INSIDE THE CURRENT ISSUE

May 2008

Operating Room


 

Outpatient Connection

Dramatic rise in hepatitis C-related deaths in the U.S.

Hepatitis C-related deaths in the United States increased by 123 percent from 1995 through 2004, the most recent year for which data are available. Mortality rates peaked in 2002, then declined slightly overall, while continuing to rise among people 55 to 64 years old. These findings appear in the April issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD).

Hepatitis C virus (HCV) is the most common blood-borne infection in the United States, affecting about 1.3 percent of the population. Up to one-in-five sufferers develop liver cirrhosis, and up to one-in-20 develop liver cancer. HCV is the top reason for liver transplantation, and the 16th leading cause of premature death in the country. Recent evidence has suggested that disease burden and mortality from chronic HCV infection may increase in the coming years, as the number of persons with longstanding infections continues to rise.

To update estimates of trends and demographics of hepatitis C-related mortality in the U.S., a team of researchers led by Matthew Wise of UCLA and including researchers from the CDC and the Los Angeles County Department of Public Health analyzed mortality rates derived from U.S. Census and multiple-cause-of-death data from 1995-2004.

During the study period, HCV-related mortality rates increased from 1.09 deaths per 100,000 persons in 1995 to 2.57 per 100,000 in 2002, before declining slightly to 2.44 per 100,000 in 2004. Average annual increases were smaller during 2000-2004 than 1995-1999. The most dramatic age-specific increases were observed among 45 to 54 year olds who had an increase of 376 percent, and 55 to 64 year olds who had an increase of 188 percent. For the latter group, rates rose for the entire duration of the study. "The highest mortality rates were observed among males, persons aged 45-54 and 55-64 years, Hispanics, non-Hispanic blacks and non-Hispanic Native American/ Alaska Natives," the authors report.

The observed increases likely reflect both true increases in mortality and the growing use of serologic tests for HCV, the authors say. "The relatively young age of persons dying from hepatitis C-related liver disease has made hepatitis C-related disease
a leading infectious cause of years of potential life lost as well as an important cause of premature mortality overall." They point out the ongoing need for measures to prevent progression of liver disease among those infected with HCV, and the need for ongoing analysis of mortality trends.

Fanning the flames of surgical fire prevention

by Susan Cantrell, ELS

Shout "Fire!" and it’s sure to grab the attention of everyone in hearing distance. Maybe the last place you’d want to hear that is as you’re sailing into LaLa Land while a surgeon hovers over you wielding an electrosurgical tool close to your tender parts. It’s a scary—make that terrifying—thought, but unfortunately it does happen.

Possible but not probable

Mark Bruley, vice president, accident and forensic investigation, ECRI Institute, Plymouth Meeting, PA, told Healthcare Purchasing News that fire in the operating room (OR) is one of three "never" events, the other two being wrong-site surgery and leaving an instrument in the patient. Obviously these are things that can be prevented and so should n-e-v-e-r happen to a patient. These are the sorts of incidents for which Medicare will soon discontinue reimbursing.

Fortunately, surgical fires don’t happen as often as you might think. Bruley noted that figures published in September 2007 by the Pennsylvania Patient Safety Reporting System cite the chance of a surgical fire in Pennsylvania as being 1 in 87,646 operations, with an average of 28 per year. Extrapolating those numbers to the entire United States, the number of fires occurring nationally ranges from 550 to 650. That’s not good, but it’s not much when balanced against the 50 million inpatient and outpatient surgeries performed each year nationally. Even better news is that 80% to 90% of the fires are minor, resulting in no injury. In only 10 to 20 cases per year are victims of surgical fires seriously burned or disfigured. That’s seldom enough to deem surgical fires as being rare, claimed Bruley.

Are surgical fires on the rise, or are we just hearing about them more? Roger Odell, co-founder, chairman, and director of Encision Inc, Boulder, CO, believes there really is no way to know the answer. "Only 1% to 2% of complications, including death, are reported to the FDA. The data base is flawed." Melissa K. Fischer, RN, BSN, CNOR, clinical specialist, Megadyne Medical Products, Draper, UT, added: "Statistics do not demonstrate that OR fires are on the rise, but there is more awareness of the problem and better reporting of smaller incidents."

On the rise or not, fire in the OR is definitely getting more attention, according to Bruley. "Increased attention to surgical fires started in 1999 with the release of the Institute of Medicine study on medical errors, ‘To Err Is Human: Building a Safer Health System.’ I think fewer fires are happening now, but they’re getting more attention because it’s more culturally acceptable to talk about medical error now."

