SEPTEMBER 1992, VOL 56, NO 3
AORN JOURNAL
Opinion Vigilance, education are keys to overcoming laser safety complacency
M
any of us have seen T-shirts that. to paraphrase a rather indelicate sentiment, \tate, “accidents happen.” As a medical laser safety officer, I would like to see these worn bq all surgeons, nurses, risk managers, and adniinihtrators as a constant reminder that laser surgery still is an imperfect technology performed by fallible humans in an imperfect world. I am being facetious, of course, but my w y gestion is based on the sobering fact that b e need increasing vigilance to ensure that our safety controls keep pace with the tremendous growth in laser surgery procedures. According to a recent article, the total US market of l a w s and supplies will nearly double from 1989 to 1994.’ In 1989, we had an estimated 21.000 medical laser units installed in hospitals. cliiiics, and other sites.’
196Os, and 1970s. As more people drove cars, more accidents occurred. As more personnel learn how to operate lasers, the risk of mistakes increases. It is a mathematical certainty. What can be done to reduce these risks? An excellent starting point is to recognize that the primary cause of laser-related accidents is not malfunctioning equipment but rather human ignorance and complacency. At Memorial Hospital Southwest, Houston, we perform about 1,600 laser surgeries each year, so it is onl) natural that staff members start to consider them “routine.” We constantly fight this complacent attitude with three or four surgeon in-service programs
Reported Accidents
L
aser surgery offers clinical and econoni IC benefits, but it is a serious error to ignore its potential risks. Hard data concerning the degree of risk are inconclusive and incomplete. The US Food and Drug Administration reports that 134 laser-related operating room accident4 occurred between late 1984 and March 19Xcj.‘ These accidents resulted in seven deaths and 4S serious injuries. These figures, however. are only the tip of the iceberg, because countlcw minor incidents not involving fire or patient injury undoubtedly go unreported. In some ways, the situation is analogou\ I O the rise in automobile use during the 1950\,
Gerri Rupke, RN. BSN. is the laser coordinatoi. aritl clinicul insti-uctor, Memorial Hospital Soiithwest, Houston. She earned an associate of arts degree in humanities at Grand Rapids (Mic,h)Junior College. She earned her bachelor- of science degree in nursing at Hoirstnn Bciptist Uiiiiw-sity. 523
SEPTEMBER 1992, VOL 56, NO 3
AORN JOURNAL
Paying more now for laser safety measures may save money in the long run. each year, an annual mandatory laser safety update for all personnel, and ongoing one-onone instruction as needed. We emphasize that everyone needs to understand how lasers work and that personnel should not try to troubleshoot any major problems. For physicians, we reiterate the importance of test-firing the device, taking their feet out of the laser pedal housing, and putting the device on standby when not in use. Paradoxically, the more successful your laser safety programs, the more you have to work at overcoming the mind-set that “accidents can’t happen here.” We never have had a serious laser-related accident at our hospital, but we have had several incidents that reminded us that we must always be vigilant. In one instance, a physician did not want to wear goggles, but a citation from the Texas Department of Health helped him see the error of his ways. Just a few months ago, a surgeon missed his target with a micro-manipulator while test-firng his device; fortunately, the laser beam only melted a hole in our Class I polypropylene drapes and did not cause ignition. Another key safety component is educating administrators and risk managers about the importance of laser safety. Hospitals are operating in a cost-cutting environment, but we cannot lose sight of the fact that everything we do in our institutions is a matter of life and death. We cannot cut costs when it comes to patient and personnel safety. Administrators also need to understand the financial benefits of preventing problems before they occur. That may mean paying more now for safety measures instead of facing a potential multimillion-dollar lawsuit in the future.
