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How new technology affects practice and patient safety
August 1997, Vd. 4, No. 4
TheJournalof the American Association of GynecoJogic Laparoscopists
How New Technology Affects Practice and Patient Safety George Berci, M.D. Working in Australia 40 years ago, and already interested in laparoscopy, I retrieved my first laparoscopic instruments from Europe to work on the improvement of diagnostic modalities without exploratory surgery. Collaborating with a young gynecologist, we performed our first laparoscopy. It was an effective procedure. The department chairman banned me from the Royal Woman's Hospital, because he said we were dangerous lunatics. This is an example of how new technology, arbitrarily rejected, can slow progress unnecessarily. But haste without method is risky. We must agree on a path. The American Association of Gynecologic Laparoscopists (AAGL) was begun by a group of physicians who understood the importance of orderly recognition and inclusion of new technology. The association was instrumental in disseminating, teaching, educating, and conducting research activities in this important diagnostic and therapeutic field. Gynecologic success in laparoscopy did not naturally transfer to the general surgical community, which was wary of working in small places from a distance. Eighteen years after AAGL was founded, the laparoscopic revolution in general surgery finally erupted. Unfortunately, this time, acceptance and dissemination were too fast. Overnight, patient demand for laparoscopic cholecystectomy blossomed due to media exposure and the sudden interest of industry to promote the procedure.
In these early and difficult years the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) organized endorsed courses and clinical trials, established guidelines for privileging and proctoring, and set up courses to teach the teachers. Like the AAGL, they helped to put a high-speed revolution on a more modest, better-controlled track. For both SAGES and AAGL, technology has been a driving force of science. They have grappled and come to terms with technology and how it affects surgical practice and patient safety. Compare the advent of new technology with riding a comet. This may be a strange analogy, but the metaphor of the comet is appropriate. It is fast and we have no control over it. My concern is that we are holding on, with great difficulty, to the tail of the technology comet, hoping it will take us to the right place at the end of the ride. Sometimes we hope that we can hold on for the entire fide. Sometimes we find ourselves praying the gods will be merciful and let us fall off. Examine the relationship between technology and its inventors and users. Are we the masters or the slaves? If we understand that we must be masters, the rest is fairly simple. The ultimate purpose of new medical technology is to help us to do our job better. Our "job" is to cure patients of disease, improve the course of disease and patients' well-being, and diminish the suffering of women whose disease we cannot yet cure. Part of that job is also to make treatment efficient and make it cost effective.
From the Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California. Address reprint requests to George Berci, M.D., Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Suite 8215, Los Angeles, CA 90048; fax 310 967 0139. Presented at the 25th annual meeting of the American Association of Gynecologic Laparoscopists, Chicago, Illinois, September 24-29, 1996.
419
New Technology Affects Praclice and Patient Safely Berci
If new technology does not meet those criteria, then we must ask, "Why are we doing this?" In developing and disseminating new technology we must adhere to a formula: 1. Encourage innovation that answers a real need. 2. Establish priorities and balance resources expended with potential benefits. 3. Maximize cross-fertilization; technology invented for one use should be effective for other applications. Imagine if the first vaccine had been thought to be good only for smallpox and was not applied to tetanus, typhoid diphtheria, or polio. Imagine a world in which antibiotics were thought to be useful only to treat pneumonia. We must evaluate critically at every phase: at inception for need, potential use, and ethical concerns (imagine a world in which the ethical dilemma of infecting a person with a live virus had never even been debated!); during development for effectiveness, cost, and safety; and during refinement for pitfalls. We must evaluate during dissemination for accurate data, ethical use, and effective, safe training, and we must do so with open minds. If necessity is the mother of invention, then strategy should be its father. Technology should not evolve spontaneously. Its evolution is our responsibility. How has new medical technology been adopted historically? It is amazing to observe how many crucial ideas were originally ignored, criticized, or disparaged by peers only to be resurrected at a later stage--far too late and at the cost of far too many lives. Semmelweis was a Hungarian obstetrician-gynecologist working in the nineteenth century