Manufacturing Facility Research Articles

An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods.

MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X. Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis. 1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0mm or > 5.0mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation. These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported.

Abstract 4136286: Safety Events with a Large-Bore Aspiration Thrombectomy Device for Pulmonary Embolism: An analysis of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experiences from 2018 to 2024

Introduction: Large bore thrombectomy is increasingly used to treat acute PE. Post-market surveillance using the U.S. FDA Manufacturer and User Facility Device Experience (MAUDE) database may capture serious device adverse events (AE) not described in small pre-market clinical trials. We aim to analyze serious AE associated with use of the Inari Medical (Irvine, California) large bore thrombectomy system to treat PE. Methods: All MAUDE events between January 1, 2018 and May 1, 2024 involving PE treatment with Triever and Flowtriever devices were reviewed and categorized based on device type, incident year, and clinical event. Based on narrative description, AE were placed into categories of cardiac, pulmonary, device malfunction, anemia, and other. Results: A total of 58 AE reports representing 50 unique clinical episodes were included. MAUDE event types were death (n=32), injury (n=23) and malfunction (n=3), and the majority (45/58) involved the larger aspiration catheters (Table 1). Death occurred in 27 of 50 unique episodes. Cardiac injury (n=19) and pulmonary injury (n=18) were most common and included 25 serious perforations. Serious AEs are listed in Table 2. Device malfunction/improper use was rare (n=7) and was not associated with death. Paradoxical embolism was described causing stroke and coronary occlusion. 3 of 4 blood loss AEs occurred prior to 2021. Conclusion: This report includes the largest description of reported AEs with large bore aspiration thrombectomy systems used to treat PE. This report describes serious events, often associated with death, that are likely infrequent and were not detected in pivotal studies or registries. Understanding these AEs may guide future technique and device refinement, and the current findings demonstrate the importance of large post-approval studies.

Abstract 4146315: Complications Associated With the 4798 Attain Stability Active Fixation Coronary Sinus Lead: Insights from the MAUDE Registry

Background: The Attain Stability Quad 4798 [Medtronic, Minneapolis, MN] lead was recently developed with a mechanism for active fixation into the venous wall, allowing for precise and secure placement in coronary venous branches. However, real-world data regarding complication rates are limited. Research Question: What are the real-world complications of the Medtronic 4798 lead? Goals: We reviewed the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for adverse events associated with the 4798 lead. Methods: We reviewed the MAUDE database on November 15, 2023, for all reported complications due to the 4798 lead from January 1, 2018 – a year before the lead was approved by the FDA – to the present. Results: A total of 2011 reports of adverse events occurred in mostly males (67.9%) patients with an average age of 70.86±12.1 years. Leads were used most frequently in 2023 (32.3%) for initial use (65.5%) but events commonly occurred intra-procedurally (73.7%). Device malfunction occurred in 43.4% of cases and included but was not limited to adverse events without an identified device problem (33.9%), device dislodgment (24.1%), infection (21.1%), and failure to capture (18.4%). In several cases, the guidewire was stuck (10.7%), or lead dislodgement (27.9%) occurred, resulting in direct helix damage (10.1%). Malfunctions resulted in injury and death in 55.8% and 1.1% of cases, respectively. Conclusions: The use of an active fixation CS lead has been associated with a significant incidence of intraprocedural helix mechanism malfunction. Further real-world surveillance and registry data can help clarify the true incidence of lead failure.

CTIM-25. PHASE2B/3 STUDY OF NEOANTIGEN-SPECIFIC T CELL IMMUNOTHERAPY IN NEWLY DIAGNOSED O6 – METHYLGUANINE METHYLTRANSFERASE UNMETHYLATED (MGMT -) GLIOBLASTOMA

Abstract MGMT- glioblastoma (GBM) is the most common malignant primary brain tumor, yet outcomes have not improved in decades despite intensive investigations. TVI-AST-008 is a randomized clinical trial of a novel neoantigen-specific T cell immunotherapy regimen proven invariably curative in rodent models and clinically effective in trials of patients with relapsed/resistant GBM. TVAX neoantigen-specific T cell immunotherapy exploits the fact that cancer cells express neoantigens, and adoptive transfer can bypass the immunosuppressive milieu near the resection cavity. In this manner, TVAX effector T cells initiate apoptosis in any residual GBM. After pathologic confirmation, autologous GBM tumor tissue sent to the TVAX GMP manufacturing facility is irradiated and utilized for proprietary vaccine production. Patients are vaccinated with a series of two intradermal injections and the resulting cancer neoantigen-specific T cells are harvested by leukapheresis. These T cells are activated and proliferated ex vivo by TVAX manufacturing to generate effector T cells. These are re-infused following standard radio-chemotherapy, followed by low-dose interleukin-2 to further stimulate T cell proliferation. In the study, MGMT- GBM patients are randomly assigned to treatment or control arms. Patients in the treatment arm undergo vaccination, then standard concurrent IMRT-chemotherapy, followed by re-infusion of TVAX autologous effector T cells. Patients in the control arm undergo standard IMRT-chemotherapy followed by adjuvant chemotherapy with temozolomide. TVI-AST-008 is an ongoing, randomization-controlled study with Fast Track designation from the FDA. The primary end point is overall survival. Additional end points include progression free survival, safety and immune response. Patients are followed with physical exams and surveillance MRI for evidence of disease progression. The trial is targeted for 15 centers in the US.

An Analysis of the Complication Reports of Expandable Lumbar Interbody Cages in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

Expandable lumbar interbody cages (ELICs) are commonly used for interbody fusion and provide lordotic correction by lengthening the anterior column of the vertebral spine. We sought to identify unique failure mechanisms and significant differences in the types of complications associated with ELICs as reported to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database. The MAUDE Database was analyzed for complication reports submitted for ELIC systems between January 2013 and July 2023. Reports were categorized by manufacturer, brand name, type of expandable cage, type of complication, year of complication, and reporter identity. Reports that were duplicated or had insufficient information were excluded from analysis. The top 5 manufacturers with the most implant-related complications were independently analyzed and compared. A total of 821 reports were analyzed. The top 5 complications reported across all manufacturers were cage breakage during insertion (25.7%), postoperative migration without collapse (16.0%), postoperative collapse (15.6%), inserter breakage (11.1%), and tubing problems (3.0%). A significant difference was detected in complication type between manufacturers (χ2=557, P<.001). The largest number of reports (120, 14.6%) was in 2016. With FDA approval of novel ELIC systems and the adoption of newer surgical techniques, understanding the range of potential complications is paramount in ensuring patient safety. This study of the MAUDE Database provides a comprehensive summary of adverse reported events associated with ELICs during the past decade. [Orthopedics. 202x;4x(x):xx-xx.].

Compact and simple antenna inspection testing range for 5G smartphones

Abstract Over-the-air antenna performance evaluation in the millimeter-wave band often relies on compact antenna test range systems, which require large reflectors and a substantial measurement range volume. Such setups are impractical for rapid testing in space-constrained environments such as antenna fault diagnosis in smartphone manufacturing facilities. This paper presents a novel design methodology for highly compact antenna inspection testing range utilizing offset parabolic reflectors specifically designed for 5G smartphones. The proposed design system employs three small offset parabolic reflectors configured to account for beam tilting caused by smartphone back covers, eliminating the need to physically reposition the smartphone during testing. By directing electromagnetic fields toward a fixed receiver antenna from multiple angles corresponding to different antenna module positions, the system streamlines the test procedure, significantly reducing measurement time and measurement range volume. The proposed antenna inspection testing range provides a cost-effective and efficient solution for 5G antenna fault diagnosis in manufacturing facilities, ensuring rapid and reliable inspection while minimizing space requirements on the production line.

Complications associated with pulsed field ablation versus radiofrequency catheter ablation of atrial fibrillation

BackgroundThe first commercial systems for pulsed field ablation(PFA) were recently approved by the Food and Drug Administration(FDA), but their safety profile in nationwide practice remains underexplored. ObjectiveThis study aimed to describe reported adverse events with PFA systems after their market release and to compare the relative proportion of complications associated with PFA versus radiofrequency(RF) ablation catheters. MethodsWe conducted a search of the Manufacturer and User Facility Device Experience database for adverse event reports involving FDA-approved PFA and RF catheters between January 1, 2024, to July 31, 2024. ResultsA total of 1,237 reports detailing clinical complications (N=156 for PFA and N=315 for RF) or catheter malfunctions (N=336 for PFA and N=430 for RF) were analyzed. The most common adverse events reported for PFA were pericardial effusion, vasovagal response, and hemolysis, and for RFA were pericardial effusion, ischemic stroke, and esophageal damage. The proportion of reported adverse events that were deaths was lower among PFA compared to RF (2.6% vs. 8.9%, P=0.010). Hemolysis (9.0% vs. 0%), coronary events (5.8% vs. 0.6%), and vasovagal responses (14.1% vs. 0%) were reported more frequently after PFA (all P<0.001). In contrast, esophageal damage (0% vs. 4.1%, P<0.001) and pulmonary vein stenosis (0% vs. 1.9%, P=0.184) were not reported with PFA, only with RF. Regarding catheter malfunctions, mechanical problems were reported in greater proportion after PFA compared with RF (87.2% vs. 17.2%, P<0.001). ConclusionThe reported complications associated with PFA and RF ablation differ significantly. Close attention to PFA-specific complications is essential for ensuring the safe use of PFA and for mitigating risk.

Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database

BackgroundIncreasing medical device usage raises concerns regarding unexpected, potentially life-threatening events that pose public health risks. Such events are reported to the Food and Drug Administration (FDA), and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database, a vital tool for post market surveillance that requires information of high quality and integrity, particularly concerning reporting sources. PurposeTo analyze reporting behavior among different reporters, including manufacturers, distributors, and user facilities, by examining differences in reported factors, namely: (1) device types, (2) product problem attribution, and (3) selection of Device Problem Codes (DPCs) associated with the root causes of events. MethodsData spanning from 2005 to 2022 was retrieved from the MAUDE database using Python. Reports were grouped by reporter type and divided according to device type, and the reporter's indication of association with a product problem. Furthermore, events were classified by their respective DPCs, which were manually grouped into four categories: device issues, user issues, clinical issues, or unknown. FindingsThe analysis revealed significant variations among reporters across all examined aspects (P < 0.00001 in all comparisons according to the proportion test). Manufacturers predominantly focused on infusion pumps (10.1%) and Implant, Endosseous, Root-Form (IER) devices (7.6%), with a product problem indication rate of 29.2% in their reports. Device issues codes were the most frequently observed category in their reports, comprising 36.3%, followed by unknown codes (32%) and clinical codes (19.3%). Distributors, on the other hand, primarily reported on IER devices (89%) and exhibited the lowest product problem indication rate at 2.7%. Clinical issues codes predominated in their reports, constituting 85.7%, followed by unknown codes (6.7%). User facilities concentrated on intravascular sets (4.7%), Electrosurgical, Cutting & Coagulation & Accessories (4.2%), and Ventricular (Assist) Bypass (4.1%). Remarkably, their product problem indication rate was the highest at 56.7%. They predominantly reported device issues codes (54.3%), followed by use codes (30.8%), and unknown codes (11.4%) ImplicationsThe notable variation among different reporters underscores the importance of incorporating diverse sources when analyzing the database, particularly in cases where majority of reports originate from manufacturers. Decision-makers must approach database information comprehensively, considering data sources and diverse perspectives to inform regulatory decisions effectively. Developing strategies that encourage various reporters to contribute their unique and complementary viewpoints is advisable.

Modeling of Steel Production Sub-Processes by Probabilistic Time Automaton and Assessing the Risk of Deviation from Stability in the Manufacturing Facility Environment

Modeling of Steel Production Sub-Processes by Probabilistic Time Automaton and Assessing the Risk of Deviation from Stability in the Manufacturing Facility Environment

Device dislodgement and embolization associated with a new leadless pacemaker.

Currently, there are two approved single chamber leadless pacemakers (LP) in the United States (US), Micra VR™; approved since 2016 and AVEIR VR™; approved in 2022. A potential complication of LPs is dislodgement and/or embolization (D/E) during or after implant. According to the IDE trials, there appears to be a significant difference in D/E rates between the two LPs that have different fixation mechanisms; Micra uses nitinol tines, while AVEIR uses an active screw helix. The aim of this study was to determine if the AVEIR VR LP has continued to exhibit D/E in the United States since it was approved by the Food and Drug Administration (FDA) in April 2022. The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched for US D/E reports communicated by the manufacturers of both LP devices. For AVEIR VR we reviewed reports from approval till December 2023, and for Micra VR we looked at reports from approval to April 2024. Excluded were reports based on information indirectly obtained from registries, journals, social media, or volunteers. Total number of US implants was acquired from the manufacturers' product performance reports. During a period of 21 months, 5990 AVEIR VR implants had been registered in the United States, of which 53 (0.88%) encountered D/E both during and after the procedure. More D/E (32; 60.4%) occurred during the implantation procedure, with device release problems being the most prominent procedural issue involved with these events. Within a 8-year period, 72 237 Micra VR implants have been registered in the United States, of which 211 (0.29%) showed D/E. The rate of D/E since the US approval of both devices was significantly higher for AVEIR VR compared to Micra VR (0.88% vs 0.29%; p < .0001). AVEIR VR implants may be complicated by dislodgement with or without embolization. Currently, the estimated incidence is about 0.9%, which is significantly higher than Micra VR. Fixation issues and separation problems of the device from the delivery catheter appear to be responsible for most of these D/E events.

Capacity Constraint Analysis Using Object Detection for Smart Manufacturing

The increasing adoption of Deep Learning (DL)-based Object Detection (OD) models in smart manufacturing has opened up new avenues for optimizing production processes. Traditional industries facing capacity constraints require noninvasive methods for in-depth operations analysis to optimize processes and increase revenue. In this study, we propose a novel framework for capacity constraint analysis that identifies bottlenecks in production facilities and conducts cycle time studies using an end-to-end pipeline. This pipeline employs a Convolutional Neural Network (CNN)-based OD model to accurately identify potential objects on the production floor, followed by a CNN-based tracker to monitor their lifecycle in each workstation. The extracted metadata are further processed through the proposed framework. Our analysis of a real-world manufacturing facility over six months revealed that the bottleneck station operated at only 73.1% productivity, falling to less than 40% on certain days; additionally, the processing time of each item increased by 53% during certain weeks due to critical labor and materials shortages. These findings highlight significant opportunities for process optimization and efficiency improvements. The proposed pipeline can be extended to other production facilities where manual labor is used to assemble parts, and can be used to analyze and manage labor and materials over time as well as to conduct audits and improve overall yields, potentially transforming capacity management in smart manufacturing environments.

Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results

Abstract Introduction Remote monitoring using an implantable pulmonary artery pressure (PAP) sensor (CardioMEMS HF system) in patients with heart failure (HF) has been consistently shown to reduce HF hospitalizations [1]. The success of this approach relies on the accurate measurement of diastolic PAP (dPAP) over time to allow early interventions such as diuretic intensification [2]. However, it remains unclear how the measurement accuracy changes over time after the initial calibration at the time of device implantation. Purpose This study aims to identify measurement inaccuracy events and to quantify the magnitude and direction of required device recalibration for CardioMEMS devices as reported in a large-scale regulatory device database. Methods We used the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) data maintained by the US Food and Drug Administration (FDA). The summary search was performed for the CardioMEMS pulmonary artery pressure sensor for the entire product life cycle from January 2009 to February 2024 [3,4]. The entries related to the measurement accuracy under ‘Device Problems’ categories were obtained. Tested accuracy was reported to have been within ±10mmHg of a reference pressure measurement throughout simulated use for 10 years [5]. Normal range for dPAP is ~8mmHg to 15mmHg [6]. Results A total of 2656 entries were obtained. Following categories were identified for the reported entries: device sensing problem (N=999, 38%); incorrect measurement (N=1349, 52%); incorrect measurement, inappropriate waveform (N=279, 11%), and incorrect, inadequate, or imprecise results or readings (N=29, 1%). After excluding 56 entries for missing information, 2600 entries were included for the analysis. A total of 1676 (64%) entries reported the need for recalibration of the CardioMEMS device. A mean PAP difference (defined as the difference of the mean PAP reference value measured at the time of recalibration minus the CardioMEMS reading obtained during the reference measurement) is shown in Figure 1. Compared to the reference pressure values at the time of recalibration, 488 (29%) of CardioMEMS readings were higher and 1188 (71%) were lower. The absolute recalibration pressure difference was 14.5 ± 9.3 mmHg (mean ± standard deviation, range 0.02-59.3 mmHg). The recalibration by more than 10 mmHg was reported in 1040 (40%) entries. Conclusions Suspected measurement inaccuracy with CardioMEMS device is not uncommon and often necessitate recalibration. Almost one-half (40%) of the recalibrations required more than 10 mmHg correction. These results should inform clinicians to consider recalibration along the course of CardioMEMS monitoring if there is discordance between clinical assessment and the values from the device.Figure 1.Figure 2

A Retrospective Study of the Adverse Events Associated With Over-the-Counter Hearing Aids in the Manufacturer and User Facility Device Experience (MAUDE) Database

A Retrospective Study of the Adverse Events Associated With Over-the-Counter Hearing Aids in the Manufacturer and User Facility Device Experience (MAUDE) Database

Real-World Safety of Prostate Cancer Focal Therapy: MAUDE Database Analysis.

Objective: The aim of this study was to assess the real-world safety profile of medical devices used in focal prostate cancer treatment utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was searched for reports on high-intensity focused ultrasound (HIFU), cryoablation, laser ablation, and irreversible electroporation (IRE) devices used in prostate cancer treatment from 1993 to 2023. Adverse events were identified and categorized. Results: We identified 175 reports for HIFU, 1362 for cryoablation, 615 for laser ablation, and 135 for IRE devices, with 28, 284, 126, and 2 respective reports, directly related to prostate cancer treatment. The aggregated data revealed the majority of complications were minor, with 82.5% (n = 363 out of 440 total complications) classified as Clavien-Dindo grade 1 or 2. Common minor complications included erectile dysfunction and urinary retention. Severe complications such as rectal fistulas were noted in HIFU and IRE treatments, along with singular mortality due to pulmonary embolism in cryoablation. Conclusions: Our analyses from MAUDE reveal that devices used in focal therapy for prostate cancer are predominantly associated with minor complications, underscoring their overall real-world safety profile. However, the occurrence of severe adverse events emphasizes the critical importance of rigorous patient selection and meticulous procedural planning. These findings provide valuable insights into the safety profile of focal therapy devices and contribute to the growing body of evidence on their use in prostate cancer treatment.