Stringent Guidelines Needed
A
s the profession of medical laser safety officer proliferates and matures, we need
524
to establish specific guidelines on what is needed to ensure safe laser practices. We can find valuable guidance on this from both the American National Standards Institute and AOFW,4 but too many of the recommendations are ambiguous or discretionary. Twelve states, including Texas, have regulations regarding the use of medical lasers, but these also fail to address some critical issues. Regulations are pending in several other states. No current state regulation specifically applies to the potential flammability of surgical drape fabrics. A bill pending in California, however, would require the State Department of Health Services and the state fire marshal1 “to prepare and adopt regulations for policies and procedures related to safety in oxygen-rich environments in surgical suites and procedural rooms in health facilities, including equipment, safety, and emergency plans.”5 It also would require personnel who work in these environments “to be educated and trained in those policies and procedures.”6 A chilling, eyewitness account of a fatal OR fire at the University of California, Los Angeles, last year describes flames spreading along the drapes in a matter of seconds.’ I concur with the recommendations of the Los Angeles Fire Department in advocating the use of Class I drapes (as determined by the National Fire Protection Association Test Method 702) for all laser procedures. At our hospital, laser safety in the operating room is linked with a commitment to continuous quality improvement (CQI) by our entire organization. We have adopted one of the guiding principles of CQI-initiate processes that prevent problems before they occur. Compliance with our policies and practices is excellent among virtually all medical staff and personnel. We are not fooled, however, by our apparent
SEPTEMBER 1992, VOL 56, NO 3
AORN JOURNAL
~.
accomplishments. Compliance can evolve Into complacency overnight. Even if we diligently train and retrain all personnel, keep up with the latest technological innovations, and Implement the most stringent safety standards, we \ t i 1 1 must acknowledge an unavoidable fact-acc I dents happen. This not only keeps us humble but alm on our toes. What better way to meet the formidable challenges laser safety officers mu\t face each day? GERRIR U P K ~K.U
potential,” Modern Healrhcare 21 (March 25, 1991) 31. 2 . Ihid. 3. Ihid. 1. American National Standards Institute, AmcrYcan National Standards f o r the Safe Use qt Liiirrs in Health Care Facilities (Toledo: American Nmonal Standards Institute, 1988); “Recommended practices for laser safety in the practice setting,” in AOKN Stundurds und Recommended Practices for Pcr.ioper-uiii,e Nursing (Denver: Association of Operating Room Nurses, Inc, 1992) 111: 10-1 to 10-5. 5 . California Legislature, 1991-1992 sess, Ahwmbly bill 2552 (Feb 6, 1992).
Notes 1 . M Wagner, “Accidents detract from I,isci
to OR drape fires.” OR Manager 7 (June 1991) 7.
\
6. Ihid. 7. P Patterson, “Education for staff is best deterrent
Routine Advanced Monitoring of Little Value
Broad-spectrum Antibiotic Recalled
Researchers say there is little value to routinel! using more sophisticated techniques to monitor myocardial ischemia during noncardiac surgery, according to an article in the July 8. 1992, issue of the Journal of the Arnei.icuri Medical Association. The study was designed to determine if there are any benefits to using transesophageal echocardiography (TEE) or 12-lead electrocardiography (ECG) instead of two-lead ECG. Heart monitoring before and during noncardiac surgery has been advocated to detect patient4 at high risk for ischemic outcomes. Of the 332 men in the study who had or were at high risk for coronary disease, 285 (86%)had undergone studies by all three i n t w operative monitoring techniques. Among thow 285 patients, 11 1 (39%) were identified by at least one technique as having episodes of intraoperative myocardial ischemia. Researchers say that when all 332 patients were analyzed, the two-lead ECG technique identified more patients (26%) as having intraoperative myocardial ischemia than either TEE ( 15%) or 12-lead ECG (1 4%). Also, TEE and 12-lead ECG did not detect 37 patients who were identified by two-lead ECG as having myocardial ischemia.
The broad-spectrum oral antibiotic temafloxacin (Omniflox) is being recalled voluntarily by Abbott Laboratories, Abbott Park, Ill, according to the US Food and Drug Administration in a June 5, 1992, news release from the US Department of Health and Human Services. The company also is voluntarily halting production of the drug. This action followed reports of severe adverse drug reactions during the first three months of marketing. Temafloxacin was approved in late January 1992 and marketed in mid-February. Since then, there have been approximately 50 reports of serious adverse reactions, including three deaths. Reported complications include severe low blood sugar, hemolytic anemia and blood cell abnormalities, kidney and liver dysfunction, and a number of allergic reactions, some of which resulted in lifc-threatening respiratory distress. Temafloxacin is one of a newer class of synthetic oral fluoroquinolones used to treat a variety of infections. Officials say similar antibiotics have not been reported to be associated with comparable numbers of serious adverse reactions.
