An evaluation of a numbered surgical sponge product

AORN Journal, May, 2007 by Michele M. Pelter, Kimberty E. Stephens, Denise Loranger

A rare but serious postoperative complication that threatens patient safety is the retention of foreign bodies used during surgery (eg, surgical sponges, needles, clamps, retractors, electrodes). The projected rate of retained foreign bodies each year for inpatient surgical procedures is 1,500 out of 28 million patients, with sponges being the most commonly retained foreign body. (1) This retention rate is based on malpractice claims; however, because hospitals are not required to report retained foreign bodies, it is likely the rate is higher than reported.

Many reasons are cited as possible causes for retained foreign bodies, including surgical factors (eg, emergent situations, surgical procedures in which an unplanned procedure was performed); patient factors (eg, patients with higher body mass index (1)); and human factors (eg, distractions during surgery, not conforming to established counting procedures (2,3)).

The consequences of a retained foreign body after surgery can be very serious. For patients, complications can include sepsis, infection, reoperation, increased length of hospitalization, hospital readmission, fistula formation, bowel obstruction, visceral perforation, and death. (1-7) According to a report issued by the Agency for Healthcare Research and Quality, the discovery of a retained foreign body added four days to the average hospital stay, and 57 patients died because of this type of error in 2000. (8)

The consequences for physicians and nurses can be professionally devastating. Retained foreign bodies put clinicians and hospitals at risk for lengthy and costly litigation and unwanted publicity. The average cost incurred from litigation in these cases is estimated to be more than $50,000. (1,3)

Despite the negative consequences of this problem, few technologies have been introduced into clinical practice to address retention of foreign bodies. In the past five years, initial research studies evaluating the use of radio-frequency systems and bar-coding technology have been published; (9,10) but currently only a few systems are available for use. No large, randomized clinical trials have been published in which researchers have evaluated the effectiveness of these technologies.

Currently, OR personnel use well-established counting and documentation procedures, such as those described in AORN's "Recommended practices for sponge, sharp, and instrument counts," (1) as their primary means of preventing retained foreign bodies. Careful counting and meticulous documentation throughout the surgical procedure can help reduce retained surgical foreign bodies. This process is quick, easy, and inexpensive; however, this system is prone to error. Errors can be linked to human performance (eg, telephone interruptions, team members not counting together, items being dropped and not found, surgical items being used in an incorrect manner). Some studies show that falsely correct sponge counts often are documented in the medical record in cases where a retained foreign body was later diagnosed. (1-3)

The entire surgical team must be involved with the counting process, but the RN acting as the circulator is responsible for ensuring the accuracy of counts and documenting all foreign bodies that enter and are removed from the patient's body. One report indicated that a surgical nurse devotes an average of 35 minutes (14.5%) of his or her time to counting protocols. (12) Nurses are crucial to the counting process, so any strategy to improve counting methods should be tested and evaluated by nurses working in the OR setting.

A team of research nurses in a western US regional health network decided to evaluate a numbered surgical sponge product to determine if its use would affect the flow of surgery and to ascertain the ease of use of this product for OR personnel. Specifically, this investigation assessed whether the introduction of numbered surgical sponges would:

* increase the time it takes to count sponges or

* interrupt the flow of the case, there by increasing the length of the surgical procedure.

The OR personnel using the numbered sponges also were asked whether the numbered sponges were easy to use and to learn to use. Additionally, respondents reported whether they perceived that the sponges were safe to use and whether they had confidence about the accuracy of the sponge count when using the numbered sponge product compared to using nonnumbered surgical sponges.

SETTING

The setting for this product evaluation was a 35-bed hospital, a sister hospital to a 520-bed, level II trauma facility located in the western United States. At the time of the evaluation, the OR had four surgical suites and performed approximately 2,000 surgical procedures each year. Although the OR in this facility is able to accommodate most major surgical procedures, the majority of the procedures performed during the evaluation period were elective procedures. Twenty-six full-time equivalent staff members were devoted to the OR department during this evaluation.