in Vienna, where he confronted the high mortality of childbed fever. He hypothesized, and then proved, that medical students leaving the morgue, who did not wash their hands or change clothes, transmitted bacteria that caused a deadly infection after delivery. Even after he proved his theory and decreased mortality, the skepticism of his jealous colleagues forced him out of his position. Returning to his home country, he suffered severe depression and died in a mental asylum in 1865. So much for pioneering! The discovery of penicillin is an example of technology delayed. In 1928 Alexander Fleming noticed that petri dishes in which he was growing bacteria were contaminated by mold spores. The bacteria beside the mold had been killed. In 1929 he published a preliminary, but
vague, description of his discovery and then turned his energies elsewhere. It was 11 years before scientists in the pathology department at Oxford rediscovered the effect of penicillin. We must be alert to capture new discoveries. The development of surgery was adolescent until the invention of X-rays. Wilhelm Conrad Roentgen, expelled from technical college in Utrecht for behavior problems, finally finished his studies in Zurich and ended up as director of physics in Wurzburg, Germany. Investigating cathode ray tubes employing high voltage, he discovered the X-ray beam. Using his wife as his fnst patient (was he concerned about keeping malpractice premiums low?), he irradiated her hand for 15 minutes and developed the first X-ray plate in history. Today, Roentgen would be arrested for wife abuse. In 1901 he received the first Nobel prize in physics. During the subsequent decades radiology enabled us to prevent millions of unnecessary surgeries, and millions more procedures were made possible. Surgery's horizons expanded exponentially as the technology was refined. Soon came the technology we almost lost: endoscopy. To see the inside the body without opening the body permitted us to diagnose and treat pathology that was previously unaccessible. We embraced it, but with reluctance. If the proof is in the exception, we must look not only at the glowing successes in our past, but at how technology often led us astray; how we allowed technology to lead us astray. Recall gastric freezing for duodenal ulcers. We as a profession fell far short in our analysis for effectiveness, cost and safety, pitfalls, and ethical use. Several thousand gastric balloons were sold and swallowed; gastritis, bleeding, and sometimes perforation resulted. In short, we did not do our homework. In another example, I must admit to being an early proponent of what turned out to be a worthless use of technology. None of us is excused from the mandate of self-criticism. The technology was extracorporeal biliary lithotripsy. Extracorporeal shockwave lithotripsy was introduced for kidney stones in 1982, quickly accepted, and proved safe and effective. It became the method of choice for treating most kidney stones. When we attempted to expand its use to the biliary tract we created a major calamity. In 1988, the first allegedly successful treatment of gallstones in 175 patients was reported. We ignored basic anatomy and physiology and did not scrutinize follow-up studies, which revealed
420
August 1997, Vol. 4, No. 4
TheJournal of the American Association of Gynecologic Laparoscopists
that the procedure was more expensive than open or laparoscopic cholecystectomy. Not doing our homework properly was disastrous. It immersed us in a procedure not compatible with results of our surgical gold standard. As an active enthusiast, ! learned a great and very expensive lesson. Another miracle--the laser. Early claims suggested that laparoscopic cholecystectomy could not be performed effectively without a $100,000 laser. The laser was effective in a number of specific treatments. It was, however, a technology in search of a use. The potential was overstated, the cost was prohibitive, and the technique was underevaluated by a medical community looking for glitz. Where do we go from here? What technologies are on the horizon? How do we open our minds without closing too many doors? How do we elevate quality control to preeminence without relegating cost containment to oblivion? And who gets to decide? We are looking at technologies that could enormously improve patient care or put us out of business; that can fix things without touching them, and touch things without seeing them. These are scary times, but also exciting ones. With the advent of the Internet came legal and ethical dilemmas. To obtain instant information is impressive and useful, but we must grapple with such issues as invasion of privacy, copyright protection, and peer review questions, just to mention a few. These issues must be resolved if we are to avoid technologic anarchy. Robotics may someday give us the precise control that the human hand can never achieve and the eye cannot measure. Virtual reality may enable us to learn and practice, and prepare us better for treating human patients. Virtual endoscopy may allow us to see things from views we have never navigated without invading the body, and sense it in three dimensions. Telemedicine is already giving us options in teaching and treating that are being defined and refined in new guidelines so that we can manage them before they manage us. The state of military ultrasound and other new imaging modalities will dwarf any notion of what we now
