The Food and Drug Administration (FDA) plays an important role in ensuring the safety of medical devices. In this cross-sectional study, researchers identified a high risk of future Class 1 FDA recall (the most serious recall designation, indicating serious risks to patient safety) among previously authorized devices (predicates) with prior Class 1 recalls.

The criminal conviction of a nurse involved in a medical error has raised concerns about a possible negative impact on error disclosure. This article discusses the ethical and legal considerations related to this prosecution and the association with patient safety.

Electronic Health Record (EHR) systems are required to meet meaningful use and certification standards to receive incentive payments from the US Department of Health and Human Services (HHS). This study identified six settlements reached between EHR vendors and the Department of Justice for misconduct related to certification of meaningful use. Certification of EHR systems that don’t meet HHS meaningful use requirements may have implications for patient safety.

The rapid expansion of digital health technologies, particularly in response to the COVID-19 pandemic, can increase patient safety risks. This article summarizes malpractice liability risks associated with digital health technologies, including electronic health record (EHR) systems, telehealth, and artificial intelligence for clinical decision support.

Retained surgical items (RSI) are a never event, a serious and preventable event. After experiencing a high rate of RSIs, this United States health system implemented a bundle to reduce RSI, improve near-miss reporting, and increase process reliability in operating rooms. The bundle consisted of five elements: surgical stop, surgical debrief, visual counters, imaging, and reporting.

Patients and clinicians may hold implicit gender biases and rate women clinicians more negatively. In this study, adverse event reports written about residents were reviewed to determine if resident gender was associated with different types and frequency of incident reports. The most comment complaint about men physicians involved a medical error, while the most common complaint type about women included a communication-related event. Additionally, women were more frequently identified by name only, without a title such as “doctor”.

Radiotherapy errors can be significant and sometimes fatal. This systematic review describes errors in patient set up based on verification systems, the immobilization devices used, and the patient’s positioning during breast cancer treatment. The advantages and drawbacks of the most common position verification systems, error types associated with immobilization systems, and the influence of treatment position are reviewed.

Inpatient suicide is sentinel event. This study examined treatment patterns among patients undergoing inpatient or outpatient psychiatric treatment who died by suicide. The research team found that patients who were primarily treated with medications were less likely to be sufficiently monitored, whereas patients who received both psychotherapy and medication were more likely to receive inadequate treatment.

Feedback from patients and other stakeholders can illuminate serious patient safety concerns. This qualitative study analyzed stakeholder feedback about patient safety risks as well as how organizations responded to stakeholder communication and discusses ways in which organizational risk management teams can leverage stakeholder feedback. Findings suggest that stakeholder communications have typically focused on safety issues such as medication errors, but that poor safety culture meant that concerns were often not acted upon.

Social determinants of health (SDOH) are non-medical factors that impact a person’s health and well-being. This commentary presents ways that risk managers can improve equity and patient safety by addressing two SDOH: health literacy and discrimination. The author recommends using existing risk management tools (e.g., error reporting, data collection) to develop strategies to address the negative impacts of SDOH.

Tort reform and changes in medical malpractice liability can impact patient safety. This longitudinal analysis found that caps on noneconomic damages in medical malpractice lawsuits were associated with higher rates of preventable adverse events in hospitals.

Obstetric and gynecologic (OB/GYN) physicians are frequently involved in malpractice lawsuits, some of which result in catastrophic payouts. This study categorized malpractice claims involving OB/GYN trainees (students, residents, and fellows) between 1986 and 2020. Cases are categorized by type of injury, patient outcome, category of error, outcome of lawsuit, and amount of settlement.

Communication failures due to hierarchy and silos create opportunities for adverse medication and treatment events. This narrative essay discusses gaps in care coordination that contributed to anticoagulant medication errors. The author outlines areas for improvement such as assignment of accountability for error and commitment to the learning health system as avenues for improvement.