Authors' objectives: In health care, errors could have serious consequences for patients and staff. High-risk industries, such as aviation, have improved safety by taking a systems approach, known as safety management systems. Safety management systems are generally considered to have four key components: leadership commitment and safety policy; safety risk management; safety assurance; and safety culture. Safety management systems need to be context-specific to be effective. Evidence on the use of safety management systems in health care is therefore needed to inform policy decisions. To investigate the application of safety management systems to patient safety in terms of effectiveness, implementation and experience. In health care, failures or errors could have serious consequences for patients, staff or the environment. Safety incidents in health care include medication errors, wrong site surgery and lack of a timely response to deterioration in a patient’s condition. Despite efforts to improve patient safety, harm still occurs to patients each year. For example, in 2020, it was estimated that 237 million medical errors occur annually in England, contributing to more than 1700 deaths. Safety in a healthcare setting is the prevention or avoidance of harm and is normally considered to be a component of the provision of quality health care. Quality health care is defined by the World Health Organization as health care or services which are effective, safe, people-centred, timely, equitable, integrated and efficient. The aim of quality health care is to achieve the desired health outcomes. Other industries where safety is a priority, such as aviation, have improved safety by taking a systems approach operationalised in the form of a safety management system (SMS). A SMS is an organised approach to managing safety and is generally considered to have four key components: leadership commitment and safety policy – an expressed leadership commitment to safety with documentation of responsibilities and processes for safety within an organisation safety risk management – the identification of hazards and risk, and assessment of how to mitigate these safety assurance – monitoring and measuring safety within the organisation and ensuring continuous improvement safety promotion and culture – training, education and communication of safety to staff at all levels. Safety management systems take a performance-based approach, with the underlying theory being that by focusing on monitoring and achieving desired outcomes rather than being based solely on compliance with policies or standards, they facilitate improvement. A systematic review published in 2012 of SMS in three safety-critical industries – aviation, marine and rail – concluded that the approach led to improvements in safety (e.g. reduced accident rates). While the basic principles of a SMS are transferrable, the details need to be context-specific to be effective. Evidence on the use of SMS in health care is therefore needed to support their effective implementation. The purpose of the review was to inform UK NHS patient safety policy and practice, by drawing on the experience of other countries where a SMS approach, or some of its principles, have been implemented in the context of health care, focusing on how this can be influenced or co-ordinated nationally. The review aimed to answer the following question: In selected countries, to what extent and in what ways is patient safety policy and strategy based on a SMS approach and what is the evidence supporting implementation and impact? Within this broad research question, we aimed to answer three specific questions: How are the components of SMS reflected in the healthcare policy documents of selected countries (see below), or their regional healthcare systems? What research or other relevant evidence is available regarding the effectiveness, implementation or experience of SMS within health care? What does existing research and other relevant evidence from the included countries tell us about the effectiveness, implementation or experience of SMS within health care?

