Study asks why surgical tools were left in 1,500 patients

Report says emergencies, complications and patient obesity -- not negligence -- lead to objects being left inside patients.

By Andis Robeznieks, amednews staff. Feb. 3, 2003.

A Jan. 16 New England Journal of Medicine report on foreign bodies left inside patients was cited plenty of times in recent news reports, but the author of the study thinks it may be cited even more in future court cases.

According to general surgeon Atul A. Gawande, MD, MPH, of Boston's Brigham and Women's Hospital, there has never been much hospitals and doctors could do legally to defend themselves if a sponge or surgical instrument was left in a patient because courts generally view these cases as res ipsa loquitur, which Dr. Gawande defines as "negligence, pure and simple."

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"What we found by analyzing in a case-controlled method is there is no evidence of negligence," he said. "Instead, we found conditions in which surgical teams were stressed led to a greater risk for error. ... It runs exactly counter to the findings that these were the result of carelessness."

For example, in emergency surgeries, Dr. Gawande and his colleagues found that the risk for leaving a foreign body in a patient increased 900%. They also found that, when unexpected changes occur during a planned surgery, the risk increases 400%, and each 10-point increase in a patient's body-mass index translates into a 100% increase in risk.

"Our study really showed it isn't negligence, and a punishment approach is not likely to work [to prevent future cases]," Dr. Gawande said. "What we found were the same constellation of events and conditions that led to these errors."

He added, "This happens despite teams following proper procedures."

More sponges are left in patients than any other foreign object.

In addition to the risk factors they found to be associated with this error, the researchers also found that the patient's age, the duration or lateness of the operation, and the involvement of multiple procedures were not significantly associated with greater risk for leaving behind a foreign object.

Dr. Gawande called leaving objects inside a patient "a rare but serious problem" that he calculated occurs about 1,500 times out of the approximately 28.4 million inpatient operations that are performed each year in the United States.

According to Terry Canale, MD, past president of the American Academy of Orthopaedic Surgeons and a professor and chair of orthopedic surgery at the University of Tennessee Health Science Center College of Medicine in Memphis, when an object is left inside a patient, it also leaves a mark on the physician.

"It's a real blemish on the surgeon -- both psychologically and on his career -- to have it happen to them," he said.

In fact, Dr. Canale said he had heard stories from "back in the dark ages" about physicians who spotted an object on an x-ray, kept it to themselves and then arranged surgery under the pretenses of "draining an abscess" in which the object was removed.

Sponges main culprit

For the study, researchers reviewed malpractice claims and incident reports filed between 1985 and 2000 with the Controlled Risk Insurance Co., a Massachusetts medical liability insurer. Fifty-four patients were found and matched against multiple control patients who had been hospitalized for the same procedures.

From the 54 patients, there was a total of 61 retained foreign objects. Thirty-seven patients had sponges in them, four had clamps, and 13 others had various other instruments, including retractors and electrodes.

Among the cases studied, the sponges and instruments were left 29 times in the abdomen or pelvis, 12 times in the vagina, four times in the thorax, and nine times in other areas including the spinal canal, face, brain, and extremities.

Since foreign objects were left behind during obstetric procedures, Dr. Gawande said "the same standards need to apply in the delivery room that apply in the operating room."

Technology may be final answer

Eventually, Dr. Gawande predicted that technology, such as handheld screening devices, would make sponge counts and x-rays obsolete.

Even though sponge and instrument counts were performed in 88% of these cases, Dr. Gawande said they were still an important prevention tool. He also suggested that radiographic screening be done on patients who could be considered high risk for this error, and predicted this would detect an object one out of every 300 high-risk surgeries.

The risk for left-behind surgical instruments is higher in obese patients.

Noting that the none of the incidents involved laparoscopic surgery, Dr. Canale predicted that "percentage-wise," these types of errors will go down as surgeries becomes routinely less invasive.

Nevertheless, he also emphasized the need to count sponges especially because, as they fill with blood, they resemble part of a bloody wound and can be easily overlooked.

"In our institution, if the sponge count is incorrect or if they can't find an instrument, an x-ray is automatic," Dr. Canale said, though this doesn't necessarily solve every problem.

Twice in his career, he said there have been incorrect sponge counts followed by x-rays. In one instance, the sponge was found on the floor, and in the other, it was never found.

In the cases studied, objects were usually found by the 21st day after surgery but, in one case, the object wasn't detected until 6 ½ years later. Thirty-seven patients needed new surgery for removal of the object, and one death was reported. Court costs averaged $52,581 for compensation and legal expenses.

ADDITIONAL INFORMATION:

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Article, "Risk Factors for Retained Instruments and Sponges after Surgery," New England Journal of Medicine, Jan. 16 (http://content.nejm.org/cgi/content/full/348/3/229)