[Risk analysis applied to the monitoring of immunosuppressor concentrations in lung transplant recipients]. / Analyse de risques appliquée au suivi des concentrations des immunosuppresseurs chez les patients transplantés pulmonaire.

Mastering and monitoring immunosuppressant concentrations is central to the care of lung transplant patients and involves multiple stakeholders. The objective is to conduct a risk analysis to evaluate the impact of various actions taken.The lung transplantation team was convened to carry out a failure mode effect analysis. The process was divided into stages where different risks were identified. The risk priority number (RPN) (severity, frequency, detectability) and risk level of criticality (frequency, severity) were established before implementation of actions (before 2009) and then after (in 2022) to classify risks according to four levels of criticality. The implemented actions included the establishment of a quality assurance process, computerization of monitoring, and double analysis by a physician/pharmacist pair.Thirty-two risks were identified during the four stages of the process: biological sampling (n = 13), reception (n = 3), analysis and treatment of levels (n = 5), transmission of information/prescriptions to the patient (n = 11). The total raw RPN (before 2009) was 839, with 12 major risks. The current total RPN (in 2022) was 452 (a decrease of 46.1%), with 7 major risks identified.The analysis enabled the objective evaluation of the effectiveness of the actions taken. The most secure stage of the process is the reception of residual level results. Efforts should focus on empowering and involving patients, as well as engaging local stakeholders in collaboration with the specialized transplantation team.

Research on PIVAS risk assessment and control strategy based on quality risk management (QRM).

OBJECTIVE: This study aims to evaluate the effectiveness of the Quality Risk Management (QRM) system in hospital pharmacy intravenous admixture services (PIVAS). METHODS: Failure Modes and Effects Analysis (FMEA) and risk matrix methods were used to systematically assess the critical risk points in PIVAS. By collecting and comparing relevant data from 2019 to 2023, key performance indicators (KPIs) before and after the implementation of the QRM system were quantitatively evaluated. RESULTS: The results showed that the safety and efficiency of pharmacy services significantly improved after the implementation of the QRM system. The medication error rate significantly decreased from 3.2% to 1.1%, the average medication preparation time reduced from 15.5 min to 8.2 min, and staff satisfaction increased from 6.0 to 8.5 points. Other indicators, such as cross-contamination rates and handling errors, also showed significant improvement (all outcomes p < 0.001). DISCUSSION: Systematic risk management effectively enhanced the operational performance of PIVAS, reduced medication errors, and improved the quality of healthcare services. This study highlights the key role of QRM in enhancing medication safety and productivity, providing empirical support for the implementation of similar systems in other healthcare institutions.

How can the failure mode and effect analysis improve the working processes in the ART center?

