CORVALLIS, Ore. - Engineers at Oregon State University are working with surgeons on a methodology to help address the human errors that can take place in operating rooms - a concept that if perfected and widely used might change the face of surgery in the United States, prevent mistakes and save lives.
Although the research is still at an early stage, a prototype has been developed for one type of surgical procedure - a laparoscopic gallbladder removal, which appears to be effective at analyzing surgical procedures, spotting potential problem areas and suggesting countermeasures that could help.
Eventually, "intelligent" computer systems and other technology might assist with this process.
The complexities of surgery, entrenched traditions of the medical profession and possible changes needed in operating room protocol could make it difficult to quickly implement any new system, researchers say. But considerable improvements may be possible, and the stakes are high. In the operating room mistakes can be fatal, or lead to longer than necessary recovery periods and other complications.
"Studies have shown that 43 percent of the adverse events that occur in hospitals are during surgery, and 70 percent of those problem cases are preventable," said Kenneth Funk, associate professor and interim head of the Department of Industrial and Manufacturing Engineering at OSU.
"Different estimates of patient deaths due to medical error range from 44,000 to 98,000 per year," Funk said. "This is not because the doctors, nurses and support staff are careless. It's simply that this is very complex work and they are fallible human beings in a very vulnerable system. Mistakes are made both inevitable and costly by the way many complex systems are designed and work."
To address this, OSU researchers have adapted processes that evolved in business, engineering, and even aviation - strict protocols that help the engineers systematically elicit knowledge about surgical processes, what can go wrong, and how to prevent or mitigate it. A "human performance database" has been created that outlines more than 200 generic types of human error. And work has begun on a complex computerized system that could revolutionize the operating room of the future.
"It's important for people in the medical profession to understand - and the surgeons on our team do understand this - that we're not trying to tell them how to conduct surgeries," Funk said.
"What we are developing is a systematic way to help them identify best practices, identify where the process is most likely to break down, and create a countermeasure to help prevent that," he added.
In their prototype of this approach, the OSU researchers studied the surgical procedures used in a laparoscopic cholecystectomy - a minimally invasive way to remove a gallbladder. As a basic operation, about 300,000 gallbladder surgeries are performed in the U.S. every year - but even for this fairly routine surgery, there are about 1,300 mortalities.
In this surgery, for instance, there is one fairly important procedure in which a certain type of needle is inserted and used to inflate the abdominal cavity - a process that's routine if done exactly right, rife with complications if it isn't. The research team of engineers and surgeons identified this as one of the places during this surgical procedure where mistakes were sometimes made. They found that a useful "countermeasure" to this important stage of the operation is anticipation of that step, extra attention by the surgeon and staff, and no distractions during that period.
"American medicine needs to make a transformation and substantive change," said Dr. James Bauer, an Oregon surgeon working on this project, who has helped pioneer this concept. "As we face the pressures of caring for an aging baby boom generation, we have to squeeze out inefficiency. And to do that, we've got to get the clinical specialists working with the engineers. Other countries are already very interested in this, and so far the U.S. is pretty much missing the boat." When these approaches are more fully developed, experts say, many of them may apply broadly to a range of surgical procedures - as well as in other high-risk domains, like aviation.
"With a lot of what happens in surgery, about 80 percent is fairly standard and 10 to 20 percent of the procedures are unique to that particular procedure," Funk said. "A lot of the surgical procedure is the same, whether you are removing a gallbladder or an appendix. So we believe that once these systems are implemented, they could be fairly useful in many areas."
Aside from helping existing surgeons, the researchers said, such systems might be even more useful in medical and surgical training. It may be easier to train new surgeons to use systems such as this than to change practices that working surgeons have used for years, Funk said.
Ultimately, the researchers hope to develop "intelligent interface" computer systems that might monitor much of what is happening in an operating room, using electronic sensors, software specific to the surgical procedure under way, and provide cautions or advice if any problems are detected.
This "Nexus" system might use bar codes, radio frequency tags, robotics, flat panel displays, speech recognition systems, powerful computers and other technology to track equipment, monitor the patient, answer queries, cue personnel and perform many other functions.
"Conceptually, this project is a little like the work we've done with aviation, in which computers help monitor flight progress, avoid cockpit interruptions and make sure the flight plans are carried out," Funk said. "Whether it's a jet aircraft or an operating room, you're still dealing with fallible human beings working in a high pressure situation with very complex, vulnerable systems."
Additional funding is being sought from the National Science Foundation to take this research beyond the existing prototype, the OSU researchers said. Initial work has been supported by grants from the John C. Erkkila, M.D., Endowment for Health and Human Performance at Good Samaritan Hospital in Corvallis.
Ken Funk, 541-737-2357
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