The convergence of a number of factors led to the development of an APSF Vision, which states, "All anesthesia professionals who utilize advanced medical devices that can directly affect a patient's vital functions and immediate safety, will be certifiably trained prior to such clinical application." Those factors included 1) the dramatically increased complexity of modern anesthesia workstations, 2) a preponderance of human error as a cause of equipment-related incidents, 3) the inadequacies inherent in conventional in-service training, 4) the known advantages of intensive training in complex tasks, and 5) the evidence reflecting failures to complete non-mandated training. The most effective manner to successfully accomplish such training is not known and requires deliberate investigation.
The goals for an APSF Board of Directors' Workshop were to: 1) define the problems and shortcomings in conventional training, 2) demonstrate the limitations and impediments inherent in mandating training, 3) describe new approaches to training that might be more successful, 4) consider analogous endpoints and successes from the aviation model, 5) explore the medico-legal and regulatory pressures driving such efforts, and 6) promote discussion and targeted efforts at implementation. The workshop was successful in gathering approximately 72 persons from the medical, nursing, technical, administrative, regulatory, insurance, government, aviation, and safety industries to participate. All of the stated goals were addressed.
The problems encountered in conventional (typically referred to as "in-service") training include a lack of commitment by manufacturer and/or clinician, a lack of time, inadequate focus on, or lack of content, and a lack of evaluation of learning. Strong leadership is required to achieve a high participation rate, particularly among physicians. Training will enhance user satisfaction, application of advanced features, resource utilization, and potentially patient safety. Previous reports have indicated a low participation rate among academic physicians who are not mandated to attend training, although a majority of those who do participate believe training is valuable, should be mandatory, but must be practical and applied. Some centers have already mandated introductory training on new machines, utilizing a variety of approaches to levels of complexity, duration, scheduling, and testing. A detailed review of the published literature revealed very little data on prospective, randomized trials demonstrating advantages of intensive training, but the few that exist, do indicate significant advantages. Unpublished and subjective reviews of equipment hazard and critical incident reports indicate a low percentage of critical incidents are training-related. One ASA organization (Committee on Equipment and Facilities), however, is recommending training, demonstration of competence, and check-out, prior to using anesthesia gas delivery equipment. Despite the paucity of medico-legal liability ascribed to a lack of training, efforts and statements that promote mandatory training may create de facto local standards of care. Records of training should be maintained by hospital administrators, who ultimately have control over training mandates. Analogies to aviation suggest that training on anesthesia equipment should be precisely focused on new and clinically relevant features, primary failure modes, and prevention and recovery. This perspective should be widely communicated to clinicians. Closed claims related to anesthesia equipment have increased substantially in the most recent 5-year analysis, although claims related to gas delivery equipment remain low at only 2% of the total. Human error is an overwhelming culprit in these claims, and death or brain damage is frequent (75% of outcomes). Focus on recurring failures is again emphasized. Hospital administrators are challenged by the costs of providing ancillary technical assistants, who sometimes serve as surrogates for inadequately trained clinicians. Clinical leaders struggle to overcome the impact of time constraints, costs, resource shortage, as well as complacency when attempting to train clinicians. Some anesthesia leaders argue that mandated, extensive device training programs are unnecessary and irrelevant because there is such a low incidence of equipment problems leading to adverse outcomes. They propose that deploying resources to implement evidence-based solutions to other major morbidities would have far greater yield for patient safety. The collective opinions of safety-minded attendees at this annual workshop seem to indicate that selective and focused training or demonstration of competence should be mandated, but only after consultation, communication of risk, and culture change are effected. Industry must provide seamless and standardized interfaces and novel training programs to lessen risks and reduce burdens on clinicians.
In summary, the APSF has developed a consensus statement in favor of requiring a process for training and/or demonstration of competence. Details follow.
