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ABSTRACT Aim Design Methods Results Conclusion Implications and Impact Reporting Method Patient or Public Contribution To identify whether the introduction of low‐low hospital beds resulted in changes in the incidence, associated patient harms and event characteristics of bed‐related falls where implemented.This retrospective quality improvement study covered 36 months: 18 months pre‐intervention and 18 months post‐intervention.Our analysis incorporated patient fall data from a hospital in upstate New York. Pre‐/post‐intervention data covered 18 months on either side of introduction at the units of implementation. Data were sourced from contemporaneously recorded incident reports and the organisation's business intelligence records. Analysis addressed the incidence rate, frequency, patient harm classification and recurrence of bed‐related falls, as well as Morse Fall Scale risk classification, patient age, gender and other individualised risk factors. Lastly, we reviewed the presence of individualised interventions, staff assistance during the event, patient census and staffing ratios. Chi‐square goodness of fit tests were employed to compare the distribution, and Brunner‐Munzel tests the stochastic equality, of the pre‐ and post‐implementation categorical and continuous data.There were no significant differences in the incidence rate of bed‐related falls, patient harms or in the need for medical intervention following implementation of the low‐low hospital beds. Neither were there any significant differences in the proportion of events resulting in detectable harm or the need for medical intervention post‐implementation. The total number of bed‐involved falls substantively increased following implementation of the low‐low beds, as did the number of events resulting in detectable harms and medical intervention. Among these, substantive increases were noted among events resulting in minor temporary harm and patients referred for diagnostic imaging. The number of events involved patients experiencing recurrent falls of any kind increased significantly post‐implementation.We found that the introduction of low‐low hospital beds preceded no change in the incidence of bed‐related falls, associated patient harms or the need for post‐event medical intervention where implemented. While data limitations precluded definitive determination with respect to certain event characteristics, several post‐implementation changes, including substantive increases in the number of falls occurring during ingress and egress, may suggest a potential for relationship worthy of future study.Low‐low hospital beds are purported to help reduce the occurrence and severity of bed‐related falls, both serious problems in inpatient settings. This study describes null outcomes following an implementation of such beds, with implications for adoption in similar settings.We adhered to the relevant Enhancing the Quality and Transparency of Health Research guidelines, specifically following the Standards for Quality Improvement Reporting Excellence standards.No patient or public involvement in the design or conduct of the study. Nurses and medical staff were involved in intervention implementation, data collection and the conception, design and conduct of the study. [ABSTRACT FROM AUTHOR]

La lithotripsie laser est une méthode clé pour détruire les calculs urinaires, exploitant la chaleur du laser. Toutefois, une gestion inappropriée de cette chaleur peut causer des dommages thermiques significatifs. Ce document explore ces dynamiques thermiques et leurs conséquences. Après un rappel sur les principes fondamentaux de la lithotripsie laser, une revue critique des recherches expérimentales et cliniques pertinentes est réalisée. Cette approche permet de synthétiser les connaissances actuelles sur l'impact des paramètres opératoires du laser sur les tissus urinaires. Le rôle des principes de conduction et de convection dans la propagation et la dissipation de la chaleur sont mis en lumière. La notion de dose thermique pour évaluer les risques thermiques, les comparaisons entre différents types de lasers (Ho:YAG et TFL), et les variations de température induites par la lithotripsie au laser dans différents contextes expérimentaux et opératoires sont évoqués. Prendre conscience des risques et approfondir la compréhension de l'interaction des lasers avec les calculs et les tissus environnants constituent les premières étapes essentielles pour prévenir les complications. Laser lithotripsy is a key method for breaking down urinary stones, utilizing the heat from the laser. However, inappropriate management of this heat can cause significant thermal damage. This document explores these thermal dynamics and their consequences. After a review of the fundamental principles of laser lithotripsy, a critical examination of relevant experimental and clinical research is conducted. This approach allows for a synthesis of current knowledge on the impact of laser operational parameters on urinary tissues. The roles of conduction and convection principles in the propagation and dissipation of heat are highlighted. The concept of thermal dose for assessing thermal risks, comparisons between different types of lasers (Ho:YAG and TFL), and the variations in temperature induced by laser lithotripsy in various experimental and operational contexts are discussed. Becoming aware of the risks and deepening the understanding of the interaction between lasers and urinary stones and surrounding tissues are essential first steps in preventing complications. [ABSTRACT FROM AUTHOR]

La lithotripsie laser est une méthode essentielle pour la fragmentation des calculs urinaires, offrant une efficacité élevée mais comportant également des risques de dommages thermiques aux tissus environnants. Cette synthèse se concentre sur les stratégies préventives visant à minimiser ces risques par le biais d'un ajustement optimal des paramètres du laser et de techniques d'irrigation améliorées. L'approche adoptée a consisté en une lecture critique des publications existantes sur la lithotripsie laser, axée sur l'évaluation des réglages des paramètres du laser, des techniques d'irrigation, et de l'utilisation de l'aspiration. L'objectif était d'identifier et rappeler les meilleures pratiques pour réduire les risques thermiques pendant les interventions. Les données extraites soulignent que l'optimisation de la densité d'énergie, le choix judicieux de la durée des pulses et une gestion prudente de la fréquence sont essentiels pour réduire les risques de dommages thermiques. Les avantages de la technique de « balayage » par rapport à la technique « burst » ont été clarifiés. L'importance de l'irrigation et le rôle potentiel de l'aspiration ont été mis en évidence en tant que mécanismes complémentaires cruciaux pour maintenir la température et la pression à des niveaux sûrs. L'adoption de ces pratiques contribue significativement à améliorer la sécurité et l'efficacité des traitements urologiques. Laser lithotripsy is an essential method for the fragmentation of urinary stones, offering high efficiency but also posing risks of thermal damage to surrounding tissues. This synthesis focuses on preventive strategies aimed at minimizing these risks through optimal adjustment of laser parameters and improved irrigation techniques. The approach adopted consisted of a critical review of existing publications on laser lithotripsy, focusing on laser parameter settings, irrigation techniques, and the use of aspiration. The goal was to identify and summarize best practices to reduce thermal risks during procedures. The data extracted emphasize that optimizing energy density, making judicious choices of pulse duration, and carefully managing frequency are essential to reducing the risks of thermal damage. The advantages of the "painting" technique over the "burst" technique have been clarified. The importance of irrigation and the potential role of aspiration have been highlighted as crucial complementary mechanisms to maintain temperature and pressure at safe levels. Adopting these practices significantly contributes to improving the safety and efficacy of urological treatments. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this review was to identify existing prevention strategies for recreational windsurfing-related acute injuries and provide clinicians with a practical overview of current evidence supporting proposed potential prevention strategies. Methods: A literature search was conducted through March 8, 2023, using relevant keywords with Boolean operators, such as "windsurfing" AND "injury prevention" and "windsurfing" AND "exercise interventions," from the PubMed and Google Scholar databases. Only peer-reviewed English-articles were included. Results: Existing prevention strategies, right-of-way rules, a new proposed set of eight potential primary to tertiary prevention strategies for windsurfing-related acute injuries, and proposed definitions of injury prevention levels equivalent to Haddon's matrix were identified and tabled. Conclusions: The proposed potential prevention strategies may facilitate clinicians in preventing recreational windsurfing-related acute injuries. Injury prevention for recreational windsurfing is underresearched. Future studies should focus on large prospective clinical trials evaluating the efficacy of prevention strategies for recreational windsurfingrelated injuries. [ABSTRACT FROM AUTHOR]

