The risk posed by retained surgical items (or RSIs) has been present since the modern era of surgery first began. Although the frequency of RSI incidences is declining, an estimated one in every 1,500 intra-abdominal surgeries in the U.S. today results in a sponge left behind in the patient.
This makes RSIs the most frequent and costly surgical “never event” and a top 10 Sentinel Event reported to the Joint Commission. While RSIs are rare, they can be dangerous and costly when they do occur, sometimes resulting in post-procedure infection, bowel perforation, abscess, pain and even death.
Health care providers, meanwhile, may face re-operative and legal expenses and a compromised reputation as a result of RSI cases that occur in their facility. The after-surgery cost of RSI incidences is more than $62,000 per hospital stay, according to the Centers for Medicare and Medicaid Services (CMS), while the average settlement and legal fees are $145,000 per RSI incident, according to an Aon/American Society of Healthcare Risk Managers study.
RF Technology Gaining Traction
Despite all the advances made in modern surgical technology, OR staff still relies primarily on strict counting protocols as the main safeguard to prevent RSI cases. But this may be starting to change, as several new technologies have emerged over the past few years that can help OR staff virtually eliminate RSI incidences.
These technologies use radio frequency (RF) to either assist in the counting of surgical items (primarily sponges and gauze) or detect such items that have been left inside patients following the surgical procedure.
Ramona L. Conner, MSN, RN, CNOR, Manager, Standards and Recommended Practices for the Association of periOperative Registered Nurses (AORN), notes that AORN’s Recommended Practices for Prevention of Retained Surgical Items starts with traditional counting protocols. “However, we recognize that counting is fraught with potential for human error, as OR nurses must count a large number of items under very stressful and exacting conditions.
“Therefore, we now recommend that health care organizations explore the use of these new technologies to help prevent RSI cases. In fact, we are seeing a decrease in RSI incidences at organizations that have implemented these new technologies as an adjunct to counting procedures.”
One of these technologies is the RF Surgical Detection System, which was cleared for use by the FDA in 2006. This system places a small Radio Frequency Identification (RFID) tag on each sponge, gauze or towel used during a surgical procedure and reads through deep cavity tissue, fluids and bone to detect if any tagged items remain inside of a patient following surgery.
A Better Way
Dr. Jeffrey Port, Associate Professor of Cardiothoracic Surgery and an Associate Attending Surgeon in the Division of Thoracic Surgery at New York Presbyterian-Weill Cornell Medical Center within the Department of Cardiothoracic Surgery, is a co-founder of RF Surgical Systems, which manufactures the RF Surgical Detection System. “While the OR team usually does a tremendous job under enormous stress, occasionally the surgical counts are incorrect, and I saw a broad range of cases where counts were incorrect early in my surgical training,” says Dr. Port.
“When this happens, the surgical team has to stop while the nurses look all over the OR for missing items. This can stymie the progress of an operation for 30 to 40 minutes or longer if a portable X-ray machine has to be brought in. It’s a big headache, not to mention a biological hazard, and I thought there had to be a better way.”
In 2011, researchers from the UNC Health Care System reported on the results of a multi-institutional study in which the RF Surgical Detection System was used in more than 3,500 surgical procedures at five centers. Long-term follow-up is ongoing, but key interim conclusions include the following:
- RF detection can speed identification and avoid the need to use radiation to locate missing sponges, thereby improving both patient safety and clinical workflow efficiency in the OR.
- RSIs occur regardless of whether the manual counts are correct, which affirms the need for a check-and-safety balance with adjunctive detection technology.
- Almost 90 percent of operations, the nursing staff reported that RF detection offered less stress during wound closure and improved overall confidence that no foreign objects were left in the patient.
“Counting sponges has been the tool used to prevent RSIs for longer than I’ve been in the OR, which is 40 years,” says Stella M. Nelson, project manager for the Surgical Services Division at UNC Hospitals. “But since it’s people-driven, it can result in errors. The RF Surgical Detection System has been a very positive experience for us.”
Last June, UNC Hospitals implemented the RF Surgical Detection System to be used in conjunction with all traditional sponge counts. “Any time we do a sponge count, we also use the system,” Nelson says. “There have been no RSI incidences since the system was put in place.”
More RF Solutions
Another RF technology solution to help prevent RSI incidences is offered by ClearCount Medical Solutions. ClearCount’s RFID technology provides a unique identification of items and data transmission to provide the utility of counting. Its SmartSponge system offers both manual count reconciliation and RSI detection, while its SmartWand-DTX system provides an electronic count while also scanning patients for items that may have been left behind during the procedure.
“Even though RSI incidences are rare, they still happen much more frequently than they should,” says ClearCount CEO David Palmer. “The majority of the time, the surgical record shows that the count was reconciled, so the OR staff doesn’t even know that items may be left behind. With our new RFID technology, zero is now the achievable standard of care for retained surgical sponges.”
SurgiCount Medical provides yet another technology solution for preventing RSIs. Its Safety-Sponge System is a sponge counting and documentation system, not an RSI detection system, that is designed to increase the accuracy of sponge counts performed in the OR by directly addressing the issue underlying the vast majority of retained sponge cases: human error that results in false “correct” counts.
“In nearly 90 percent of cases with a retained sponge, the final count was erroneously thought to be correct,” says Tony Ebree, senior vice president of sales for SurgiCount Medical.
The Safety-Sponge System uses simple barcode technology by placing a unique identifier on each Safety-Sponge. Used together with a small, mobile computer and scanner, the components ensure accurate, real-time intra-operative counts. According to Embree, more than 62 million Safety-Sponges have been successfully used in more than 3 million procedures, and the system has been validated by the largest completely independent clinical study ever published on retained foreign objects.
What RF Can and Can’t Do
It’s important to note that all of these technologies are designed primarily to help prevent the retention of surgical sponges, towels and gauze-they do not help guard against retention of surgical instruments, needles, fragments and other items. According to Dr. Port, however, sponges, towels and gauze account for 80 percent or more of retained items, so these technologies can virtually eliminate the majority of RSI incidences.
Also, RF Surgical Systems is currently working on RF technology that can be applied to instruments, Dr. Port adds. “Manual counting protocols have worked well for many years-these technologies aren’t designed to replace counting, but rather to add to it,” he says.
Given the stress and uncertainty involved in traditional counting, not to mention the patient dangers and costs that can result from RSIs, every OR nurse would probably agree: Anything that can be done to eliminate RSIs is a welcome addition to the OR.