Caroline Coyle, General Manager Anesthesia Care, GE Healthcare described the technological convergence of minimization, automation, intelligent deliveries, virtualization, remote control, access of information, and globalization that now defines our modern anesthesia workstations. Originally composed of pneumatic and mechanical systems for ventilation, fresh gas, and volatile agent delivery, the modern anesthesia machine may now feature electronic and computer feed-back control of these systems. For example, ventilation modes now include volume correction and sensing of patient breathing with synchronization, and both fresh gas and volatile agents may be controlled completely electronically through keypad entry of desired settings. Monitoring of the patient and control of the machine are now integrated, and streams of data are fed to automated information management systems (AIMS). Coyle posed the question, "Will this technology result in safer patient outcomes and what does this mean for training?" and suggested that conventional in-service needs to be replaced by more advanced and effective training in order to achieve reliable benefits from this technology. She compared the results of 2 recent training programs at academic installations that differed in their duration of participation, willingness to follow company-prescribed training, and the use of clinician specialists. The hospital that received only 25% of the prescribed training and did not effectively train or employ clinician-specialists, consumed 6 times the amount of service calls (46% of which were training deficiencies) and required extensive clinical follow-ups, when compared to the hospital that received the full company-prescribed training. Common problems were related to the ignorance of checkout procedures and machine calibrations and the misunderstanding of alarms and backup modes. Coyle also described mistaken perceptions about the equipment, greater operating costs (e.g., increased absorbent usage), delayed starts, and a limited ability to take advantage of advanced operating features. In stark contrast, there was only one training-related issue in the other institution. She referenced a prior report stating that most clinicians thought training should be mandatory, and concluded that education would benefit all of us. Exactly what the best mechanism is and how it is best accomplished is uncertain, but first, cultural and political barriers must be addressed and customers must appreciate the need for advanced training. Coyle concluded that the benefits from mandating training would be seen in a very short period of time
Michael A. Olympio, MD, co-moderator of the workshop and leader of the APSF Technology Training Initiative began with the assertion that inadequate training was perceived as a national problem. He cited a news article describing controversies over training vs. promotion of high-tech medical devices, and referenced one single, prospective, controlled trial demonstrating how intensive training caused more effective application and troubleshooting of a new anesthesia machine during a simulated crisis. Olympio further described consistent evidence that human error is responsible for the majority of equipment failures, and that more training is required to overcome such failures, according to leading experts. He summarized the factors leading to the development of the previously described (APSF Newsletter Fall 2006) Technology Training Initiative, particularly referring to manufacturers' observations that many clinicians do not show up for training, and their perception that very few even care about it. That initiative attempted to mandate extensive training on new, advanced anesthesia machines at this author's institution. Rates of completion of the entire training program declined from student nurse anesthetist to CRNA/resident, and most dramatically to faculty, as the one group for whom training was not specifically mandated. However, participation in hands-on workshop training was similarly very high among all 4 groups, consistent with the participants' opinion that it was the most effective component for learning. Olympio described the afterthoughts of the chair, Raymond Roy, PhD, MD (whose workshop presentation is described below), who did not mandate training for the faculty. Roy initially felt such training should be viewed as a safety initiative without mandate, but after the low participation results, he felt training should be mandated after faculty buy-in with negative consequences to those who failed to obtain it. Participants overwhelmingly felt the training was valuable and 78% thought such training should be mandated. Olympio then emphasized the differences in the type of training Coyle's installations received, and reiterated the APSF Vision statement, that, as shown "The manner in which . . . training is applied or successfully accomplished is not known, and requires deliberate investigation."
In a related, ongoing study, Olympio and colleagues are collecting control data on the manner of training in recent installations. Four departmental examples varied in a number of important aspects including, but not limited to 1) the degree of mandate and consequences for failure to attend, 2) the extent and duration of the training program, 3) the size and numbers of trainees, 4) the provision of follow-up training, 5) the on-, or off-duty timing of the training, 6) the additional salary needed for relief clinicians, and 7) the attitudes toward training by some clinicians. Two of the 4 departmental leaders spontaneously commented on the negative attitudes of a few clinicians who did not want to attend training, using the words arrogant, or resistant to change. The early, retrospective nature of the data did not allow for precise numerical comparisons.