OBJECTIVE(S): Assisted reproductive technology (ART) Centers and laboratories perform complex tasks with patients and their gametes/embryos daily. The degree of problems/non-conformances in such surroundings must be minimized at zero point. This study aimed to establish the proper risk management system with well-defined process steps to prevent and eliminate problems/non-conformances. STUDY DESIGN: Failure mode and effect analysis (FMEA) was introduced in the ART Center and the IVF laboratory. ART Center working processes were grouped into the categories of Clinical procedures, Forms, Identification, Personnel, Patients, and Facility. Working processes in the IVF laboratory were grouped into the categories of Consumables, Media, Equipment, Personnel, Working space, and Procedures. The traceability and safety of the working processes were evaluated before and after corrective measures regarding risk priority number (RPN). The severity (S), occurrence (O), and detection (D) index of problems/non-conformance were scaled from 1 to 5. The RPN was calculated by multiplying the SOD index, and the cut-off value for RPN was ≥12. RESULTS: The increased RPN was found in the following working processes of the ART Center: Embryo transfer and pregnancy (RPN = 18) in the category of Clinical procedures; Informed consents and agreements (RPN = 16) in the category Forms; Continuous education of the knowledge and skills (RPN = 12) in Personnel category; Space conditions (RPN = 24) and Equipment (RPN = 12) in the category Facility. In the IVF laboratory, increased RPN was found in the following working processes: Production of the plasticware (RPN = 12), Transport (RPN = 12) and Storage (RPN = 12) in the category Consumables; Media production (RPN = 16) in category Media; Alarm notification system for the critical equipment (RPN = 12) in category Equipment; Personnel number and qualifications (RPN = 12), Standard operative procedures (SOP) (RPN = 12) and Continuous education of the knowledge and skills (RPN = 12) in category Personnel; Working conditions (RPN = 18) and Security (RPN = 20) in Working space; Patient identification (RPN = 20), Biological samples identification (RPN = 20), Records (RPN = 12), ART procedure (RPN = 30), Embryo transfer (RPN = 30) and Cryopreservation and thawing of biological samples (RPN = 30) in category Procedures. According to the RPN score, corrective measures were implemented. Most RPN scores were reduced after the implementation of the electronic witnessing system in patient/sample tracing steps. Phases Patient identification and Biological sample identification showed a double reduction of RPN scores, from 20 to 10. Also, for critical steps in ART procedures, Embryo transfer, Cryopreservation, and thawing of biological samples, the RPN score was reduced from 30 to 10. Proper education of personnel was another corrective measure that significantly contributed to a reduction of RPN scores in most of the categories. CONCLUSION(S): The FMEA analysis is useful in recognizing the critical steps of an ART Center. The RPN scores for patient traceability were successfully reduced using the electronic witnessing system. Nonetheless, the study has certain limitations, as FMEA is highly dependent on the specific healthcare organization, adherence to national guidelines, and the subjective nature of SOD and RPN evaluations.

Healthcare failure mode and effect analysis combined service blueprint - Mitigating mass casualty triage in emergency units: A qualitative study.

INTRODUCTION: The 24-hour operation of medical emergency units involves crucial first-hand information and medical treatments, which could involve potential complications and disputes if not handled with the utmost professionalism. Effective logistical support and timely activation are crucial in mass casualty triage to prevent systematic treatment issues and chaos. OBJECTIVE: This study explores the integration of Healthcare Failure Mode and Effect Analysis (HFMEA) with a service blueprint to mitigate medical risks and enhance mass casualty triage efficiency in emergency units. METHOD: An expert team analyzed emergency unit standard operating procedure cases using a service blueprint to visually represent mass casualty triage scenarios. The HFMEA identified potential hazards and failure risks in healthcare service delivery during mass casualty triage. RESULTS: Fifteen high-risk hazard indexes exceeding the standard score of eight were identified among three main processes and thirty-one potential failure reasons. The initial operational time for mass casualty triage was approximately 104 min, significantly reduced to 34 min after process revision (p = 0.043, <0.05). CONCLUSIONS: This study demonstrates effective time management in mass casualty triage, potentially saving up to an hour. Improved operational efficiency allows for focused resuscitation efforts, alleviating concerns about timely patient flow initiation.

Effect Analysis of the HFMEA Model Applied in Sputum Specimen Management Among Patients with Tuberculosis.

Objective: Accurate diagnosis is very important to block the transmission of tuberculosis. The quality of sputum culture affects the diagnostic accuracy. The quality of sputum samples is not optimistic. Therefore, this study investigated whether health care failure mode and effect analysis (HFMEA) can improve specimen quality and detection efficiency in sputum specimen management in tuberculosis departments. Methods: This study is a non-randomized controlled trial study. A convenience sampling method was used to select 110 patients who visited the Department of Tuberculosis of the Second Hospital of Nanjing from September to November 2022 and December 2022 to February 2023 as the control group and the experimental group. Control groups followed standard operating procedures for sputum specimen collection. In the experimental group, HFMEA model was used to control the quality on this basis. After 3 months of intervention, the qualified rate and positive detection rate of sputum samples were compared between the two groups. Results: A total of 634 sputum specimens were included in the experimental group and 647 in the control group. Compared with the control group, the qualification rate of sputum specimens was higher in the experimental group (84.54% vs 79.13%); the positive detection rates of the X-Pert assay (27.88% vs 16.19%), sputum culture (20.29% vs 12.68%), and sputum smear (22.29% vs 15.81%) were all higher in the experimental group (all P < 0.05). Patients in the experimental group had higher knowledge mastery and nurse sputum sample management scores (P < 0.05). However, patient satisfaction with sputum specimen management in the experimental group was lower than in the control group (7.72 ± 0.74 vs 8.38 ± 0.85, P < 0.001). Conclusion: The application of the HFMEA model in sputum specimen management can effectively improve specimen quality and positive detection rates.