525
AORN JOURNAL
Opinion Vigilance, education are keys to overcoming laser safety complacency
M
any of us have seen T-shirts that. to paraphrase a rather indelicate sentiment, \tate, “accidents happen.” As a medical laser safety officer, I would like to see these worn bq all surgeons, nurses, risk managers, and adniinihtrators as a constant reminder that laser surgery still is an imperfect technology performed by fallible humans in an imperfect world. I am being facetious, of course, but my w y gestion is based on the sobering fact that b e need increasing vigilance to ensure that our safety controls keep pace with the tremendous growth in laser surgery procedures. According to a recent article, the total US market of l a w s and supplies will nearly double from 1989 to 1994.’ In 1989, we had an estimated 21.000 medical laser units installed in hospitals. cliiiics, and other sites.’
196Os, and 1970s. As more people drove cars, more accidents occurred. As more personnel learn how to operate lasers, the risk of mistakes increases. It is a mathematical certainty. What can be done to reduce these risks? An excellent starting point is to recognize that the primary cause of laser-related accidents is not malfunctioning equipment but rather human ignorance and complacency. At Memorial Hospital Southwest, Houston, we perform about 1,600 laser surgeries each year, so it is onl) natural that staff members start to consider them “routine.” We constantly fight this complacent attitude with three or four surgeon in-service programs
Reported Accidents
L
aser surgery offers clinical and econoni IC benefits, but it is a serious error to ignore its potential risks. Hard data concerning the degree of risk are inconclusive and incomplete. The US Food and Drug Administration reports that 134 laser-related operating room accident4 occurred between late 1984 and March 19Xcj.‘ These accidents resulted in seven deaths and 4S serious injuries. These figures, however. are only the tip of the iceberg, because countlcw minor incidents not involving fire or patient injury undoubtedly go unreported. In some ways, the situation is analogou\ I O the rise in automobile use during the 1950\,
Gerri Rupke, RN. BSN. is the laser coordinatoi. aritl clinicul insti-uctor, Memorial Hospital Soiithwest, Houston. She earned an associate of arts degree in humanities at Grand Rapids (Mic,h)Junior College. She earned her bachelor- of science degree in nursing at Hoirstnn Bciptist Uiiiiw-sity. 523
SEPTEMBER 1992, VOL 56, NO 3
AORN JOURNAL
Paying more now for laser safety measures may save money in the long run. each year, an annual mandatory laser safety update for all personnel, and ongoing one-onone instruction as needed. We emphasize that everyone needs to understand how lasers work and that personnel should not try to troubleshoot any major problems. For physicians, we reiterate the importance of test-firing the device, taking their feet out of the laser pedal housing, and putting the device on standby when not in use. Paradoxically, the more successful your laser safety programs, the more you have to work at overcoming the mind-set that “accidents can’t happen here.” We never have had a serious laser-related accident at our hospital, but we have had several incidents that reminded us that we must always be vigilant. In one instance, a physician did not want to wear goggles, but a citation from the Texas Department of Health helped him see the error of his ways. Just a few months ago, a surgeon missed his target with a micro-manipulator while test-firng his device; fortunately, the laser beam only melted a hole in our Class I polypropylene drapes and did not cause ignition. Another key safety component is educating administrators and risk managers about the importance of laser safety. Hospitals are operating in a cost-cutting environment, but we cannot lose sight of the fact that everything we do in our institutions is a matter of life and death. We cannot cut costs when it comes to patient and personnel safety. Administrators also need to understand the financial benefits of preventing problems before they occur. That may mean paying more now for safety measures instead of facing a potential multimillion-dollar lawsuit in the future.
