Safety & quality resources: Overview

Abstract
Purpose: Desflurane is a widely used volatile anesthetic with multiple clinical advantages, but comprehensive pharmacovigilance analyses are needed to optimize its safety profile. This study aimed to analyze and classify adverse events(AEs) associated with desflurane in the Food and Drug Administration Adverse Event Reporting System(FAERS) database and evaluate potential safety signals.

Patients and methods: We analyzed FAERS reports from 2004Q1 to 2025Q1 where desflurane was the primary suspect(PS) drug. Cases were classified using Medical Dictionary for Regulatory Activities (MedDRA27.1) terminology and processed following FDA-recommended deduplication strategy. Four disproportionality analyses were conducted: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results: Among 1,191 cases, bradycardia was most frequent (n = 39; ROR = 38.72, 95% CI 28.14-53.28) with 79.4% classified as serious. Notable findings included anaphylactic shock (n = 23; 69.6% serious), bronchospasm (n = 22), and malignant hyperthermia(MH) (n = 20; 25% mortality). Acute respiratory distress syndrome (ARDS) (n = 2) and disseminated intravascular coagulation (DIC) (n = 2) were documented - a previously unreported association with desflurane exposure.

Conclusion: Our analysis reveals clinically significant safety signals associated with desflurane, including cardiovascular, anaphylactic, and respiratory complications that may require enhanced perioperative monitoring. The study underscores the critical importance of sustained post-marketing surveillance for detecting rare but serious safety signals, not typically evident in pre-approval clinical trials.

Abstract
When planning surgical procedures for patients with conventional pacemakers, leadless pacemakers, cardiac resynchronization therapy devices, or implantable cardioverter-defibrillators, it is imperative to assess the risk of electromagnetic interference to ensure the safe functioning of these cardiac implantable electronic devices (CIEDs) during surgery. This paper explores the strategies for managing both conventional CIEDs and leadless devices during such procedures, emphasizing the importance of the preoperative evaluation, appropriate device programming, intraoperative monitoring, and postoperative evaluation. This report highlights the critical role of collaboration with cardiology and the CIED team in ensuring patient safety during surgical procedures. Ultimately, diligent intraoperative management, adherence to guidelines when available, and preparedness to address any complications are essential for protecting CIED function during surgical procedures.

Abstract
Anaesthetic airway incidents persist as a significant concern in patient safety and, despite extensive investigations, continue to cause patient harm. Traditional safety investigations predominantly adhere to Safety-I principles, focusing on identifying and rectifying errors, often yielding limited new findings. In this analysis conducted within the webAIRS database, the focus shifted towards Safety-II principles. The aim of this study was to identify factors contributing to airway management safety by examining incidents that did not result in adverse patient outcomes. Incidents categorised as 'difficult intubation' or 'failed intubation' without causing harm to the patient and reported to webAIRS between 2016 and 2022, were included in the analysis.An inductive qualitative content analysis of narrative data from 129 such incidents revealed that the majority of reported events depicted scenarios deviating from controlled and planned circumstances. During the analysis four themes were identified: patient factors, system factors, individual anaesthetist factors and airway management strategy. Within the first three themes, multiple factors were linked to airway management strategies. The findings of this qualitative analysis show that 'Work as done' often differs from 'Work as imagined'.This qualitative analysis highlighted the dynamic nature of human management, as individuals respond to unplanned or unexpected events, showcasing adaptability and positive contributions to incident performance. Expanding the understanding of patient safety to also include Safety-II principles, provides a deeper and wider understanding of airway management safety.