The SmartSponge System from ClearCount Medical Solutions employs RFID technology to both count and detect sponges during surgery, increasing efficiency and performance in the OR, and most importantly, improving patient safety.

by Amanda McGowan, Editor, Surgical Products

For a patient, going through surgery can be a frightening experience. In any procedure, a certain level of trust must exist between the surgical staff and the patient that the professionals in the operating room will take care of that patient from the moment they are opened to the moment they are closed, and through everything in between. So when a surgical sponge is mistakenly left inside a patient after surgery, which as the most frequent retained foreign object, occurs on average at least once a year at every major medical institution, it can leave a patient questioning their trust in the surgical staff-and concerned for their safety.

"Sponges are a dangerous thing to leave inside people, often more serious than leaving even a needle or some instruments because the porous material really fosters growth of an infection," says Steve Fleck, co-founder and Chief Technology Officer at ClearCount Medical Solutions in Pittsburgh, PA. "There are instances of people having needles inside them for years without an infection. That won't happen with a sponge. You'll know."

Retained foreign objects are the most frequent surgical 'never event,' as defined by Centers for Medicare and Medicaid Services (CMS), and one of the most costly. As of October 2008, CMS and several private insurers no longer reimburse hospitals for procedures associated with never events, and according to the Federal Register, the average Medicare payment for admissions in which an object is left behind in surgery is $61,962. Not only is the hospital responsible for all re-operation costs, but it can also expect to pay anywhere from $50,000 to $100,000 or more in litigation for a procedure in which a surgical sponge was retained. Surgical staff can be held personally liable for the incident, resulting in negative licensure implications. In terms of patient safety, leaving a sponge in a patient can have serious health consequences-organ damage, sepsis and death.

To resolve this problem, ClearCount developed the SmartSponge System, a FDA-cleared radio frequency identification (RFID) solution that both counts and detects surgical sponges during a procedure. Using RFID, each sponge is equipped with a unique identification tag. The system can read each sponge's tag to identify the sponge, count it before and after surgery, and detect the sponge within the patient.

Along with the RFID technology, what's truly unique about the system is that it was influenced by the user-surgeons and OR nurses-every step of the way to grant the optimal solution in preventing retained surgical sponges in the OR.

Point Of Pain

"What we're most proud of is the fact that our device was really conceived by an operating room nurse," says Fleck.

The idea of the SmartSponge System dates back to the mid-90s, when a co-founder of the company, Sharon Morris, RN, was working as an operating room nurse traveling to different medical institutions and experiencing many methods for counting sponges and instruments during surgery. Most techniques involved nurses counting the sponges by hand-before and after the surgery, even if the procedure required hundreds of sponges, which could stick together, covered in blood. If there was a count discrepancy, the surgery stopped and the patient was X-rayed to locate the missing sponge.

While there were slight variations among institutions, one consistency was that sponge counts were problematic. "They're always a point of pain for the nurses and a potential safety concern for the patients," Fleck explains.

The entire manual system is error-prone, Fleck says-and the statistics prove it. Published studies show miscounts of sponges occur in up to 13 percent, or one in eight, surgeries. One in every 1,000 to 1,500 intra-abdominal surgeries results in a sponge left behind in the patient. In 70 to 90 percent of the cases in which a retained foreign object occurs, the sponge counts by the surgical team are reported as correct. Emergency procedures, patients with larger body masses and changeovers in staff during long surgeries all increase the risk of leaving a sponge inside the patient.

"Morris was in several close calls where it took half an hour to an hour to find that last sponge before the patient was closed up and wheeled out of the room," says Fleck. "So, from both a personal pain standpoint of digging through the trash and handling all those bloody sponges, and from a patient safety standpoint of having those close calls where the patient almost left the room with a sponge in them, she thought to herself, 'There has to be a better way to do this.'"

User-Driven System

"RFID relies on the unique identification of every tag so it enables counting, but it also wirelessly detects these foreign objects through the human body, through blood and tissue and fluids, so you don't need any line of sight," Fleck explains. "It really is the optimal technology for the surgical environment."

While the ClearCount engineers don't need any convincing that RFID is the best solution for the problem of retained surgical sponges, three years spent in the OR in various medical institutions, testing the system and getting feedback from surgical staff shows that OR nurses are not as easily swayed.

