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