Never Say “Never”

ClearCount Medical Solution’s SmartSponge System is the first FDA-cleared RFID product to both count and detect sponges during surgery—and its design is almost completely driven by the user

Never event"—a term defined by Centers for Medicare and Medicaid Services (CMS) as preventable injuries and infections in patients that occur during hospital stays and, as of October 2008, incidents for which CMS and a number of private insurers no longer reimburse hospitals.

Retained foreign objects are the most frequent of the surgical ‘never events,' and one of the most costly. 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. Surgical staff can be held personally liable for the incident, and in terms of patient safety, leaving a sponge in a patient can have serious health consequences—organ damage, sepsis and death.

"Sponges are a dangerous thing to leave inside people—often more serious than leaving a needle or some other 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." 

As the most frequent foreign object, a surgical sponge is retained from a patient at least once a year at every major medical institution. To resolve this problem, ClearCount developed the SmartSponge System, the first FDA-cleared radio frequency identification (RFID) system that both counts and detects surgical sponges during a procedure.  

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 Sharon Morris, RN, a co-founder of the company was working as an operating room nurse traveling to different medical institutions and experiencing the methods for counting sponges and instruments during procedures. Most techniques involved nurses manually counting the sponges before and after surgery.  

The sponges are generally an 18" x 18"  cloth used to soak up blood and other bodily fluids, clean a patient or sometimes prop up an organ during a procedure.  

Depending on the surgery, hundreds of sponges may be used in a single procedure. Before the surgery, a nurse must count the sponges by hand. After use, they are thrown out into a small, metal bucket on the floor.  

As the bucket fills, the nurse must go through the sponges—even if they are blood-covered, stuck together—and manually count them. 

At the end of the surgery, the nurse should have the same number of used sponges as before the surgery. If there is a discrepancy, the surgical team stops the procedure and X-rays the patient to locate the missing sponge.  

The sponges are usually hard to detect in an X-ray image, although an X-ray detectable blue strip is usually present on each sponge for improved visibility.

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. In 70 to 90 percent of the cases where a retained foreign object occurs, the sponge counts by the surgical team are reported as correct.

"Morris was in several close calls where it took up to an hour to find that last sponge before the patient was closed up and wheeled out of the room," says Fleck. 

"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 Design

"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 says. "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 prototypes and getting feedback, shows the OR nurses are not as easily swayed. "Sometimes," Fleck says, "the instincts of the nurses were counterintuitive to our engineering instincts."

From this standpoint, 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.

"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?'" 

At first, Fleck explains, ClearCount designed a system strictly based on the wand concept.

In this model, each sponge contained its respective RFID tag. Once the surgery was complete, the surgical staff could wave the wand over the patient, detect any sponges still in the patient and remove them.

The system worked with 100 percent accuracy when tested in a clinical setting at Stanford University. Still, this method didn't work for the OR nurses, who didn't feel comfortable relying on the wand working properly to account for sponges—they wouldn't give up counting them, and how were they to know the wand was working?

In response to this feedback, ClearCount engineers modified the system's design to count sponges before and after surgery, in addition to detecting sponges inside the patient. Essentially, the system now works to mimic the manual method of counting sponges, but automate the process for increased accuracy. The system's components work together like this:

1. ClearCount sponges come from a sponge manufacturer pre-packaged, pre-sterilized and equipped with an RFID tag securely sewn into a pouch in the corner.  

The tag is smaller than a dime, and does not affect the performance of the sponge. The tag contains a microchip the size of the tip of pencil with an antenna and other electronic components such as resistors and capacitors. 

The microchip contains a unique identifier (UID) and user-programmable data with codes to identify the type of sponge.  

The data is encrypted so ClearCount sponges are not read by other RFID systems, and other RFID tags are not 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 will not degrade or crack and can be sterilized.

2. Once the surgical staff opens the packaged sponges, the sponges are passed over the in-scanner. Within a second, the scanner identifies the information on every tag and validates its data is working properly. The system is counting throughout the surgery, up to nine times per second, to ensure accuracy and validate data. 

3. An 8" LCD screen atop the unit updates the count as sponges are scanned in and validates the sponge's data. At any time, more sponges can be added to the count, and the reader updates the count on the display.

4. When the sponges are through being used, they are thrown into the out-scanner bucket. The sponges can be thrown away in any fashion—dry, blood-covered, any type of sponge stuck together—and the RFID reader sorts the sponges, reads each sponge's RFID tag, and updates the total count on the display.

5. In the case of a count discrepancy, the system also contains a SmartWand tethered to the device. The wand contains an RFID antenna with circuitry to match the impedance between the wand and the reader. The user enters the system into Wand Mode and scans the wand over the patient to detect the missing sponge inside the patient.

The system also incorporates a user feedback mechanism to cater to the nurses' second concern—that they know the system is working properly. Before every surgery, a SmartTag is placed under the patient.

This is an RFID tag that contains circuitry to match the SmartWand. If the wand must be used, the wand reads the SmartTag beneath the patient and illuminates a green light on the wand's handle as well as communicates on the LCD display that the wand is reading the SmartTag through the patient and is working properly to detect any missing sponges.

Efficient Performance

While reducing incidents of retained surgical sponges in patients, Fleck adds the SmartSponge System improves efficiency in the OR. Less time is spent searching for unaccounted-for sponges so surgeons can more efficiently complete the surgery and close up the patient.

Response to the system has been so positive that ClearCount is working on tagging surgical instruments to offer a complete RFID-counting solution in operating rooms. The company also offers a Never Event Warranty up to $100,000 to cover non-reimbursable surgical costs in the case of a retained ClearCount sponge.

"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."