Olympio went on to describe a prospective, randomized, controlled, IRB-approved pilot study by the APSF Committee on Technology, "An Outcomes-Based Comparison of Mandated vs. Non-mandated Anesthesia Machine Introductory Training," and its hypothesis that, "Mandating introductory training of complicated modern anesthesia machines will enhance user satisfaction, resource utilization, and the safe operation, understanding, and troubleshooting of the machine." The ambitious plan relies upon the joint cooperation of manufacturers and clinicians within the APSF and the cooperation of academic departments. Olympio described the efforts to develop standardized and valid assessment instruments that would address the necessity for mandating or not-mandating training. He emphasized that all programs would receive the same training, and that the mandate would be the only treatment variable tested.
To enhance the validity and the need for such a study, the APSF independently consulted the ASA Practice Parameters Research Team to "Determine the impact of medical device training on anesthesiologist knowledge, competence, and acceptance of devices." The researchers were asked to specifically focus on mandated and/or intensive training, and upon devices which were generally used by all anesthesia clinicians (i.e., anesthesia machines, infusion pumps, AIMS, and advanced airway devices). The consultants' extensive review of the literature found only 19 manuscripts that had evidence-based outcomes and no published trials of mandated vs. non-mandated training. Only 8 studies were related to the anesthesia machine, and only 2 of those were randomized controlled trials, both of which demonstrated improvements in operation and troubleshooting. The experts concluded that:
An ECRI Institute database of 225 combined "Health Devices Alerts" and FDA MAUDE reports covering the past 5 years of "anesthesia training," and "anesthesia pre-use check" were studied by 2 committee members and were subjectively found to contain few events in which more extensive, focused training would have likely prevented the incident. They did, however, find many instances that involved providers not doing what they should have done, with even basic training. More importantly, the 2 reviewers felt that such voluntarily reported databases would be unlikely to report failures of training; such data would rather be located in inaccessible risk-management files. Numerically, Olympio estimated that only 8% of the 225 reports could be related to ineffective (or lack of) training. Finally, Olympio reported on a recent "recommendation" to the ASA House of Delegates by the ASA Committee on Equipment and Facilities that, "The Committee on Standards and Practice Parameters draft a Practice Alert recommending training and demonstrated competence in the use of any particular type of anesthesia machine or workstation, as well as completion and documentation of a pre-use checkout of that workstation, before an anesthesia provider uses it to deliver patient care."
Urs R. Gsteiger, Esq., Horton and Gsteiger, P.L.L.C. of Winston-Salem, NC, repeatedly emphasized that there was not much case law involving the adequacy of technical training, and that the APSF was well ahead of the legal profession in discussing such matters. He described one example in which the lack of training on emergency operation of respiratory equipment was a cause of poor outcome and liability. Gsteiger noted that only one Federal statute, the Safe Medical Devices Act of 1990 is known to apply to such issues, but is directed to the manufacturer. This statute contains hospital reporting requirements, but does not contain direct training requirements. Furthermore, he commented that state medical boards could mandate licensure requirements for training, or could respond to complaints by taking action against improperly trained physicians, but no such activities were known to have occurred. Likewise, these actions have not been seen from other clinical providers, or from the Joint Commission. He suggested that hospital administrators, driven by medical staff or risk management, could effectively regulate device training, and that risk management is indeed where the database on lack-of-training issues is located. Gsteiger explained that hospital administration could force changes in credentialing if in fact the risk management group deemed that it were necessary. The legal issue that remains, however, is whether or not proper training would result in better outcomes. Only 2 reported cases in 50 states are known to have attributed liability secondary to lack of training, and they were described. Gsteiger emphasized that legal standards of care are based upon expert testimony by members of our own profession, and are not set by the jury. He then conjectured, "Does requiring training set a standard that otherwise may not exist?" Only the experts can testify that a failure to train violates the standard, and if influential groups mandate training, then it raises the possibility that such training does become a standard. In fact, Gsteiger argued that some professionals would already testify that training is mandatory. In summary, he recommended:
Gsteiger emphasized that if there were no adverse consequences for a failure to train, then it would not get done. Finally, he stated that clinicians should do what is safe and what we feel should be done.