PURPOSE:Real-time magnetic resonance imaging (MRI) is a promising alternative to X-ray fluoroscopy for guiding cardiovascular catheterization procedures. Major challenges, however, include the lack of guidewires that are compatible with the MRI environment, not susceptible to radiofrequency-induced heating, and reliably visualized. Preclinical evaluation of new guidewire designs has been conducted at 1.5T. Here we further evaluate the safety (device heating), device visualization, and procedural feasibility of 3T MRI-guided cardiovascular catheterization using a novel MRI-visible glass-fiber epoxy-based guidewire in phantoms and porcine models. METHODS:To evaluate device safety, guidewire tip heating (GTH) was measured in phantom experiments with different combinations of catheters and guidewires. In vivo cardiovascular catheterization procedures were performed in both healthy (N = 5) and infarcted (N = 5) porcine models under real-time 3T MRI guidance using a glass-fiber epoxy-based guidewire. The times for each procedural step were recorded separately. Guidewire visualization was assessed by measuring the dimensions of the guidewire-induced signal void and contrast-to-noise ratio (CNR) between the guidewire tip signal void and the blood signal in real-time gradient-echo MRI (specific absorption rate [SAR] = 0.04 W/kg). RESULTS:In the phantom experiments, GTH did not exceed 0.35°C when using the real-time gradient-echo sequence (SAR = 0.04 W/kg), demonstrating the safety of the glass-fiber epoxy-based guidewire at 3T. The catheter was successfully placed in the left ventricle (LV) under real-time MRI for all five healthy subjects and three out of five infarcted subjects. Signal void dimensions and CNR values showed consistent visualization of the glass-fiber epoxy-based guidewire in real-time MRI. The average time (minutes:seconds) for the catheterization procedure in all subjects was 4:32, although the procedure time varied depending on the subject's specific anatomy (standard deviation = 4:41). CONCLUSIONS:Real-time 3T MRI-guided cardiovascular catheterization using a new MRI-visible glass-fiber epoxy-based guidewire is feasible in terms of visualization and guidewire navigation, and safe in terms of radiofrequency-induced guidewire tip heating.

The coronavirus disease 2019 (COVID-19), which has raised concerns about infection control for every clinical procedure, including flexible fiberoptic bronchoscopy (FFB), has drawn the attention of clinicians across the globe. A pulmonologist frequently conducts this procedure to diagnose and treat pulmonary diseases like COVID-19. This procedure involves direct airway observation and generates aerosol from the patient. However, it is considered a double-edged sword, as the risk of infection and instrument contamination always haunts its clinical benefit to the patients and the operators. Therefore, a guideline for preparing and indicating FFB in COVID-19 must be addressed appropriately by emphasizing the importance of infection prevention and control. Fortunately, several recommendations and findings have emerged over the past three years, which should support safe FFB procedures for its operators with controlled infection. This study summarizes the indication, objective, contraindication, risk, preparation, and findings in diagnostic and therapeutic FFB patients with COVID-19.

Although 7-T MRI has recently received approval for use in clinical patient care, there are distinct safety issues associated with this relatively high magnetic field. Forces on metallic implants and radiofrequency power deposition and heating are safety considerations at 7 T. Patient bioeffects such as vertigo, dizziness, false feelings of motion, nausea, nystagmus, magnetophosphenes, and electrogustatory effects are more common and potentially more pronounced at 7 T than at lower field strengths. Herein the authors review safety issues associated with 7-T MRI. The rationale for safety concerns at this field strength are discussed as well as potential approaches to mitigate risk to patients and health care professionals.

Abstract Background In recent years, various home‐use health devices have gained popularity. The abdominal roller is one of these. Spinal cord injury without radiological abnormality is known to occur even with relatively minor injuries, but there are few reports of such injuries caused by a roller. Case Presentation Two cases of spinal cord injuries caused by a roller are reported. In both cases, injuries occurred during the standing rollout by a patient in an inebriated state, and the patients were rushed to an emergency department. Conclusion Because the use of abdominal rollers may result in extremely serious disabilities, it is necessary to emphasize the appropriate use of such equipment.

Percutaneous peripheral nerve stimulation (PNS) is an FDA-cleared pain treatment. Occasionally, fragments of the lead (MicroLead, SPR Therapeutics, LLC, Cleveland, OH, USA) may be retained following lead removal. Since the lead is metallic, there are associated magnetic resonance imaging (MRI) risks. Therefore, the objective of this investigation was to evaluate MRI-related issues (i.e., magnetic field interactions, heating, and artifacts) for various lead fragments.Testing was conducted using standardized techniques on lead fragments of different lengths (i.e., 50, 75, and 100% of maximum possible fragment length of 12.7 cm) to determine MRI-related problems. Magnetic field interactions (i.e., translational attraction and torque) and artifacts were tested for the longest lead fragment at 3 Tesla. MRI-related heating was evaluated at 1.5 Tesla/64 MHz and 3 Tesla/128 MHz with each lead fragment placed in a gelled-saline filled phantom. Temperatures were recorded on the lead fragments while using relatively high RF power levels. Artifacts were evaluated using T1-weighted, spin echo, and gradient echo (GRE) pulse sequences.The longest lead fragment produced only minor magnetic field interactions. For the lead fragments evaluated, physiologically inconsequential MRI-related heating occurred at 1.5 Tesla/64 MHz while under certain 3 Tesla/128 MHz conditions, excessive temperature elevations may occur. Artifacts extended approximately 7 mm from the lead fragment on the GRE pulse sequence, suggesting that anatomy located at a position greater than this distance may be visualized on MRI.MRI may be performed safely in patients with retained lead fragments at 1.5 Tesla using the specific conditions of this study (i.e., MR Conditional). Due to possible excessive temperature rises at 3 Tesla, performing MRI at that field strength is currently inadvisable.

BackgroundMagnetic resonance imaging (MRI) has been performed safely in patients without MRI-conditional cardiac implantable electronic devices (CIEDs), but experience specifically with cardiac magnetic resonance imaging (CMR) is limited in this patient population.ObjectiveEvaluate the safety of CMR in non-MRI-conditional CIEDs and the interpretability of images using wideband sequences.MethodsWe performed 114 consecutive CMR studies in 111 patients (mean age 59 ± 14 years, with 12 pacemakers, 73 implantable cardioverter defibrillators, 29 biventricular defibrillators) using a wideband pulse sequence for late gadolinium enhancement (LGE) imaging. A standardized protocol for device management and patient monitoring was followed. Patients were evaluated for major clinical adverse events and device parameter changes immediately after CMR and at clinical follow-up.ResultsIn total, 111 CMR studies were completed successfully. There were no patient deaths, new arrhythmias, immediate generator or lead failures, electrical resets, or pacing capture failures in dependent patients. Right atrial, right ventricular, and left ventricular lead impedances were significantly lower post CMR, with median differences -7 Ω (interquartile range [IQR] -20 to 0 Ω; P < .0001), 0 Ω (IQR -19 to 0 Ω; P = .0001), and -10 Ω (IQR -30 to 0 Ω; P = .023), respectively. These changes persisted through the follow-up period, with median differences -18.5 Ω (IQR -41 to -66 Ω; P = .007), -19 Ω (IQR -44 to -7 Ω; P = .006), and -30 Ω (IQR -130 to 0 Ω; P = .003), respectively. Ninety-seven studies (87%) had no artifact limiting interpretation.ConclusionsCMR can be performed safely in non-MRI-conditional CIEDs using a standardized protocol. Use of a wideband pulse sequence for LGE imaging yields a high rate of studies unaffected by artifact.

Electricity is a dangerous tool. When used carefully it can substantially improve safety, outcomes and efficiency within the operating theatre; but if used without due caution it can cause significant harm or death. Understanding the principles and practicalities of electrical supply, equipment design and safety mechanisms helps us identify and mitigate the risks to ourselves, our colleagues and our patients. Specific medical devices that apply current directly to the body for therapeutic effect (e.g. surgical diathermy, defibrillators) can be the most dangerous; if appropriate practices are not followed then the risk of electrical injury is high. In this article we cover the principles and knowledge required to ensure basic electrical safety within the operating theatre. [ABSTRACT FROM AUTHOR]

A distribution transformer is one of the most important equipments in the power grid, and its operational status is directly related to the security and stability of the entire power system. The performance of transformer windings determines the service life of the transformer. It is of great significance to evaluate the performance of transformer windings accurately, reliably, and effectively after the short-circuit test of the transformer. Aiming at the problem that the natural vibration frequency of the transformer measured before and after the short circuit may not be the same under the impact of the short circuit of the transformer, this paper puts forward the evaluation method for the performance evaluation of the winding of the transformer after the short circuit test and adopts the method of combining the analytic hierarchy process with the fuzzy evaluation method to quantitatively obtain the score for the performance evaluation of the winding. And that evaluation language is given according to the score. Finally, the evaluation of the transformer winding performance after the short-circuit test is realized. The evaluation results show that this method can effectively get the performance index of the transformer winding, without the need for hanging cover inspection, and solve the subjectivity of human eye observation to objectively, accurately, and quantitatively describe the performance state of the transformer winding. The method is favorable for power grid monitoring and maintenance personnel to accurately evaluate the operation stability of the transformer and has very positive significance for improving the short-circuit impact resistance of the transformer and ensuring the safety and stability of the operation of a power system. [ABSTRACT FROM AUTHOR]

Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety., Competing Interests: Disclosures: Disclosure forms are available with the article online.

Background: Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death." Understanding recalls and their causes is important for patient safety., Objective: To characterize Class I recalls of cardiovascular devices and the clinical evidence supporting authorization., Design: In this cross-sectional study, cardiovascular device recalls from 1 January 2013 through 31 December 2022 were identified using the FDA's annual log. Information about devices was extracted from publicly available FDA decision summaries., Setting: The FDA Medical Device Recalls database., Participants: Cardiovascular devices with Class I recalls., Measurements: Recalls were characterized by their causes and scope. Devices were characterized by their regulatory history (product code, special designations) and clinical evidence (premarket testing, postmarket surveillance). Clinical studies were analyzed for quality, including end point selection (clinical vs. surrogate, use of composites)., Results: From 2013 to 2022, there were 137 Class I recall events affecting 157 unique cardiovascular devices, of which 112 (71.3%) were moderate-risk 510(k) devices and 45 (28.7%) were high-risk premarket approval (PMA) devices. Recalls affected a median of 7649 units (IQR, 953 to 28 446) and were most commonly attributed to device design (43 [31.4%]). Forty-two (26.8%) devices had multiple Class I recalls. Thirty (19.1%) devices underwent premarket clinical testing (7 [6.2%] 510(k) devices, 17 [85.0%] PMA devices, and 6 [24.0%] PMA supplement devices). Most studies used surrogate (27 [79.4%]) and composite (24 [70.6%]) measures as primary end points. Twenty-two (48.9%) PMA devices had required postapproval studies, with 14 reporting delays. No 510(k) devices were subject to postmarket surveillance., Limitation: Details about clinical testing may be missing from FDA summaries., Conclusion: Cardiovascular devices with Class I recalls were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually., Primary Funding Source: None., Competing Interests: Disclosures: All relevant financial relationships have been mitigated. Disclosure forms are available with the article online.

The "5 gauss line" is a phrase that is likely to be familiar to everyone working with MRI, but what is its significance, how was it defined, and what changes are currently in progress? This review explores the history of 5 gauss (0.5 mT) as a threshold for protecting against inadvertently putting cardiac pacemakers, implantable cardioverter defibrillators, and other active implantable medical devices into a "magnet mode." Additionally, it describes the background to the recent change of this threshold to 9 gauss (0.9 mT) in the International Standard IEC 60601-2-33 edition 4.0 that defines basic safety requirements for MRI. Practical implications of this change and some ongoing and emerging issues are also discussed., (© 2024 The Authors. Magnetic Resonance in Medicine published by Wiley Periodicals LLC on behalf of International Society for Magnetic Resonance in Medicine.)

