The chief questions that you have to address in dealing with laparoscopic electrosurgery safety are who's at risk of being burned and how significant that risk is.

The answer to the former is your patients. And to the latter: very significant. Every time a surgeon steps on the monopolar foot pedal during laparoscopy, the possibility of a potentially fatal stray electrosurgical burn exists. Further, surgical facilities themselves may be at significant risk of being burned - albeit in a different sense.

The laparoscopic surgery subgroup of the Association of Trial Lawyers was founded in 1994 on a belief that laparoscopy is an area ripe for liability claims. In 1995, Tony Tsarouhas, Esq., a founding member, said that the group had 'identified stray electrosurgery current during laparoscopy as a promising basis' for malpractice cases.

Despite these two powerfully motivating factors - patient safety and practitioner and facility liability - only about one in 20 U.S. hospitals is taking advantage of the fail-safe technology that exists to eliminate the possibility of such burns, according to an industry source.

When sparks fly
Two phenomena can let electrical current come in contact with non-target tissue during electrosurgery and result in potentially fatal burns.

The first is insulation failure. Manufacturers of conventional instruments warn that when insulation fails, it poses a serious threat to patients. Surgical facilities, they say, must be careful to inspect and maintain their instruments. But this puts biomedical engineers and surgeons in an untenable position.

For one thing, insulation defects can be so small that they're invisible to the naked eye. And the smaller the insulation defect, the more dangerous it is. Microscopic insulation defects can concentrate the current density transferred to nearby non-target tissue, increasing the chance of a severe internal burn.

In a 2004 study of 1,438 conventional laparoscopic instruments at 33 hospitals, 18 percent of devices were found to have insulation flaws. Of those, 58 percent had flaws in areas outside the field of view during surgical procedures. The study also noted that 57 percent of the flawed instruments had failures that weren't visible to the naked eye.

A device such as Insulscan, a wand that is passed over a laparoscopic instrument before and after surgery to detect insulation failure, can detect insulation defects that are invisible to the naked eye, but it does nothing to prevent insulation failure from occurring during surgery.

Nor does it mitigate the second culprit, which is capacitive coupling, an electrical phenomenon that comes about via the mixing of reusable and disposable instruments and can allow current to pass through intact insulation, resulting in stray current that produces tissue burns.

Unseen and potentially unrecognized
The Journal of the Society of Laparoendoscopic Surgery identifies several potential complications that can result from stray electrosurgical burns - among them 'vessel hemorrhage, and organ damage, perforation and peritonitis.'

But unlike external skin burns at the site of the patient return electrode, which are usually recognized immediately, stray electrosurgical burns can occur outside the view of the laparoscope and unbeknownst to surgeons. As a result, surgeons can neither intervene to prevent such injuries nor treat them.

When patients who've suffered stray electrosurgical burns are home within 24 hours, it may be several days before those patients perceive clinically significant symptoms and return to their physicians, as tissue with a thermal injury usually presents 48 hours to 72 hours post-op. Further complicating the situation is the fact that these patients often present with what seem to be relatively normal post-operative symptoms, such as low-grade fever, abdominal pain and moderately elevated white blood count.

Moreover, secondary infections can compromise injured areas, making the identification of the primary cause difficult to diagnose. As a result, you may erroneously attribute symptoms to other phenomena, such as instrument laceration.

The most feared complication of a stray electrosurgical burn is bowel perforation that results in leakage of the intestinal contents into the peritoneal cavity, resulting in fecal peritonitis or other conditions. Bowel injury and resulting complications account for most of the fatalities associated with laparoscopic procedures. Even with modern antibiotics, the mortality rate from peritonitis is approximately 25 percent, according to ECRI, a non-profit medical device research and testing agency.

Burned patients who survive are likely to endure physical pain and suffering, prolonged recoveries, extensive follow-up treatments and corrective surgeries that significantly affect their abilities and quality of life.

A seamless solution
At Gwinnett Health System in Lawrenceville, Ga., where I'm the advanced technology coordinator, we've not only eliminated the possibility of stray electrosurgical burns due to insulation failure and capacitive coupling, but we've done so in a cost-neutral way.

The only fail-safe method for preventing stray electrosurgical burns is active electrode monitoring, a system developed by Encision, Inc. With AEM, instruments are continuously shielded and monitored, directing stray energy away from patients. If insulation failure occurs or capacitively coupled energy reaches dangerous levels, the electrosurgical unit shuts down automatically and the surgical staff is alerted.

Through attrition, we replace laparoscopic instruments yearly. At Gwinnett, we replaced our worn and defective instrumentation with reusable AEM instrumentation, which costs about $1,200 per tray - about the same price as replacing a standard monopolar laparoscopic instrument in a tray - and is compatible with all new electrosurgical units.

In fact, by replacing our worn and defective instrumentation with reusable AEM instrumentation, we've actually reduced our overall cost per procedure.

The transition was also seamless for our surgeons, whose surgical techniques were unaffected. The AEM instruments look and function like the instruments they were already used to using.

Buckle down and buckle up
It may seem odd that such a small percentage of medical centers - only about 5 percent, according to Encision - are taking advantage of a technology that simultaneously reduces patient morbidity and the legal exposure of both physicians and administrators, without raising costs or interrupting routines. But that's the situation in which we find ourselves.

I wonder sometimes if it will take an accident involving a high-profile patient, such as a celebrity, to help make this common-sense practice more prevalent. Just as seatbelts and airbags have become standard equipment in automobiles, I hope to see AEM technology become standard equipment in hospitals and surgery centers - and the sooner, the better.