George Elliott, Vice President, Volant Systems introduced himself as a 15-year instructor pilot with the Air National Guard, and a 21-year veteran pilot trainer with US Airways. He and his group developed the standard by which all current scheduled pilot instructors are graded, and he is a consultant to time-critical risk and resources industries such as the US Marines, Navy, trucking, and NASCAR. He likened our specialty to those, as we must also make risky decisions in time sensitive domains. From the beginning of aviation, the US government realized the military applications of flight, and therefore established control over training in the early 1920s. Having paid for training, they wanted evidence of its effectiveness, and a return on their money. Elliott reminded the audience that since pilots die of their own training deficiencies, they too supported the efforts to regulate training. In the early 1990s the US government could no longer keep up with demand, and relinquished control of training to the individual airline companies. The frequency of mandatory retraining was cut in half to once per year, and consisted of incident-based scenarios, derived exclusively from actual complications encountered the previous year. If new equipment instruction could be computerized, then it was placed into e-learning modules and sent electronically to pilots. Elliott described how most critical incidents and accidents were not related to equipment failure, but rather to pilot failure related to increasing task loading and distractions in the cockpit. He concluded with recommendations to
Robert A. Caplan, MD, member of the APSF Executive Committee and the ASA Closed Claims Project Committee stated that equipment claims have increased to 17% of the total 7,328 closed claims through 2004, in contrast to 9.5% in the 1980s and 1990s. Increasing complexity could be responsible, but gas delivery equipment problems still represent only a very small (2%) proportion of the total 7,328 claims. Caplan went on to describe the most frequent equipment claims arising from central venous and arterial access catheters, indicating that for all equipment claims, the clinician's conduct was judged to be less than standard of care more frequently (44%) than for non-equipment claims (34%). Although equipment claims paid more frequently (64% vs. 51%), they paid significantly lower amounts (28-31% of non-equipment claims), and clinician misuse was 3-times more common than pure equipment failure. Caplan emphasized that analysis of closed claims indicates that we should look for recurring patterns of injury within categories of equipment-related injury to determine what to train. For example, one-half of gas delivery equipment claims arise from the breathing circuit and caused death or brain damage in 75% of cases. Misuse of the anesthesia machine itself is very rare, occurring in only 2% of cases. After describing other injury patterns for vascular access and warming, Caplan recommended
He further indicated that misuse of equipment is frequently not reported in the literature.
Erwin R. Stainback, Director of Surgical Services, North Carolina Baptist Hospital, stated that training was a daunting task due to disparities in the influence the hospital has over the 4 types of anesthesia professionals (faculty, resident, CRNA, and student nurse anesthetist). In particular, his hospital has minimal influence over faculty physicians. Stainback described 4 examples of high technology device installations that required increasing numbers of support personnel as a substitute for adequate training. For example, currently 6 individuals and an additional 8 are being proposed to support the Surgical Information Systems (includes AIMS system), and they most frequently addressed issues related to inadequate training or understanding of the equipment. Similar needs were described for minimally invasive technologies, navigationally-assisted surgery equipment and laser technology, amounting to hundreds of thousands of dollars per year. Stainback explained that training accountability ultimately resides with the hospital Board and CEO, through the development of medical staff bylaws, and policy and procedure manuals, but effectively resides with the Chief CRNA, Resident Education coordinator, and Nurse Anesthesia Training Program coordinators, and Medical Staff leaders or Department chairs. He felt that practical simulation training was the most effective means, but highly inefficient as compared to classroom learning. Stainback described the impediments to training:
He noted that the enforcement of training could be accomplished as an initial requirement for employment, or through suspension of pay, withholding pay increases, revocation of privileges, and lower level case assignments. And, if training were to be mandated, its effects could be studied through analysis of sentinel events, reduced support calls, reduction in technical support, increased life of capital, and re-education rates. Finally, Stainback described 2 successful training programs with robotic surgery and terra-recon, which required a certification ID prior to use of the equipment. He provided a vivid personal example of how his lack of training in the operation of sophisticated and expensive sports cars prevented his full enjoyment and appreciation of their capabilities in a unique driving experience.
