Retained surgical items (RSIs) are termed a “never event” by the National Quality Forum, and have been since 2009. In theory, a “never event” is a medical error that should not occur under any circumstances (Int J Acad Med 2016; 2:5-21). However, with regard to RSIs, it’s far from true they never occur.
Since 2014, there have been 400 reports to The Joint Commission on RSIs (bit.ly/RSIreports). The National Institutes of Health estimates approximately 1,500 RSIs each year and a review of government data suggests even higher—4,500 to 6,000 times per year (N Engl J Med 2003; 348:229-35; bit.ly/RSIincidence). While the actual number of RSIs each year is not known, one thing is more certain: A lawsuit involving RSI is very difficult to defend.
A recent news headline likely caught the attention of urologists: A scalpel was discovered in the abdomen of a patient who underwent a radical prostatectomy in 2013. Urologic complications of RSIs have been described in a variety of case reports. One report presented two pediatric cases of gossypiboma associated with urethral stricture following urologic surgery (Int J Surg Case Rep 2013; 4:425-8). In another case, a patient presented with food particles in her urine a few weeks after an abdominal hysterectomy. She was found to have a retained surgical hemostat and sponge, leading to the development of a fistula between the ileum and the dome of the bladder and resulting in fecaluria (Case Rep Urol 2014; 2014:723592). In another, a surgical sponge was left after a partial nephrectomy and found later on computed tomography during a workup for bladder outlet obstruction (Int J Acad Med 2016; 2:5-21).
Also by Brianne Goodwin, JD, RN: How incidental radiology findings can lead to malpractice litigation
A plaintiff’s attorney would likely attack a case of RSI with the legal theory of res ipsa loquitur, meaning, “the thing speaks for itself.” This requires that the attorney show three things: that the harm would not normally occur absent negligence, the harm was caused by an instrumentality within the exclusive control of the defendant, and the plaintiff did not contribute to the harm.
In essence, the argument is the fact that a surgical item has been retained is, in and of itself, proof that malpractice has occurred. Also of importance, in many jurisdictions, the statute of limitations for RSIs may be different than that of medical malpractice. The law in many states offers some protection to the plaintiff who does not discover an RSI for an extended period of time, known as the discovery rule. If the RSI was not discovered, and it could not reasonably have been discovered, the statute of limitations will not begin to run until discovery of the RSI. Thus, one may be able to sue several years later for an RSI that went undiscovered.
Review of one insurer’s closed claims database showed that the average indemnity payout for a claim involving a retained surgical item for hospitals and physicians was approximately $473,000 from 2007 to 2011. For cases involving permanent major damage to a patient, the average claim was $2 million. Another insurer reported individual physician indemnity ranging from $105,000 to $865,000 with a total payout for retained surgical items of $26 million over 4 years (bit.ly/RSIpayout).
In addition, the Centers for Medicare & Medicaid Services has adopted rules that effectively eliminate reimbursement for the costs associated with the RSIs and other “never events” (Int J Acad Med 2016; 2:5-21). Therefore, the hospital or organization must absorb the costs of the surgery and associated hospitalization, adding to the overall economic burden of cases of RSI.