The reports are eye-opening. A patient requiring a leg amputation wakes up from surgery to find that the wrong limb was severed. A hysterectomy patient discovers a blood-soaked sponge was left inside her during the procedure. A non-cancer patient has a radical mastectomy after another patient’s X-rays are mistakenly placed in her medical records.

For surgeons who believe such errors are few and far between and could never happen to them, the statistics suggest otherwise. As recently as 2003, the Joint Commission on Accreditation of Healthcare Organizations was receiving five to eight new reports of surgical errors each month from facilities that provide surgical services, and because such occurrences are almost all voluntarily reported, some are concerned that many more cases may be going unreported.

"Surgical errors are certainly a concern," said Rick Croteau, executive director for patient safety initiatives, JCAHO. "They can happen and they do happen, even to some of the most skilled [surgeons]."

Such mistakes take on many shapes. They can be as obvious as performing the wrong surgical procedure, operating on the wrong body part and even the wrong patient, leaving surgical instruments within the patient’s body or perforating organs with a surgical instrument. They can also stem from inadequate pre- or post-operative care, including prolonged or delayed surgery, or the use of contaminated instruments.

Statistics show that wrong site surgeries account for the lion’s share of surgical errors and are most prevalent in orthopedic, podiatric, general, neurologic and urologic procedures. The JCAHO revealed that 76 percent of reported cases involved surgery on the wrong body part or site, while 13 percent represented wrong patient surgery and 11 percent involved wrong surgical procedures.

"With wrong site surgeries, specifically, we were surprised by the number of sentinel events that were being reported to us," added Croteau. Those incidents led to one of the first sentinel alerts ever issued by the agency. Since that 1998 alert, the JCAHO continued to see more incidents being reported – a development that Croteau credited, at least in part, to the growing attention being given to the problem.

The heightened emphasis surrounding medical and surgical errors, including the highly publicized 1999 report by the Institute of Medicine, has also made patients more aware of the risks – and as a result, many indicate they are concerned about their own outcomes. A 2004 Harris Interactive poll of 2,847 U.S. adults revealed that 55 percent were concerned about hospital-based surgical errors. Thirty-nine percent were "extremely concerned" and 16 percent noted they were "very concerned."

"Public concern about medical, surgical and diagnostic errors is high, and many have doubts about the ability of our medical institutions to prevent these types of errors," noted Katherine Binns, senior vice president of healthcare at Harris Interactive.

Knowledge is power

Despite the risks and concerns, the good news is surgeons and their staff have a bevy of tools at their disposal to help them reduce the likelihood of surgical errors.

The recommendations in the JCAHO’s sentinel event alerts have been incorporated into the agency’s national patient safety goals, and as of July 2004, all Joint Commission accredited organizations must comply with its "Universal Protocol for Preventing Wrong Site, Wrong Procedures, Wrong Person Surgery." The protocol, endorsed by 51 organizations, draws upon, expands and integrates a series of existing requirements under the 2003 and 2004 National Patient Safety Goals, and applies to all operative and other invasive procedures. Its core components include the preoperative verification process; marking of the operative site; taking a "time out" immediately before starting the procedure; and adapting the requirements to non-operating room settings, including procedures performed at the bedside.

Surgical error incidences, however alarming, have helped highlight shortcomings in the operating room that contribute to the events. Sources agree that communication breakdown and cultural challenges – including intimidation by surgeons – are at the root of most surgical errors.

"Communication falls under the O.R. culture component, and it’s critical for reducing surgical errors," stressed Faith Schaffer, director of perioperative services, Deaconness Billings Clinic in Billings, MT. "It can’t be just about the surgeon. The staff needs to feel that they are a contributing member of the team."

Schaffer is the first to admit that wasn’t always the case at her facility. A VHA survey that targeted how surgical staff viewed their role on the team was a real eye-opener. "It was surprising to see the difference in staff’s perspective versus the surgeons’," she explained, adding that surgeons viewed a successful team as one that did as the surgeon told them, while the staff viewed success in terms of team contribution. "Our shortcomings were that the staff didn’t feel as though they were truly a contributing member. The survey results made us aware of the changes that needed to take place. We knew that would involve changing culture, and we knew that wouldn’t be easy."

Deaconness Billings Clinic took on the challenge by becoming one of 16 organizations (19 hospitals total) to pilot a new VHA program to improve patient safety in the O.R. The program, entitled "Transformation of the Operating Room", is the first to acknowledge O.R. culture and aims to realign the power structure in the surgical suite so physicians and staff can work as an effective interdepartmental team. Hospital executives and finance staff are also involved.