Purpose: Intraoral coils (IOCs) in magnetic resonance imaging (MRI) significantly improve the signal-to-noise ratio compared with conventional extraoral coils. To assess the safety of IOCs, we propose a 2-step procedure to evaluate radiofrequency-induced heating of IOCs and compare maximum temperature increases in 3 different types of IOCs., Methods: The 2-step safety assessment consists of electric field measurements and simulations to identify local hotspots followed by temperature measurements during MRI. With this method, 3 different coil types (inductively coupled IFC, transmit/receive tLoop, and receive-only tLoopRx) were tested at 1.5 T and 3 T for both tuned and detuned coil states. High SAR and regular MRI protocols were applied for 2 coil positions., Results: The measured E field maps display distinct hotspots for all tuned IOCs, which were reduced by at least 40-fold when the IOCs were detuned. Maximum temperature rise was higher when the coils were positioned at the periphery of the phantom with the coil planes parallel to B 0 . When neither active nor passive detuning was applied, maximum temperature increase of ΔT = 1.3/0.5/1.8 K was found for IFC/tLoop/tLoopRx coils. Hotspots detected by E field measurements, and simulations were consistent. In the simulations, the results were different for homogeneous phantoms compared with full anatomical models. The 2-step test procedure is applicable to different coil types., Conclusions: The results indicate that a risk for radiofrequency-induced heating exists for tuned IOCs, so that adequate detuning circuits need to be integrated in the coils to ensure safe operation., Competing Interests: Conflicts of interest and sources of funding: none declared., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Intracranial electroencephalography (iEEG) involves placing intracranial electrodes to localise seizures in patients with medically refractory epilepsy. While magnetic resonance imaging (MRI) enables visualisation of electrodes within patient-specific anatomy, the safety of these electrodes must be confirmed prior to routine clinical utilisation. Therefore, the purpose of this study was to evaluate the safety of iEEG electrodes from a particular manufacturer in a 3.0-Tesla (3.0T) MRI environment., Methods: Measurements of magnetically induced displacement force and torque were determined for each of the 10 test articles using standardised techniques. Test articles were subsequently evaluated for radiofrequency-induced heating using a Perspex phantom in both open and 'fault' conditions. Additionally, we assessed radiofrequency (RF)-induced heating with all test articles placed into the phantom simultaneously to simulate an implantation, again in both open and 'fault' conditions. Finally, each test article was evaluated for MRI artefacts., Results: The magnetically induced displacement force was found to be less than the force on the article due to gravity for all test articles. Similarly, the maximum magnetically induced torque was less than the worst-case torque due to gravity for all test articles apart from the 8-contact strip - for which it was 11% greater - and the depthalon cap. The maximum temperature change for any portion of any test article assessed individually was 1.7°C, or 1.2°C for any device component meant to be implanted intracranially. In the implantation configuration, the maximum recorded temperature change was 0.7°C., Conclusions: MRI may be safely performed for localising iEEG electrodes at 3.0T under certain conditions., (© 2024 The Authors. Journal of Medical Radiation Sciences published by John Wiley & Sons Australia, Ltd on behalf of Australian Society of Medical Imaging and Radiation Therapy and New Zealand Institute of Medical Radiation Technology.)

Introduction: Machines are equipment that increases productivity and efficiency in a workplace. Machine Reliability, Integrity, and Availability are the most critical factors to ensure machinery safety in a workplace. Methods: Throughout this study, a series of reviews of previous literature are described in relation to the elements of reliability, integrity and availability. This study examines the methods used to investigate levels of each element as well as the results of performing the analysis. Each review is chosen from the aspect of the safety feature that can be interpreted from the research study. A scientific model that utilizes an improved Bottom-up Approach is proposed to further improve the worker's safety and enhance the productivity of an industry. Results: Research shows that the chosen reviews have positive and negative change towards the level of machinery safety and a more substantial approach is needed to further strengthen the issue. The proposed model combines the effort of employee and various management organization as a team. The model is validated using Bias- Variance Trade off method that analyses the proposed model in a 27MW power plant with a selection of employee and management. Conclusion: Model validation proves that the proposed model is an effective method to increase the machinery reliability, integrity and availability in a workplace. The scientific methodology provided will help management as a team to avert mechanical accidents from occurring at an initial stage.

• There is insufficient data to compare the radiosafety of the monoplane and biplane angiography systems. • Appropriate modifications of the acquisition parameters and protocols result in radiation reduction. • Further research in this area and personnel training are needed to minimize patient and operator exposures. The radiation dose during digital subtraction angiography (DSA) examination is determined on the basis of many factors. The aim of this study was to evaluate the dose-area product, air kerma, and fluoroscopy time on monoplane and biplane DSA of the cerebral arteries. Our results show that biplane angiography offered lower DAP, cumulative air kerma at the reference point and fluoroscopy time despite comparable procedure time.. Further research in this area and personnel training warrant the improvement of the radiosafety of angiographic interventional procedures and further development of angiographic technology. [ABSTRACT FROM AUTHOR]

• PSQA has been a mainstay of radiotherapy safety, but its value has been debated. • The value of PSQA and other related safeguards were analyzed using systems theory. • The information provided by PSQA has some, but limited, value in supporting other safeguards. • Simplifying PSQA into an automated and unambiguous test for catastrophic errors would be beneficial. While patient-specific quality assurance (PSQA) has been integral to intensity-modulated treatments, its value is debated. A systems approach to safety is essential for understanding complex systems like radiation oncology but is often overlooked in PSQA research. This study aims to elucidate PSQA's fundamental value and identify opportunities for enhancing safety in intensity-modulated treatments. First, causal scenarios that could lead to patient harm were identified using a prospective safety assessment technique developed for complex systems. Second, PSQA's ability to mitigate these scenarios was evaluated using standard stability and control principles. The analysis also included safeguards related to PSQA, such as daily linac QA, equipment commissioning, and equipment design. Ten causal scenarios were identified, highlighting well-known issues like flawed algorithms, data corruption, and hardware errors. Mitigation is achieved through advanced dose calculation and optimization algorithms, software and data integration, and preconfigured beam data, which improve decision-making and system state determination. Modern linac control systems enhance all aspects of system stability and control. Commissioning, daily linac QA, and PSQA are effective in enhancing the determination of system states only when feedback is non-overlapping and unambiguous. Given equipment improvement and related safeguards, the feedback generated from PSQA has diminished in value. To better complement other safeguards, PSQA should evolve to provide automated, unambiguous detection of any potential catastrophic treatment deviations prior to treatment. This evolution would allow physicists to focus on more critical aspects of patient care in radiation oncology. [ABSTRACT FROM AUTHOR]

PurposeRadiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices.Methods and materialsMAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.ResultsThere were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P