Authors' results and conclusions: Fifty-three publications were included, from Australia (5), Canada (7), Ireland (8), New Zealand (9) and the Netherlands (24). The Netherlands was the only country with a patient safety programme explicitly based on a safety management system approach. The programme was associated with improvement in some aspects of patient safety in hospitals but there was significant variation in its implementation and outcomes. The main components of a safety management system were also identified to some extent in the patient safety approaches of the other four countries, along with evidence of influence from high-risk industries and ‘safety science’ more widely. Only the Dutch patient safety programme was explicitly based on a safety management system approach. Concepts from high-risk industries and broader safety science had influenced the patient safety approach in the other countries, and the ongoing approach in the Netherlands, but this was less systematic and explicit. Approaches to patient safety in all countries reflect increasing awareness that for an initiative to be successful, it needs to be context-specific. Fifty-three publications were included, from Australia (5), Canada (7), Ireland (8), New Zealand (9) and the Netherlands (24). Twenty-five of those were research or evaluations; the rest were policy (26) or other (2) types of documents. Of the five included countries, the Netherlands was the only country which had introduced a National Patient Safety Programme (2008–12) explicitly based on a high-risk industry SMS approach. The programme was based on two pillars: all Dutch hospitals were required to have a certified SMS and to implement patient safety recommendations focusing on 10 high-priority themes (e.g. medication safety). The scope of the SMS was gradually extended to make the system more comprehensive. Specific objectives were set for each theme; an overarching target of reducing hospital-based, potentially preventable adverse events and mortality by 50% by 2013 was also agreed. Multiple studies evaluated the implementation and impact of the programme. Of note, a longitudinal review of patient records called Healthcare-related Harm Monitor (Monitor Zorggerelateerde Schade in Dutch) was conducted every 4 years to capture the impact on potentially preventable adverse events and mortality at a national level. The scope of the Monitor was gradually expanded to include specific topics of interest (e.g. technology-related adverse events, medication safety, vulnerable older people and the quality of patient records). Another longitudinal study measured the impact of the programme on safety culture. An in-depth evaluation of the implementation of the themes was carried out in the last year of the programme (2011–2). Additional evaluations were conducted after 2012 focusing on specific themes, some of which were carried out from both a Safety-I and Safety-II perspective and included interventional elements. Analysis of data from 2011 to 2012 showed a 45% decrease in the proportion of patients experiencing potentially preventable adverse events (out of all hospital admissions): from 2.9% [95% confidence interval (CI) 2.3% to 3.7%] in 2008 to 1.6% (95% CI 1.1% to 2.2%) in 2011–2 (p 

Authors' methods: We conducted a systematic review of research and other evidence from high-income countries that have publicly funded healthcare systems with universal coverage and key evidence available in English. We included Australia, Canada, Ireland, New Zealand and the Netherlands. We searched the websites of, and contacted experts from, patient safety organisations in each country, and searched MEDLINE (December 2023) and EMBASE (via Ovid), Cumulative Index to Nursing and Allied Health Literature (EBSCO) and Web of Science (February 2024). We included policy documents, research and other evidence relating to the effectiveness, implementation or experience of the safety approach in each country. We summarised and mapped included evidence onto an initial framework based on analysis of safety management systems in high-risk industries. We shared drafts with experts in each country for comment. No standardised quality appraisal was conducted but those studies evaluating impact were critically examined for risk of bias. Although we followed best practice for conducting systematic reviews, some limitations should be acknowledged. We did not conduct formal quality appraisal, but the risk of bias in studies evaluating impact was examined. We also tried to mitigate the risk of partial understanding (from the use of policy documents) by talking to experts from each country. We conducted a systematic review of evidence from English-speaking countries, or countries where most of the key policy documents and research papers are available in English. We included only high-income countries that have publicly funded healthcare systems with universal coverage, as the evidence from such countries is most relevant to the UK context. The following countries were included: Australia, Canada, Ireland, New Zealand and the Netherlands. The UK was not included as the review aimed to inform NHS policy and practice by drawing on the experience of other countries. We searched the websites of, and contacted, national patient safety organisations from these countries to identify key policy documents and evidence that might not be captured through database searches. Online meetings with experts from the respective countries were held to understand the context within each country and identify further sources of evidence. We also searched MEDLINE (in December 2023) and EMBASE (via Ovid), Cumulative Index to Nursing and Allied Health Literature (EBSCO) and Web of Science (WoS): Core collection (in February 2024). Two reviewers independently screened all identified records at title/abstract level and the full texts of the records selected in the first round. We included policy documents, research and other relevant evidence relating to the effectiveness, implementation or experience of the SMS or safety approach in the respective healthcare system. Data were extracted from each included publication by one reviewer and checked by a second reviewer. No formal, standardised quality appraisal was carried out, but we examined and reported the risk of bias in studies evaluating impact. We reviewed policy documents and research papers from high-risk industries (focusing on aviation, oil and gas and nuclear energy) and developed an analytical framework to guide data extraction and narrative synthesis. We adopted a case-study approach whereby the patient safety approach in each country was described and analysed separately. Draft descriptions of the patient safety approach taken in each country were shared with experts from the respective countries for comment. We then carried out a cross-national comparison of the SMS or safety approach in health care as the final step of the analysis.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/NIHR136105

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hsdr/QPLF8546

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/QPLF8546

Organisation Name: NIHR Health Services and Delivery Research programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk