Prospective systematic risk analysis of the digital technology use within pharmaceutical care.

BACKGROUND: Digital technologies are present in every phase of a drug lifecycle, from drug design and development to its dispensing and use. However, given the rapid development and implementation of digital solutions, their monitoring, evaluation and risk assessment are limited and lacking. OBJECTIVE: This research is aiming to identify potential errors, quantify and prioritize associated risks in the context of certain technologies used in pharmaceutical care, as well as define corrective measures to improve patient safety and the quality of pharmaceutical care. METHODS: A ten-member multidisciplinary team conducted Failure Mode & Effect Analysis (FMEA) to identify critical risks, their causes and effects, along with developing corrective measures within the selected digital health components: Telepharmacy, mHealth, Artificial intelligence (AI) and Software infrastructure and systems. Critical risks were determined by calculating risk priority numbers (RPNs) from severity, occurence, and detectability scores. RESULTS: This study identified 42 risks regarding the 4 components. After calculating RPNs and the threshold RPN (RPN=30), 8 critical risks were identified. Corrective measures were proposed for these failure modes, after which the risks were re-evaluated (RPN sum was reduced from 414 to 156). The risk with the highest RPN value was Internet/identity fraud, while the rest included inadequate and incomplete data entry and management, flawed implementation, human and technology errors, and lack of transparency, personalization and infrastructure. For the critical risks, 42 different causes were recognized on a system, technological and individual level while their effects were discussed in terms of patient safety and business management in pharmacies. CONCLUSION: Digitalization of pharmaceutical practice promises greater effectiveness of pharmaceutical care, but in order to achieve this, efforts, resources and initiatives must be directed towards timely identification of problems, appropriate monitoring and building adequate infrastructure that can support safe implementation of digital tools and services despite the swift development of innovations.

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.

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.

Healthcare Failure Mode and Effect Analysis in Surgery Setting: A Bibliometrics Analysis and Literature Review.

Background: In the ever-evolving healthcare landscape, the imperative to ensure patient safety has driven the adoption of robust safety approaches. One of the most popular methods is Healthcare Failure Mode and Effect Analysis (HFMEA). Objective: This study aims to conduct a bibliometric analysis of HFMEA research in a surgery setting to identify relevant authors, topics, and journals, highlighting the scholarly collaboration trends in this area. This analysis can provide valuable insights into the current state of research, emerging trends, and future research directions. Methods: The data was acquired online from the PubMed database on December 16th, 2023. The downloaded data were analyzed using Google Sheets to predict trends. The publication output was then analyzed using VOSviewer. Subsequently, Biblioshiny was used to analyze the characteristics of the study, productive author, institution, and country; thematic map analysis; and topic timeline analysis. Results: This study analyzes 25 documents spanning 2005 to 2022, reflecting a collaborative effort involving 155 contributors. The upward trend in annual scientific publications, notably the surge from 2014 onwards and significant peaks in 2019 and 2022, underscores the growing recognition of HFMEA in enhancing patient safety within surgical environments. The prominent influence from prolific authors like Ahmed K, leading institutions such as King's College London, and the substantial contributions from Norway and the USA in shaping the HFMEA research landscape. Conclusion: This study contributes valuable insights that can shape the trajectory of HFMEA in the evolving landscape of surgical healthcare, ensuring enhanced patient safety and quality improvement.

Application of health failure mode and effect analysis for the airbag pressure management of patients with artificial airways / 中华危重病急救医学

Objective:To analyze the application effect of health failure mode and effect analysis (HFMEA) model in patients with artificial airways in the cardiovascular surgery intensive care unit (CSICU) by establishing a HFMEA project team, and to develop targeted improvement measures and processes.Methods:The patients undergoing cardiovascular surgeries and with established artificial airways in the Shandong Provincial Hospital Affiliated to Shandong First Medical University were recruited from October 2021 to March 2022. The enrolled patients were divided into the conventional management group and the HFMEA model management group according to random number table method. The conventional management group applied the conventional procedures for monitoring the air bag pressure. The HFMEA model management group used the HFMEA model to implement and improve the airbag pressure monitoring process. The efficacy of HFMEA was assessed by comparing the incidence of ventilator-associated pneumonia (VAP), the pass rate of airbag pressure monitoring, the duration of endotracheal intubation and the length of CSICU stay between two groups. The practicability of HFMEA model was evaluated by analyzing the theoretical assessment scores and practical skill scores of nurses and their satisfaction scores with HFMEA.Results:Compared with the conventional management group, the patients in the HFMEA mode management group had a significantly higher rate of passing airbag pressure monitoring [94.99% (2 994/3 152) vs. 69.97% (1 626/2 324), P < 0.01], shorter duration of endotracheal intubation and length of CSICU stay [duration of endotracheal intubation (hours): 6 (7, 12) vs. 6 (8, 13), length of CSICU stay (hours): 40 (45, 65) vs. 41 (46, 85), both P < 0.05], but the incidences of VAP between the two groups were similar. The theoretical assessment scores and practical skill scores of nurses were significantly higher (theoretical assessment score: 44.47±2.72 vs. 37.59±6.56, practical skill score: 44.56±2.66 vs. 40.03±4.32, total score: 89.03±3.07 vs. 77.63±9.56, all P < 0.05) in the HFMEA mode management group. And the satisfaction scores with airbag pressure management were also significantly higher in the HFMEA mode management group (7.72±1.11 vs. 6.44±1.32, P < 0.05). Conclusions:The application of the HFMEA can improve the airbag pressure measures and standardize the monitoring procedures in patients with artificial airways, and reduce the risk of clinical nursing. It is safe and effective for patients with invasive mechanical ventilation in the CSICU.

