William M. Gild

A Comparison of Pediatric and Adult Anesthesia Closed Malpractice Claims

BackgroundSince 1985, the Committee on Professional Liability of the American Society of Anesthesiologists has evaluated closed anesthesia malpractice claims. This study compared pediatric and adult closed claims with respect to the mechanisms of injury, outcome, the costs, and the role of care judged to be substandard. MethodsUsing a standardized form and method developed for analysis of closed claims, the American Society of Anesthesiologists Closed Claims Data Base was used to compare pediatric with adult anesthesia-related adverse events. ResultsOf the 2,400 total claims, 238 (1096) were in the pediatric age group (15 yr of age or younger). The pediatric claims presented a different distribution of damaging events compared with that of adults. In particular, respiratory events were more common among pediatric claims (43% versus 30% in adult claims; P ≤. 0.01). The mortality rate was greater in the pediatric claims (50% versus35% in adult claims; P≤ 0.01), anesthetic care more often was judged less than appropriate (54% versus 44% in adult claims; P ≤ 0.01), the complications more frequently were thought to be preventable with better monitoring (45% versus 30% in adult claims; P≤ 0.01), and the distribution of payments to the plaintiff was different (median payment,

Burns from warming devices in anesthesia. A closed claims analysis.

111,234 versus

Linking process and outcome of care in a continuous quality improvement program for anesthesia services.

90,000 in adult claims; P ≤ 0.05). Many of the differences between pediatric and adult claims were explained by a higher prevalence of patient injury caused by inadequate ventilation in the pediatric claims (20% versus 9% in adult claims; P ≤ 0.01). In pediatric compared with adult inadequate ventilation claims, poor medical condition and/ or obesity (6% versus 41%; P ≤ 0.01) were uncommon associated factors. Cyanosis (49%) and/or bradycardia (64%) often preceded cardiac arrest in pediatric claims related to inadequate ventilation, resulting in death (70%) or brain damage (30%) in previously healthy children. Although clinical clues suggested hypoxemia as a common mechanism of injury, the files did not contain enough information to explain the genesis of hypoxemia in these claims. ConclusionsComparison of adult and pediatric closed claims revealed a large prevalence of respiratory related damaging events—most frequently related to inadequate ventilation. In the opinion of the reviewers, 89% of the pediatric claims related to inadequate ventilation could have been prevented with pulse oxlmetry and/or end tidal CO2 measurement. However, pulse oximetry appeared to prevent poor outcome in only one of seven claims in which pulse oximetry was used and could possibly have done so.

Risk Management in Cardiac Anesthesia: The ASA Closed Claims Project Perspective

Background:Prevention of hypothermia is an important aspect of anesthetic management. Methods used for its prevention may, however, cause cutaneous burns. We reviewed the American Society of Anesthesiologists (ASA) Closed Claims Project database to determine if there were recurrent patterns of injury arising from intraoperative warming methods. Methods:The ASA Closed Claims Project database is a collection of closed malpractice claims that have been reviewed in a standardized format. All claims for burns were reviewed. Results:Among the 3,000 total claims there were 54 burns, of which 28 resulted from materials or devices used to warm patients. Intravenous fluid bags or bottles warmed in an oven and then applied to the patients skin were responsible for 18 of the 28 (64%) burns associated with warming devices. These burns from intravenous fluid bags or bottles occurred in predominantly healthy (ASA physical status 1-2) young (age 38 ± 17 yr, mean ± standard deviation) women undergoing routine gynecologic or peripheral orthopedic surgery under general anesthesia. Of the eight burns from electrically powered warming equipment, five resulted from circulating-water mattresses. Conclusions:Intravenous fluid bags or bottles warmed in an operating room oven represent a hazard to anesthetized patients. Because intravenous fluid bags or bottles are not an efficient method of patient warming, there seems to be little justification for their use.

Conventional neuromuscular monitoring versus acceleromyography: it's not the monitor but the anesthetist.

We developed a continous quality improvement (CQI) program for anesthesia services based on self- reporting of critical incidents and negative outcomes through a dichotomous (yes/no) response on the anes thesia record. Immediate case investigation provides data for systematic peer review of anesthesia man agement. Trend analysis of the database of critical incidents and negative outcomes identifies opportu nities for improvement. The CQI program resulted in the reporting of nearly twice as many problems re lated to anesthesia management (5% of all anes thetics) as did the checklist it replaced (2.7%). Esca lation of patient care (3.2%) and operational ineffi ciencies (2.2%) were more common than patient injury (1.5% of all anesthetics). Among the 537 cases with anesthesia management problems were 119 hu man errors and equipment problems (22%). Regional nerve blocks and airway management represented the most common problem areas. Improvement in anesthesia services was made through prompt imple mentation of strategies for problem prevention de vised by the practitioners themselves through peer review, literature review, and clinical investigations.

Eye injuries associated with anesthesia

The ASA Closed Claims Project has generated a standardized collection of case summaries of adverse anesthetic outcomes, with the objectives of identifying major areas of anesthesiologist liability and the contribution of substandard care to anesthetic injury. Seventy-six (3%) of the files in the projects current database of over 2,400 case summaries are for anesthesia-related injuries sustained during cardiac surgery. The most common adverse outcomes in the cardiac surgical group were death (36%), brain damage (16%), stroke (13%), and nerve damage (11%). Equipment malfunction or misuse was responsible for 37% of the adverse outcomes in the cardiac group, compared with only 9% in the noncardiac group (P = < 0.01). Conversely, respiratory-related damaging events were responsible for only 9% of adverse outcomes in the cardiac group, compared with 32% of adverse outcomes in the noncardiac claims (P = < 0.01); incidences of damaging events related to the cardiovascular system and those events related to inadequate or inappropriate fluid therapy were similar in both groups. Although there are several important limitations intrinsic to closed-claims analysis, data from the Closed Claims Project suggest that careful attention to IV catheter management and cardiopulmonary bypass equipment will reduce the risk of injury to patients.

Substance abuse among anesthesiologists.

In Reply:—We appreciate Drs. Fisher’s and Shafer’s interest in our work. We agree with their view that our model did not optimally fit all data points. There is a large variation in the placebo and 2.0 mg/kg group, and it was difficult to define a model that optimally fits these data points. For higher doses of sugammadex, the model fits the data very well. We have conducted a Phase 2 clinical trial. Those studies attempt to learn what is a good (if not optimal) drug regimen to achieve useful clinical value (acceptable benefit/risk). In contrast to the confirming phases of drug development, the learning phases entail so-called explanatory analyses; i.e., analyses that estimate the quantitative relationship between inputs and outcomes according to some mechanistic view of the relationship. In a Phase 2 study, a nominal design, including all ostensibly controllable factors affecting the conduct of the trial, is an abstract ideal. In fact, in any real study, deviations from nominal design are inevitable. We decided to apply the model to our data which has been defined a priori, and has been used for several data sets on sugammadex which already have been published. We did not want to retrospectively change the predefined approach of our statistical efficacy analysis. In future confirmatory studies on sugammadex it will be possible to develop and apply a more sophisticated model. The suggestions of Drs. Fisher and Shafer will be very useful in that context. Karin S. Khuenl-Brady, M.D., D.E.A.A.,* Matthias Eikermann, M.D., Ph.D. *Medical University Innsbruck, Innsbruck, Austria. karin.khuenlbrady@i-med.ac.at