Comparative Assessment of Risk and Turn-Around Time between Sequence-Based Typing and Next-Generation Sequencing for HLA Typing.

This study compared laboratory risk and turn-around time (TAT) between sequence-based typing (SBT) and next-generation sequencing (NGS) for human leukocyte antigen (HLA) typing. For risk assessment, we utilized the risk priority number (RPN) score based on failure mode and effect analysis (FMEA) and a risk acceptability matrix (RAM) according to the Clinical Laboratory Standards Institute (CLSI) guidelines (EP23-A). Total TAT was documented for the analytical phase, and hands-on time was defined as manual processes conducted by medical technicians. NGS showed a significantly higher total RPN score than SBT (1169 vs. 465). NGS indicated a higher mean RPN score, indicating elevated severity and detectability scores in comparison to SBT (RPN 23 vs. 12, p = 0.001; severity 5 vs. 3, p = 0.005; detectability 5 vs. 4, p < 0.001, respectively). NGS required a greater number of steps than SBT (44 vs. 25 steps), all of which were acceptable for the RAM. NGS showed a longer total TAT, total hands-on time, and hands-on time per step than SBT (26:47:20 vs. 12:32:06, 03:59:35 vs. 00:47:39, 00:05:13 vs. 00:01:54 hh:mm:ss, respectively). Transitioning from SBT to NGS for HLA typing involves increased risk and an extended TAT. This study underscored the importance of evaluating these factors to optimize laboratory efficiency in HLA typing.

Application of FMEA model and 6S management method in reducing dispensing errors in PIVAS of children’s hospitals / 中国药房

OBJECTIVE To reduce dispensing errors in pharmacy intravenous admixture service （PIVAS） of children’s hospitals. METHODS The risk of dispensing procedures in our PIVAS was identified by applying failure mode and effect analysis （FMEA） model. Potential failure modes that might lead to dispensing errors in each link were determined， and failure causes were analyzed. The severity， incidence and detection degree of potential failure modes were quantitatively scored， and their risk priority number （RPN） was calculated to screen failure modes that needed to be improved in priority； the corresponding improvement measures were developed by 6S management method from six aspects， namely， finishing （seiri）， rectifying （seiton）， sweeping （seiso）， sanitation （seiketsu）， literacy （shitsuke） and safety. The effect of intervention before and after rectification was evaluated. RESULTS Based on the RPN， 32 potential failure modes were selected， of which a total of 18 critical failure modes that needed to be improved in priority. After implementing corresponding measures according to 6S management method， the RPN of 18 critical failure modes decreased. The total RPN decreased from 497 to 142 with a decrease rate of 71.43%. The error rates of 15 critical failure modes were significantly lower than before implementation （P＜0.05）. CONCLUSIONS Applying FMEA model and 6S management method to the risk control of all aspects of PIVAS workflow can effectively reduce the risk of PIVAS dispensing errors and ensure the safety of children’s intravenous medication.

