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Wrong Site Surgery

Wrong site surgery is the term used to describe a surgical procedure that is performed in error. The procedure may be done on the wrong side of the body (like the left knee instead of the right knee), the wrong patient, or the wrong level or part of the body (like the wrong vertebrae in the spine or the wrong finger of the hand). The incidence of wrong site surgery isn't very common. But when it occurs, it sometimes causes a great deal of media attention, and it can be physically and emotionally devastating for the patient.

Between January 1995 and December 31, 2005, there were 455 cases of wrong-site surgery reported to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In 2001, JCAHO reviewed a database of 150 cases of wrong site surgery. A cause was able to be identified in 126 cases. In 76 percent of cases, patients received surgery on the wrong part or site of the body. For 13 percent, the surgery was performed on the wrong patient. In 11 percent of cases, the patient received the wrong surgical procedure. About 41 percent of wrong site surgeries were related to orthopedic or podiatric surgery, 20 percent were for general surgery, 14 percent for neurosurgery, 11 percent to urologic surgery.

Preventing Wrong Site Surgery

A recent study, published in the April 2006 issue of Archives of Surgery, found wrong site surgery to be a relatively rare problem. The researchers estimate a wrong site error serious enough to warrant a report or trigger a lawsuit occurs about once every five to 10 years in a single, large hospital. However, there are some ways to reduce the risk.

In 2003, JCAHO issued some important guidelines, called "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery." The agency says surgeons and health care workers should ensure they have complete patient information and documentation before the start of surgery. Missing information, questions and discrepancies should be resolved ahead of time. The surgeon should carefully (and correctly) identify the surgical site, verifying the information with the patient. The site should be clearly marked with a pen so it can be confirmed as the correct site prior to the first incision. Surgical staff should also take a "time out" once the patient is in the operating room to make a final verification of the correct patient, correct surgery, correct site, and if appropriate, correct tools or implants to be used during surgery.

The American Academy of Orthopaedic Surgeons asks surgeons to "sign" the operating site with their initials before the patient is taken into the operating room. The "signing" should be done with permanent ink and take place during a preoperative visit. For patients having spinal surgery, the Academy recommends intra-operative X-rays be used to image the problem and verify the correct level of the spine being targeted.

The Smart Wristband

The systems used to prevent wrong-site errors are still dependent upon full participation. Despite the best efforts, checks and verifications may still not be made. So patients can still be vulnerable.

Richard Chole, M.D., Ph.D., Ear, Nose and Throat Specialist at Washington University in Saint Louis, has developed a system that increases patient safety in the operating room. The "CheckSite" system uses the same technology found in anti-theft devices in department stores.

There are four components to CheckSite: a wristband, skin marker, deactivation label and sentry posts (like the posts at the doorway exiting a store). The wristband is similar to the kind now issued to all hospital patients when they are admitted to the hospital. But there's an important difference. The bracelet is embedded with a special microchip.

Sometime prior to surgery, the surgeon or a designated staff member meets with the patient to verify medical information, answer questions and verify the correct site of the surgery. The CheckSite marker is used to mark the site with indelible ink. Once the site is marked, a label is peeled off the side of the marker and placed on the patient's wristband. The label deactivates the chip in the wristband.

When the patient is taken for surgery, the bed must pass through the sentry posts mounted in the hallway between the preoperative area and the operating room. If the surgical site has been marked and the label placed on the wristband, the bed will pass quietly through the detection system. But if protocol hasn't been followed (i.e., the site isn't marked and the chip remains activated), a loud alarm or flashing light will warn staff of the need to verify the surgical site.

Humans being what they are, errors can still be made in the operating room but the CheckSite system provides a "smart" way to reduce some of those risks. At Washington University in Saint Louis doctors have been using the system for several months and have found it to be very helpful. Patients are also reassured about the extra steps being taken to ensure their safety in the operating room.

Richard Chole, is the founder and co-owner of CheckSite Medical, the company that produces the smart wristband. The patent for the device is held by Washington University School of Medicine, Office of Technology Management.

For information about the smart wristband, log onto the company's website at http://www.checksitemedical.com.

For general information and tips on preventing wrong-site surgery:
  • American Academy of Orthopaedic Surgeons
  • AORN
  • Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
  • National Patient Safety Foundation
  • North American Spine Society