consider possible. We must prepare for an age of medicine that includes enhanced human performance, remote access, point-of-care data acquisition, autonomous (closed-loop) control, and genetic algorithms. We cannot focus on high tech without considering high ethics. The marriage between surgeon and corporation is an important but delicate one. Business, royalties, and consulting fees are all acceptable facets of that marriage. Science, however, must be kept whole and separate. Prospective trials are important in evaluating any new technology or technique. They are even more important when the appearance of conflict may exist. Reproducible results from disinterested, unaffiliated scientists are a must. Here are some questions we must ask ourselves: 9 Will the technology distance me more from my patients? If it does, is it worth the price? 9 Does it fill a serious need? 9 Will it improve the life of the patient? 9 Have adequate trials been conducted? 9 Is it the right thing to do? If the patient were my wife, my child, my parent, would I be considering the use of this technology? 9 Is it cost effective? 9 What are the consequences of taking this technologic step? 9 What are the consequences of not taking it? 9 Am I impartial? We must push the edge of the envelope, but teach ourselves when not to mail the letter. On the question of who gets to decide, the answer is that we must. For surely, if we do not do i t - - a n d do it rationally--the government will do it for us. There are many domains in which we have no command, many circumstances in which we can only react. The golden rule for new technology should be: we assert dominion over the development of technology and we accept the responsibility for what we create. Dare to dream, to imagine, to invent, to innovate. But harness those dreams and direct them appropriately.
421
TheJournalof the American Association of GynecoJogic Laparoscopists
How New Technology Affects Practice and Patient Safety George Berci, M.D. Working in Australia 40 years ago, and already interested in laparoscopy, I retrieved my first laparoscopic instruments from Europe to work on the improvement of diagnostic modalities without exploratory surgery. Collaborating with a young gynecologist, we performed our first laparoscopy. It was an effective procedure. The department chairman banned me from the Royal Woman's Hospital, because he said we were dangerous lunatics. This is an example of how new technology, arbitrarily rejected, can slow progress unnecessarily. But haste without method is risky. We must agree on a path. The American Association of Gynecologic Laparoscopists (AAGL) was begun by a group of physicians who understood the importance of orderly recognition and inclusion of new technology. The association was instrumental in disseminating, teaching, educating, and conducting research activities in this important diagnostic and therapeutic field. Gynecologic success in laparoscopy did not naturally transfer to the general surgical community, which was wary of working in small places from a distance. Eighteen years after AAGL was founded, the laparoscopic revolution in general surgery finally erupted. Unfortunately, this time, acceptance and dissemination were too fast. Overnight, patient demand for laparoscopic cholecystectomy blossomed due to media exposure and the sudden interest of industry to promote the procedure.
In these early and difficult years the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) organized endorsed courses and clinical trials, established guidelines for privileging and proctoring, and set up courses to teach the teachers. Like the AAGL, they helped to put a high-speed revolution on a more modest, better-controlled track. For both SAGES and AAGL, technology has been a driving force of science. They have grappled and come to terms with technology and how it affects surgical practice and patient safety. Compare the advent of new technology with riding a comet. This may be a strange analogy, but the metaphor of the comet is appropriate. It is fast and we have no control over it. My concern is that we are holding on, with great difficulty, to the tail of the technology comet, hoping it will take us to the right place at the end of the ride. Sometimes we hope that we can hold on for the entire fide. Sometimes we find ourselves praying the gods will be merciful and let us fall off. Examine the relationship between technology and its inventors and users. Are we the masters or the slaves? If we understand that we must be masters, the rest is fairly simple. The ultimate purpose of new medical technology is to help us to do our job better. Our "job" is to cure patients of disease, improve the course of disease and patients' well-being, and diminish the suffering of women whose disease we cannot yet cure. Part of that job is also to make treatment efficient and make it cost effective.