"The one thing the nurses have in common is they really do care deeply about the patient. That is their charge in the operating room-to look over the patient and ensure their safety during the procedure," Fleck says. "Sometimes, the instincts of the nurses were counterintuitive to our engineering instincts."

From this standpoint, Fleck says, the most important factor in the system is reliability and the nurses' ability to trust the system and its technology. The OR nurses want a system that mirrors their current processes of accounting for sponges-they can't simply trust the technology is working.

"That was the big input into the design of this device," Fleck continues. "'How do we design this so that we are constantly giving feedback to our user that our components are functioning, that they're working, so they know everything is OK?'"

To do this, the system implements user-feedback mechanisms to validate the RFID technology is working to accurately count and detect sponges throughout a surgery. More specifically, this is how all the components of the system work during a surgical procedure:

1. ClearCount surgical sponges come from a sponge manufacturer pre-packaged and pre-sterilized. Each sponge is equipped with a RFID tag securely sewn into a pouch in the corner. The tag does not affect the performance of the sponge, is smaller than a dime and contains a microchip providing, along with other information, a unique identifier (UID) that never repeats.

2. This data is encrypted, meaning ClearCount sponges cannot be read by other RFID systems, and other RFID tags cannot be read by the SmartSponge system. The finished RFID tag is encapsulated in a rugged biocompatible plastic. Impervious to fluids and surgical instruments, the tag has been tested to ensure it won't degrade or crack, and can also be sterilized.

3. When the surgical staff opens the package of sponges, the sponges are passed over the in-scanner. Within a second, the scanner reads the information, including the UID, on every sponge, identifying the sponge and validating its data is working properly.

4. An 8-inch color LCD screen atop the unit updates the total count as sponges are scanned in and shows how many sponges are now in the case ready to be used in the surgery. At any time, more sponges can be added to the count, and the reader updates the count on the display.

5. When the sponges are through being used during the surgery, they are thrown into the out-scanner bucket. According to Fleck, the sponges can be thrown away in any fashion-dry, blood-covered, any type of sponge stuck together-and the RFID reader sorts through, counts each sponge individually by reading its RFID tag, and updates the sponge count on the display. The counter is continuously counting-up to nine times per second-and keeps the data on the display updated.

At the end of the surgery, the number of sponges scanned in should be the same as those scanned out. In the case of a count discrepancy, a SmartWand is tethered to the device to detect any missing sponges in the patient. The user enters the system into Wand Mode, scans over the patient and allows the wand to read the RFID tag in the missing sponge to locate it in the patient.

Once again, the system incorporates a user-feedback mechanism to show the user the wand is functioning correctly. An RFID label called a SmartTag is placed underneath the patient before every surgery. As the wand scans the patient, it reads the RFID tag underneath. A green light illuminates on the handle of the wand, and the display updates to confirm the wand is functioning and has read the RFID tag through the patient.

Higher Quality Care

While reducing incidents of retained surgical sponges, Fleck adds that the SmartSponge System also improves the efficiency in the OR and strengthens the overall quality of care. Less time is spent searching for unaccounted-for sponges so surgeons can more efficiently complete the surgery and close up the patient. Because the unit is self-contained, it can be wheeled from OR to OR without extensive setup, and training is reported to take a mere 15 minutes.

Finally, the system is a financially sensible choice for hospitals and surgery centers, Fleck says. In the long run, the one-time investment in the SmartSponge System is a cost-effective solution to prevent the re-operation time and expenses and litigation fees associated with retained surgical sponges. The company also offers a Never Event Warranty up to $100,000 to cover unreimbursed surgical costs in the case of a retained ClearCount sponge.

Surgical professionals are generally on-board with any solution that proves to better OR efficiency and patient safety, Fleck adds. Therefore, it's not surprising the response from surgeons and OR nurses has been positive in the past year the SmartSponge System has been available. In fact, feedback for the system has been so supportive that the company is now working on tagging surgical instruments for a complete RFID-counting solution in the OR.

"I think people are starting to realize there really does need to be a technology-enabled solution to help us get to zero retained foreign objects," Fleck says. "And as people are realizing that, they are turning to RFID because it makes the most sense. It's the most obvious solution to this problem."