A patient is taken into the operating room for a routine procedure and comes out with an unexpected gift: a sponge (or some other surgical instrument) left inside their body.

As much as it sounds like the scene out of a movie, or even just an urban legend, the problem of retained foreign bodies after surgery happens as often as 3,000 to 5,000 times a year, according to David Palmer, president/CEO of ClearCount Medical Solutions (Pittsburgh).

ClearCount, a company focused on developing smarter solutions to improve patient safety inside the OR, reported yesterday that its SmartSponge System based on radio frequency identification (RFID) had received FDA clearance.

“The problem of surgical sponges being left behind in various body spaces is something that every surgeon and perioperative care nurse in this country has at least thought about, even if they have not directly experienced the problem,” said Verna Gibbs, MD, director of the No Thing Left Behind initiative , which aims to prevent retained surgical items. “These events are the product of poor communication and faulty processes of care that cause patient injury. The ClearCount SmartSponge System is an ingenious and simple solution to address both problems in communication and problems in counting practices. This is an exciting new modality which could help surgeons and nurses do a better job in the OR and deserves to be evaluated.”

According to Palmer, the SmartSponge System is the world’s first RFID system that detects and counts surgical sponges and towels during surgical procedures. The device is intended to improve patient safety and efficiency by alerting staff when there is a missing sponge, he added.

Gautam Gandhi, a co-founder of ClearCount, told Medical Device Daily that the system began as a project in 2003 while he was a graduate student at Carnegie Mellon University (Pittsburgh). The privately held company was founded in 2004.

Gandhi, the company’s chief marketing officer, said that RFID is similar to technology used to prevent shoplifters from leaving a store with stolen goods, with a few exceptions. When a customer walks out of a store and sets off the theft-prevention alarm, the system will beep but it doesn’t really tell the store personnel why it beeped, Gandhi explained. Those systems only beep one time whether the person has one item or 20 items, he said, and it’s the same beep whether the stolen item is worth $10 or $10,000.

RFID systems are comprised of two basic components: a reader and tags, which are applied to the items to be tracked. RFID tags contain small integrated circuits that contain unique identification codes as well as programmable memory that can be used to store information about the items being tracked. ClearCount’s RFID tags are passive — they have no power supply of their own. They are powered by the radio signal from the scanner. These signals are designed to be read between a few inches and several feet away, and no line of sight is required between reader and tag in order for data to be communicated, the company said.

“RFID actually puts information on the tag ... it allows us to actually count and identify the sponges,” Gandhi said. “You throw the sponges into a bucket and it counts them. So then when something is missing it’s easy for the surgeon to know what is missing.”

The RFID-based solution was designed after extensive work with nurses and surgeons at leading healthcare institutions, according to the company. The SmartSponge System uses Texas Instruments ’ (Dallas) Tag-it HF-I portfolio of high-frequency products to automate the process of managing surgical sponges during surgery. The sponges are permanently affixed with passive RFID tags smaller than a dime.

“Unlike other technologies, ClearCount’s RFID-based SmartSponge System allows users to simultaneously count and differentiate between types of sponges. Additionally, since RFID does not require a line of sight between the reader and tags, there is no need to physically separate sponges or orient the tags in any way to scan them. This minimizes the handling of soiled sponges by nursing staff,” said Steve Fleck, the company’s co-founder and chief technology officer.

Current procedures for tracking instruments and sponges involve a baseline count before surgery begins, a second count before the surgeon begins sewing the incision, a third count at wound closure and a final count before closing the skin. This manual process is time-consuming and subject to human error. When there is a discrepancy in the counts, at most hospitals, an X-ray is required before leaving the OR. Additionally, many hospitals call for X-rays for high-risk cases such as emergencies, transplants and surgeries greater than five hours in order to assure no retained objects.

“A retained sponge incident can lead to serious complications, including sepsis, unnecessary X-rays, need for repeat surgeries and even death,” Gandhi said. “The economic benefit is clear — the SmartSponge System advances operating room safety and reduces hospital and surgeon liability.”

The company said the FDA clearance is another milestone for ClearCount Medical Solutions, which supported a study titled “Initial Clinical Evaluation of a Handheld Device for Detecting Retained Surgical Gauze Sponges Using Radiofrequency Identification Technology.” The study was published in the medical journal Archives of Surgery in 2006.

Alex Macario, MD, professor of anesthesia at the Stanford University School of Medicine (Stanford, California) and lead author of the study, said that although procedures are in place to track objects during surgery, errors do do occur.

“This risk significantly increases in emergencies, with unplanned changes in procedure and with patients that have a higher body-mass index,” Macario said.

According to another study in Massachusetts, foreign objects were left in the body in one out of every 10,000 surgeries, the company noted. Those objects added four days to an average hospital stay and resulted in 57 deaths in 2000. Two-thirds of all objects left in the body cavity were surgical sponges.

Gandhi also said the SmartSponge is a stand-alone system that does not require any integration with existing operating room equipment.

ClearCount said it expects to make available a commercial solution that fully integrates into the current workflow of the operating room by the end of this year.