Fire and smoke still smolder as electrosurgery safety issues - Operating Room

Ever since electrosurgery began in the 1920s, manufacturers have searched for ways to make the technology as safe as possible for the OR team and for the patients they serve. It is a mission that continues today and vendors report significant progress in developing equipment that reduces the risk of fire, burns and smoke.

But as long as incendiary byproducts of electrosurgery exist, watchdog groups like AORN, JCAHO and ECRI will be on guard. Specifically, Oakbrook Terrace, IL-based JCAHO issued a safety advisory in June stating that OR fires are "significantly under-reported" and called for more publicity as a means of raising awareness of the issue.

"While considered rare occurrences, surgical fires are frightening and devastating experiences," the JCAHO bulletin stated. "Of the more than 23 million inpatient surgeries and 27 million outpatient surgeries performed each year, fires break out in surgical suites an estimated 100 times a year, resulting in up to 20 serious injuries and one or two patient deaths, based on data from the FDA and ECRI."

Despite these figures, the Joint Commission's patient safety reporting database has registered just two surgical fires since 1996.

The OR is a combustion-friendly environment, however, containing sources that make up the "fire triangle" of heat, fuel and oxygen. Heat sources, like surgical lasers, electric current and high-intensity fiber optics are in close proximity to flammable garments, volatile gas and alcohol prepping agents.

"The basic elements of a fire are always present during surgery and a misstep in procedure or a momentary lapse of caution can quickly result in a catastrophe," said Mark Bruley, vice president of accident and forensic investigation for ECRI, which is based outside of Philadelphia in Plymouth Meeting, PA. Bruley, a 25-year veteran of OR fire investigations, said electrosurgical and laser equipment is involved in nearly 90 percent of the reported incidents.

"Electrosurgical equipment is an unavoidable ignition source, so this is not surprising," Bruley said.

Ultimately though, it is the responsibility of each surgical team member--the surgeon, the anesthesiologist and the nurses--to pay close attention to their specific side of the fire triangle to avoid danger, JCAHO officials say.

Minimizing burn risk

Patient burns are another major concern regarding electrosurgery. In one instance in early October, a jury in Illinois awarded a patient $19 million stemming from complications resulting from an undiagnosed injury during a 1998 laparoscopic procedure at a suburban Chicago hospital. The hospital was found liable for standard-of-care breaches for its failure to diagnose an inadvertent abdominal tissue injury that led to a stroke and bacterial infection that required nine surgeries in two weeks.

A root cause analysis conducted by the hospital suspected a thermal burn, though an official cause was not determined.

"This case shows the legal exposure hospitals have with regard to patient injury," said Jim Bowman, president of Boulder, CO-based Encision. "It's a well-documented risk with minimally invasive surgery, and our instruments prevent that risk. Among the measures that hospital took was to implement our technology."

Encision's AEM (Active Electrode Monitoring) laparoscopic instruments are designed to give surgeons better control of the electric current--the catalyst for burns--through enhanced monitoring and insulation. A layered shield is referenced to the ground with a circuit-breaker shutoff and hooked into the generator.

"Even the best surgeon can't prevent stray burns," Bowman said. "Capacitive coupling is a natural phenomenon that produces current even if the insulation is intact. It increases the potential for a stray burn outside the surgeon's field of view, unrecognized until an infection runs rampant."

In development for two years, AEM sales have soared by 50 percent in the past year, Bowman said. Although currently available for laparoscopic procedures, Encision is also considering applying the technology to thoracic and cardio-thoracic surgeries.

"Right now about 75 percent of laparoscopic procedures use instruments that are applicable for our product," Bowman said. "We're confident that monitored equipment will become the standard."

Clearing the air

Residual smoke is a longstanding OR issue surrounding electrosurgery. Craig Fernandes, director of acute care marketing for DeRoyal, Powell, TN, sees a certain irony in that regard. "Hospitals are non-smoking facilities, but the OR looks like the San Francisco fog," he said.

Smoke evacuation is an established technology, but in recent years DeRoyal has been touting newer innovations, such as a telescoping cautery pencil called ExtendEVAC that captures surgical smoke at the point of origin. By design, the smoke is caught the instant it is generated during cauterization and drawn through a smoke evacuation channel into 10 feet of flexible tubing. Fumes are removed by using a canister or wail suction with an ultra-low penetration air filter, or with a standalone smoke evacuation system. The company also makes a snap-on sheath for cautery pencils that jettisons smoke in the same fashion.

Precise manipulation of cautery tools is also paramount in minimizing smoke plumes and tissue burns, which is why DeRoyal has high hopes for its Breazeale Fine Touch cautery pencil, due on the market next month. Designed commercially with input from its namesake, Knoxville cosmetic surgeon Ed Breazeale, MD, the bulk of the pencil's weight has been shifted front the rear to the front, as have its control buttons.

"Dr. Breazeale thought it was odd that cautery pencils are weighted toward the back when you have more control at the tip," Fernandes said. "When you grab a pen, you grip it as far forward as possible. If you try to write your name by holding the pen from the back, you'll find there is a loss of control and detail. It's the same principle with the standard cautery pencil. A loss of detail means a broader range of tissue is getting cauterized."

Valleylab addresses the problem with their OptiMumm[TM] smoke evacuation system and the pencil mounted AccuVac[TM] smoke evacuation attachment. They quietly capture and filter surgical smoke to remove odor, particulates, and other potentially hazardous byproducts of electrosurgical procedures.

The ultrasonic alternative

Manufacturers of ultrasonic surgical equipment are pointing to OR safety issues as just one of the reasons why hospitals should adopt their products. Instead of using electricity, the instruments use ultrasonic energy as a cutting and cautery medium. The devices produce mist instead of smoke and don't cause fires or burns.