Construction and Application of Intelligent Management System of Operating Room Pharmacy Based on Failure Mode and Effect Analysis Method / 医药导报

Objective To establish an intelligent management system of operating room pharmacy,to promote the standardized management of drugs in the operating room,and to provide reference and experience for medical institutions.Methods Based on the failure mode and effect analysis(FMEA)method,the risk identification and assessment of the operating room pharmacy workflow were carried out of the Second Affiliated Hospital of Soozhou University.According to the risk priority index(RPN)value,the failure mode that needs to be improved was determined,the causes of failure were analyzed,intervention measures were formulated,and the improvement effect was evaluated.Results A total of 12 failure modes were found in the workflow of the operating room pharmacy.After the intelligent medicine cabinet and corresponding management system were used,the RPN value decreased by 337 in total,with a decrease rate of 67.8%.The level of narcotic drug management,the timeliness of patient medication,and the satisfaction of medical staff were significantly improved.Conclusions The FMEA method can effectively identify the risk links of the operating room pharmacy.The construction and application of the intelligent operating room pharmacy management system have significantly improved the drug management level of the operating room and the quality of medical services.

Meta-analysis on failure mode and effect analysis for the prevention of ICU-acquired infection / 中国感染控制杂志

Objective To systematically evaluate the effectiveness of failure mode and effect analysis(FMEA)in the prevention of intensive care unit(ICU)-acquired infection.Methods Two researchers independently searched relevant literatures from foreign and Chinese databases,with a search deadline of July 15,2022.Independent screening of literatures,extraction of data and evaluation on overall quality were performed according to inclusion and exclusion criteria.RevMan 5.4 software was used to conduct Meta-analysis on the preventive effect of the in-cluded literatures.Results A total of 19 literatures were included in analysis.Meta-analysis results showed that ap-plication of FMEA method reduced the incidences of ventilator-associated pneumonia(OR=0.40,95％CI[0.31-0.51],P＜0.01),catheter-associated urinary tract infection(OR=0.29,95％CI[0.17-0.51],P＜0.01),cen-tral line-associated bloodstream infection(OR=0.28,95％CI[0.18-0.46],P＜0.01),and multidrug-resistant organism infection(OR=0.46,95％CI[0.37-0.58],P＜0.01)in ICU patients,as well as incidence of health-care-associated infection(HAI)in ICU(OR=0.46,95％CI[0.37-0.59],P＜0.01),and significantly improved the satisfaction of ICU patients and their families(OR=2.34,95％CI[1.72-3.17],P＜0.01).Conclusion FMEA can effectively prevent ICU-acquired infection and improve the quality of HAI management.

Evaluating the academic scientific laboratories' safety by applying failure mode and effect analysis (FMEA) at the public university in Lebanon.

Workers at scientific academic laboratories are at risk of potential exposure to different types of hazards. The study's purpose was to assess the potential failure modes (FMs) of hazards facing them through the application of the Failure Mode and Effect Analysis (FMEA) method to propose corrective actions preventive actions (CAPA) to mitigate them and to improve the safety outcomes in these workplaces (WP) at the Lebanese public University (PbU). The potential FMs leading to accident occurrence in biological and chemical labs were identified and prioritized, their causes and effects were determined by applying two surveys, and the risk priority number (RPN) for each failure was calculated. A total of 24 FMs were identified. The most alarming FM having the highest RPN scores (80) was found in the workplace 'category requiring an emergency for corrective actions (CA), it is related to the unavailability of a hazard pictogram plot and the lack of labeling of chemicals and waste containers according to their categories. The FMs having RPN scores (75-60) requiring an urgent CA were assigned to other hazards of the WP, chemical, biological, and failure of the educational system. The need to program for the remaining FMs (RPN scores 20-48) is related to the safety, biological, physical, and radioactive categories 'hazards. It is recommended to apply continuously FMEA and implement the CA proposed for each detected FM in the scientific laboratories of the PbU in order to support the decision-makers to improve laboratory safety.