"VHA’s [TOR program] will help hospitals make systemic, smart changes clinically, operationally and culturally," noted Peter Plantes, M.D., vice president of VHA Inc. "Until hospitals implement the steps necessary for change, they will continue to lose patients’ lives and millions of dollars."

Since implementing the program, Schaffer said the majority of surgeons have risen to the occasion. In fact, some surgeons – and even executives – are eagerly embracing the cultural transformation in the O.R. "The cultural component of the program is definitely the most difficult. But it’s also the most important because without it, the other components (which address clinical and financial issues) won’t fall into place."

The fact that the TOR is data-driven has helped make surgeons more aware of necessary changes. According to Kathy Irvin, director of surgical services programs for VHA, the two surgeons who were part of the initial TOR task force became sold on the program – including the cultural component – when they saw the first round of survey data in September. "Now they’re championing it." She added that the data generated by the TOR will enable facilities to benchmark against others, as well as themselves.

JCAHO’s Croteau said he’s impressed by the VHA program because it is taking the agency’s Universal Protocol requirements to the next level. "Our protocol outlines what to do to prevent surgical errors, but there aren’t a lot of specifics," he explained, noting that the JCAHO requirements are designed to be tailored to facilities’ unique settings. "Programs like the VHA’s are terrific because they can help with protocol development."

Patient safety initiatives such as the JCAHO’s Universal Protocol and the VHA’s TOR may also go a long way toward easing the community’s concerns. In fact, the survey conducted by Harris Interactive found that most adults are confident that initiatives to help prevent surgical errors will prove effective in advancing patient safety.

New products make the cut

Facilities seeking yet another layer of protection against certain types of surgical errors don’t have to look far. Numerous vendors have entered the market with products aimed at preventing errors, wrong-site surgery and mistakes stemming from inaccurate or inadequate patient information.

A "smart" wristband that enforces surgical site marking is one example. Invented by Richard Chole, M.D., Ph.D., a physician at Washington School of Medicine in St. Louis, the CheckSite technology consists of a wristband embedded with a miniature, disposable electronic device, along with 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 sets off a detector, which can be set up to give a visual or auditory signal, and to page hospital personnel.

"This is the only hardwired system that reminds surgeons to mark the site," explained Tim Chole, executive vice president of sales and marketing for CheckSite Medical, and son of the product’s inventor.

The system, which has been on the market since September 2005, is already up and running at Barnes-Jewish Hospital in St. Louis, and according to Chole, since CheckSite was implemented, there have been no wrong site surgeries and no near misses. Chole said the cost of the CheckSite system isn’t prohibitive, either. Although there are some initial installation expenses, the costs are minimal because the wristband replaces the traditional patient I.D. bracelet and the pen replaces facilities’ current markers. "The incremental cost per patient is only about $2.50."

Other "smart" technology is also making headway in the surgical error prevention segment. The SurgiChip, for example, is the first RFID product approved for marking an anatomical surgical site. The system embeds and prints information on an RFID smart label that travels with the patient into surgery to help prevent errors. The patient’s name and surgery site are printed on the SurgiChip tag, along with the types of surgery, date of surgery and the surgeon’s name. The information is placed in the patient’s file and is verified by the patient immediately prior to sedation. The chip is then applied near the location where the incision will be made. Once in the O.R., a handheld reader is used to confirm the information and to ensure that the label matches the patient’s chart and ID wristband.

Fully implantable RFID chips are also being used, although to a lesser degree. The VeriChip implantable RFID microchip – which is implanted in the right arm– links a patient to their medical history and helps provide caregivers with vital information that can help prevent medical errors. Although it is not marketed specifically for surgical error prevention, it could prove beneficial in that arena, according to John Procter, a spokesman for VeriChip Corp., Delray Beach, FL. "If an unidentified patient has the chip implemented and then enters the hospital in an unconscious or unresponsive state, it can give healthcare workers valuable information that can help them best manage that individual."

Procter predicts implantable RFID chips will be the wave of the future. "I think there will come a time where they are viewed much the same as other implantable medical devices, such as pacemakers or stents."

There are also adhesive labels on the market, which are designed to mark the site. While they can be useful, Croteau stressed that facilities should use them only in conjunction with marking directly on the skin with a pen. He also urged facilities not to mark non-operative sites, "because that can increase confusion and actually lead to errors."

While products aimed at reducing surgical errors can certainly prove valuable to O.R. staff, sources agreed that they should be viewed as an adjunct to a comprehensive error prevention strategy.