Application of catheter information platform based on failure mode and effect analysis in preventing central venous catheter-related infection in intensive care unit / 中国实用护理杂志

Objective:To investigate the effect of failure mode and effect analysis (FMEA) based catheter information platform in preventing catheter-related bloodstream infection (CRBSI) in intensive care unit to improve the current status of CRBSI.Methods:In this study, a retrospective cohort study was conducted using the purposive sampling method, and 140 patients with indwelling central venous catheters admitted to the ICU of Peking University Shenzhen Hospital from August to December 2021 were set as the control group; the 140 patients with indwelling central venous catheters admitted to the ICU from January to May 2022 were set as the observation group. The control group used electronic forms to record and manage at the bedside after CRBSI cluster nursing measures were given, and the observation group used the catheter information platform based on FMEA to conduct information management on catheter evaluation and maintenance process after CRBSI cluster nursing measures were given. Compared the implementation rate (6 items), implementation time, qualification rate, and incidence of CRBSI in ICU patients between two groups of ICU nurses.Results:The implementation rate of CRBSI cluster nursing measures among ICU nurses in the observation group: strict hand hygiene by nurses was 87%(122/140), maximum aseptic barrier during puncture was 97%(136/140), aseptic operation during catheter maintenance was 91%(128/140), 75% alcohol disinfection of connectors was 84%(118/140), 24-hour change of infusion lines was 95%(133/140), and timely change of patches/dressings was 89%(125/140), they were greater than those in the control group 70%(98/140), 87%(122/140), 71%(100/140), 61%(86/140), 71%(99/140), 69%(96/140), the differences were statistically significant ( χ2 values were 9.67 to 29.07, all P<0.05); the execution time and qualification rate among ICU nurses in the observation group were (9.11 ± 2.83) minutes and 91.4% (128/140), the control group were (10.00 ± 2.84) minutes and 60.7% (85/140), with statistically significant differences ( t value was -2.64, χ2 values was 36.28, all P<0.05). Conclusions:The FMEA-based catheterization information platform can help enhance the efficiency of the implementation of CRBSI clustering nursing measures by ICU nurses, improve the quality of care, and thus reduce the occurrence of CRBSI, and the feasibility of clinical promotion is high.

Application of healthcare failure mode and effect analysis in preventing nursing interruption with negative outcome in operating room / 中国实用护理杂志

Objective:To explore the effect of healthcare failure mode and effect analysis (HFMEA) in reducing the incidence of nursing interruption with negative outcome in operating room, so as to maximize the smooth progress of the surgical process.Methods:This was a quasi experimental study. The gastrointestinal surgery room of Shandong Provincial Hospital Affiliated to Shandong First Medical University was selected for the study. According to the surgical sequence, 38 surgeries performed in the gastrointestinal surgery suite from August 15-30, 2021 were set as the control group, and the conventional healthcare cooperation model process was implemented; 42 surgeries performed from September 15-30, 2021 were set as the intervention group, and the operating room under the HFMEA model was implemented negative outcome care disruption event management process.A video tracking method combined with a surgical care disruption event register was used to investigate the occurrence of negative outcome care disruption events in the operating room, comparing the number, duration, source of disruption events and the incidence of near miss events in the operating room between the control group and the intervention group.Results:In the control group, there were 38 observed surgeries, 190 negative outcome care interruptions, negative outcome interruptions of (5.26 ± 1.02) min duration, and no near misses; in the intervention group, there were 42 observed surgeries, 84 negative outcome care interruptions, negative outcome interruptions of (2.06 ± 0.08) min duration, and no near misses. There were statistically significant differences in the number, duration of negative outcome care interruptions between the intervention group and the control group ( χ2 = - 18.71, t = - 20.28; all P<0.01). There was statistically significant difference in the source of negative outcome care interruptions between the intervention group and the control group ( χ2 = - 12.71, P<0.01). Conclusions:HFMEA model can effectively reduce the number of negative nursing interruptions in the operating room, shorten the duration of interruptions, and minimize potential safety hazards caused by nursing interruptions, which is conducive to ensuring the safety of patients.