Administração de anti-infecciosos em pacientes críticos: gestão proativa de riscos / Administration of anti-infectives in critically ill patients: proactive risk management / Administración de antiinfecciosos en pacientes críticos: gestión proactiva del riesgo

Objetivo: analisar a gestão de riscos proativa do processo de administração de anti-infecciosos em Unidade de Terapia Intensiva. Método: estudo qualitativo, em pesquisa-ação, com observação participante e grupo focal, realizado de 2019 a 2021. Foi mapeado o processo, analisados os riscos, planejadas ações de melhorias e redesenhado o processo. Resultados: a prescrição ocorria em sistema eletrônico e os registros da administração em impressos. O processo de administração de anti-infecciosos possuía 19 atividades, dois subprocessos, 16 modos de falhas e 23 causas potenciais. Os modos de falhas foram relacionados à assepsia e erro de dose no preparo de anti-infecciosos e as causas apontadas foram a falha humana na violação das técnicas e o lapso de memória. Cinco especialistas redesenharam o processo resultando em alterações de atividades e no sistema. Conclusão: a gestão de riscos proativa aplicada ao processo de administração de anti-infecciosos propiciou identificar riscos, suas causas e priorizar ações de melhorias, o que pode viabilizar tomadas de decisões apropriadas(AU)

Objective: to analyze the proactive risk management of the anti-infective administration process in an Intensive Care Unit. Method: qualitative study, in action research, with participant observation and focus group, from 2019 to 2021. The process was mapped, risks analyzed, improvement actions planned and the process redesigned. Results: the prescription occurred in an electronic system and the administration records in printed form. The anti-infective administration process had 19 activities, two sub-processes, 16 failure modes and 23 potential causes. The failure modes were related to asepsis and dose error in the preparation of anti-infectives and the identified causes were human error in violating techniques and memory lapse. Five specialists redesigned the process resulting in changes in activities and in the system. Conclusion: proactive risk management applied to the anti-infective administration process was effective in identifying risks, their causes and prioritizing improvement actions(AU)

Objetivo: analizar la gestión proactiva de riesgos del proceso de administración de antiinfecciosos en una Unidad de Cuidados Intensivos. Método: estudio cualitativo, en investigación-acción, con observación participante y grupo focal, que tuvo lugar del 2019 al 2021. Se mapeó el proceso, se analizaron los riesgos, se planificaron acciones de mejora y se rediseñó el proceso. Resultados: la prescripción ocurrió en sistema electrónico y los registros de administración en forma impresa. El proceso de administración de antiinfecciosos tuvo 19 actividades, dos subprocesos, 16 modos de falla y 23 causas potenciales. Los modos de falla estuvieron relacionados con la asepsia y error de dosis en la preparación de antiinfecciosos y las causas identificadas fueron error humano por violación de técnicas y lapsus de memoria. Cinco especialistas rediseñaron el proceso generando cambios en las actividades y en el sistema. Conclusión: la gestión proactiva de riesgos aplicada al proceso de administración de antiinfecciosos fue efectiva para identificar riesgos, sus causas y priorizar acciones de mejora, lo que puede factibilizar la toma de decisiones adecuadasa(AU)

Modernization of safety environment for a dedicated beamline for proton ocular therapy.

BACKGROUND: Proton therapy is an effective treatment for ocular melanoma, and other tumors of the eye. The fixed horizontal beamline dedicated to ocular treatments at Massachusetts General Hospital was originally commissioned in 2002, with much of the equipment, safety features, and practices dating back to an earlier implementation at Harvard Cyclotron in the 1970s. PURPOSE: To describe the experience of reevaluation and enhancement of the safety environment for one of the longest continuously operating proton therapy programs. METHODS: Several enhancements in quality control had been introduced throughout the years of operation, as described in this manuscript, to better align the practice with the evolving standards of proton therapy and the demands of a modern hospital. We spotlight the design and results of the failure mode and effect analysis (FMEA), and subsequent actions introduced to mitigate the modes associated with elevated risk. The findings of the FMEA informed the specifications for the new software application, which facilitated the improved management of the treatment workflow and the image-guidance aspects of ocular treatments. RESULTS: Eleven failure modes identified as having the highest risk are described. Six of these were mitigated with the clinical roll-out of a new application for image-guided radiation therapy (IGRT). Others were addressed through task automation, the broader introduction of checklists, and enhancements in pre-treatment staff-led time-out. CONCLUSIONS: Throughout the task of modernizing the safety system of our dedicated ocular beamline, FMEA proved to be an effective instrument in soliciting inputs from the staff about safety and workflow concerns, helping to identify steps associated with elevated failure risks. Risks were reduced with the clinical introduction of a new IGRT application, which integrates quality management tools widely recognized for their role in risk mitigation: automation of the data transfer and workflow steps, and with the introduction of checklists and redundancy cross-checks.