Dr. Raymond Roy, PhD, MD, professor and Chair of the Department of Anesthesiology, Wake Forest University School of Medicine was invited to deliberately present this contrarian view (acknowledging his prior statements in support of training mandates). Roy indicated that this contrarian stance is based upon a different view of the significance of the problem. He emphatically and strongly presented the contrarian case that we do not know with certainty either the numerator or the denominator for equipment-related malfunctions. Even if we did, the overall risk of surgery is related to many other things, including medical risk, surgical risk, and provider errors. He quoted a Thailand study indicating an equipment-related risk of death of only 1/101,350, which was magnitudes below the provider risk and still further below total risk. Arguing that the elimination of every equipment problem would not change overall risk, Roy challenged us to put our efforts into major, proven interventions for decreasing perioperative morbidity (e.g., use of beta-blockers, use of shorter-acting muscle relaxants, use of local anesthetics to prevent ileus, timing of antibiotics, and the prevention of hyperglycemia and hypothermia). Roy went on to challenge the aviation analogy to anesthesia as inaccurate, since it is the pilot's job to operate the device, and pilots have ample time to learn about that device. He rather used the analogy of a rental car, in that we do not require training before driving away, and condemned the "engineering manual" approach to machine training as being contextually unrelated to clinical care. Roy suggested that machine training be incorporated into the clinical context of case presentations, lectures, or simulations, since the implementation of wide-spread training is hampered by the logistics of practice type, number of devices, and technical support. At his institution, machine training would require nearly 300 clinician-days in the first year alone. In summary, Roy argued that:
Breakout group leaders were asked to consider the following issues within 4 separate audience groups:
The group first considered the validation of training programs and assessment tools, and had a number of recommendations:
They subsequently addressed the question of how to effect physician participation, commenting that making the training mandatory is naive and short-lived, and that it cannot be a long-term strategy; users must be motivated with incentives as a better and lasting plan. Eventually, peer pressure from a majority participation and credentialing, will lead to subsequent participation. Participation will be enabled markedly by standardization.
The initial part of the discussion centered on whether the design of the new advanced medical devices should be more simplistic so that less training would be required. Some advised that only innovations providing significant improvement in patient care or delivery of care should be introduced, as opposed to non-essential "flashy" features that increase the level of complexity. However, some industry representatives noted that the way they distinguish themselves from the competition is to provide these unique features. At a minimum, most members agreed that a standard nomenclature for features should be utilized, perhaps with help from the Data Dictionary Task Force. One example of the need for standardization was in the labeling of different ventilatory modes, such as SIMV.
Regarding the validation of training, many felt that knowledge and application skills could be combined into a single, more effective simulation test, as testing for knowledge alone frequently results in poor retention. Others noted that the number of calls to the company or super-user would be a very useful, objective measure of the adequacy of training. Participants expressed concern over the need for periodic retraining and new training as replacement machines are introduced.
The majority of the group believed that the Joint Commission would be the most appropriate regulatory body to oversee training for advanced medical devices, and, that hospitals would not necessarily support training for advanced medical devices unless it was required by the Joint Commission or some other entity such as P4P or Leapfrog group. The cost of such training would be assumed by the hospitals or provider group, and potentially transferred to the patient.
The question of how to effect physician participation was almost unanimously "mandatory training." Most group members did not think that physicians would spend the extra time for training if it were optional, and that perhaps it should be tied to the credentialing process. It was felt that the best way to initiate this process was to have entities such as the APSF make strong recommendations for it, with the ASA instituting standards or a patient safety initiative, and/or the Joint Commission or CMS requiring it.
The group discussed why physicians tended to be so noncompliant when training is offered but not required. The general consensus was that many feel that the use of devices is intuitive and that they simply don't need anyone to tell them what they can figure out for themselves. One quote was, "They think it's like video games," but, "many do not realize that newer machines are becoming increasingly complex." The feeling of this group was that training must be mandated to be effective and that the most likely body to be able to do that is the anesthesia department itself. The department is able to make its own requirements for membership and could penalize failures to attend mandated training through withholding of salary or deletion from the surgical schedule (for the self-employed). There was agreement that the stick works better than the carrot, and although equipment problems are rare, it does not mean we cannot require training. Departments mandate ACLS training all the time, even though cardiac arrests in the OR are rare events.