To determine the relationship between the delivered gas flows via nasal cannulas and face masks and the set gas flow and the breathing circuit pressure when connecting to the Y-adapter of the anesthesia breathing circuit and using the oxygen blender on the anesthesia machine, relevant to surgery when there is concern for causing a fire. The flow rates that are delivered at various flow rates and circuit pressures have not been previously studied. Laboratory investigation. Academic medical center. None. The gas flows from each of 3 anesthesia machines from the same manufacturer were systematically increased from 1 to 15 L/min with changes to the adjustable pressure limiting valve to maintain 0–40 cm water pressure in the breathing circuit for nasal cannula testing and at 20–30 cm water circuit pressure for face masks. The delivered gas flows to the cannula were determined using a float-ball flowmeter for combinations of set gas flows and circuit pressures after connecting the cannula tubing to the Y-piece of the anesthesia circuit via a tracheal tube adapter. Decreasing the supply tubing length on the delivered flow rates was evaluated. There was a highly linear relationship between the anesthesia circuit pressure and the delivered nasal cannula flow rates, with 0 flow observed when the APL valve was fully open (i.e., 0 cm water). However, even under maximum conditions (40 cm water and 15 L/min), the delivered nasal cannula flow rate was 3.5 L/min. Shortening the 6.5-ft cannula tubing increased the flow at 20 and 30 cm water by approximately 0.12 L/min/ft. The estimated FiO 2 assuming a minute ventilation of 5 L/min and 30% FiO 2 ranged from 21.7% to 27.0% at nasal cannula flow rates of 0.5 to 4.0 L/min. When using a face mask and the APL fully closed, delivered flow rates were 0.25 L/min less than the set flow rate between 1 and 3 L/min and equal to the set flow rate between 4 and 8 L/min. When using a nasal cannula adapted to the Y-piece of the anesthesia circuit, the delivery system is linearly dependent on the pressure in the circuit and uninfluenced by the flow rate set on the anesthesia machine. However, only modest flow rates (≤ 3.5 L/min) and a limited increase in the inspired FiO 2 are possible when using this delivery method. When using a face mask and the anesthesia circuit, flow rates close to the set flow rate are possible with the APL valve fully closed. Patients scheduled for sedation for head and neck procedures with increased fire risk who require more than a marginal increase in the FiO 2 to maintain an acceptable pulse oximetry saturation may need general anesthesia with tracheal intubation. • During upper body surgery under sedation the delivered oxygen concentration should be ≤30% to mitigate the fire risk • Regulated nasal cannula delivery can be provided using anesthesia circuit Y-connector and anesthesia machine oxygen blender • Cannula flow rates were ≤ 3.5 L/min and linearly related to the anesthesia circuit pressure, with no flow at 0 cm pressure • Mask flow rates equaled the set flow rate at ≥ 4 L/min with the APL valve fully closed and 0.25 L/min less from 1 to 3 L/min • When using the anesthesia circuit for oxygen via nasal cannula, close the APL valve to achieve 20 to 30 cm water pressure [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to evaluate the safety, efficiency, and cost expenditure of remote programming in patients with Parkinson's disease (PD) after deep brain stimulation (DBS). Methods: A total of 74 patients who underwent DBS at the Department of Neurosurgery, Zhongnan Hospital of Wuhan University between June 2018 and June 2020 were enrolled in this study. There were 27 patients in the remote programming group and 47 patients in the outpatient programming group. Clinical data, programming efficiency, adverse events, expenditure, and satisfaction were compared between the two groups. Results: A total of 36 times of remote programming were performed on the 27 patients in the remote programming group, and four had mild adverse events during programming, and the adverse events disappeared within 1 week. The satisfaction questionnaire showed that 97.3% of the patients were satisfied with the surgical effect. The patients in the remote programming group (88.9%) were more likely to receive long-term programming after DBS than the patients in the outpatient programming group (74.5%). The Parkinsonism symptoms improved in both programming groups. The majority (18/27) of patients in the remote programming group lived away from the programming center, while the majority (27/47) of patients in the outpatient programming group lived in Wuhan, where the programming center was located (P = 0.046). The cost per patient per programming was US$ 43.5 in the remote programming group and $59.5 (56–82.7) in the outpatient programming group (P < 0.001). The median time cost for each visit was 30 min (25–30) in the remote programming group and 150 min (135–270.0) in the outpatient programming group (P < 0.001). Conclusion: Remote programming is safe and effective after DBS in patients with Parkinson's disease. Moreover, it reduces expenditure and time costs for patients and achieves high satisfaction, particularly for patients living far from programming centers. [ABSTRACT FROM AUTHOR]

Copyright of Experimental Technology & Management is the property of Experimental Technology & Management Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Large Electric Machine & Hydraulic Turbine is the property of Large Electric Machine & Hydraulic Turbine Editorial Office and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ObjectiveThe purpose of this study was to evaluate the safety, efficiency, and cost expenditure of remote programming in patients with Parkinson's disease (PD) after deep brain stimulation (DBS).MethodsA total of 74 patients who underwent DBS at the Department of Neurosurgery, Zhongnan Hospital of Wuhan University between June 2018 and June 2020 were enrolled in this study. There were 27 patients in the remote programming group and 47 patients in the outpatient programming group. Clinical data, programming efficiency, adverse events, expenditure, and satisfaction were compared between the two groups.ResultsA total of 36 times of remote programming were performed on the 27 patients in the remote programming group, and four had mild adverse events during programming, and the adverse events disappeared within 1 week. The satisfaction questionnaire showed that 97.3% of the patients were satisfied with the surgical effect. The patients in the remote programming group (88.9%) were more likely to receive long-term programming after DBS than the patients in the outpatient programming group (74.5%). The Parkinsonism symptoms improved in both programming groups. The majority (18/27) of patients in the remote programming group lived away from the programming center, while the majority (27/47) of patients in the outpatient programming group lived in Wuhan, where the programming center was located (P = 0.046). The cost per patient per programming was US$ 43.5 in the remote programming group and $59.5 (56–82.7) in the outpatient programming group (P < 0.001). The median time cost for each visit was 30 min (25–30) in the remote programming group and 150 min (135–270.0) in the outpatient programming group (P < 0.001).ConclusionRemote programming is safe and effective after DBS in patients with Parkinson's disease. Moreover, it reduces expenditure and time costs for patients and achieves high satisfaction, particularly for patients living far from programming centers.

Background: Swimming pools are recreation and sport sites where the lack of safety and health can have severe adverse effect on public health. This study aimed to identify and assess health and safety risks using HAZID and ALARP techniques in the different parts of the swimming pools. Methods: In this applied study, health risks were identified by field observations and environmental health questionnaire consisting swimming pool environmental health checklist, safety of equipment and so on. Then, the risks were categorized and corrective revisions were proposed. Data were analyzed using SPSS version 19. Results: After data analysis, 41 types of safety hazard and 35 types of health risk (potential and existing) were identified. A total of 7 work units and 6 jobs in swimming pools were classified, and 52 types of health risk and 69 types of safety risk were identified, assessed, and classified. After providing corrective measures, according to the ALARP principle, unacceptable risks were eliminated and 64 risk were classified as acceptable. Conclusion: According to the results, most of the health risks were related to the swimming pools area. So that health training course for swimmers and increasing health culture have an important role in controlling health risks. Changing the attitude of swimming pools managers and personnel towards health, safety and environment (HSE) issues also have an important role in controlling health and safety risks.

The existence of inrush current poses a significant problem during the start-up process within three-phase voltage-source rectifiers. To address this problem, this study proposes a strategy to suppress the inrush current effectively based on the virtual-resistor- control method, while preventing the increase in cost of the system and complexity of the algorithm. First, a mathematical model is established based on the dq coordinate frame, and the primary cause of the inrush current is analyzed. Then, the design process of the virtual-resistor-control method is detailed. Finally, the accuracy and effectiveness of the proposed method are verified by simulations and experiments. The results show that the inrush current can be more than two times the rated current before the addition of the virtual resistor. The start-up process can be realized without the inrush current after the addition of the virtual resistor, it does not need to increase hardware costs, there is no secondary inrush current, and the sensitivity of the parameters and the complexity of control are low.

