Healthcare workers (HCWs) caring for COVID-19 infected patients are exposed to stressful and traumatic events with potential for severe and sustained adverse mental and physical health consequences. Our aim was to assess the magnitude of physical and mental health outcomes of HCWs due to the prolonged use of personal protective equipment (PPE) treating COVID-19 patients. This cross-sectional study assessed the symptoms of stress, anxiety, insomnia, and psychological resilience using the Stress and Anxiety to Viral Epidemics (SAVE) scale, Insomnia Severity Index (ISI), and Resilience Scale (RS), respectively, in Italy between 1st February and 31st March 2022. The physical outcomes reported included vertigo, dyspnea, nausea, micturition desire, retroauricular pain, thirst, discomfort at work, physical fatigue, and thermal stress. The relationships between prolonged PPE use and psychological outcomes and physical discomforts were analyzed using Generalized Linear Models (GLMs). We calculated the factor mean scores and a binary outcome to measure study outcomes. We found that 23% of the respondents reported stress related symptoms, 33% anxiety, 43% moderate to severe insomnia, and 67% reported moderate to very low resilience. The GLMs suggested that older people (>55 years old) are less likely to suffer from stress compared to younger people (<35 y.o); conversely, HCW aged more than 35 years are more inclined to suffer from insomnia than younger people (3 years old, enrolled in training programs for nursing, social work, technical training and other healthcare professionals increased the probability of reported physical discomforts. HCW that worked on non COVID-19 wards and used PPE for low-medium exposure level, were at lower risks for lasting physical side effects as compared to the HCW who worked in high-risk PPE intense, COVID-19 environments. The study suggests that frontline HCWs who had extensive PPE exposure while directly engaged in the diagnosis, treatment, and care for patients with COVID-19 are at significant risks for lasting physical and psychological harm and distress.

The application of the Italian law No. 24/2017, which focused on patient safety and medical liability, in the Italian National Health Service has been evaluated by a survey conducted five years after the promulgation of the law. The law required the establishment of healthcare risk management and patient safety centers in all Italian regions and the appointment of a Clinical Risk Manager (CRM) in all Italian public and private healthcare facilities. This study demonstrates that five years after the approval of the law, it has not yet been fully implemented. The survey revealed a lack of adequate permanent staff in all the Regional Centers, with two employees on average per Center. Few meetings were held with the Regional Healthcare System decision-makers with less than four meetings per year. This reduces the capacity to carry out functions. In addition, the role of the CRMs is weak in most healthcare facilities. More than 20% of CRMs have other roles in the same organization. Some important tasks have reduced application, e.g., assessment of the inappropriateness risk (reported only by 35.3% of CRM) and use of patient safety indicators for monitoring hospitals (20.6% of CRM). The function of the Regional Centers during the COVID-19 pandemic was limited despite the CRMs being very committed. The CRMs units undertake limited research and have reduced collaboration with citizen associations. Despite most of the CRMs believing that the law has had an important role in improving patient safety, 70% of them identified clinicians’ resistance to change and lack of funding dedicated to implementing the law as the main barriers to the management of risk.

Introduction: Controlling bleeding is one of the most closely monitored aspects of surgery and is considered both a potential complication and a possible source of malpractice, representing a significant risk for the surgeon. Floseal (Baxter Healthcare Corporation) is a hemostatic matrix composed of gelatin and thrombin, designed to control bleeding in surgical settings where standard techniques are ineffective or impractical. This study aimed to provide a comprehensive overview of the use of Floseal kits across a variety of surgical procedures. Particular attention was given to the ergonomic characteristics, usability, and effectiveness of the device in relation to procedural complexity and the associated risk of hemorrhage. Methodology: Data from 95 clinical cases were collected through a survey of a sample of surgeons from three hospitals in the Tuscany Region (Italy). The survey gathered information on the use of Floseal kits across different types of surgeries, as well as the ergonomic aspects of their application. Additionally, a qualitative ergonomic analysis was performed through indirect observation of videos showing Floseal’s use during surgical procedures. Based on these findings, potential medico-legal implications were also evaluated. Results: The survey results indicated that 93% of procedures required only one Floseal kit, with the highest usage observed in open surgeries (76%). The device was rated as highly effective, receiving scores of 4-5 on a Likert scale, and demonstrated excellent ease of use in 73% of cases. In terms of ergonomics, Floseal showed outstanding ease of application without significant difficulties, even in complex procedures such as robotic and laparoscopic surgeries. Discussion: Attention to proper usage is essential to avoid errors, such as application in non-expandable areas or the risk of intravascular thrombosis. Proper preparation of the device is necessary to ensure rapid intervention times. Additionally, some considerations are discussed regarding the potential role of AI in improving device ergonomics and its applications in surgical practice. Conclusion: Floseal is a highly effective and user-friendly hemostatic device with broad applicability across various surgical specialties. The limited kit consumption per procedure (93% of surgeries required only one kit) contributes to waste reduction and optimal hemorrhage management. Moreover, the ergonomic design and usability of the device enhance its effectiveness in controlling bleeding during surgery.

Background: Large-scale vaccination was crucial to address the global COVID-19 pandemic and its associated health risks, including fatal and disabling diseases. However, there were significant challenges to be overcome to ensure the safe and effective implementation of the vaccination program. The aim of the present study was to assess patient safety threats related to the anti-COVID-19 large-scale vaccination process. Methods: Between February and May 2021, we conducted a proper analysis to proactively identify risks and potential Failure Modes (FMs) in the COVID-19 vaccination process using the Failure Mode, Effects, and Criticality Analysis (FMECA) technique at an Italian Public Health Authority. A standardized risk scoring system was used to assess the severity, frequency, and detectability of events associated with potential failures. Criticalities were identified in both the preparatory and operational areas of the vaccination process, and several potential FMs were listed in descending order of risk score (Risk Priority Number, RPN) to ensure prioritization of interventions. Results: The most critical steps were found to be in the operational area rather than in the preparatory one. The highest RPNs were associated with failure or inadequate management of severe allergic reactions that can lead to serious harm and even death of the vaccinated person (RPN 60) and failure to keep updated vaccination teams’ knowledge (RPN 36). Conclusions: Ensuring patient safety and effective clinical risk management are crucial in mass vaccination campaigns. By prioritizing these aspects through collaboration with various stakeholders and implementing preventive measures, patient trust—on which vaccination campaign success relies—can be built and maintained.