Explore the vast range of titles available.

BackgroundHealthcare staff adapt to challenges faced when delivering healthcare by using workarounds. Sometimes, safety standards, the very things used to routinely mitigate risk in healthcare, are the obstacles that staff work around. While workarounds have negative connotations, there is an argument that, in some circumstances, they contribute to the delivery of safe care.ObjectivesIn this scoping review, we explore the circumstances and perceived implications of safety standard workarounds (SSWAs) conducted in the delivery of frontline care.MethodWe searched MEDLINE, CINAHL, PsycINFO and Web of Science for articles reporting on the circumstances and perceived implications of SSWAs in healthcare. Data charting was undertaken by two researchers. A narrative synthesis was developed to produce a summary of findings.ResultsWe included 27 papers in the review, which reported on workarounds of 21 safety standards. Over half of the papers (59%) described working around standards related to medicine safety. As medication standards featured frequently in papers, SSWAs were reported to be performed by registered nurses in 67% of papers, doctors in 41% of papers and pharmacists in 19% of papers. Organisational causes were the most prominent reason for workarounds.Papers reported on the perceived impact of SSWAs for care quality. At times SSWAs were being used to support the delivery of person-centred, timely, efficient and effective care. Implications of SSWAs for safety were diverse. Some papers reported SSWAs had both positive and negative implications for safety simultaneously. SSWAs were reported to be beneficial for patients more often than they were detrimental.ConclusionSSWAs are used frequently during the delivery of everyday care, particularly during medication-related processes. These workarounds are often used to balance different risks and, in some circumstances, to achieve safe care.

Objectives. To examine whether lethal means counseling and provision of cable locks prompt safe firearm storage relative to control among firearm-owning members of the Mississippi National Guard. Methods. This randomized controlled trial utilized a 2 × 2 factorial design (lethal means counseling vs control, provision of cable locks vs no cable locks). Follow-up assessments took place at 3 and 6 months after baseline. Data were collected (n = 232; 87.5% male; mean age = 35.01 years; 77.2% White) from February 2018 through July 2020. Results. Relative to control, lethal means counseling and provision of cable locks resulted in greater adoption of several safe storage methods over time. Lethal means counseling outperformed control (3 months: 55.0% vs 39.0%; odds ratio [OR] = 1.91). Cable locks outperformed control at 3 and 6 months on number of storage methods (1.41 vs 1.11; d = 0.29 and 1.34 vs 1.16; d = 0.15, respectively) and locking devices (59.8% vs 29.9%; OR = 3.49 and 58.4% vs 35.8%; OR = 2.52, respectively) Conclusions. Lethal means counseling and cable locks can result in sustained changes in firearm storage. Public Health Implications. The military may benefit from lethal means counseling, perhaps administering at point of entry. Trial Registration. Clinical Trials.gov identifier: NCT03375099.

Are all food ingredients, dietary supplement ingredients and even foods, required to meet the same safety standards? Are they all equally safe? If so, then why do the various categories have different expressions describing their safety, such as “reasonable certainty of no harm” for food ingredients and “reasonable expectation of no harm” for dietary supplement ingredients? The basis for these different expressions is that they are not standards of safety, but standards of proof of safety. Just as in criminal vs. civil courts, the threshold for proving guilt or fault is different, so too are there differences between various categories of consumer products regulated by the US Food and Drug Administration. This manuscript describes the threshold requirements for each standard, as well as to the identity of the decision makers on what is safe, their credentials as decision makers and the databases mandated for their use.

Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This article explores the historical evolution of medical device regulation, the role of standards organizations, and the impact of regulatory practices on device safety. Highlighting the critical need for stringent regulations, informed by instances where medical devices caused patient harm, we discuss the processes and collaborations between various international standards and regulatory frameworks that ensure device safety and effectiveness. This comprehensive review addresses the complexities of regulatory compliance and standardization, aiming to bridge the knowledge gap among healthcare providers and enhance the implementation of safety standards in medical technology.

To be authorized for use in the National Health Service (NHS) in England, digital health technologies (DHTs) must meet 2 mandatory clinical risk management standards, Data Coordination Board (DCB) 0129 and 0160, demonstrating that risks from design and use have been assessed and mitigated. NHS organizations must not procure a DHT without DCB0129 assurance and must not deploy one without DCB0160 assurance. Despite legal requirement, no public data exist on how many DHTs are in use in the NHS or how many are assured. This study aimed to determine the number of DHTs in use in the NHS in England and assess their assurance status against mandated clinical safety standards. In early 2025, 239 NHS organizations in England received a freedom of information notice requesting information on the number of DHTs they were using and their assurance against DCB0129 and DCB0160 standards. Of the 239 NHS organizations, 204 (85.4%) responded, of which 178 (87.3%) provided full or partial data, covering 14,747 DHT deployments. The mean number of deployed DHTs per organization was 82.8 (SD 146.1; 95% CI 61.4-104.3) with substantial variation between NHS provider trusts (mean 107.1, SD 161.1; 95% CI 79.8-134.3), ambulance trusts (mean 13.0, SD 8.2; 95% CI 7.6-18.4), and integrated care boards (mean 8.1, SD 16.0; 95% CI 2.8-13.5). Overall organizational compliance rates were low, with a median of 25.6% (IQR 7.8%-55.7%) deployed DHTs being fully assured; for NHS provider trusts compliance was lower at 24.5% (IQR 8.1%-50%). A total of 13 (6.4%) of the 204 organizations reported that all their DHTs were fully assured, while 16 (7.8%) reported that none were assured. Across all DHTs with reported assurance data, 17.3% (95% CI 16.6%-18.1%) were fully assured against both standards, 13.3% were partially assured against one standard, and 70.1% (95% CI 69.1%-71.1%) had no documented assurance. This is the first study to quantify both the scale of DHT deployment in NHS organizations in England and the extent of compliance with mandatory safety standards. More than 10,000 DHTs currently in use lack documented assurance against clinical safety standards. In a typical NHS trust, 3 out of 4 digital tools influencing patient care do not demonstrate compliance with minimum legal or clinical safety requirements. These findings raise significant concerns about the risks posed to patients by these technologies; the capacity of organizations to assess and mitigate them; and the legal ramifications of when, not if, harm occurs. Crucially, failure to assure digital technologies poses a significant risk to one of the core ambitions of the NHS 10-Year Health Plan for England; safely transitioning from analogue to digital care models. These findings are unlikely to be unique to the NHS and should prompt health care systems worldwide to assess the risks posed by their DHT deployments.

