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    Preventing retained foreign objects in ob/gyn surgery

    Objects unintentionally left in patients after surgery hold dire consequences for patients, practitioners, surgical teams, and institutions. The systematic approach presented can minimize the risks and improve outcomes for everyone involved.

    Key iconKey Points

    • In the legal arena, adverse occurrences, such as retained foreign objects, represent evidence that care was substandard and indefensible.
    • Ceasing noncritical activity during surgical counts reduces distractions and improves accuracy.
    • Although radiologic screening reduces risk of RFOs, it also exposes the patient to addtional radiation.
    • Specific recommendations for sponge counting after surgical procedure are limited.
    • High- and low-tech approaches can be used alone or in tandem to prevent RFOs.
    • Remember that neither sponge counts nor intraoperative radiographs are without error.

    Incidence of retained foreign objects

    The incidence of RFOs varies among studies, ranging from approximately 1 in 5,500 to 1 in 18,000 operations.1,3 The Connecticut Department of Public Health has published its statistics of adverse events, including 78 occurrences of an RFO in patients after surgery or other procedure during the period of 2004 through the first half of 2009, making it the fourth most common adverse event.9

    The Joint Commission's sentinel event statistics reported 360 instances of unintentional retention of a foreign body during the period of 2005 through March 2010.10

    In a study of closed malpractice claims of the Medical Professional Mutual Insurance Company (ProMutual, Boston) from 1988 to 1994, of the 9,729 claims reviewed, 67 claims (0.7%) involved 40 patients with retained surgical sponges.4

    Of the 40 claims filed against physicians, 22 (55%) involved abdominal surgery, of which 11 were obstetric or gynecologic in nature (6 cesarean deliveries, 4 hysterectomies, and 1 tubal ligation). In addition, 11 of those 40 cases (27%) involved uncomplicated vaginal deliveries. In 76% of the cases, the sponge count was inaccurately reported as being correct. Median indemnity payments were $5,063 for retained vaginal sponges and $68,857 for those involving abdominal procedures.

    According to a 2009 report, the total legal costs involving an RFO case was estimated to be $166,135 in today's dollars.11 In these cases, the legal doctrine of res ipsa loquitor may be applied because the adverse occurrence represents evidence that the care was substandard and indefensible.

    Gawande and colleagues completed a landmark case-control study of malpractice claims in Massachusetts from 1985 to 2001 involving retained surgical instruments or sponges.1 In their study of 61 RFOs, 69% involved sponges; 31% were instruments. Fifty-four percent involved foreign bodies left in the abdomen or pelvis; 22% of RFOs were left in the vagina.

    Retained foreign objects were detected on average at 21 days postsurgery. Radiographs detected 67% of the objects, and 24% were detected in physical examination or self-examination (particularly those left in the vagina). Nine percent were detected at repeat surgery. In 37 cases (69%), patients required reoperation for removal of the object and management of complications. In 12 cases (22%), the RFO resulted in small bowel fistula, obstruction, or visceral perforation. In 1 case, the RFO resulted in death.

    Table 1 Risk factors associated with retained foreign objects
    In this study, investigators found that the factors more likely to be associated with RFOs included having an emergency surgical procedure, an unexpected change in procedure, a procedure involving more than 1 surgical team, and failure to count sponges and instruments (Table 1).1 Patients with RFOs had a significantly higher body-mass index than did the control patients. In 88% of cases, the sponge and instrument count was erroneously recorded as correct at the end of the procedure. In the 47 cases that prompted litigation and were closed at the time of the report, the average cost was $52,581.

    Given the large numbers of obstetric and gynecologic procedures performed annually, along with the emergency nature of some cesarean deliveries and the increased body mass of many patients, the potential for an RFO is high in our specialty.


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