Where to turn for help

Encision Inc.’s Active Electrode Monitoring

It seems reasonable to assume that staff are surgical-fire savvy, but often that’s not the case. Bruley pointed out that educating clinical staff on the risk of surgical fire is critical, because it’s not something that’s usually addressed in most surgery or anesthesia residency programs. O’Dell added: "Education amongst all disciplines—anesthesia personnel, perioperative nurses, and surgeons—is needed. Policies, protocols, and procedures must be in place for preventing surgical burns. Energy sources are not the root cause. Oxygen-enriched atmosphere or flammable liquids that are not allowed to dry are two of the most common causes of OR fires."

Fortunately, there are some excellent resources for which to turn for help. The bank of literature on surgical fires is growing, in large part due to ECRI Institute’s efforts. ECRI alone has published over 50 articles on the subject, both in their own monthly journal, Health Devices, and elsewhere. ECRI’s clinical web site, Medical Device Safety Reports (MDSR), is chock full of information on surgical fires. Go to http://www.mdsr.ecri.org, and search for "fire" to investigate articles on various aspects of surgical fires. Bruley also recommends making use of educational aids, such as ECRI’s poster that summarizes how to prevent surgical fires, posting them in places where staff can’t miss seeing them, such as the back door of toilet stalls (but not posting them where the patients can see, because it could cause them undue stress). The poster on preventing surgical fires is available at http://www.mdsr.ecri.org/static/surgical_fire_poster.pdf. While you’re on the MDSR web site, check out ECRI’s Electrosurgical Checklist at http://www.mdsr.ecri.org/summary/detail.aspx?doc_id=8271&q=fire.

Bruley also noted that, "Over the past 2 years, several professional societies, such as the American Society of Anesthesiologists (ASA) and AORN have developed recommendations for preventing surgical fires. ASA’s recently approved "Practice Advisory for the Prevention and Management of Operating Room Fires" is slated for publication within a couple of months in their journal, Anesthesiology.

"AORN has published recommended practices regarding fire prevention, which are very well done, as well as recommended practices for minimally invasive surgery and prevention of laparoscopic burns," said Odell. AORN also offers a Fire Safety Tool Kit, which members can download and earn 4.0 contact hours. Member price is $20.95; nonmember price is $131.95. (Note: Standard and Associate memberships to AORN are $100; so, nonmembers could join AORN, buy the kit at member price, and save $11.00.)

The Fire Triad

The fire triangle relates surgical team members
to components of surgical fires

The operating room (OR) is essentially a formula for fire. The components necessary for creating fire are present in abundance. Fischer believes that "training and awareness of the Fire Triad" can minimize risk. "The three sides of the Triad represent the following: fuel source, heat or ignition source, and oxidizer or oxygen source. These three areas, when brought together, place the patient and room staff at a very high risk for a fire. Each area of the triangle belongs to a specific role in the OR. The fuel source is typically the nurse’s role, as drapes, preps, and dressings are provided to the field by the nurses. The ignition source is frequently the role of the surgeon, who is applying the electrosurgical pencil or laser. The oxidizer, or oxygen source, belongs to the anesthesia provider. By providing training focused toward all members of the surgical team, risk for surgical fires can be greatly reduced if not prevented."

Communication key to prevention

Communication between the players is the key to balancing these components to prevent tragedy. Bruley noted: "Preventive measures almost solely rely on good communication in the OR. Surgeons and anesthesiologists need to understand what the other is doing. The surgeon needs to know how much oxygen the anesthesiologist is delivering to the patient; the anesthesiologist needs to know which instruments are being used that have the potential for fire. Most fires (75%) are caused by oxygen that has built up under the drapes during surgery under local anesthesia," explained Bruley. "This happens because the surgical team has not communicated well."

Bruley suggests following the lead of Christiana Care Health system in Delaware. This facility developed a "time out" for surgical fire, similar to a time out for identifying the patient or counting sponges after surgery. About 20 seconds prior to each surgery is reserved for communication between the surgical team. It’s a time when participants can ask each other about the risks for surgical fire unique to the case coming up.

In case of fire

Breakdown of locations of surgical fires
occurring in and around patients

Fire in the operating room presents dangers specific and unique to the circumstances. The response that’s best in so-called average circumstances may not be the best choice in the event of surgical fire, but one thing is for sure: response had better be quick. Fischer explained the most important thing to know in responding to a surgical fire: "The most important thing is how to respond quickly to a situation. If a flame is not brought under control, the high oxygen content, with the many fuel sources in the OR, will result in an out-of-control situation."

If you have a surgical fire, Bruley believes instinctive reaction by the surgical team is the best response: the anesthesia provider should stop the flow of gas; the surgeon should remove the burning material; and the nurses should extinguish the burning material. Once the fire has been extinguished, attention must be turned to the patient, resuming ventilation but using only air until it’s certain the fire is totally out, then resuming use of oxygen appropriate to the patient’s needs; controlling bleeding; evacuating the patient if in danger from smoke or fire; and examining the patient for injuries. If the fire cannot be controlled quickly, the OR staff and the fire department must be notified. The room should be isolated to contain smoke and fire.

