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Describes simulation-based learning in medical education and presents four these that make a framework for simulations: (1) best standards of care and training; (2) error management and patient safety; (3) patient autonomy; and (4) social justice and resource allocation. (SLD)

The difficulties in identifying adverse effects of medical devices are described, based on a study published in 2004. The researchers used several different systems to identify medical device adverse events, but no one system was able to identify all the adverse events. Advances in reporting tools may make it easier to collect data on medical device adverse events.

Adverse drug reactions may substantially increase the cost of care for hospitalized patients. Over a 6-month period, 190 patients at two teaching hospitals experienced adverse drug events (ADEs). Sixty of those reactions were avoidable. Compared with similar patients not experiencing an ADE, experiencing an ADE increased the length of hospital stay by an average of two extra days and costs by $2,600. Preventable ADEs increased hospital stay by 4.5 days and increased costs by $4,700. Costs do not include costs of injuries to patients or malpractice costs., Objective.--To assess the additional resource utilization associated with an adverse drug event (ADE). Design.--Nested case-control study within a prospective cohort study. Participants.--The cohort included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary-care hospitals over a 6-month period. Cases were patients with an ADE, and the control for each case was the patient on the same unit as the case with the most similar pre-event length of stay. Main Outcome Measures.--Postevent length of stay and total costs. Methods.--Incidents were detected by self-report stimulated by nurses and pharmacists and by daily chart review, and were classified as to whether they represented ADEs. Information on length of stay and charges was obtained from billing data, and costs were estimated by multiplying components of charges times hospital-specific ratios of costs to charges. Results.--During the study period, there were 247 ADEs among 207 admissions. After outliers and multiple episodes were excluded, there were 190 ADEs, of which 60 were preventable. In paired regression analyses adjusting for multiple factors, including severity, comorbidity, and case mix, the additional length of stay associated with an ADE was 2.2 days (P=.04), and the increase in cost associated with an ADE was $3244 (P=.04). For preventable ADEs, the increases were 4.6 days in length of stay (P=.03) and $5857 in total cost (P=.07). After adjusting for our sampling strategy, the estimated postevent costs attributable to an ADE were $2595 for all ADEs and $4685 for preventable ADEs. Based on these costs and data about the incidence of ADEs, we estimate that the annual costs attributable to all ADEs and preventable ADEs for a 700-bed teaching hospital are $5.6 million and $2.8 million, respectively. Conclusions.--The substantial costs of ADEs to hospitals justify investment in efforts to prevent these events. Moreover, these estimates are conservative because they do not include the costs of injuries to patients or malpractice costs. JAMA. 1997;277:307-311

Injury due to errors in drug prescribing and usage is common and preventable. Researchers examined 247 adverse drug events (ADEs) and 194 potential ADEs reported in a six month period at two large Massachusetts hospitals. An ADE is defined as an injury from a drug which is administered medically. Of the adverse drug events 70 were considered preventable. In 83 of the potential ADEs, mistakes were recognized before the drug was given. A total of 101 drugs were used in the 247 ADEs. The most common drugs involved were were morphine, meperidine, and oxycodone. The rate of ADEs was highest in intensive care units. The most serious ADEs tended to be the most preventable. Preventable ADEs appear to be commonly caused by ordering errors, especially incorrect drug dosages. The mistakes are costly to the health care system, and are a major cause of hospital injuries. Better delivery systems should be developed that will spot errors., Objectives. - To assess incidence and preventability of adverse drug events (ADEs) and potential ADEs. To analyze preventable events to develop prevention strategies. Design. - Prospective cohort study. Participants. - All 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical intensive care units and four medical and two surgical general care units. Main Outcome Measures. - Adverse drug events and potential ADEs. Methods. - Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented ADEs or potential ADEs and as to severity and preventability. Results. - Over 6 months, 247 ADEs and 194 potential ADEs were identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential ADEs per 100 nonobstetrical admissions, for mean numbers per hospital per year of approximately 1900 ADEs and 1600 potential ADEs. Of all ADEs, 1% were fatal (none preventable), 12% life-threatening, 30% serious, and 57% significant. Twenty-eight percent were judged preventable. Of the life-threatening and serious ADEs, 42% were preventable, compared with 18% of significant ADEs. Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%); transcription (6%) and dispensing errors (4%) were less common. Errors were much more likely to be intercepted if the error occurred earlier in the process: 48% at the ordering stage vs 0% at the administration stage. Conclusion. - Adverse drug events were common and often preventable; serious ADEs were more likely to be preventable. Most resulted from errors at the ordering stage, but many also occurred at the administration stage. Prevention strategies should target both stages of the drug delivery process. (JAMA. 1995;274:29-34)

Improvements in delivery systems are needed to control the number of errors made in the ordering, dispensing and administering of drugs. Systems should be designed that discourage mistakes and allow for quick detection of errors. A total of 334 errors were linked to 264 preventable adverse drug incidents in a six-month period at two large hospitals. Thirty-nine percent of the errors were found in physician ordering. Lack of knowledge about the drug was the most common cause, accounting for 98 errors. Systems that assure the right drug is given in proper dosage appeared deficient, causing 40 errors. Other significant mistakes were attributed to the lack availability of patient information, faulty transcription of physicians' orders and patient allergy information. Nurses often interceded in correcting physician's orders., Objective. - To identify and evaluate the systems failures that underlie errors causing adverse drug events (ADEs) and potential ADEs. Design. - Systems analysis of events from a prospective cohort study. Participants. - All admissions to 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Main Outcome Measures. - Errors, proximal causes, and systems failures. Methods. - Errors were detected by interviews of those involved. Errors were classified according to proximal cause and underlying systems failure by multidisciplinary teams of physicians, nurses, pharmacists, and systems analysts. Results. - During this period, 334 errors were detected as the causes of 264 preventable ADEs and potential ADEs. Sixteen major systems failures were identified as the underlying causes of the errors. The most common systems failure was in the dissemination of drug knowledge, particularly to physicians, accounting for 29% of the 334 errors. inadequate availability of patient information, such as the results of laboratory tests, was associated with 18% of errors. Seven systems failures accounted for 78% of the errors; all could be improved by better information systems. Conclusions. - Hospital personnel willingly participated in the detection and investigation of drug use errors and were able to identify underlying systems failures. The most common defects were in systems to disseminate knowledge about drugs and to make drug and patient information readily accessible at the time it is needed. Systems changes to improve dissemination and display of drug and patient data should make errors in the use of drugs less likely. (JAMA. 1995;274:35-43)

Situation awareness has primarily been confined to the aviation field. We believe that situation awareness is an equally important characteristic in the complex, dynamic, and risky field of anesthesiology. We describe three aspects of situations of which the decision maker must remain aware: subtle cues, evolving situations, and special knowledge elements. We provide examples of real or simulated anesthesia situations in which situation awareness is clearly involved in the provision of optimal patient care, and we map the elements of situation awareness onto a cognitive process model of the anesthesiologist. Finally, we consider how situation awareness can be further investigated and taught in this medical domain using anesthesia simulators and analyses of real cases. The study of situation awareness in anesthesiology may provide a good example of the wider application of the concept of situation awareness to nonaerospace environments.

Continuous quality improvement is an accepted mandate in healthcare services. The delivery of the best, evidence based quality of care ultimately depends on the competences of practitioners as well as the system that supports their work. Medical education has been increasingly called upon to insure providers possess the skills and understanding necessary to fulfill the quality mission. Patient safety has in the past five years rapidly risen to the top of the healthcare policy agenda, and been incorporated into quality initiatives. Demand for curricula in patient safety and transfer of safety lessons learned in other risky industries have created new responsibilities for medical educators. Simulation based medical education will help fill these needs. Simulation offers ethical benefits, increased precision and relevance of training and competency assessment, and new methods of teaching error management and safety culture.Established and successful simulation methods such as standardized patients and task trainers are being joined by newer approaches enabled by improved technology. [ABSTRACT FROM AUTHOR]

Medical training must at some point use live patients to hone the skills of health professionals. But there is also an obligation to provide optimal treatment and to ensure patients' safety and well-being. Balancing these 2 needs represents a fundamental ethical tension in medical education. Simulation-based learning can help mitigate this tension by developing health professionals' knowledge, skills, and attitudes while protecting patients from unnecessary risk. Simulation-based training has been institutionalized in other high-hazard professions, such as aviation, nuclear power, and the military, to maximize training safety and minimize risk. Health care has lagged behind in simulation applications for a number of reasons, including cost, lack of rigorous proof of effect, and resistance to change. Recently, the international patient safety movement and the U.S. federal policy agenda have created a receptive atmosphere for expanding the use of simulators in medical training, stressing the ethical imperative to "first do no harm" in the face of validated, large epidemiological studies describing unacceptable preventable injuries to patients as a result of medical management. Four themes provide a framework for an ethical analysis of simulation-based medical education: best standards of care and training, error management and patient safety, patient autonomy, and social justice and resource allocation. These themes are examined from the perspectives of patients, learners, educators, and society. The use of simulation wherever feasible conveys a critical educational and ethical message to all: patients are to be protected whenever possible and they are not commodities to be used as conveniences of training.