Optimizing Sheet Metal Formation through Advanced Hydroforming Simulation Technique

In this study, we investigate into the simulation of sheet metal hydroforming for crafting the cap of the axle-hub of a tip trailer within our manufacturing facility. This cap serves a crucial role in safeguarding wheel bearings from the detrimental effects of dust, sand, and dirt. The motivation for this work arises from the challenges encountered during the fixation of a conventional dust cap, which often falls off when subjected to pressure or threading, particularly when the tractor is in motion. The innovative approach pursued in this research involves the utilization of lightweight aluminum sheet metal for cap production, owing to its facile formability. The cap design incorporates four evenly distributed holes around its circumference and secures to the flange using screws. Prior to the manufacturing phase, a simulation of the cap-forming process was conducted using ANSYS Model 15, a computer-aided engineering program. The necessary models were crafted in CATIA, a computer-aided design program, streamlining the entire process to enhance efficiency, reduce costs, and minimize manpower requirements. The simulation encompassed three different thicknesses (1 mm, 2 mm, and 3 mm) for two distinct aluminum alloys, namely 1100 and 5652. The objective was to discern the optimal alloy for the forming process. Essential mechanical properties, including ultimate tensile strength, modulus of elasticity, and yield stress, were input into the ANSYS program to accurately reflect the materials' behavior during forming. The outcomes of our investigation revealed that aluminum alloy 5652 outperformed 1100 in terms of formability. The former exhibited a forming pressure of 300.2 MPa, while the latter required 298.3 MPa for the same forming depth (40 mm) across all three thickness variations. Additionally, the study demonstrated that 5652 is not only more efficient but also safer and more resilient than 1100.

Occupational safety and hidden risks in a furniture factory: A comprehensive assessment of hazards related to noise, lighting, thermal comfort, and dust exposure

This study assessed the occupational health and safety conditions in a furniture manufacturing facility, focusing on key environmental factors such as noise, lighting, thermal comfort, and dust exposure. Noise measurements recorded levels as high as 95.3 dB(A) during CNC machine operations, exceeding legal exposure limits of 87 dB(A), posing significant risks to workers’ hearing health. Lighting assessments showed levels ranging from 134 to 247 lux in production lines, which falls below the recommended threshold of 300 lux for adequate visibility. Thermal comfort was evaluated with temperature readings at 14.2 °C and relative humidity at 43%, revealing marginal comfort conditions that could reduce worker efficiency and satisfaction. Dust exposure measurements indicated respirable dust concentrations reaching 3.69 mg/m³ in the cutting department, which is close to the permissible exposure limit of 5 mg/m³, raising concerns about long-term respiratory health. These findings suggest several measures to improve workplace safety, including enhanced engineering controls, mandatory personal protective equipment (PPE), improved lighting systems, optimised thermal conditions, and advanced ventilation to reduce dust exposure. This comprehensive evaluation provides critical insights for improving furniture factories’ occupational health and safety practices.

Experimental Study on Seismic Performance Evaluation of a Multi-Story Steel Building Model with Rolling-Type Seismic Base Isolation

Critical structures such as hospitals, high-precision manufacturing facilities, telecommunications centers, and fire stations, especially, need to maintain their functionality even during severe earthquakes. In this sense, seismic isolation technology serves as a vital design method for preserving their functionality. Seismic isolators, also known as earthquake isolation systems, are used to reduce the effects of earthquakes on buildings by isolating them from the ground they are located on. By ensuring that less acceleration and force demand is transmitted to the superstructure, both the building and the equipment and the devices in the building are prevented from being damaged by earthquakes. This experimental study aims to conduct vibration tests on a small-scale multi-story steel-building model equipped with a specially designed rolling-type seismic base isolation system. The relationship between the test model and the prototype was achieved by frequency simulation. The tests will be performed on a shake table under six different earthquake accelerations to examine the model’s dynamic behavior. The primary goal is to evaluate the isolation performance of the rolling-type seismic base isolator under seismic loads, with a focus on recording the vibrations at the top of the test building. It has been observed that the isolator placed at the base of the building significantly reduced the peak acceleration and displacement values of the floor motion. Under the most severe earthquake record applied to the shake table, the acceleration at the top of the building with the isolator was found to be reduced by approximately 50%, compared to the non-isolated case.

A comparison of procedure-related adverse events between two right ventricular leadless pacemakers.