Fortunately, many small surgical fires can be resolved simply by patting them out with a gloved hand or a towel, but it’s important to be prepared for the worst. "Fire drills can help to maintain awareness," advised Bruley. Fire drills require advance planning and should be practiced to determine their effectiveness. Plans should be developed for the different kinds of fires that can occur in an OR and should clearly outline how each staff member should respond; what, when, and how to communicate within the OR, within the OR suite, with the remainder of the facility, and with local authorities; where and how to remove the patient safely; how to prevent spread of smoke; location and operation of fire extinguishers, fire-alarm pull stations, and exits; location, operation, and coverage area of electrical-supply panels; location, operation, and coverage of medical-gas shutoff valves; and what to expect from the local fire fighters.

Additionally, ECRI recommends that carbon dioxide extinguishers—not water-based or dry-powder extinguishers—be mounted just inside the entrance of each OR in the hospital. ECRI discourages use of fire blankets in the OR because they can worsen fire due to oxygen buildup under drapes, causing further injury to the patient, and because the blanket can displace instruments, also causing injury.

Stifling Murphy’s Law

"Risk management’s new buzz words are ‘loss prevention’," noted Odell. Addressing loss prevention, things that can go wrong, can help to thwart Murphy’s Law in the OR. "If less harm is done, you have fewer lawsuits and lower insurance premiums. Industry can help by optimizing instruments through engineering designs that mitigate or eliminate stray energy burns."

An electrosurgical pencil tip modified incorrectly with a red catheter can cause fire and patient injuries because it is petroleum-based.

Encision designed and sells an instrument that automatically shuts off when it detects stray energy due to insulation failure or capacitive coupling. The technology is known as active electrode monitoring. "AORN has recommended use of active electrode monitoring as best practice since 1999," said Odell. "Encision’s ACTIVE ELECTRODE MONITORING system is registered by the FDA to protect patients from unseen stray energy burns during laparoscopic procedures. Intraabdominal burns can result in peritonitis, which carries a death rate of 20%. We have had not even one substantiated report of a burn while our instrument was in use. Our product is warranted to be fail-safe. Non-shielded, non-monitored laparoscopic instruments have an inherent design defect. They’re not fail-safe, and they can kill somebody brand new out of the box."

Recommending use of disposable active cords, Odell noted that insulation failure can be caused when cords that deliver energy are placed in an autoclave several times a day at 270oF. He also noted that, when not in use, active electrodes should be placed in a sterile, insulated holster. Most importantly, said Odell, "Always use recommended electrosurgical practices. ECRI and AORN have covered the entire waterfront."

Fischer explained how Megadyne’s products are designed to reduce risk of surgical fire. "Electrosurgical generators and accessories are the number one heat source for OR fires; so, Megadyne takes product safety and education seriously. Our generator has a clear tone alerting staff members when the pencil has been activated. Some fires have occurred when the pencil was activated without staff awareness. Megadyne provides a safety holster for our pencils for storage of the active electrode when not in use. Megadyne provides a full line of modified insulated tips for use in narrowed cavities. Prior to this type of product, physicians often modified their own tips
using a red rubber catheter. This modification actually led to OR fires and patient injuries due to the product being petroleum-based and not made for this function."

Odell observed that, in today’s medical environment, a hospital could be called on the carpet for failing to use safety equipment to protect patients and staff. He also noted that at least one insurance company, State Volunteer Mutual Insurance Company (SVMIC), Brentwood, TN, strongly encourages their physician policyholders to use active electrode monitoring systems for patient safety. SVMIC offers an online, interactive, self-study program entitled "Avoidance and Management of Complications in Laparoscopic Surgery." O’Dell, who serves on the faculty, explained that physicians get a 10% discount off their annual premium for participating in the self-study program.

Megadyne offers a CEU presentation on preventing surgical fires, available at no charge for their customers. It can be scheduled as part of a monthly inservice or other staff meeting. "The objectives of this program," explained Fischer, "are to help raise awareness of the risks of surgical fires by identifying the sides of the Fire Triad and how those items may interact to cause surgical fires. The program also outlines key factors that may contribute to an OR fire and interventions that nurses and other staff members can take to mitigate the risks." To schedule a program, call 1-800-747-6110.

Suggested Reading

1. ECRI Institute. Surgical fire safety. Health Devices 2006;35:45-66.

2. ECRI Institute. A clinician’s guide to surgical fires: how they occur, how to prevent them, how to put them out. Health Devices 2003;32:5-24.

3. Bruley ME. Surgical fires: perioperative communication is essential to prevent this rare but devastating complication. Qual Saf Health Care 2004;13:467-471.

4. The Joint Commission. Sentinel Event Alert: Preventing surgical fires. http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_29.htm.

5. Association of periOperative Registered Nurses. Perioperative standards and recommended practices, 2008. Denver, CO: AORN; 2008.