From the Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California. Address reprint requests to George Berci, M.D., Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Suite 8215, Los Angeles, CA 90048; fax 310 967 0139. Presented at the 25th annual meeting of the American Association of Gynecologic Laparoscopists, Chicago, Illinois, September 24-29, 1996.
419
New Technology Affects Praclice and Patient Safely Berci
If new technology does not meet those criteria, then we must ask, "Why are we doing this?" In developing and disseminating new technology we must adhere to a formula: 1. Encourage innovation that answers a real need. 2. Establish priorities and balance resources expended with potential benefits. 3. Maximize cross-fertilization; technology invented for one use should be effective for other applications. Imagine if the first vaccine had been thought to be good only for smallpox and was not applied to tetanus, typhoid diphtheria, or polio. Imagine a world in which antibiotics were thought to be useful only to treat pneumonia. We must evaluate critically at every phase: at inception for need, potential use, and ethical concerns (imagine a world in which the ethical dilemma of infecting a person with a live virus had never even been debated!); during development for effectiveness, cost, and safety; and during refinement for pitfalls. We must evaluate during dissemination for accurate data, ethical use, and effective, safe training, and we must do so with open minds. If necessity is the mother of invention, then strategy should be its father. Technology should not evolve spontaneously. Its evolution is our responsibility. How has new medical technology been adopted historically? It is amazing to observe how many crucial ideas were originally ignored, criticized, or disparaged by peers only to be resurrected at a later stage--far too late and at the cost of far too many lives. Semmelweis was a Hungarian obstetrician-gynecologist working in the nineteenth century in Vienna, where he confronted the high mortality of childbed fever. He hypothesized, and then proved, that medical students leaving the morgue, who did not wash their hands or change clothes, transmitted bacteria that caused a deadly infection after delivery. Even after he proved his theory and decreased mortality, the skepticism of his jealous colleagues forced him out of his position. Returning to his home country, he suffered severe depression and died in a mental asylum in 1865. So much for pioneering! The discovery of penicillin is an example of technology delayed. In 1928 Alexander Fleming noticed that petri dishes in which he was growing bacteria were contaminated by mold spores. The bacteria beside the mold had been killed. In 1929 he published a preliminary, but
vague, description of his discovery and then turned his energies elsewhere. It was 11 years before scientists in the pathology department at Oxford rediscovered the effect of penicillin. We must be alert to capture new discoveries. The development of surgery was adolescent until the invention of X-rays. Wilhelm Conrad Roentgen, expelled from technical college in Utrecht for behavior problems, finally finished his studies in Zurich and ended up as director of physics in Wurzburg, Germany. Investigating cathode ray tubes employing high voltage, he discovered the X-ray beam. Using his wife as his fnst patient (was he concerned about keeping malpractice premiums low?), he irradiated her hand for 15 minutes and developed the first X-ray plate in history. Today, Roentgen would be arrested for wife abuse. In 1901 he received the first Nobel prize in physics. During the subsequent decades radiology enabled us to prevent millions of unnecessary surgeries, and millions more procedures were made possible. Surgery's horizons expanded exponentially as the technology was refined. Soon came the technology we almost lost: endoscopy. To see the inside the body without opening the body permitted us to diagnose and treat pathology that was previously unaccessible. We embraced it, but with reluctance. If the proof is in the exception, we must look not only at the glowing successes in our past, but at how technology often led us astray; how we allowed technology to lead us astray. Recall gastric freezing for duodenal ulcers. We as a profession fell far short in our analysis for effectiveness, cost and safety, pitfalls, and ethical use. Several thousand gastric balloons were sold and swallowed; gastritis, bleeding, and sometimes perforation resulted. In short, we did not do our homework. In another example, I must admit to being an early proponent of what turned out to be a worthless use of technology. None of us is excused from the mandate of self-criticism. The technology was extracorporeal biliary lithotripsy. Extracorporeal shockwave lithotripsy was introduced for kidney stones in 1982, quickly accepted, and proved safe and effective. It became the method of choice for treating most kidney stones. When we attempted to expand its use to the biliary tract we created a major calamity. In 1988, the first allegedly successful treatment of gallstones in 175 patients was reported. We ignored basic anatomy and physiology and did not scrutinize follow-up studies, which revealed
