In the near future, an alarm sounding outside the operating room door may have surgeons reaching for their pens. That's because a new device has been designed to alert the surgical team if a patient's incision site hasn't been marked.
Invented by a physician at Washington University School of Medicine in St. Louis, the device—a wristband that enforces surgical-site marking—should help eliminate wrong-site surgeries.
About 4,000 wrong-site surgeries take place in the United States each year—that's about one in 17,000 surgeries—and are the fifth most frequent life-threatening medical error.
CheckSite bracelets are designed to prevent wrong-site surgeries.
Using a marker pen on the patient's skin to indicate the surgical site has become common practice in hospitals across the country. Barnes-Jewish Hospital, the primary adult teaching hospital for the School of Medicine, began requiring the practice three years ago. On July 1, 2004, the Joint Commission on Accreditation of Healthcare Organizations adopted a set of formal guidelines that establish marking surgical sites as a nationwide policy.
"Even with the policy in place, wrong-site errors still do occur, and that's almost always because the surgical site hasn't been marked," says inventor Richard A. Chole, M.D., Ph.D., the Lindburg Professor and Head of the Department of Otolaryngology and professor of molecular biology and pharmacology. "Wrong-site errors stem from a breakdown in communication among the preop staff, the operating room staff, and the patient or the patient's family, and the device will help correct that."
Chole's invention consists of a wristband embedded with a miniature, disposable electronic device—like the anti-theft chips attached to consumer items—plus a marker pen with a specialized sticker that deactivates the chip. When the surgeon or another designated staff member marks the patient's surgical site, in consultation with the patient or the patient's family, he or she removes the sticker from the pen and places it on the patient's wristband to deactivate the chip.
If these steps aren't followed, the wristband will set off a detector placed in the hallway between the preoperative area and the operating suite. The detector can be set up to give a visual or auditory signal and to page hospital personnel.
"It's a simple way to remind surgeons to mark the site," says Chole, a Washington University ear specialist at Barnes-Jewish Hospital. "The band and pen are very simple to use and just add the small extra step of placing the deactivation sticker on the wristband."
"The system makes everyone more aware, and the wristband is a good way to get the patient engaged with the process, too," says Edna Woods, R.N., Surgical Services Administrator at the Center for Advanced Medicine.
A St. Louis-based company called CheckSite Medical (CheckSiteMedical.com) has been formed to develop and distribute the technology. Headed by Stephen Chole, the company conducted a successful trial of the technology at the Center for Advanced Medicine at the School of Medicine and will soon place monitors outside of all of the surgical suites in Barnes-Jewish Hospital.
"The system worked very well in our trial," Woods says. "We're eager to implement it throughout the hospital. We want to do everything we can to ensure patient safety."
CheckSite plans to distribute the technology nationwide and is performing pilot trials in other regional hospitals. According to Richard Chole, the technology will be inexpensive, costing around $2.50 for the wristband and pen and $7-8,000 for installation of the detectors.
Washington University will hold the patent on the invention. "The University's Office of Technology Management was extremely helpful getting the technology off the ground," Richard Chole says. "I went to them with my idea and they handled the entire patent process."
Richard Chole is founder and co-owner of CheckSite Medical.
Washington University School of Medicine's full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.