Bar-coding surgical sponges

AORN Journal, July, 2008 by George Allen

Annals of Surgery

April 2008

Retention of sponges and instruments is a rare but persistent and serious medical error that can result in serious sequelae, including reoperation for removal, bowel perforation, and even death. These episodes frequently lead to litigation, negative publicity, and distress for the providers involved. The standard procedure to prevent retained foreign objects depends on two members of the surgical team concurrently counting every item as it is introduced onto the sterile field and again at the end of the surgical procedure. A discrepancy occurs any time a subsequent count does not agree with a previous count.

When a discrepancy occurs, a search of the room and sterile field is conducted. If the search is negative, radiographs are taken to confirm that no items are retained inside the patient; however, the weak link in this procedure is the deception of a falsely correct count. In these cases, the count lends a false sense of security when, in fact, a misplaced item has been left in the patient.

Recently, technological adjuncts to manual sponge counting have emerged as potential solutions to retained sponges, with small pilot studies demonstrating the feasibility of embedding radio-frequency identification tags in sponges. These systems are, as yet, untested technologies with their own failure rates, however, and it is not certain that they will function more reliably than the current manual counting approach.

Another approach is the placement of bar codes on surgical sponges to allow computer assisted sponge counting as a supplement to manual counts. Bar-coding technology has proven to be effective in improving the safety of medication administration, and a bar-coded sponge system has been introduced in the United States. Although a bar-coded sponge system may be promising, it is not certain to reduce errors. The purpose of this randomized controlled study was to evaluate a computer-assisted method for counting sponges using a bar-code system compared to the standard sponge-counting protocol.

Patients undergoing an elective, weekday procedure performed by a general surgeon, surgical oncologist, or colorectal surgeon in a general surgery OR at Brigham and Women's Hospital, Boston, Massachusetts, were eligible for the study. A total of 56 surgical technologists (STs) and circulating RNs and 36 surgeons participated in the study.

For the purpose of the study, two types of discrepancies were defined. Miscounts were defined as a number of sponges counted that does not reflect the number of sponges actually present, such as with a double count or undercount; this usually is resolved by recounting. A misplaced sponge was defined as a sponge that is unintentionally lost on the floor, in the trash, or on the sterile field. A retained sponge is a specific type of misplaced sponge that is located within the patient's body cavity, either before the patient leaves the OR (ie, representing a near miss) or postoperatively (ie, representing an adverse event).

The same sponges, which contained a unique tag annealed to the gauze, were used in both the control and experimental arms of the study. For both arms of the study, the team followed the standard protocol for counting instruments and sponges at the start of and during the procedure, including a simultaneous manual count by the ST and circulating RN. In the intervention arm, the sponges also were scanned using a handheld bar-code reader as they were added to the sterile field and again as they were removed. The control arm of the study was limited to the manual count.

The primary endpoint was the number of incidents of miscounted or misplaced sponges detected in each arm of the study. Secondary outcomes included the total time devoted to counting activities, the number of miscounts, the number of misplaced or retained sponges, the number of surgeries with any discrepancy, each type of discrepancy, and the number of x-rays required to resolve the discrepancies. Three physician observers using standardized data intake forms collected data beginning with set up for the procedure until all counting activities were concluded and the patient left the OR. Data collected for each counting activity included:

* start and end time;

* team members involved;

* phase of the counting protocol; and

* number and type of item being counted.

All discrepancies were documented as well as the amount of time required to identify and reconcile the discrepancy. At the end of each procedure, an immediate postoperative survey was administered to the attending surgeon and nursing and ST team members, asking them to evaluate the counting process, team function, and their level of confidence that no sponge was left behind. A final survey assessed providers' evaluations of the system at the completion of the study. In addition, observers collected demographic, clinical, and procedural data for each patient on the day of surgery and reviewed the patients' paper and electronic medical records 60 days after surgery to assess whether a retained sponge was found postoperatively. Common statistical techniques were used to analyze the data.