San Diego Company Offers Solution To Most Common Surgical Mistake
There are more than 35 million surgeries every year in the United States. The vast majority of them happen without a hitch.
But sometimes an object like a surgical sponge is left inside of a patient. These kinds of mistakes can be life threatening for the patient, and expensive for the hospital and surgeons involved.
One thing you can count on during surgery: there will be blood.
Surgeons use super-absorbent towels, called sponges, to mop up blood and other fluids.
Once they’re soaked, the sponges are put in a receptacle.
At the end of the procedure, nurses do a manual count of the sponges to make sure they’re all accounted for. Only then is the patient finally sewn up and sent to the recovery room.
That’s the way it’s supposed to happen, anyway.
But every year in the U.S., an estimated 4,000 sponges or other surgical objects are mistakenly left inside patients’ bodies.
UC San Diego transplant surgeon Tony Perricone said sponges left behind can become a major source of infections.
“’Cause your body’s trying to fight it," Perricone explained. "So it will continually cause an inflammatory condition in the patient and it will continue to worsen, and worst case scenario, it actually causes a complication where maybe it erodes into an important vital structure.
It happened to Nelson Bailey, a judge in Palm Beach County, Florida.
He had two intestinal surgeries at Good Samaritan Medical Center in West Palm Beach in 2009.
For months afterwards, he was in pain. It kept getting worse. He had numerous X-rays and CAT scans.
Finally, doctors identified the problem: the surgeon had left a 12-by-12-inch sponge wrapped around Bailey’s intestines.
Bailey went to another hospital to get it removed.
"The surgeon who did the operation there told me when he opened me up, it smelled like a sewage plant," the judge recalled. "There was infection in there. And I was lucky that it hadn’t gone into a stage of being fatal."
A company called RF Surgical Systems, which does its research and development in San Diego, makes a product designed to eliminate these kinds of medical errors.
It’s a surgical sponge that contains a small radio-frequency tag. At the end of a surgery, an electronic wand detects whether any sponges have been left inside a patient.
CEO Kevin Cosens said his system is not meant to replace the manual counting of sponges.
"What our technology is, is an extra level of safety. It’s an adjunct to counting," Cosens explained. "The nurses do a great job in counting. This is a way to sort of validate when there is a miscount, when they miscount, as well as when their counts are correct, ‘cause interestingly enough, most times, when there’s a retained object, is when the counts are falsely correct."
Indeed, one study reveals 62 percent of retained surgical objects were found after the count was mistakenly reported as correct.
The RF tagging system includes the monitors, wand and sponges. The cost? Only $10 per surgery.
San Diego’s Sharp Memorial Hospital performs more than 20,000 surgeries each year.
The director of surgical services, Beverly Self, said her hospital is familiar with the radio-frequency tagged sponges. But she said Sharp has decided to stay with its current system: sponges that contain an X-ray detectible tag.
"At the end of the case, if for any reason we have a sponge that is missing, we will do an X-ray. That is 100 percent, it tells us if the sponge is in, because this is X-ray detectible," Self said.
But it’s not foolproof. Just ask Judge Bailey. The sponges his hospital used were X-ray detectable.
"The count record that they kept showed that all of the sponges that had been placed in me, had been removed," Bailey said. "One of the problems I had in addition to everything else is two different radiologists looked at the follow up X-rays and CAT scans and failed to identify the sponge."
The average cost to settle a case of an object left inside a patient is around $350,000.
Nationwide each year, hospitals and surgeons have to pay out a total of more than $1 billion in claims for these mistakes.
RF Surgical Systems' Cosens said don’t forget the human toll.
"Each one of these statistics has a human face on them," Cosens said, "where they have to go back in and be re-operated on, maybe losing sections of their intestine or maybe losing the ability to have children, having to have hysterectomies."
Cosens said more than 200 hospitals use his system, including UC San Diego and Naval Medical Center San Diego in Balboa Park.
None of them have left a sponge inside a patient.