Today's technology-laden operating rooms rely on the centuries-old practice of nurses visually counting instruments and surgical sponges — what goes in should come out.
Studies indicate, however, that one in every 1,000 to 1,500 abdominal surgeries results in a sponge being left behind. A sponge mistakenly sewn into a patient can lead to serious complications, such as a bloodstream infection, unnecessary X-rays to find the missing gauze, a need for repeat surgery and even death.
A five-year-old, Ross-based company has developed a no-sponge-left-behind system.
ClearCount Medical Solutions Inc.'s SmartSponge brings sponge-counting into the 21st century through the use of RFI — radio frequency identification chips that are imbedded in each sponge.
"Our device automates a manual, error-prone process," said David Palmer, ClearCount's CEO.
SmartSponge goes beyond eliminating potential sponge-counting errors. With its circular SmartWand, the system also detects sponges accidentally left inside a patient and left anywhere inside an operating room following a procedure.
The ClearCount system recently was named one of Popular Science magazine's Top 100 technology innovations for 2009.
Even with nurses on average performing five sponge counts per procedure, mistakes do occur, particularly in a trauma situation, experts said. When a gunshot victim is brought to an emergency room, the speed of treatment - not sponge counts — are of the upmost importance.
"The numbers concerning sponges left in surgery patients don't surprise me," said Leo McCafferty, a board-certified plastic and reconstructive surgeon and clinical assistant professor of plastic surgery at the University of Pittsburgh School of Medicine.
"Many times a sponge isn't left in the patient but may find its way into the garbage or be caught in the folds of a gown. Then a nurse has to go through all the garbage while the patient is kept under anesthesia until the missing sponge is found," McCafferty explained.
Using ClearCount's system, nurses scan packages of sponges before an operation. The technology verifies and counts each sponge's internal chip — recording the total in an "In" column on a display monitor.
Used sponges are tossed into an attached SmartBucket with a built-in sensing device, which verifies each chip and tallies the "outs." Ideally, the figures in the two columns match. If not, the number of missing sponges appears in a third column, titled "find" — a signal to use the SmartWand, which digitally locates sponges still inside the patient.
The federal government and private investors agree that ClearCount's system has tremendous potential. Prior to January, when ClearCount began selling the $18,000 SmartSponge system commercially, the company had raised about $8 million in capital.
"We've made five investments totaling $487,000 — we like the product, we like the management, and the investment partners are solid," said John Manzetti, CEO of Pittsburgh Life Sciences Greenhouse, the South Oakland-based, public-private partnership that invests in area companies involved with life-sciences-related products.
Pittsburgh-based venture-capital firm Draper Triangle Ventures first became aware of ClearCount soon after it was founded by Carnegie Mellon University graduates Steve Fleck and Gautam Gandhi in 2004.
"We were sort of monitoring the company from afar and, in early 2008, were reintroduced to what was going on," said Mike Stubler, managing director and co-founder of Draper Triangle and a current ClearCount board member. "Hands-down, this is the best solution in the market."
Draper Triangle is ClearCount's largest shareholder, contributing $3.5 million of $7.5 million in two rounds of financing raised in the last two years.
Memorial Sloan Kettering Cancer Center in New York was ClearCount's first commercial customer. The renowned hospital ordered 21 SmartSponge systems.
Palmer, of ClearCount, said other hospitals have ordered the SmartSponge system, including the VA Pittsburgh Healthcare System in Oakland, which are to be installed.
Revenues in 2010 are projected at well over $1 million.
The company is moving forward with product development, now waiting for Food and Drug Administration approval to market a smaller, less expensive SmartSponge system.
ClearCount was awarded a $1.1 million Small Business Innovation Research grant through the National Institutes of Health in early 2006 to support development and testing of a surgical-instrumentation tracking system.
Palmer said that product is about 18 months away from marketing.