Stringent Guidelines Needed
A
s the profession of medical laser safety officer proliferates and matures, we need
524
to establish specific guidelines on what is needed to ensure safe laser practices. We can find valuable guidance on this from both the American National Standards Institute and AOFW,4 but too many of the recommendations are ambiguous or discretionary. Twelve states, including Texas, have regulations regarding the use of medical lasers, but these also fail to address some critical issues. Regulations are pending in several other states. No current state regulation specifically applies to the potential flammability of surgical drape fabrics. A bill pending in California, however, would require the State Department of Health Services and the state fire marshal1 “to prepare and adopt regulations for policies and procedures related to safety in oxygen-rich environments in surgical suites and procedural rooms in health facilities, including equipment, safety, and emergency plans.”5 It also would require personnel who work in these environments “to be educated and trained in those policies and procedures.”6 A chilling, eyewitness account of a fatal OR fire at the University of California, Los Angeles, last year describes flames spreading along the drapes in a matter of seconds.’ I concur with the recommendations of the Los Angeles Fire Department in advocating the use of Class I drapes (as determined by the National Fire Protection Association Test Method 702) for all laser procedures. At our hospital, laser safety in the operating room is linked with a commitment to continuous quality improvement (CQI) by our entire organization. We have adopted one of the guiding principles of CQI-initiate processes that prevent problems before they occur. Compliance with our policies and practices is excellent among virtually all medical staff and personnel. We are not fooled, however, by our apparent
SEPTEMBER 1992, VOL 56, NO 3
AORN JOURNAL
~.
accomplishments. Compliance can evolve Into complacency overnight. Even if we diligently train and retrain all personnel, keep up with the latest technological innovations, and Implement the most stringent safety standards, we \ t i 1 1 must acknowledge an unavoidable fact-acc I dents happen. This not only keeps us humble but alm on our toes. What better way to meet the formidable challenges laser safety officers mu\t face each day? GERRIR U P K ~K.U
potential,” Modern Healrhcare 21 (March 25, 1991) 31. 2 . Ihid. 3. Ihid. 1. American National Standards Institute, AmcrYcan National Standards f o r the Safe Use qt Liiirrs in Health Care Facilities (Toledo: American Nmonal Standards Institute, 1988); “Recommended practices for laser safety in the practice setting,” in AOKN Stundurds und Recommended Practices for Pcr.ioper-uiii,e Nursing (Denver: Association of Operating Room Nurses, Inc, 1992) 111: 10-1 to 10-5. 5 . California Legislature, 1991-1992 sess, Ahwmbly bill 2552 (Feb 6, 1992).
Notes 1 . M Wagner, “Accidents detract from I,isci
to OR drape fires.” OR Manager 7 (June 1991) 7.
\
6. Ihid. 7. P Patterson, “Education for staff is best deterrent
Routine Advanced Monitoring of Little Value
Broad-spectrum Antibiotic Recalled
Researchers say there is little value to routinel! using more sophisticated techniques to monitor myocardial ischemia during noncardiac surgery, according to an article in the July 8. 1992, issue of the Journal of the Arnei.icuri Medical Association. The study was designed to determine if there are any benefits to using transesophageal echocardiography (TEE) or 12-lead electrocardiography (ECG) instead of two-lead ECG. Heart monitoring before and during noncardiac surgery has been advocated to detect patient4 at high risk for ischemic outcomes. Of the 332 men in the study who had or were at high risk for coronary disease, 285 (86%)had undergone studies by all three i n t w operative monitoring techniques. Among thow 285 patients, 11 1 (39%) were identified by at least one technique as having episodes of intraoperative myocardial ischemia. Researchers say that when all 332 patients were analyzed, the two-lead ECG technique identified more patients (26%) as having intraoperative myocardial ischemia than either TEE ( 15%) or 12-lead ECG (1 4%). Also, TEE and 12-lead ECG did not detect 37 patients who were identified by two-lead ECG as having myocardial ischemia.
The broad-spectrum oral antibiotic temafloxacin (Omniflox) is being recalled voluntarily by Abbott Laboratories, Abbott Park, Ill, according to the US Food and Drug Administration in a June 5, 1992, news release from the US Department of Health and Human Services. The company also is voluntarily halting production of the drug. This action followed reports of severe adverse drug reactions during the first three months of marketing. Temafloxacin was approved in late January 1992 and marketed in mid-February. Since then, there have been approximately 50 reports of serious adverse reactions, including three deaths. Reported complications include severe low blood sugar, hemolytic anemia and blood cell abnormalities, kidney and liver dysfunction, and a number of allergic reactions, some of which resulted in lifc-threatening respiratory distress. Temafloxacin is one of a newer class of synthetic oral fluoroquinolones used to treat a variety of infections. Officials say similar antibiotics have not been reported to be associated with comparable numbers of serious adverse reactions.
525