Improved safety and quality in intravascular brachytherapy: A multi-institutional study using failure modes and effects analysis.

PURPOSE: Highlight safety considerations in intravascular brachytherapy (IVBT) programs, provide relevant quality assurance (QA) and safety measures, and establish their effectiveness. METHODS AND MATERIALS: Radiation oncologists, medical physicists, and cardiologists from three institutions performed a failure modes and effects analysis (FMEA) on the radiation delivery portion of IVBT. We identified 40 failure modes and rated the severity, occurrence, and detectability before and after consideration of safety practices. Risk priority numbers (RPN) and relative risk rankings were determined, and a sample QA safety checklist was developed. RESULTS: We developed a process map based on multi-institutional consensus. Highest-RPN failure modes were due to incorrect source train length, incorrect vessel diameter, and missing prior radiation history. Based on these, we proposed QA and safety measures: ten of which were not previously recommended. These measures improved occurrence and detectability: reducing the average RPN from 116 to 58 and median from 84 to 40. Importantly, the average RPN of the top 10% of failure modes reduced from 311 to 172. With QA considered, the highest risk failure modes were from contamination and incorrect source train length. CONCLUSIONS: We identified several high-risk failure modes in IVBT procedures and practical safety and QA measures to address them.

Optimization of the emergency endoscopy process for patients with esophagogastric variceal bleeding using failure mode and effect analysis.

OBJECTIVE: To optimize the emergency endoscopy process for patients with esophagogastric variceal bleeding (EGVB) using failure mode and effect analysis (FMEA). METHOD: In this retrospective analysis, we enrolled patients who were hospitalized in Ganzhou People's Hospital from January 2021 to December 2021. They were divided into 51 cases before and 51 cases after the intervention according to the time of FMEA model intervention. The risk of unsafe transport, endoscopic hemostasis success rate, RPN (risk priority number) value, dual venous access time, resuscitation success rate, emergency endoscopy timeout execution rate, patient health education awareness rate, and endoscopic ligation of esophageal varices (EVL) procedure volume were compared accordingly before and after the procedure. RESULTS: After the FMEA intervention, the emergency endoscopy process for EGVB patients was optimized, the risk of unsafe transport for emergency EGVB endoscopy was reduced, and the success rate of emergency endoscopic hemostasis for patients was improved. Also, the failure mode of RPN values greater than 12 was improved. After the countermeasures were implemented, the resuscitation success rate of EGVB patients reached 95%, the safe transport pass rate increased from 88% to 98.7%, and the patient health education awareness increased from 69% to 92%. The number of EGVB patients who underwent EVL surgery ranked second in the province. The waiting time, gastric function recovery time, dual venous access time, and hospital stay of patients who underwent the optimized procedure were significantly shorter compared to those before implementation (all P<0.01). The incidence of adverse events was significantly lower in patients who underwent the optimized procedure compared to the pre-implementation period (P<0.01). CONCLUSION: Applying FMEA to analyze and optimize the process of EGVB patients undergoing emergency endoscopy can maximize patient life safety and treatment safety, as well as improve medical quality and care safety.

Semi-Quantitative Risk Assessment of African Swine Fever Virus Introduction in Outdoor Pig Farms.