Background: Accidents caused by children’s play equipment are a severe health threat to them. Implementing the requirements of the safety standards is necessary to ensure the safety of such equipment. The current study aimed to determine the general safety of playground equipment in general parks in Gonabad City, Iran. We also compared the level of the general safety of this equipment with national standards. Methods: This cross-sectional and analytical study was conducted in all the parks of Gonabad City during the autumn and winter of 2017. The required information on the playgrounds in the public parks of this city was collected by a checklist. The checklist was designed based on the general safety of playgrounds standards (national standard 1-6436) in 124 items. Results: On average, 9.55 of standard requirements were not implemented in examined parks. Moreover, none of the studied parks fully complied with current standards. We observed fractures, cracks, or deformation in equipment, rough surfaces with the risk of injury, hazardous conditions due to inappropriate design that could harm children, as well as the lack of middle aggressors. These were non-compliant components observed at least 70% of the studied parks. Conclusion: Removing points with fracture and defective points, and improving the level of children’s playground is essential. The obtained data also emphasized the need for periodic safety audits and the improvement of the safety level of children’s playground equipment.

In order to achieve precise risk control of medical devices, it is necessary to establish a scientific evaluation system throughout the entire life cycle of medical devices that focuses on risk identification and risk control. This study summarizes the medical device adverse event monitoring system of the US on regulatory agencies and regulatory law, adverse events reporting forms and time limits, adverse event database, adverse event report analysis and evaluation, as well as adverse event feedback and control. Furthermore, some examples are provided to illustrate the application of the MAUDE database in risk analysis, physical and mechanical performance research, and clinical evaluation of medical device registration and application materials.

Hip arthroplasty represents a large proportion of orthopaedic activity, constantly increasing. Automating monitoring from clinical data warehouses is an opportunity to dynamically monitor devices and patient outcomes allowing improve clinical practices. Our objective was to assess quantitative and qualitative concordance between claim data and device supply data in order to create an ecohort of patients undergoing a hip replacement. We performed a single-centre cohort pilot study, from one clinical data warehouse of a French University Hospital, from January 1, 2010 to December 31, 2019. We included all adult patients undergoing a hip arthroplasty, and with at least one hip medical device provided. Patients younger than 18 years or opposed to the reuse of their data were excluded from the analysis. Our primary outcome was the percentage of hospital stays with both hip arthroplasty and hip device provided. The patient and stay characteristics assessed in this study were: age, sex, length of stay, surgery procedure (replacement, repositioning, change, or reconstruction), medical motif for surgery (osteoarthritis, fracture, cancer, infection, or other) and device provided (head, stem, shell, or other). We found 3,380 stays and 2,934 patients, 96.4% of them had both a hip surgery procedure and a hip device provided. These data from different sources are close enough to be integrated in a common clinical data warehouse. [ABSTRACT FROM AUTHOR]

AimTo report on the MRI compatibility of the Ex-PRESS glaucoma filtration device, a tiny metallic implant placed into the anterior chamber of the eye that is much smaller than traditional glaucoma shunts, and to educate the radiology community regarding its appearance.Materials and methodsSeven patients with Ex-PRESS glaucoma filtration devices were identified that had undergone MRI at San Francisco General Hospital/University of California San Francisco Medical Center by searching and cross-referencing the radiology reporting system and the electronic medical record. MRI images were reviewed for artefact interfering with interpretation. Ophthalmology examinations were reviewed for evidence of complications.ResultsEighteen individual MRI examinations were performed during 12 unique MRI events on these 7 patients. 13/18 individual MRI examinations and 7/12 MRI events were performed at 3 T with the others performed at 1.5 T. Mean time from Ex-PRESS implantation to MRI was 17.5 months. Mean time from MRI to first ophthalmology examination was 1.1 months and from MRI to latest ophthalmology examination was 6.6 months. Susceptibility artefact did not interfere with image interpretation and no complications related to MRI were encountered.ConclusionThe Ex-PRESS glaucoma filtration device appears to be safe for MRI at 1.5 and 3 T and does not produce significant susceptibility artefact to affect diagnostic interpretation adversely.

Data collection automation through the reuse of real-world digital data from clinical data warehouses (CDW) could represent a great opportunity to improve medical device monitoring. For instance, this approach is starting to be used for the design of automated decision support systems for joint replacement monitoring. However, a number of obstacles remains, such as data quality and interoperability through the use of common and regularly updated terminologies, and the use of a Unique Device Identifier (UDI). To present the existing models of automated surveillance of orthopedic devices, a systematic review of initiatives using real-world digital health data to monitor joint replacement surgery was performed following the PRISMA 2020 guidelines. The main objective was to identify the data sources, the target populations, the population size, the device location, and the main results of studies on such initiatives. Analysis of the identified studies showed that real-world digital data offer many opportunities for improving the automation of monitoring in orthopedics. The contribution of real-world data, especially through natural language processing, UDI use in CDW and the integration of device databases, is needed for automated and more robust health surveillance. [ABSTRACT FROM AUTHOR]

We studied whether sustained hemodynamic support (>7 d) with the Impella 5.0 heart pump can be used as a bridge to clinical decisions in patients who present with cardiogenic shock, and whether such support can improve their outcomes. We retrospectively reviewed cases of patients who had Impella 5.0 support at our hospital from August 2017 through May 2019. Thirty-four patients (23 with cardiogenic shock and 11 with severely decompensated heart failure) underwent sustained support for a mean duration of 11.7 ± 9.3 days (range, ≤48 d). Of 29 patients (85.3%) who survived to next therapy, 15 were weaned from the Impella, 8 underwent durable left ventricular assist device placement, 4 were escalated to venoarterial extracorporeal membrane oxygenation support, and 2 underwent heart transplantation. The 30-day survival rate was 76.5% (26 of 34 patients). Only 2 patients had a major adverse event: one each had an ischemic stroke and flail mitral leaflet. None of the devices malfunctioned. Sustained hemodynamic support with the Impella 5.0 not only improved outcomes in patients who presented with cardiogenic shock, but also provided time for multidisciplinary evaluation of potential cardiac recovery, or the need for durable left ventricular assist device implantation or heart transplantation. Our study shows the value of using the Impella 5.0 as a bridge to clinical decisions. [ABSTRACT FROM AUTHOR]

ObjectiveThe objective of this study was to determine magnetic resonance imaging (MRI)-related heating for a low-intensity focused ultrasound pulsation (LIFUP) device used during MRI performed at 3 T/128 MHz.Materials and methodsA special phantom was constructed to mimic the thermal properties of the human brain, and a piece of human temporal bone (skull) was embedded on top. Four fluoroptic thermometry probes, placed above and below the skull, were used to measure temperature changes during MRI (3 T/128 MHz; scanner-reported head average specific absorption rate 1.1-2 W/kg) with and without concurrent LIFUP sonication. LIFUP sonication was applied using a focused ultrasound device (BXPulsar 1001, Brainsonix, Inc., Los Angeles, CA, USA) at a derated spatial-peak temporal-average intensity of 3870 mW/cm(2) .ResultsMRI performed at relatively high specific absorption rate (SAR) caused a slight elevation in temperature (≤0.6°C). Concurrent use of MRI at a medium-strength SAR and LIFUP sonication resulted in maximum temperature rise of 3.1°C after 8 min of continuous use.ConclusionsUnder the specific conditions utilized for this investigation, LIFUP sonication does not appear to present significant heating risks when used concurrently with MRI. This information has important implications for the use of the LIFUP sonication in human subjects undergoing MRI at 3 T/128 MHz.

ObjectiveThe objective of this study was to determine magnetic resonance imaging (MRI)-related heating for a low-intensity focused ultrasound pulsation (LIFUP) device used during MRI performed at 3 T/128 MHz.Materials and methodsA special phantom was constructed to mimic the thermal properties of the human brain, and a piece of human temporal bone (skull) was embedded on top. Four fluoroptic thermometry probes, placed above and below the skull, were used to measure temperature changes during MRI (3 T/128 MHz; scanner-reported head average specific absorption rate 1.1-2 W/kg) with and without concurrent LIFUP sonication. LIFUP sonication was applied using a focused ultrasound device (BXPulsar 1001, Brainsonix, Inc., Los Angeles, CA, USA) at a derated spatial-peak temporal-average intensity of 3870 mW/cm(2) .ResultsMRI performed at relatively high specific absorption rate (SAR) caused a slight elevation in temperature (≤0.6°C). Concurrent use of MRI at a medium-strength SAR and LIFUP sonication resulted in maximum temperature rise of 3.1°C after 8 min of continuous use.ConclusionsUnder the specific conditions utilized for this investigation, LIFUP sonication does not appear to present significant heating risks when used concurrently with MRI. This information has important implications for the use of the LIFUP sonication in human subjects undergoing MRI at 3 T/128 MHz.

Purpose: This study aimed to investigate the levels of compliance with safe handling of antineoplastic agents, time pressure, knowledge of safe handling of antineoplastic agents, and workplace safety climate, and to identify factors influencing compliance with the safe handling of antineoplastic agents among clinical nurses. Methods: For this cross-sectional study, anonymous written surveys were conducted on a convenience sample of 130 clinical nurses at a university-affiliated hospital between July 10 and 20, 2020. Data were analyzed through descriptive statistics, t-tests, analyses of variance, Pearson's correlation, and hierarchical multiple regression analysis using SPSS. Results: The average level of compliance with safe handling of antineoplastic agents was 120.81 out of 175. The significant correlates for compliance with safe handling of antineoplastic agents were clinical experience, knowledge of safe handling of antineoplastic agents, and workplace safety climate. These accounted for 38% of the total variance in compliance with the safe handling of antineoplastic agents. Conclusion: The findings suggest that to increase compliance with safe handling of antineoplastic agents, workplace safety climate and knowledge of safe handling of antineoplastic agents should be improved. The development and application of an effective training program on the safe handling of antineoplastic agents would lead to improvements in this area. [ABSTRACT FROM AUTHOR]

Background and purposeEndovascular navigation under MR imaging guidance can be facilitated by a catheter with steerable microcoils on the tip. Not only do microcoils create visible artifacts allowing catheter tracking, but also they create a small magnetic moment permitting remote-controlled catheter tip deflection. A side product of catheter tip electrical currents, however, is the heat that might damage blood vessels. We sought to determine the upper boundary of electrical currents safely usable at 1.5T in a coil-tipped microcatheter system.Materials and methodsAlumina tubes with solenoid copper coils were attached to neurovascular microcatheters with heat shrink-wrap. Catheters were tested in carotid arteries of 8 pigs. The catheters were advanced under x-ray fluoroscopy and MR imaging. Currents from 0 mA to 700 mA were applied to test heating and potential vascular damage. Postmortem histologic analysis was the primary endpoint.ResultsSeveral heat-mitigation strategies demonstrated negligible vascular damage compared with control arteries. Coil currents ≤300 mA resulted in no damage (0/58 samples) compared with 9 (25%) of 36 samples for > 300-mA activations (P = .0001). Tip coil activation ≤1 minute and a proximal carotid guide catheter saline drip > 2 mL/minute also had a nonsignificantly lower likelihood of vascular damage. For catheter tip coil activations ≤300 mA for ≤1 minute in normal carotid flow, 0 of 43 samples had tissue damage.ConclusionsActivations of copper coils at the tip of microcatheters at low currents in 1.5T MR scanners can be achieved without significant damage to blood vessel walls in a controlled experimental setting. Further optimization of catheter design and procedure protocols is necessary for safe remote control magnetic catheter guidance.

Background and purposeWe hypothesized that a favorable vascular profile (FVP) defined as anatomic intactness of the Circle of Willis combined with a stable cerebral perfusion pressure (mean arterial blood pressure>65 mm Hg) is a prerequisite for collateral recruitment and maintenance and may improve outcome. We performed post hoc analyses of a subset of the Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial data set to identify whether FVP is associated with independent outcome.MethodsSENTIS was a randomized, controlled device trial comparing hemodynamic augmentation with the NeuroFlo device to best medical treatment. We identified all patients from the primary dataset (n=515 patients) with available intracranial vascular imaging at baseline. Vascular imaging data were read blind to clinical and treatment data. We performed univariate and multivariate analyses to identify predictors of independent outcome (modified Rankin Scale 0-2) at 90 days.ResultsA total of 192/515 SENTIS subjects had available baseline vascular imaging (91 treated/101 controls). Baseline characteristics did not differ between groups. Overall, FVP was seen in 89.6% of patients and predicted independent outcome in univariate (odds ratio, 7.46; 95% confidence interval, 1.68-33.18; P=0.0082) and multiple logistic regression analyses (odds ratio, 10.22; 95% confidence interval, 1.78-58.57; P=0.0091). Aside from FVP, only baseline National Institutes of Health Stroke Scales (NIHSS; odds ratio, 0.74; 95% confidence interval, 0.67-0.82, P

BackgroundThe Acorn CorCap Cardiac Support Device (CSD; Acorn Cardiovascular Inc, St. Paul, MN) is a woven polyester jacket that is placed around the heart and designed to reverse the progressive remodeling associated with dilated cardiomyopathy. However, the effects of the Acorn CSD on myofiber stress and ventricular function remain unknown. We tested the hypothesis that the Acorn CSD reduces end-diastolic (ED) myofiber stress.MethodsA previously described weakly coupled biventricular finite element (FE) model and circulatory model based on magnetic resonance images of a dog with dilated cardiomyopathy was used. Virtual applications of the CSD alone (Acorn), CSD with rotated fabric fiber orientation (rotated), CSD with 5% prestretch (tight), and CSD wrapped only around the left ventricle (LV; LV-only) were performed, and the effect on myofiber stress at ED and pump function was calculated.ResultsThe Acorn CSD has a large effect on ED myofiber stress in the LV free wall, with reductions of 55%, 79%, 92%, and 40% in the Acorn, rotated, tight, and LV-only cases, respectively. However, there is a tradeoff in which the Acorn CSD reduces stroke volume at LV end-diastolic pressure of 8 mm Hg by 23%, 25%, 30%, and 7%, respectively, in the Acorn, rotated, tight, and LV-only cases.ConclusionsThe Acorn CSD significantly reduces ED myofiber stress. However, CSD wrapped only around the LV was the only case with minimal negative effect on pump function. Findings suggest that LV-only CSD and Acorn fabric orientation should be optimized to allow maximal myofiber stress reduction with minimal reduction in pump function.