The Medtronic Micra VR and Abbott AVEIR VR are the leadless pacemakers (LPM) currently available in the United States (US). Micra VR employs fixation tines and the AVEIR VR uses an active fixation helix. Micra VR requires fixation before electrical measurements are obtained, while R-waves may be mapped by AVEIR VR without fixation. Little comparative data is available for these LPMs. Accordingly, we compared the incidences of procedure-related major adverse clinical events (MACE) and device problems in the US for Micra VR and AVEIR VR during 2022-2024. We searched the FDA's Manufacturer and User Facility Device Experience (MAUDE) database for US reports of MACE and device problems that were filed from April 2022 to December 2023 for AVEIR VR, and from June 2022 to April 2024 for Micra VR. Totals for US-registered LPM implants were obtained from the manufacturers' product performance reports. During the study period, 5990 AVEIR VR and 10 940 Micra VR implants were registered in the US. We found 305 MAUDE reports for AVEIR VR (5.1%), versus 541 MAUDE reports for Micra VR (4.9%) (p = .702). The incidence of MACE was 0.72% (43/5990) for AVEIR VR versus 0.59% (65/10 940) for Micra VR, (p = .387). The incidences of procedure-related death, cardiac perforation. cardiac arrest, emergency pericardial drainage or reparative surgery were similar for both LPMs (p > .05). Micra VR had more unacceptable thresholds requiring LPM replacement compared to AVEIR VR (95;0.9% vs. 24;0.4%; p = .001). AVEIR VR had a statistically higher incidence of device dislodgement during (32) and after (21) implant compared to Micra VR (53 (0.9%) vs. 46 (0.4%), p < .001). Micra VR and AVEIR VR have similar procedural safety profiles, including the incidences of death and perforation. However, device problems differed significantly, possibly related to their design differences. Compared to Micra VR, AVEIR VR appears to have an advantageous threshold measurement capability but is more prone to device dislodgement.

Mode 2 critical systems practice for complex safety decisions: Reflections from New Zealand's dairy industry

AbstractPoor decision‐making contributes to disasters in complex industrial systems. Improving group decision‐making practices for safety‐critical interventions is crucial yet hindered by a fragmented safety science literature. Our study applies Jackson's critical systems practice (CSP) to a complex safety problem at a New Zealand dairy manufacturing facility. Reflective practice, employed in the study and writing this article, underlines CSP's usefulness in navigating complex emergent safety challenges. Key insights include clarifying cognitive complexity amongst participants early in an intervention, focusing more sharply on crucial safety outcomes by using critical facilitation and enhancing CSP's ‘Check’ stage using reflective practice. We conclude by calling on scholars to prioritise the application of CSP in real‐world contexts to deepen our understanding of systemic praxis and generate actionable improvements.

Noise emission characteristics of cosmetics manufacturing plants

Recently, a rapid increase in the establishment of cosmetics manufacturing facilities has been observed in Korea because of the growing export of K-beauty products. Many of these factories are certified under good manufacturing practice (GMP) standards and show significant interest in quality management, industrial injury prevention, and productivity enhancement. Among industrial injuries, noise-induced hearing loss holds the largest share, rendering it crucial for industrial injury prevention. Therefore, this study aimed to assess the noise exposure status in cosmetics manufacturing facility spaces. Analysis revealed that the 24-h average continuous noise level (L_eq) was approximately 69.0 dB(A). The measured areas were divided into three rooms based on their purpose, of which the Manufacturing Room showed the highest noise levels ranging from 74.0 to 77.0 dB(A). Additionally, the Blister Packaging and Sealing Room ranged from 64.1 to 66.1 dB(A), and the Box Packing Room ranged from 64.3 to 65.8 dB(A), all within acceptable limits and not exceeding day-night noise correction exposure standards. From the perspective of industrial injury prevention and monitoring, this study aims to implement these measurement results within the metaverse in the future for visualization.