Using healthcare failure mode and effect analysis to reduce the emergency waiting risk / 中国实用护理杂志

Objective:To explore the application of effect of healthcare failure mode and effect analysis (HFMEA) in emergency waiting risk management.Methods:From May 2020 to April 2021, totally 87 902 emergency waiting patients from the First Affiliated Hospital of Anhui Medical University were assigned to control group by cluster sampling method. From May 2021 to April 2022, 80 594 emergency waiting patients were assigned to observed group. The patients in the control group received routine emergency waiting of itinerant management mode. In contrast, the patients in the observed group received emergency waiting risk management mode based on HFMEA. The process risk priority number (RPN) and waiting risk management index between two groups were compared.Results:The mean RPN of the observed group was (98.48 ± 8.27) points, significantly lower than that of the control group (251.27 ± 16.95) points. The nurses′ pre-identification rates of changes in the condition and adverse reaction in the observed group were 10.77%(8680/80 594) and 13.37%(10 775/80 594), which were higher than those in the control group, 5.77%(5072/87 902) and 8.12%(7134/87 902), the differences were statistically significant ( χ2 values were 1402.32 and 1221.66, all P<0.05). Conclusions:The application of HFMEA to optimize the emergency waiting management process can effectively reduce the risk of emergency waiting and improve the quality of emergency waiting management.

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.

Proactive Risk Assessment through Failure Mode and Effect Analysis (FMEA) for Perioperative Management Model of Oral Anticoagulant Therapy: A Pilot Project.

INTRODUCTION: Correct perioperative management of anticoagulant therapy is essential to prevent thromboembolic events and reduce the risk of bleeding. The lack of universally accepted guidelines makes perioperative anticoagulant therapy management difficult. The present study aims to identify the perioperative risks of oral anticoagulant therapy and to reduce adverse events through Failure Mode and Effect Analysis (FMEA). MATERIALS AND METHODS: A multidisciplinary working group was set up, and four main phases of the process were identified. Each of these phases was divided into micro-activities to identify the related possible failure modes and their potential consequences. The Risk Priority Number was calculated for each failure mode. RESULTS AND DISCUSSION: Seventeen failure modes were identified in the entire perioperative period; those with a higher priority of intervention concern the incorrect timing between therapy suspension and surgery, and the incorrect assessment of the bleeding risk related to the invasive procedure. CONCLUSION: The FMEA method can help identify anticoagulant therapy perioperative failures and implement the management and patient safety of surgical procedures.

Risk assessment of failure during transitioning from in-centre to home haemodialysis.

BACKGROUND: Introducing a de-novo home haemodialysis (HHD) program often raises safety concerns as errors could potentially lead to serious adverse events. Despite the complexity of performing haemodialysis at home without the supervision of healthcare staff, HHD has a good safety record. We aim to pre-emptively identify and reduce the risks to our new HHD program by risk assessment and using failure mode and effects analysis (FMEA) to identify potential defects in the design and planning of HHD. METHODS: We performed a general risk assessment of failure during transitioning from in-centre to HHD with a failure mode and effects analysis focused on the highest areas of failure. We collaborated with key team members from a well-established HHD program and one HHD patient. Risk assessment was conducted separately and then through video conference meetings for joint deliberation. We listed all key processes, sub-processes, step and then identified failure mode by scoring based on risk priority numbers. Solutions were then designed to eliminate and mitigate risk. RESULTS: Transitioning to HHD was found to have the highest risk of failure with 3 main processes and 34 steps. We identified a total of 59 areas with potential failures. The median and mean risk priority number (RPN) scores from failure mode effect analysis were 5 and 38, with the highest RPN related to vascular access at 256. As many failure modes with high RPN scores were related to vascular access, we focussed on FMEA by identifying the risk mitigation strategies and possible solutions in all 9 areas in access-related medical emergencies in a bundled- approach. We discussed, the risk reduction areas of setting up HHD and how to address incidents that occurred and those not preventable. CONCLUSIONS: We developed a safety framework for a de-novo HHD program by performing FMEA in high-risk areas. The involvement of two teams with different clinical experience for HHD allowed us to successfully pre-emptively identify risks and develop solutions.