In a previous study, a semi-quantitative risk assessment was developed to rank pig holdings in terms of likelihood of introducing African swine fever virus (ASFV) by assessing their compliance with biosecurity and exposure to geographical risk factors. The method was initially developed for confined pig holdings, but given that ASF is endemic in wild boar of several countries, we modified the approach to make it suitable for free-range farms as well. In the current study, a total of 41 outdoor pig farms were assessed in an area where exposure to wild boar was generally high (density from 2.3 to 10.3 wild boar per Km2). As expected, non-compliance with biosecurity measures was frequent in outdoor farms, and the frequency of non-compliance indicated that the absence of adequate separation of pigs from the external environment was the major weakness in the farms assessed. In 46.3% of them, there was no fence or, if present, it was not adequate to avoid contact with wild boar. However, the approach adopted proved to be suitable for identifying intervention priorities to mitigate the risk of ASFV spread in free-range pig herds and for identifying the weaknesses of individual farms, as recommended by EFSA in 2021, which suggests implementing tools to improve biosecurity by favoring higher-risk farms.

Determining the quality control frequency of an MR-linac using risk matrix (RM) analysis.

PURPOSE: Quality control (QC) is performed routinely through professional guidelines. However, the recommended QC frequency may not be optimal among different institutional settings. Here we propose a novel method for determining the optimal QC frequency using risk matrix (RM) analysis. METHODS AND MATERIALS: A newly installed Magnetic Resonance linac (MR-linac) was chosen as the testing platform and six routine QC items were investigated. Failures of these QC items can adversely affect treatment outcome for the patient. Accordingly, each QC item with its assigned frequency forms a unique failure mode (FM). Using FM-effect analysis (FMEA), the severity (S), occurrence (O), and detection (D) of each FM was obtained. Next, S and D based on RM was used to determine the appropriate QC frequency. Finally, the performance of new frequency for each QC item was evaluated using the metric E = O/D. RESULTS: One new QC frequency was the same as the old frequency, two new QC frequencies were less than the old ones, and three new QC frequencies were higher than the old ones. For six QC items, E values at the new frequencies were not less than their values at the old frequencies. This indicates that the risk of machine failure is reduced at the new QC frequencies. CONCLUSIONS: The application of RM analysis provides a useful tool for determining the optimal frequencies for routine linac QC. This study demonstrated that linac QC can be performed in a way that maintains high performance of the treatment machine in a radiotherapy clinic.

Threat Assessment and Risk Analysis (TARA) for Interoperable Medical Devices in the Operating Room Inspired by the Automotive Industry.

Prevailing trends in the automotive and medical device industry, such as life cycle overarching configurability, connectivity, and automation, require an adaption of development processes, especially regarding the security and safety thereof. The changing requirements imply that interfaces are more exposed to the outside world, making them more vulnerable to cyberattacks or data leaks. Consequently, not only do development processes need to be revised but also cybersecurity countermeasures and a focus on safety, as well as privacy, have become vital. While vehicles are especially exposed to cybersecurity and safety risks, the medical devices industry faces similar issues. In the automotive industry, proposals and draft regulations exist for security-related risk assessment processes. The medical device industry, which has less experience in these topics and is more heterogeneous, may benefit from drawing inspiration from these efforts. We examined and compared current standards, processes, and methods in both the automotive and medical industries. Based on the requirements regarding safety and security for risk analysis in the medical device industry, we propose the adoption of methods already established in the automotive industry. Furthermore, we present an example based on an interoperable Operating Room table (OR table).

Semi-quantitative risk assessment of African swine fever virus introduction in pig farms.

