[Application of Digital Galvanometer Scanner System for CO2 Fractional Laser Safety Improvement].

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.

Implications of variability on medical device chemical equivalence assessment.

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.

Tractors, Trees, and Rollover Protective Structures: A Cause for Concern.

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.

Barriers to the Use of Recombinant Bacterial Endotoxins Test Methods in Parenteral Drug, Vaccine and Device Safety Testing.

The Bacterial Endotoxins Test (BET) is a critical safety test that is used to detect bacterial endotoxins, which are the major contributor to fever-inducing contamination risks known as pyrogens. All parenteral therapies, including every lot of injected drugs, vaccines, medical devices, must be tested for pyrogens to ensure patient safety. Bacterial endotoxins test methods were developed as a highly sensitive detection method for bacterial endotoxins, after the discovery of a clotting cascade in horseshoe crab blood. However, horseshoe crab species are limited to some inshore coastal habitats along the Atlantic coast of the USA and others throughout Asia. Fully functional horseshoe crab clotting factors can be manufactured via recombinant protein production, and several BET methods featuring recombinant horseshoe crab proteins have now been developed for commercial use. Recombinant Bacterial Endotoxins Test (rBET) methods based on the use of recombinant Factor C (rFC) were established in the European Pharmacopoeia - however, these methods have not yet been granted compendial status in the United States Pharmacopoeia (USP). In order to facilitate dialogue between stakeholders, the Physicians Committee for Responsible Medicine hosted two virtual roundtable discussions on the perceived barriers to the use of rBET methods for US FDA requirements. Stakeholders agreed that multiple rFC-based methods have been demonstrated to have suitable analytical performance, as described in ICH Q2 on the Validation of Analytical Procedures and USP <1225> on the Validation of Compendial Procedures. United States Pharmacopoeia compendial inclusion of the rFC-based and other rBET methods was favoured, in order to reduce the additional burdens created by a lack of global harmonisation on BET testing requirements.

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.

BACKGROUND: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. METHODS: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. RESULTS: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. CONCLUSION: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

Medical Device Safety Training by Using Quick Response Codes and Extended Reality-Based Technologies.

This article describes the results of three different study settings where the use of QR codes and XR technologies were tested for medical device training among 132 social and health care professionals. Data from three types of learning events and different contents of training indicated that the professionals considered these novel technologies both beneficial for learning and useful in their working environments for training safe use of medical devices. Based on the collected data, these technologies can be considered prospective options for medical device training.

The news about rollover protective structures: Findings from an analysis of news from Iowa, Nebraska, Kansas, and Missouri.

INTRODUCTION: Rollover protective structures (ROPS) can prevent fatal tractor overturns, a leading cause of death among farmers. This content analysis aims to understand how this life-saving strategy appears in news about farm safety. METHODS: As part of a larger study of farm safety news coverage from four agricultural states, we conducted a content analysis of articles that mentioned ROPS. RESULTS: Few (10%) articles about farm safety explicitly mentioned ROPS. When ROPS were mentioned, they were described in terms of their potential to save lives or prevent injury. CONCLUSION: Despite proven success, ROPS-and programs to make ROPS more widely available to farmers-are all but absent from news coverage in key agricultural states. This represents a missed opportunity not only to motivate farmers to install ROPS, but also to demonstrate to policymakers the importance of establishing and maintaining funding to prevent the most frequent cause of death on farms. Farmers face barriers to installing life-saving equipment. Without an increase in ROPS utilization and improved access to prevention programs, farmers, especially low-income farmers, will remain at disproportionate risk for death and injury.

Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla.

