WORKING TO COUNTER THE RISKS OF LAPAROSCOPIC SURGERY
March 2005
By CHRISTINE KORTALS
Laparoscopic surgery is a common surgery used for a variety of conditions in women. It is used for nearly 80% of gynecological applications, ranging from hysterectomies to ectopic pregnancies. It is also popular and cost effective for gall bladder removals and hernia applications.
According to an August 2000 Laparoscopic Injury Study published by the Physician Insurers Association of America (PIAA): "Females made up the majority of claimants accounting for eighty-one percent of all claimants. The majority of female claimants were under the age of 50, with more than one-third in the 30-39 age group."
Enter Encision Inc., a local corporation fast becoming a national treasure of technology in the field of laparoscopic surgery.
Encision Inc., based in Gunbarrel, has developed and patented surgical technology solutions to counter the risks of injury still inherent in even minimally invasive surgery.
In laparoscopic surgery, a patient's abdominal cavity is distended by carbon dioxide and instruments are inserted through small ports that measure the diameter of pencils or drinking straws.
Tiny cameras are also inserted into the abdominal cavity through these ports, allowing surgeons to monitor their maneuvers via television screen. This minimally invasive surgery makes incisions and recovery time less painful, speeds regaining of ambulatory independence, and is significantly less costly than conventional surgery.
Electrosurgical instrument tips, charged up to 700 degrees Celsius (1,292 degrees Fahrenheit), are invaluable to seal off bleeding, and they greatly improve physician dexterity in removing tumors.
At 60% saline, our own bodyweight conducts electricity effectively enough to naturally facilitate such electrotreatments; however, unfocused electrical leaks can be disastrous for the same reason.
These electrical leaks and burns are some of the unfortunate side affects that can come when a person undergoes laparoscopic surgery. Often occurring outside the surgeon's keyhole view, electrosurgical equipment failures account for 5.4% of all injuries associated with the 4.4 million laparoscopic surgeries performed annually in this country.
Moreover, doctors intent on working the ends of their instruments to complete laparoscopic procedures fail to diagnose at least 67% of internal burn injuries at the time of surgery.
In the days following, symptoms of internal tissue burns or organ damage may manifest as severe abdominal pain, often accompanied by fever. Postoperative complications from stray electrosurgical currents may, and already have in several documented cases, progress to peritonitis, sepsis and even untimely death.
Active Electrode Monitoring (AEM) is a full, patented product line of laparoscopic surgery instruments developed by Encision, featuring innovative design enhancements to prevent patient injury caused by stray electrosurgical burns. Developed by former Valleylab engineer, Roger Odell, this technology has been the foundation of Encision's market position since 1990.
"I've been doing medical demonstrations for over 30 years," says Odell, now CEO and VP of Business Development. "Despite physicians' best skills, and despite the most modern hospital standards, undetected flaws or perforations in either the insulation or the capacitive coupling of surgical instruments can cause stray electrosurgical burns to non-targeted tissue," Odell explains.
AEM technology works like a grounded circuit breaker for electrical surgical generators. First, electrons in AEM laparoscopic instruments are shielded, or contained within rigid insulated coaxial cables. Second, monitoring technology is user-independent, automatically shutting off the generator when stray electrical current is detected. With AEM technology, 100 percent of electrical power is assuredly funneled through surgical rods and instrument heads to be precisely and exclusively delivered where needed.
In addressing electrosurgical safety issues and patient recovery risks, Encision's products have also entered the forefront of medicolegal protection against physician and hospital indemnity. The June 2002 issue of Healthcare Purchasing News published an article titled "Guarding against an unseen killer: Stray electrosurgical burns" (C. Werner).
The article reads, "In a legal sense, the issue became so prevalent that in 1994, the American Trial Lawyers Association formed a laparoscopy group specifically to address the large number of accidents arising from these surgeries. According to statistics from the Society of Laparoendoscopic Surgeons, in 1995 some 13 percent of members who attended that group's annual meeting reported having one or more laparoscopic electrosurgical malpractice cases currently in litigation. The two prime causes of stray electrosurgical burns, said the panelists, are insulation failure and capacitive coupling."
On an average laparoscopic surgery tray of 25 instruments, only three or four are hooked to electrical currents and wires. Coupled with an average instrument replacement rate of every one to three years, converting to AEM-equipped instruments at replacement time is cost-neutral.
Prominent Texas-based Baylor Medical Center has fully converted to Encision's trademark AEM Laparoscopic Instruments; Columbus, OH-based OHIC Insurance Company "strongly recommends" AEM technology to its 30-state hospital clients.
AEM technology is also considered a recommended practice by numerous medical professional organizations, including the Association of periOperative Nurses' "Standards, Recommended Practices and Guidelines," and the Society of American Gastrointestinal Endoscopic Surgeons.
Encision received the Frost and Sullivan Technology Leadership Award in 2003, and is aggressively entering Canadian, Australian and New Zealand markets.
Closer to home, the Longmont Surgery Center has been using Encision's patented AEM technology for six years. Administrator Shirley Torwirt encourages patients to ask questions of their physicians and medical facility officials, to ensure that they are attended by the highest skill sets and best equipment.
Marcia McHaffie, Encision's Controller and Judith King, VP of Risk and Quality Management, feel pride in supporting and contributing to so many life-impacting solutions. Their attention to detail, experience in medical economics, and efficient working relationship allows them to continuously monitor and fine-tune the vital operating statistics of their business.
Although Encision already owns eight patents, the increased outlays were necessary positioning costs in its competitive market. Jack Serino, CEO of Encision since 2004, brings his veteran medical management experience to this timely juncture of market-ready technology and globalized healthcare demands. "Seeing the before-and-after, the very visual results in our environment," McHaffie explains, "we develop a specialized type of process thinking that draws information together, to form synergies."
King agrees, adding her gratification that "we really feel that we are making healthcare safer every day, particularly for women."