). Most of the others were due to written errors in the record (38%). Only one discrepancy was a true miscount. No retained surgical objects were detected in patients while still in the OR or in the 60-day postoperative review.18
Egorova and colleagues reviewed 153,263 cardiac procedures in New York State between 2000 and 2004.3 They calculated the sensitivity of counting to be 77% and the specificity to be 99%. For their review, the odds of an RSO were 100 times greater if counts were discrepant. Despite this fact, the positive predictive value was only 1.6%.3
Even when surgical counts are correct, objects have been left in body cavities. Gawande and colleagues found that 88% of the 69 cases of RSOs they studied occurred despite final surgical counts being deemed correct.5 Cima and colleagues also found that the majority (62%) of retained surgical objects occurred when counts were erroneously reported to be correct.7
Radiographs Manual counts represent a valuable means of ensuring patient safety and controlling inventory during operative procedures, but errors in counting do occur and render manual counting alone inadequate. When counting alone does not prevent the retention of surgical objects, some institutions have adopted a policy of selective or universal screening using radiographs.5,14 Dossett and colleagues investigated the cost-effectiveness of performing radiographs after emergent open cavity procedures.19 Assuming that legal fees would amount to more than $44,000 per case of RSOs, the authors found the anticipated cost of routine radiographs to be $705 per emergency procedure relative to the $1,155 for the routine counting method. Given this data, they concluded that performing routine radiographs in the setting of emergency cases involving open cavities is more cost-effective than performing surgical counts.19
Gawande and colleagues also recommend radiographic screening of high-risk patients at the end of procedures, even when counts are correct.5 Based on their study, an estimated 300 radiographs would be needed to detect one RSO, which would cost an estimated $300 to prevent malpractice claims of more than $50,000 per case.5
Radiographs are a good tool to detect RSOs. Although the sensitivity, specificity, and positive predictive values for radiographs are generally better than those for surgical counts, they are not 100%. Macilquham and colleagues studied the ability to detect surgical needles of various sizes with the use of radiographs.20 They found that none of their observers (surgeons, radiologists, or nurses) were able to identify needles smaller than 13 mm (typically attached to a 6-O suture) on a radiograph. Although only single images were obtained and factors such as patient weight and radiographic exposure were not controlled, this study demonstrates that radiographic imaging may not prevent all cases of RSOs.20
Cima and colleagues conducted a 4-year prospective study involving 191,168 operations and 34 cases of RSOs.7 They found that intraoperative radiographs were more effective than counting and less costly than legal fees. Unfortunately, intraoperative radiographs performed when counts were discrepant failed to detect 33% of RSOs. Routine survey radiographs performed postprocedure (as the patient was leaving the operating room prior to going to the recovery room) failed to detect 10% of the remaining RSOs.7
Therefore, it is clear that neither of the current methods used alone or in combination is 100% effective in preventing the retention of surgical objects. In order to remove the human error from the equation, new technologies must be used to ensure inventory control and patient safety.
NEW PREVENTIVE TECHNOLOGIES
Bar coding A relatively new technology that has been used to decrease the risk of RSOs is bar coding of sponges and instruments. A two-dimensional data matrix label (which contains a unique identifier for each sponge or instrument) is counted using a scanner at the beginning and end of each case. This system is similar to bar code scanning in grocery stores and can produce a paper printout of surgical counts. This technology has been available since 2006 but is not in widespread use.
