Preventable deaths involving surgery: a systematic analysis of coroners’ case reports in England and Wales 2013-2023
Creators: name: Aronson, Jeffrey K
name: Richards, Georgia C.
name: Heneghan, Carl
name: Bremner, Benjamin Taylor
Publisher: name: Open Science Framework
Year: 2023
Subjects: subject: Public Health
subject: Medicine and Health Sciences
subject: Surgery
subject: Medical Specialties

description: 1.0 Background Globally, 313 million surgical procedures are performed each year (1). However, of those 4.2 million people die within 30 days of the operation (2). In England and Wales over 3.1 million surgical procedures were undertaken in 2020 (3). It is estimated that in the United Kingdom (UK) death occurs within 30 days after 1.1% of operations and within 90 days after 2.3% (4). A systematic review and meta-analysis in medical settings suggests that preventable patient harm is more prevalent in surgical settings (10%) than in the overall patient population (6%) (5). Similarly, a retrospective case record review of acute hospitals in England showed that patients admitted under surgical specialists were more likely to have a preventable death than those under medical ones (6). Although evidence hints at an important association between surgery and preventable deaths, the operations involved, the types of harms that lead to death, and the reasons for such harms remain underexplored. Unlike pharmacological interventions, which have robust regulatory processes and national agencies (e.g. the Medicines and Healthcare products Regulatory Agency - MHRA), the regulation of surgical interventions is more complex (7). Surgeons are regulated by the General Medical Council (GMC) and hospitals are reviewed by various bodies, including the Care Quality Commission (CQC) (8). The Royal College of Surgeons and specialty associations provide guidance on surgical practice (9). However, there is no single overarching vigilance system for collecting harms from all surgical procedures to improve learning. For medical products, the MHRA’s Yellow Card Scheme collects information on suspected harms from healthcare products in the UK, including medications, vaccines, and medical devices (10). Both the public and healthcare professionals can report safety concerns, such as a suspected adverse reaction to a medication. Surgical registries in the UK are used to collect information about outcomes of specific surgical procedures; these include the National Joint Registry (NJR), the National Hip Fracture Database (NHFD), and the National Bariatric Surgery Registry (NBSR) (11). Since 1984, coroners in England and Wales have had a duty to report and communicate details of deaths when the coroner believes that action should be taken to prevent future deaths (12). Prevention of Future Deaths reports, henceforth referred to as PFDs, were introduced to provide coroners with an official system for reporting such deaths. PFDs are mandated under Paragraph 7 of Schedule 5 of the Coroners and Justice Act 2009, and under Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 (13,14). If a coroner deems that a death could have been prevented, it is their duty to write a PFD and to send it to individuals and/or organisations that are capable of action. When a person or organisation receives a PFD report from a coroner, they have 56 days in which they must respond by statute. The PFD system has three processes: 1) coroners generate PFDs and send them to relevant parties; 2) recipients respond to concerns raised in PFDs and propose actions; 3) recipients undertake proposed actions to prevent similar deaths. A narrative review of studies investigating PFDs identified 17 publications that examined PFDs (15). Most included studies explored preventable deaths involving medicines (n=8; 47%). The review explored the strengths and limitations of PFDs and showed that PFDs offer important information that could support hospitals to improve patient safety. However, the review also identified inconsistent reporting, low response rates to PFDs, and difficulty in accessing, analysing, and monitoring PFDs, which currently limits their use. Deaths involving surgery had not yet been researched. Investigation of PFDs involving surgery could provide insights for improving patient safety as well as an approach for vigilance to improve learning and reduce risks for individuals undergoing surgery.