Background Integrated occupational safety and health and patient safety management are essential for addressing the challenges faced by healthcare services today. Developing and evaluating tools that support this work is crucial. This project aims to assess the effectiveness of a structured method for systematic and integrated occupational safety and health and patient safety management systems (SIOHPS). Additionally, the project includes embedded economic and process evaluation. This article presents the overall design of the SIOHPS-project, with a specific focus on the design and evaluation of the (cost-)effectiveness study. Methods The project is guided by the Medical Research Council (MRC) framework for complex interventions and is coproduced with key stakeholders. The intervention is designed to support systematic occupational health and patient safety management systems, incorporating both Safety I and Safety II perspectives. It is grounded in safety culture theory and knowledge about team debriefing for learning. The intervention consists of several core components, including targeted education, end-of-shift team debriefings, and support for systematic management. The intervention is supported by a digital tool. A program theory guides the evaluation. A pragmatic stepped-wedge cluster-controlled design (p-SWD) is used, with hospital healthcare units as clusters. The p-SWD includes three steps, with at least four clusters transitioning from the control to the intervention group at each step. A minimum of twelve healthcare units from two different regions in Sweden will participate. The intervention effect will be evaluated using sick leave and quality of care as primary outcomes. Secondary outcomes include safety climate, work environment factors, healthcare worker health, performance, patient safety and quality of nursing care. Primary and secondary analyses are conducted based on intention-to-treat approach. Cost-effectiveness will be assessed using cost-benefit and cost-consequence analyses. Discussion The need of methods that integrate systematic occupational safety and health and patient safety management has been emphasized by different stakeholders worldwide. The SIOHPS study has strong potential for nationwide implementation in Sweden to help healthcare organizations address current challenges. Additionally, the project will contribute to existing safety culture theory by exploring the integration of these domains. Trial registration ClinicalTrials.gov Identifier: NCT06398860. Registration date: 2024-04-30.

Falls are the leading preventable cause of morbidity, mortality, and premature institutionalization for community-dwelling older adults. To test the effectiveness of a behavioral intervention on fall risk among older adults receiving services from an Area Agency on Aging. This randomized clinical trial examined a home hazard removal intervention in the community using a race- and sex-stratified randomization design. Older adults receiving services from the Area Agency on Aging in urban St Louis, Missouri, were assigned to a home hazard removal intervention delivered over 2 weeks with a 6-month booster or usual care control. Eligible participants were adults aged 65 years or older who did not have dementia, were at high risk for falling, and resided in the community. Enrollment occurred from January 2015 to September 2016; 12-month follow-up occurred from February 2016 to October 2017. Data were analyzed from February 2019 to July 2021. The intervention was a home hazard removal program delivered by an occupational therapist in the home that included a comprehensive clinical assessment and a tailored hazard removal plan. Usual care control consisted of annual assessments and community referral. The primary outcome was the hazard of a fall over 12 months. Prespecified secondary outcomes included the rate of falls over 12 months, daily activity performance, falls self-efficacy, and self-reported quality of life. A total of 310 participants (mean [SD] age, 75 [7.4] years; 229 [74%] women; 161 Black participants [52%]) were randomized, with 155 participants assigned to the intervention and 155 participants assigned to usual care. Retention was 127 participants (82%) in the intervention group and 126 participants (81%) in the control group. There was no difference for our primary outcome of fall hazard (hazard ratio, 0.90; 95% CI, 0.66-1.27). There was a 38% reduction in the rate of falling in the intervention group compared with the control group (relative risk, 0.62; 95% CI, 0.40-0.95; P = .03). At 12 months, the rate of falls per person-year was 1.5 (95% CI, 1.32-1.75) in the intervention group and 2.3 (95% CI, 2.08-2.60) in the control group. There was no difference in daily activity performance (adjusted difference, -0.20; 95% CI, -0.95 to 0.55; P = .60), falls self-efficacy (adjusted difference, -0.12; 95% CI, -1.25 to 1.01; P = .84), or quality of life (adjusted difference, 0.84; 95% CI, -0.95 to 2.64; P = .35). This randomized clinical trial found that a brief home hazard removal program did not reduce the hazard of falls among community-dwelling older adults at high risk for falling. The intervention was effective in achieving a reduced rate of falls, a prespecified secondary outcome. This effectiveness study has the potential for delivery through the national aging services network. ClinicalTrials.gov Identifier: NCT02392013.