Still, those benefits are derivative of the technology and weren't the primary motivation behind its development, said Joe Williams, senior product manager fur general surgery at Melville, NY-based Olympus Surgical Products.

"We're not saying electrosurgery is out of control and that things must change," he said. "We looked at ultrasonic technology intuitively and said 'here's another modality that doesn't pass dangerous energy.' Inherently it was safer."

Olympus' SonoSurg ultrasonic system became available in 1998 and was re-launched in 2002. It is designed to coagulate and cut blood vessels that are 3mm and smaller and is applicable for various minimally invasive and open surgeries.

Besides the safety factor, Olympus is also emphasizing the reusability and clinical performance of the SonoSurg system. The SonoSurg scissors can typically be reused at least 20 times and are autoclavable and immersible in standard cleaning solvents.

The key to clinical efficacy is the frequency modulation,said marketingmanager Stacey Persky.

"Most people think bigger is better, but in this case the opposite is true," she said. "The smaller the frequency, the larger the wavelength, which is what drives the power. "Since the wavelength is larger, it maintains maximum power over the entire probe instead of just a portion of it."

So far, sales of ultrasonic equipment have exceeded Olympus' expectations. And while company officials say they don't foresee the technology displacing traditional electrosurgery entirely, they contend it will become the medium of choice for a host of procedures.

Devising diverse devices

Like every other medical market, manufacturers of electrosurgical equipment are constantly seeking ways to create and modify products that provide fiscal value along with clinical efficacy and safety assurances. McGaw Park, IL-based V. Mueller has taken this approach with its new Top Cut electrosurgical scissors, which feature a reusable handle and single-use blades. Limiting disposability to the blade means surgeons have optimum sharpness and sterility for each procedure while economically reusing the handle and shaft of the scissors, said Edgar Allen, V. Mueller's senior marketing manager.

"Because you're not reprocessing the blade, it cuts the risk of infection and there are no sharpening costs," he said. "Countless times we hear from customers who say that they need products to perform at the optimum consistently, and this does."

Allen stopped short of calling Top Cut a new breed of instrument, but said all indications are that hybrid reusable-disposable products are the wave of the future.

"What's most important is VOC--the voice of the customer," he said. "If they demand more products like this, that's the direction we'll go. Surgeries are becoming predominantly minimally invasive and we intend to develop products for that market that will take it to the next level."

Fire safety training guides

Even though the use of ignition-resistant materials and nonflammable anesthetics has increased, the Association of periOperative Registered Nurses says that fire danger persists in the surgical suite. The AORN's 20-minute video "Fire Safety in the Perioperative Setting" strives to increase awareness of OR fire prevention and how to respond if a fire should occur. The video and accompanying study guide identifies potential fire hazards and methods to eliminate them. Copies are available for $85 (AORN members) and $170 (non-members). To order, contact Cine-Med at 800-633-0004.

Another resource is an article based on the report "A Clinician's Guide to Surgical Fires," which ran in the October 2003 issue of the ECRI journal Risk Management Reporter. The article offers insight into surgical fire risks, why and how fires start and how staff should best respond. Case studies of fires investigated by ECRI are included, along with tips on how the fires could have been prevented. To purchase the issue, priced at $60, contact Sharon Murphy 610-825-6000, ext, 5145, by fax at 610-834-1275, or by e-mail at smurphy@ecri.org.

A few electrosurgical safety tips

Surgical fire experts recommend the following actions for using electrosurgical tools safely:

* Use the lowest possible electrosurgical unit power settings as appropriate for the surgery, as well as the lowest possible oxygen supply that will maintain adequate saturation for the patient. Reducing the level of oxygen in the surgical environment under the drapes during electrosurgery is extremely important to decrease the risk of sparking and nearby fuel ignition in the oxidizer---enriched atmosphere.

* Activate electrosurgical and cautery units only when the tip is in view and always place the ECU active electrodes in a safety holster when not in active use.

* If using a holster is inconvenient or awkward, place the electrode away from the patient and surgical drapes on an instrument tray or Mayo stand. If this is not possible, disconnect the active electrode cable.

* Adhere to the recommendations for the life expectancy of the cord.

Sources: ECRI, NYPORTS

New York OR Fires

The New York Patient Occurrence and Tracking System reports that
of the thousands of surgeries performed in the state over the
past five years, electrosurgical tools have been linked to 95
occurences. Following is a breakdown of incidents:

                 Service             Number of
                                     Occurences

General          Injury requiring    10
Surgery          repair

                 Equipment
                 malfunctions with   7
                 or without injury

                 Burn                15

Gynecology       Injury repairing    2
                 repair

                 Equipment           2
                 malfunctions with
                 or without injury

                 Burns               9

Orthopedics      Inquiry requiring   1
                 repair

                 Equipment           1
                 malfunctions with
                 or without injury

Otolaryngology   Inquiry requiring   1
                 repair

                 Equipment           3
                 malfunctions with
                 or without injury

                 Burns               7

                 Total               Procedure
                 Patients

General          31                  Laparoscopic
Surgery                              cholecystectomy
                                     6 occurences

Gynecology       11                  Total abdominal
                                     hysterectomy
                                     3 occurences

                                     Vaginal
                                     hysterectomy
                                     2 occurences

Orthopedics      11                  Revision of hip
                                     replacement
                                     3 occurences

                                     Revision of
                                     arthroplasty
                                     of shoulder
                                     3 occurences

Otolaryngology   8                   Tonsillectomy/
                                     adenoidectomy
                                     4 occurences

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