420
August 1997, Vol. 4, No. 4
TheJournal of the American Association of Gynecologic Laparoscopists
that the procedure was more expensive than open or laparoscopic cholecystectomy. Not doing our homework properly was disastrous. It immersed us in a procedure not compatible with results of our surgical gold standard. As an active enthusiast, ! learned a great and very expensive lesson. Another miracle--the laser. Early claims suggested that laparoscopic cholecystectomy could not be performed effectively without a $100,000 laser. The laser was effective in a number of specific treatments. It was, however, a technology in search of a use. The potential was overstated, the cost was prohibitive, and the technique was underevaluated by a medical community looking for glitz. Where do we go from here? What technologies are on the horizon? How do we open our minds without closing too many doors? How do we elevate quality control to preeminence without relegating cost containment to oblivion? And who gets to decide? We are looking at technologies that could enormously improve patient care or put us out of business; that can fix things without touching them, and touch things without seeing them. These are scary times, but also exciting ones. With the advent of the Internet came legal and ethical dilemmas. To obtain instant information is impressive and useful, but we must grapple with such issues as invasion of privacy, copyright protection, and peer review questions, just to mention a few. These issues must be resolved if we are to avoid technologic anarchy. Robotics may someday give us the precise control that the human hand can never achieve and the eye cannot measure. Virtual reality may enable us to learn and practice, and prepare us better for treating human patients. Virtual endoscopy may allow us to see things from views we have never navigated without invading the body, and sense it in three dimensions. Telemedicine is already giving us options in teaching and treating that are being defined and refined in new guidelines so that we can manage them before they manage us. The state of military ultrasound and other new imaging modalities will dwarf any notion of what we now
consider possible. We must prepare for an age of medicine that includes enhanced human performance, remote access, point-of-care data acquisition, autonomous (closed-loop) control, and genetic algorithms. We cannot focus on high tech without considering high ethics. The marriage between surgeon and corporation is an important but delicate one. Business, royalties, and consulting fees are all acceptable facets of that marriage. Science, however, must be kept whole and separate. Prospective trials are important in evaluating any new technology or technique. They are even more important when the appearance of conflict may exist. Reproducible results from disinterested, unaffiliated scientists are a must. Here are some questions we must ask ourselves: 9 Will the technology distance me more from my patients? If it does, is it worth the price? 9 Does it fill a serious need? 9 Will it improve the life of the patient? 9 Have adequate trials been conducted? 9 Is it the right thing to do? If the patient were my wife, my child, my parent, would I be considering the use of this technology? 9 Is it cost effective? 9 What are the consequences of taking this technologic step? 9 What are the consequences of not taking it? 9 Am I impartial? We must push the edge of the envelope, but teach ourselves when not to mail the letter. On the question of who gets to decide, the answer is that we must. For surely, if we do not do i t - - a n d do it rationally--the government will do it for us. There are many domains in which we have no command, many circumstances in which we can only react. The golden rule for new technology should be: we assert dominion over the development of technology and we accept the responsibility for what we create. Dare to dream, to imagine, to invent, to innovate. But harness those dreams and direct them appropriately.
421