Figure 2: CAPACITIVE COUPLING

Significant morbidity is associated with stray electrosurgical burns, including physical pain and suffering, a prolonged recovery, extensive follow-up medical treatment, and corrective surgeries that radically affect a patient’s physical abilities and quality of life. The complications of these stray internal burns can put the patient in a life-threatening condition. The most feared complication is bowel perforation, resulting in intestinal content leakage into the peritoneal cavity (i.e., fecal peritonitis). Bowel injury and resulting complications account for most of the fatalities associated with laparoscopic procedures.

THE FINANCIAL RISK TO SURGICAL FACILITIES
Laparoscopy is one of the most common procedures resulting in medical malpractice claims, with 5.4 percent of injuries being traced to the electrosurgical equipment. That adds up to over 237,000 patients per year—enough to fill an average football stadium several times over. This is an unacceptable risk to patient safety. To clearly illustrate that laparoscopy is an area ripe for liability claims, the Association of Trial Lawyers created an entire subgroup dedicated to laparoscopic surgery claims in 1994. Tony Tsarouhas, Esq., a founding member of the Laparoscopic Surgery subgroup of the Association of Trial Lawyers, indicated that the group had “identified stray electrosurgery current during laparoscopy as a promising basis” for malpractice cases.

THE ONLY FAIL-SAFE SOLUTION: AEM TECHNOLOGY
The seriousness of stray electrosurgical burns should convince OR professionals to take a proactive stance in ensuring patient safety during laparoscopic monopolar electrosurgical procedures. Introducing Active Electrode Monitoring (AEM) technology to surgical facilities guarantees the prevention of unintended laparoscopic burns. AEM is a system in which shielded and monitored instruments continuously direct stray energy away from the patient via a protective shield (see Figure 3). In the event insulation failure occurs or capacitively coupled energy reaches dangerous levels, the electrosurgical unit (ESU) shuts down automatically and the surgical staff is alerted. With the AEM system, the patient is NEVER at risk for stray electrosurgical burns due to insulation failure and capacitive coupling.


Figure 3: 5mm shielded and monitored AEM Laparoscopic Instrument

MEDICAL RECOGNITION OF AEM TECHNOLOGY
AEM technology is fail-safe, cost-effective, and does not significantly affect the surgeon’s clinical practice/surgical technique or time in the OR. Additionally, active electrode monitoring has received favorable views from the laparoscopic community. In 1995, ECRI/Health Devices tested the first generation of AEM and stated, “We prefer it over other protective measures because we believe that it is the most effective means currently available of minimizing the potential for patient injuries due to active electrode insulation defects or capacitance.”

A 1998 article appearing in the Journal of the Society of Laparoendoscopic Surgeons stated that, “active electrode monitoring should be strongly considered for all laparoscopic monopolar electrosurgical procedures.”

In a 1995 technical bulletin on electrosurgical safety, the American Association of Gynecologic Laparoscopists suggested their members “consider active electrode monitoring." In 1999, an article appearing in the Journal of Healthcare Risk Management recommended, “the use of active electrode monitoring technology to shield electrosurgical instruments and monitor for stray current,” as a way to, “help reduce electrosurgery injuries.”

In 1999, the Association of periOperative Registered Nurses (AORN) published their Recommended Practices for Endoscopic Minimally Invasive Surgery, stating that the, “use of active electrode monitoring devices minimizes chance insulation failure, direct coupling, and capacitive coupling.”

IMPLEMENTATION OF AEM® TECHNOLOGY
Nationwide, more than 300 hospitals have converted to AEM technology, with the number growing every year. The cost justification for AEM technology is relatively easy. Through attrition, laparoscopic instruments are replaced yearly. Replacing worn and defective instrumentation with reusable AEM instrumentation, in many cases, actually reduces the overall cost per procedure. Use of ARM instruments eliminates the chance of catastrophic patient injury, thereby reducing the hospital’s liability exposure in laparoscopy.

Currently in the marketplace, there is only one company that provides AEM laparoscopic instruments. That company is Encision, Inc., based in Boulder, Colorado. Encision has a full line of 5 mm AEM laparoscopic instruments that are equivalent in function, ergonomics, size, shape, length and tip-styles as conventional instruments, but with advanced safety from the “shielded and monitored” AEM design.

For more information visit their website: www.encision.com.


Physician Insurers of America, Laparoscopic Injury Study (Rockville, Md; Physician Insurers Association of America, 2000).
Perantinides PG et al. The Medicolegal Risks of Thermal Injury During Laparoscopic Monopolar Electrosurgery. The Journal of Healthcare Risk Management. Winter 1998;18(1): 49.

PIAA Laparoscopic Procedure Study. May1994.
Lap electrosurgery targeted by malpractice attorneys. Laparoscopic Surgery Update. August 1995;3(8):87

ECRl/Health Devices. Guidance Article: Evaluation of Electroscope Electroshield System. January 1995; 24(1): 18.

Brill Al et al. Patient Safety During Laparoscopic Monopolar Electrosurgery— Principles and Guidelines. Journal of the Society of Laparoendoscopic Surgery (JSLS). 1998; 2(3): 224.

The American Association of Gynecologic Laparoscopists Technical Bulletin Committee. AAGL Technical Bulletin: Electrosurgical Safety. January 1995;1:6
Perantinides PG et al. The Medicolegal Risks of Thermal Injury During Laparoscopic Monopolar Electrosurgery; Journal of Healthcare Risk Management. AORN. 1999 Standards, Recommended Practices, and Guidelines. (1994; AORN, Denver, CO): 227.