A semi-quantitative risk assessment was developed to classify pig farms in terms of the probability of introduction of African swine fever virus (ASFV). Following on-farm data collection via a specific checklist, we applied a modified failure mode and effect analysis (FMEA) to calculate the risk priority codes (RPC's), indicating increasing risk levels ranging from 1 to 5. The importance of biosecurity measures was attributed by experts. To consider geographic risk factors, we classified pig farms based on local density of farmed pigs, and on the estimated wild boar population density. The combination of RPC's with geographical risk factors resulted into a final ranking of pig farms in terms of the risk of ASFV introduction. Furthermore, the estimation of frequency and levels of non-compliance with biosecurity measures was used to identify weak points in risk prevention at farm level. The outcome of the risk assessment was affected by choices in assigning non-compliance scores and importance to specific components of biosecurity. The method was applied in 60 commercial farms in major pig production areas in Italy. Furthermore, we applied a reduced version of our checklist in 12 non-commercial/small commercial (≤20 pigs) farms in the northern Apennines. In commercial farms, highest RPC's were obtained for biosecurity measures associated with personnel practices and farm buildings/planimetry. Intervention should be addressed to training of personnel on biosecurity and ASF, to avoid contacts with other pig herds, and to improve practices in the entrance into the farm. Sharing trucks with other farms, and loading/unloading of pigs were other weak points. Fencing was classified as insufficient in 70% of the commercial farms. Among these farms, breeding units were characterised by the lowest risk of ASFV introduction (although differences among median ranks were not statistically significant: P-value = 0.07; Kruskal-Wallis test), and increasing herd size was not significantly correlated with a higher risk (Kendall's τ = -0.13; P-value = 0.14). Density of farmed pig was greatest in the main pig production area in northern Italy. Conversely, exposure to wild boars was greatest for non-commercial/small commercial farms on the Apennines, which were also characterised by non-compliance with critical biosecurity measures.

Human error identification and risk prioritization in LPG unloading operations.

Objectives. Errors due to human activities in any operation are analyzed using human reliability analysis in which the principal step is to identify potential human errors followed by quantification and analysis of the error. This work intends to apply a methodology for identifying human errors and to prioritize the risk associated with them in a liquefied petroleum gas (LPG) unloading operation. Methods. The methodology uses hierarchical task analysis which provides the basic framework, along with a systematic human error reduction and prediction approach which aids in identification and categorization of the errors associated with each task with the help of predefined error taxonomy. Also, in order to quantify the risk associated with each identified error, fuzzy failure mode and effect analysis has been adopted. To rank and prioritize the risk associated with each identified error where the individual constituent components are non-commensurable in nature, the VIseKriterijumska Optimizacija I Kompromisno Resenje method has been incorporated. Results and conclusions. Applicability of the methodology presented will help comprehend the severity of risk corresponding to each error at different levels, and the ranking mechanism thus developed in this work aids to prioritize the action to minimize the likelihood of errors.

Failure mode and effect analysis for risk management of unplanned extubation after esophageal cancer surgery / 中国胸心血管外科临床杂志

@#Objective 聽 聽 To explore the application value of failure mode and effect analysis (FMEA) in the risk management of unplanned extubation after esophageal cancer surgery. Methods 聽 聽 A total of 1 140 patients who underwent esophageal cancer surgery in our department from January 2015 to May 2017 were selected as a control group, including 948 males and 192 females with an average age of 64.45卤4.53 years. FMEA was used to analyze the risk management process of unplanned extubation. The potential risk factors in each process were found by calculating the risk priority number (RPN) value, and the improvement plan was formulated for the key process with RPN>125 points. Then 1 117 patients who underwent esophageal cancer surgery from June 2017 to December 2019 were selected as a trial group, including 972 males and 145 females with an average age of 64.60卤5.22 years, and the FMEA risk management mode was applied. Results 聽 聽 The corrective measures were taken to optimize the high-risk process, and the RPN values of 9 high-risk processes were reduced to below 125 points after using FMEA risk management mode. The rate of unplanned extubation in the trial group was lower than that in the control group (P<0.05). Conclusion 聽 聽 The application of FMEA in the risk management of unplanned extubation after esophageal cancer surgery can reduce the rate of unplanned extubation, improve the quality of nursing, and ensure the safety of patients.