Safety & quality: Overview

Sugammadex has been used for more than ten years in Australia and New Zealand and has been implicated as an effective treatment, and in some cases a potential cause, of a critical incident. We aimed to identify and analyse critical incidents involving sugammadex reported to webAIRS, a de-identified voluntary online critical incident reporting system in Australia and New Zealand. We identified 116 incidents where the reporter implicated sugammadex as either a cause (23 cases) or a treatment (93 cases) during anaesthesia. There were 17 incidents suggestive of sugammadex anaphylaxis, although not all were confirmed by skin testing. There were six incidents when bradycardia was temporally related to sugammadex administration, although it was not possible to exclude other causes or contributory factors. There were nine incidents in which sugammadex was used to reverse aminosteroid-related neuromuscular blockade successfully in a 'can't intubate, can't oxygenate' (CICO) situation, and a further 67 incidents in which sugammadex was used to reverse aminosteroid neuromuscular blockade as part of the management of other critical incidents. While sugammadex was used during the management of 16 cases of anaphylaxis, there was no clear indication that this altered the course of the anaphylaxis in any of the cases. These reports indicate that sugammadex can be a potential trigger for anaphylaxis and that its use may be associated with the development of significant bradycardia. However, it is not possible to estimate or even speculate on the incidence of these sugammadex-related incidents on the basis of voluntary reporting to a database such as webAIRS. The reports also indicate that sugammadex has been used successfully to reverse residual or deep aminosteroid neuromuscular blockade in critical incident situations and to help rescue CICO scenarios. These findings provide further support for ensuring the ready availability of sugammadex wherever aminosteroid muscle relaxants are used.

Abstract
This cross-sectional overview of the second 4000 incidents reported to webAIRS has findings that are very similar to the previous overview of the first 4000 incidents. The distribution of patient age, body mass index and American Society of Anesthesiologists physical status was similar, as was anaesthetist gender, grade, location and time of day of incidents. About 35% of incidents occurred during non-elective procedures (vs. 33% in the first 4000 incidents). The proportion of incidents in the various main categories was also similar, with respiratory/airway being most common, followed by cardiovascular, medication-related and medical device or equipment-related incidents. Together these categories made up about 78% of all incidents in both overviews. The immediate outcome was comparable with reports of harm in about a quarter of incidents and a similar rate of deaths (4.7% vs. 4.2%). However, the proportion of patients who had received total intravenous anaesthesia was higher (17.6% vs. 7.7%) and the proportion of patients who received combined intravenous and inhalational anaesthesia was lower (52.3% vs. 58.4%), as was the proportion receiving local anaesthesia alone (1.6% vs. 6.7%). There was a small increase in the number of incidents resulting in unplanned admission to a high dependency or intensive care unit (18.1% vs. 13.5%). It is not clear whether these differences represent trends or random observations. About 48% of incidents were considered preventable by the reporters (vs. 52% in the first 4000). These findings support continued emphasis on human and system factors to promote and improve patient safety in anaesthesia care.