Greenburg and colleagues performed a randomized controlled trial comparing manual counting of sponges to scanning of bar-coded sponges.18 The authors found that the bar code system detected more than twice as many (32 versus 13) discrepancies in the surgical counts relative to manual counting. The use of the bar code system added approximately 3 minutes to each operative case at a cost of approximately $9 per procedure. Unfortunately, the system was not helpful in locating the missing surgical object and did not decrease the time it took to resolve the discrepant count. As each bar-coded object must be scanned prior to and after the procedure, human error in scanning the objects can occur.18
Electronic article surveillance Another new technology for preventing RSOs is the use of electronic article surveillance (EAS) tags. This technology is similar to the sensor tags used to prevent theft in retail stores. Fabian used electronic markers measuring 4531033 mm to test the detection rate in cadavers.21 The 300 active electronic markers attached to sponges were detected with 100% accuracy. There were no false-negative or false-positive results. Testing in which markers were attached to surgical instruments revealed an 85% to 95% detection rate. Tags placed on magnetic stainless steel instruments yielded poorer results. In addition, any object with an electronic marker must be sterilized using gas or gamma radiation rather than steam autoclaving. Fabian also acknowledged that
the size of the markers would have to be considerably smaller in order to accommodate their use on small instruments.21
Radio frequency identification Another new technology using radio frequency identification (RFID) tags can improve detection of surgical sponges and instruments intraoperatively.22 The system includes tiny microchips embedded in surgical sponges to act as transponders. A microchip measuring 20 mm in diameter and 2 mm in thickness is sewn into the surgical sponge and then sterilized. The handheld battery-powered RFID scanning wand can be waved over the surgical site to locate any retained sponges.
Macario and colleagues studied the sensitivity and specificity of the radio frequency identification device in eight operative patients.22 The surgeon using the device was blinded to the sponge placement. In all cases, the RFID wand correctly detected the tagged sponges. There were no false-positive or false-negative results. Surgeons detected the radio frequency identification sponges in less than 3 seconds on average. The nurses and surgeons who used the device gave it high marks for ease of use and ability to improve patient safety. Some criticisms of the system included the need for user training, desire for a smaller scanning wand, desire for visually unique RFID sponges, better start/stop capabilities on the wand, better ability to localize retained sponges, better signal of positive sponge detection (voice/beeping or green light), and the desire for transparent sterile sheaths to cover the wand.22
Rogers and colleagues investigated the readability of RFID tags when submerged in water or bodily fluids.23 These tags retained a high rate of readability (99%) even when saturated with fluid and contained within body cavities. In addition, because the tag is highly radiopaque, RFID sponges can be easily detected using radiographs if suspected readability is diminished.
THE BOTTOM LINE
The current practice of counting sponges, needles, and instruments manually is fraught with potential error. The inability to count due to the emergent nature of the case as well as interruptions and distractions during counting make the process error prone. Even when surgical counts are deemed correct, they may not be.
Although intraoperative or postoperative radiographs have proven to be cost-effective, they are not 100% reliable. Factors such as patient weight, exposure time of the films, number of image views, size of the missing surgical object, and ability of the reader are important determinants of
the success in locating a missing surgical object. Many of these factors cannot be controlled and therefore even when combined with manual counting, radiographs can not detect all RSOs.
Of the new technologies developed to prevent RSOs, bar coding provides a unique method of inventory control. Unfortunately, it affords improvements only in discovering discrepant counts and does not aid in the detection of RSOs in body cavities. EAS does provide a method of RSO detection that is highly reliable for sponges, but it is not as effective with surgical instruments. In addition, more complicated sterilization methods must be used with these devices. The most promising new technology is the RFID tag. The research regarding this method has proven that it is effective and easy to use. Although some refinement of the method is needed, it may be the future of inventory control in operative procedures.
The retention of surgical objects is a serious and costly medical error, and recent changes in CMS payment policy may make the error even more expensive for hospitals. When considering the legal fees for a single RSO event, most strategies to prevent RSOs appear to be cost-effective. The cost of preventing patient morbidity and mortality associated with RSOs is equally important. From a patient safety standpoint, hospitals and surgery centers should be devoted to strategies aimed at preventing the retention of surgical objects. In addition, prevention of RSOs can reduce complications, morbidity, and mortality; decrease physical, mental, and emotional suffering; reduce medical and legal costs; and improve health care systems and public health. JAAPA
Tory Cobb practiced in the Department of Neurological Surgery, Marshfield Clinic, Marshfield, Wisconsin when this article was written. She is now an assistant professor and the administrative clinical coordinator in the PA program at Pacific University, Hillsboro, Oregon. She has indicated no relationships to disclose relating to the content of this article.
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