An analog PID controller-based galvanometer scanner is widely used by fractional laser medical equipment (FLME) to scan lasers across tissue surfaces, achieving the desired therapeutic effect. This type of driver, primarily composed of passive components and operational amplifiers, can only accept commands from the central controller of the FLME, with a simple hardware circuit-based fault diagnosis; thus, the safety of the FLME is compromised. To address these issues, the failure mechanisms of galvanometers and their impact on the safety of FLME are thoroughly analyzed first. Then, an adaptive limit protection method, a coil open circuit fault diagnosis, a communication timeout protection based on two handshakes, and a galvanometer control timeout protection are proposed, respectively, based on a digital driver platform, to supplement the deficiencies in the original fault diagnosis and protection system. This ensures the safety of the FLME. Finally, the effectiveness of the proposed strategies is validated through experiments.

Chemical equivalence testing can be used to assess the biocompatibility implications of a materials or manufacturing change for a medical device. This testing can provide a relatively facile means to evaluate whether the change may result in additional or different toxicological concerns. However, one of the major challenges in the interpretation of chemical equivalence data is the lack established criteria for determining if two sets of extractables data are effectively equivalent. To address this gap, we propose a two-part approach based upon a relatively simple statistical model. First, the probability of a false positive conclusion, wherein there is an incorrectly perceived increase for a given analyte in the comparator relative to the baseline device, can be reduced to a prescribed level by establishing an appropriate acceptance criterion for the ratio of the observed means. Second, the probability of a false negative conclusion, where an actual increase in a given analyte cannot be discerned from the test results, can be minimized by specifying a limiting value of applicability based on the margin of safety (MoS) of the analyte. This approach provides a quantitative, statistically motivated method to interpret chemical equivalence data, despite the relatively high intrinsic variability and small number of replicates typically associated with a chemical characterization evaluation., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Inc.)

Injury and fatality events that are caused by tree work and tractor-related activities contribute to the already elevated rates of work-related injuries in the agriculture and logging sectors. This brief report highlights the circumstances surrounding these events, as well as a number of surveillance sources that identify the extent to which they contribute to the injury burden in these hazardous industries. These data sources include fatality investigations, agricultural injury news reports, consumer product injury data captured from emergency rooms and near-miss reporting data captured from individuals participating in the National Rollover Protective Structure Rebate Program (NRRP). Several recommendations for further research and interventional efforts are outlined, with particular consideration of the manner in which rollbars have been involved in falling object incidents.

Background: Upper body limitations are a common disability in neurological conditions including stroke and multiple sclerosis. Care of patients with upper body limitations while in bed involves positioning techniques to maximise comfort and independence. The Bed Band is a nurse-led innovation to support people with limited mobility to maintain a comfortable position in bed, thereby promoting comfort and independence with activities of daily living., Aim: To co-design and implement adaptations to the Bed Band prototype with recommendations for user instructions towards enhanced product design and future development., Methods: A co-design approach involving collaboration between academic and industry partners. Expert stakeholders provided feedback on the Bed Band via an online focus group before healthy volunteers tested the product in a healthcare simulation suite. Data were thematically analysed and findings sense checked by expert stakeholders who then prioritised adaptations to the Bed Band using a modified Delphi technique., Results: Three themes resulted from the analysis: (1) reaction to the Bed Band; (2) potential risks and mitigation; and (3) product adaptations. Simplicity was a strength of the innovation which easily enabled positional support. Adaptations to the Bed Band informed the development of an enhanced prototype for testing in future studies., Conclusion: Co-design of the Bed Band prototype involving experts and healthy volunteers enabled early identification of potential risks with recommendations to mitigate them and priority adaptations. Further studies are required in hospital patients and community populations with upper mobility issues to determine the efficacy of the Bed Band and optimal duration of use., Competing Interests: Competing interests: RG is a student nurse at UHI and director of Person Centred Solutions. FR is a student nurse at UHI and a staff member at Person Centred Solutions. RG and FR contributed as industry partners but were not involved in participant recruitment, data collection or data analysis., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

A novel islanding detection technique by hybridising empirical mode decomposition (EMD) and multi-scale mathematical morphology (MMM) is proposed to detect the islanding condition in a distributed generation system to ensure personnel and equipment safety. The proposed method first uses EMD to efficiently separate the collected raw signal into the number of intrinsic mode functions (IMFs) with different frequency scales and the signal is reconstructed considering important IMFs which carry transient features for further analysis using their correlation coefficients. MMM is used for determining a ratio index named as MMMRI, the threshold value of the proposed MMMRI decides islanding and other power quality (PQ) disturbances. The proposed hybrid method name coined as EMD-MMMRI. The main motivation behind hybridising two signal processing techniques is to reduce detection time and improve accuracy. The efficacy of the method is demonstrated for different PQ disturbances and islanding events simulated on a grid-connected, heavily wind energy penetrated distributed generation system using MATLAB/Simulink environment. The test bench validation of the proposed technique is obtained through TMS 320C6713 Starter Kit (DSK) in digital signal processor platform. The efficacy of proposed work is demonstrated with large number of simulation studies. [ABSTRACT FROM AUTHOR]

Purpose: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. Materials and Methods: We reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event. Results: There were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown. Conclusions: The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.

Introduction: One of the major concerns in laryngeal laser surgery is the risk of airway fire. The introduction ofwrapped tubes and metal tubes has reduced the fire hazards. However, these tubes are expensive and do not provide convenient access to the surgical field. There are few laboratory studies addressing the resistance of polyvinylchloride tubes against ignition in the given circumstances. Nevertheless, its safety should be approved in clinical practices. Materials and Methods: This retrospective studyevaluated the airway management on 1024 patients undergoing laryngeal laser surgery. The data collection included the information about the type of endotracheal tube (ETT), mode of ventilation, and airway hazards (e.g., tube ignition). Results: Polyvinylchloride tubes and conventional positive pressure ventilation was applied for most of the patients (84.1%). The tube cuff was pierced with laser beam in 22 cases (2.5%). However, there was no case of ETT ignition or airway fire. Conclusion: Polyvinylchloride tubes can be safely used in this subset of surgeries pending meticulous attention to the safety recommendations.

Subclavian access is commonly used in the intensive care unit (ICU) for central venous catheterization. Many complications have been reported during the placement of central venous catheters including pneumothorax, hemothorax, hematoma, and bleeding. The direct, through the thoracic wall, catheterization of pulmonary artery is a very rare one with only three previous reports in the literature. We report a patient who was catheterized for subclavian venous catheter placement, but the imaging techniques (chest X-ray and computed tomography with reconstruction of the images) revealed the direct positioning of the catheter into the pulmonary trunk, fortunately without other adverse events for the patient. Our case report in accordance with recent review of the literature strongly emphasizes the benefits of performing ultrasound-guided interventions in ICU. [ABSTRACT FROM AUTHOR]