Historically, about 5% of all non-obstetrical malpractice claims arising out of surgery involve retained foreign bodies. A 2009 report in the Journal of Robotic surgery states that 1 in 1,500 open abdominal or chest procedures results in a retained surgical item. In a significant number of those claims, the retained foreign body is a sponge, towel, pad, or other “soft” surgical supply. Until recently, hospitals and surgery centers would embed small metal threads in these soft materials so that they would be detectable by portable x-ray. This requires the surgical staff to keep a current count at all times. Such counts are time-consuming and errors can still be made. When the count doesn’t match at the end of the procedure, a portable x-ray unit is brought into the surgical suite and the patient is x-rayed to determined whether a foreign body has been retained. Such a procedure prolongs surgery, increases cost, and exposes the patient to radiation unnecessarily. In a majority of cases involving retained sponges, the nurses’ sponge count at the conclusion of the procedure was recorded as “correct,” so this procedure was not utilized.
Defending such cases is extremely difficult, although not impossible. In Indiana, as in many places, a malpractice claim based on a retained foreign body is subject to the principle of res ipsa loquitur, or “the thing speaks for itself.” In such cases, the burden of proof shifts to the surgeon to prove that he was not negligent in failing to remove the foreign body before closing the patient. And it is a long established principle that the duty to remove sponges before closing the patient cannot be delegated to nursing personnel.
A surgeon is charged, as a matter of law, with the duty to remove sponges used in the operation, which sponges will not be of use in the abdomen after the operation. Ordinary care and caution forbids a surgeon to delegate the absolute authority and responsibility to a nurse or nurses to account for sponges and to thus escape responsibility himself.
Funk v. Bonham, 204 Ind. 170, 180, 183 N.E. 312, 316 (1932).
New technology is available, however, that may cause these cases to become extinct. The FDA has approved the use of radio frequency identification (RFI) chips to automatically keep track of the sponges, pads and towels used during surgery. This allows surgeons to complete cases more quickly, without spending time confirming the absence of any such retained foreign bodies. Although RFI technology does not detect clamps or other surgical instruments, it is much quicker than using portable x-ray equipment to find sponges and towels, and does not expose the patient to unnecessary radiation.
RFI technology includes chips that are sewn into the soft surgical supplies and a wand-like instrument that is simply waved over the surgical site prior to closure. Each chip is unique and its unique identifier is displayed on a monitor that tracks each chip. As the sponge is removed from the surgical field, the technology displays it and notes that it has been counted. If there is any sponge that has not been counted, that is displayed on the device. The system also includes a wand-like device that is waved over the surgical site and detects any chips, which would indicate the presence of a retained sponge, towel, etc. When the wand detects a chip, a red LED light is displayed and an alarm sounds.
Some hospitals use the RFI technology only for high risk procedures, such as those undergoing emergency surgery, obese patients, cesarean sections, and patients undergoing surgery on more than one area of the body. Others have implemented it for all surgical procedures.
It is only a matter of time before the use of RFI technology will become “standard of care” in surgery. When that happens, we may have seen the last of retained sponge malpractice cases.