The group also discussed a recent training mandate in a large academic department for a new anesthesia machine. After some initial reluctance on the part of some group members, they all simply fell in line when it became apparent that there would be "no exceptions" to the decision by the department that training was compulsory and that there were economic consequences for failures to comply. Members of non-academic groups said they felt a similar approach would likely work in their own departments. There was further questioning about the knowledge/performance type of testing that followed the training, and these assessment tools were designed by the equipment company representatives and members of the department working together. Following training, the program simply issued a certificate of completion, arguing that it might confer less liability than a certification of competence. However, an attorney in the group questioned that supposition. The spokesperson for this program stated, "Partnering with the manufacturers was key," and they trained several super-users who then administered much of the training and testing to the rest of that department. Some group participants observed that training seemed to go better when provided by people who "do what you do" and who can answer clinical questions as well as questions about the machine itself.
The economics of equipment training was next discussed. Participants realized that anesthesia groups may want training for different reasons than do the manufacturers. They may be trying to prevent clinical problems while the manufacturers may be trying to prevent service calls and technical questions. Clearly, the training needs to meet the needs of both while still being time and cost efficient. Ultimately the purchasing group pays for the training, but there was a consensus that this should probably be bundled in with the cost of the equipment "at a high enough level" rather than as a line item, so that there isn't a tendency to scrimp on training in order to save money. One group member commented that training should be more modern and accessible to physicians in the OR. Since most anesthesia providers are quite computer literate, training could be available online. (Although many ORs now have Internet access, it was felt attention should not be diverted from patient care for this process.) Having computer training online would make it easier for locum-tenens who might be coming into the department to train at home in advance of their scheduled OR time.
Finally, the group suggested and agreed that the APSF should issue an opinion piece, perhaps in their Newsletter, regarding the necessity of mandatory training so that anesthesia department heads can start thinking about how they might implement this in their own facilities. This group included the representative from The Joint Commission to the APSF, who stated in response to a question, that The Joint Commission would not usually get involved at this point in time, but if "leaders such as this organization" or other designated "experts" developed a consensus that technical training was crucial, then The Joint Commission might step in to require it of all accredited facilities. The comment was made that although equipment problems have been rare, they are likely to increase with increasing complexity of machine design unless we do something now about training.
Several key points were discussed by this group:
A brief audience discussion period followed the group presentations. Participants stated that it would take progressive thinkers to move such an effort forward, but insurance companies could propel such an effort by reducing premiums for those who participate. Another comment emphasized the necessity for clinician "buy-in" first, then mandate, such that professionals would have the opportunity to control, modify, and improve their own training requirements. Several echoed the sentiment that the failure of faculty participation in the Wake Forest pilot program was the result of a failure to consult with the participants first, and that such a buy-in was recommended by 2 speakers, Coyle and Roy. A stated perception of arrogance on the part of physicians who refused training was challenged by others, with the assertion that non-conformists might well be highly-trained, respected, and professional clinicians. Still others felt that general apathy was a leading cause of non-attendance at training sessions. An assertion that pilots had lots of time to train was challenged by an acknowledgement of their being frequently away from home even while not flying. Finally, in a requested show of hands as to who would favor recommending mandatory training requirements, all hands rose in favor of mandating training with the exception of only 1 attendee, who felt that the workshop presentations did not provide sufficient evidence to require mandated training.
In consideration of 1) the increased complexity of modern anesthesia equipment, 2) a preponderance of human error as a cause of relatively infrequent equipment-related failure, 3) the inadequacies of conventional in-service training and failures to complete non-mandated training, 4) the advantages of, but paucity of scientific evidence for intensive and directed training, and 5) medico-legal perspectives on training, the APSF makes the following recommendations:
Although existing literature does not describe frequent adverse anesthesia events owing to the anesthesia professional's lack of understanding of equipment, the APSF believes the logic is compelling to require confirmation of competency before using unfamiliar and/or complex anesthesia equipment that can directly affect patient safety. In this regard, the APSF believes that each facility should develop a required, formal process to assure that anesthesia professionals have received appropriate training and/or demonstrated competence in the use of such medical devices. Manufacturers should refine and initially offer this training. This required process for administering training and/or for demonstrating competence should be efficient, timely, and pertinent in addressing new critical features and relevant failure modes. The most effective manner to successfully accomplish this training and testing is not known and requires deliberate investigation.