AEM improves patient safety, reduces liability

Risk of stray electrosurgical burns decreases

The number of laparoscopic malpractice claims filed between 1995 and 1999 totaled 1,426, almost double the number filed between 1990 and 1994, according to the Laparoscopic Injury Study published by the Physicians Insurers Association of America in Rockville, MD. The total award amounts in laparoscopy cases also increased dramatically from $42.3 million for 1990 to 1994 to more than $104 million between 1995 and 1999.

The increasing amount of malpractice claim awards and the anticipated increase of laparoscopic procedures to more than 3 million in the year 2010,1 are good reasons to reduce as much risk as possible in your same-day surgery program now, says Kay Ball, RN, MSA, CNOR, FAAN, perioperative consultant and educator in Lewis Center, OH. "The best way to protect your patients from injury and your same-day surgery program from malpractice suits is the implementation of active electrode monitoring [AEM]," Ball emphasizes.

Many laparoscopic injuries are caused by burns from stray electrosurgical current, she says. "The limited view of the surgeon in laparoscopic procedures prevents him or her from seeing the injury if it occurs outside the surgical field," Ball adds.

She says there are three categories of thermal injuries that occur during laparoscopic surgery:

Direct coupling. Also referred to as "pilot error," direct coupling occurs when the active electrode touches or arcs to another metal instrument, Ball says. The electricity subsequently travels through the second instrument, and it can burn tissue that is touching the instrument.

Capacitive coupling. Stray electrical current can travel through the insulation of an active electrode to any surrounding conductor such as a metal trocar sheath or even blood in the surgical field, she explains.

Insulation failure. Even if you scan your equipment after re-processing, you can miss a microscopic crack, Ball says. Also, the insulation might not be cracked but can have a weak spot that can be blown open with the increased voltage during surgery. If you are not monitoring the equipment during surgery, you’ll never know about the potential patient injury, she adds.

AEM was introduced in 1996 by Boulder, CO-based Encision (then known as ElectroScope), but the initial instruments utilized a 7 mm port when most surgeons were using 5 mm or 10 mm ports, says Vangie Dennis, RN, CNOR, advance technology coordinator at Promina Gwinnett Health System in Lawrenceville, GA. "About three years ago, Encision reproduced every laparoscopic instrument that is commonly used, so we opted to switch completely to [AEM]," Dennis says. Because the instruments were identical to those they had been using, the change was transparent to the surgeons, she adds.

AEM removes the risk of capacitive coupling and insulation failure during surgery because the shielded and monitored instruments are continuously directing stray energy away from the patient via a protective shield, Dennis says. If insulation failure occurs or energy readings reach dangerous levels, the electrosurgical unit automatically shuts down, she explains.

Dennis’ facility made the switch to AEM after a committee composed of clinical and financial staff members evaluated three options to protect patients from thermal burns. Visual inspection of instruments before and after surgery as well as utilization of an insulation-testing device before and after each procedure were two options that were dismissed, she says.

Visual inspection won’t catch microscopic cracks that actually can be the most dangerous since they will concentrate energy on one area, she explains. Scanning the insulation after a procedure will discover a hole created during surgery, but the patient may already have been injured, Dennis adds.

Cost was not a significant issue because the AEM instruments do not cost significantly more, and they are sturdier, she points out. "We also decided that our risk for a costly medical malpractice suit was higher if we did not take advantage of a technology that can increase patient safety," Dennis says.

The cost of injuries due to stray electrical burns easily can reach $2 million, according to reports from the Laparoscopic Litigation Group of the Association of Trial Lawyers of America in Washington, DC, says Janet A. Lewis, RN, MA, CNOR, administrative director of surgical services at Integris Baptist Medical Center in Oklahoma City. Because the benefits of AEM technology are known and recommended for use by professional organizations,2,3 same-day surgery programs can be responsible for punitive awards because they had knowledge of safety concerns related to electrosurgical injuries but did nothing to protect the patient, she adds.

Her facility switched to all AEM instruments after surgeons and the hospital’s patient safety committee endorsed the change, Lewis says. Staff concerns about the switch involved modification of connections and interactions with trocars, but all of these issues were addressed through education and refinements that Encision is making, she adds.

More than 200 facilities have converted to AEM, says Jim Bowman, president and chief executive officer of Encision. That number will continue to increase since the range of AEM instruments now makes it easy to implement with no impact on the surgeon’s ability to perform procedures, he adds.

Injuries from stray electrosurgical injury include bowel perforation or a burn that can lead to bowel perforation, Dennis says. Other complications can include organ damage and vessel hemorrhage, she says. The real danger of these injuries is that they aren’t identified at the time of surgery and the delay can result in serious infections, she explains.

Dennis says that conversion to AEM made sense for her high-volume facility. It is a matter of good judgment and risk management, she explains. "We did not want to wait until someone was injured before we implemented AEM."

References

1. Medical Data International. US Markets for Endo-Laparoscopic Surgery Products. Santa Ana, CA; 1999.

2. Association of periOperative Registered Nurses. Stand-ards, Recommended Practices, and Guidelines. Denver; 2001.

3. Brill AI, Feste JR, Hamilton TL, et al. Patient safety during laparoscopic monopolar electrosurgery — principles and guidelines. Journal of the Society of Laparoendoscopic Surgery 1998; 2:221-225.

Sources

For more information about active electrode monitoring, contact:

Kay Ball, RN, MSA, CNOR, FAAN, Perioperative Consultant/Educator, 6743 S. Old State Road, Lewis Center, OH 43034-9227. Telephone: (740) 548-4972. Fax: (740) 548-6894. E-mail: KayBall@aol.com.

Janet A. Lewis, RN, MA, CNOR, Administrative Director of Surgical Services, Integris Baptist Medical Center, 3300 Northwest Expressway, Oklahoma City, OK 73112-4481. Telephone: (405) 949-3226. E-mail: janet.lewis@integris-health.com.

Vangie Dennis, RN, Advanced Technology Coordinator, 1000 Medical Center Blvd., Lawrenceville, GA 30045. Telephone: (678) 442-4188. Fax: (678) 442-2936. E-mail: Vdennis@promina.org.

For information about active electrode monitoring equipment, contact: Encision, 4848 Sterling Drive, Boulder, CO 80301. Telephone: (303) 444-2600. Fax: (303) 444-2693. E-mail: info@encision.com. Web: www.encision.com.