OBJECTIVES: To evaluate at 1.5 and 3 T MRI the safety and performance of trademarked ENO®, TEO®, or OTO® pacing systems with automated MRI Mode and the image quality of non-enhanced MR examinations. METHODS: A total of 267 implanted patients underwent MRI examination (brain, cardiac, shoulder, cervical spine) at 1.5 (n = 126) or 3 T (n = 141). MRI-related device complications, lead electrical performances stability at 1-month post-MRI, proper functioning of the automated MRI mode and image quality were evaluated. RESULTS: Freedom from MRI-related complications at 1 month post-MRI was 100% in both 1.5 and 3 T arms (both p < 0.0001). The stability of pacing capture threshold was respectively at 1.5 and 3 T (atrial:: 98.9% (p = 0.001) and 100% (p < 0.0001); ventricular: both 100% (p < 0001)). The stability of sensing was respectively at 1.5 and 3 T (atrial: 100% (p = 0.0001) and 96.9% (p = 0.01); ventricular: 100% (p < 0.0001) and 99.1% (p = 0.0001)). All devices switched automatically to the programmed asynchronous mode in the MRI environment and to initially programmed mode after the MRI exam. While all MR examinations were assessed as interpretable, artifacts deteriorated a subset of examinations including mostly cardiac and shoulder ones. CONCLUSION: This study demonstrates the safety and electrical stability of ENO®, TEO®, or OTO® pacing systems at 1 month post-MRI at 1.5 and 3 T. Even if artifacts were noticed in a subset of examinations, overall interpretability was preserved. CLINICAL RELEVANCE STATEMENT: ENO®, TEO®, and OTO® pacing systems switch to MR-mode when detecting magnetic field and switch back on conventional mode after MRI. Their safety and electrical stability at 1 month post MRI were shown at 1.5 and 3 T. Overall interpretability was preserved. KEY POINTS: • Patients implanted with an MRI conditional cardiac pacemaker can be safely scanned under 1.5 or 3 Tesla MRI with preserved interpretability. • Electrical parameters of the MRI conditional pacing system remain stable after a 1.5 or 3 Tesla MRI scan. • The automated MRI mode enabled the automatic switch to asynchronous mode in the MRI environment and to initial settings after the MRI scan in all patients.

ROPS commentary-Addressing our fatal blind spot: Applying evidence-based solutions to reduce the most frequent cause of death on U.S. farms.

Tractor overturns are the most prominent contributing factor to death on U.S. farms and have been for decades. While public health researchers hypothesized years ago that overturn fatalities would largely disappear as older tractors were replaced by newer ones, this has not happened. In the meantime, farmers continue to die in these easily preventable and tragic events. Not only are tractor rollover protective structures (ROPS) 99% effective in preventing death in the event of an overturn, a national program exists to connect farmers with ROPS. While this program has been popular with farmers, and the cost-effectiveness of providing farmers with technical support and cost-sharing rebates has been demonstrated, many states lack access to ROPS rebates, even those states with the highest number of overturn fatalities. Given the evidence, it is difficult to reconcile the lack of policy or public investment in a solution that decisively addresses the most pernicious contributor to death in the agricultural industry. In this commentary, we highlight the science behind this proven solution to tractor overturns and the essential role that the media and implementation science can play in encouraging policy-makers to save lives.

Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy.

INTRODUCTION: The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model. METHODS: Computed tomography (CT)-guided RAB MWA was performed in the peripheral lung parenchyma of 17 Yorkshire swine (40-50 kg) and procedural adverse events (AEs) documented. The acute group (day 0, n = 5) received 4 MWAs at 100 W for 1, 3, 5, and 10 min in 4 different lung lobes. Subacute and chronic groups (days 3 and 30, n = 6 each) received one MWA (100 W, 10 min) per animal. RESULTS: The study was completed without major procedural complications. No postprocedural AEs including death, pneumothorax, bronchopleural fistula, hemothorax, or pleural effusions were observed. No gross or histological findings suggestive of thromboembolism were found in any organ. One 3-Day and one 30-Day swine exhibited coughing that required no medication (minor AEs), and one 30-Day animal required antibiotic medication (major AE) for a suspected lower respiratory tract infection that subsided after two weeks. CT-based volumetric estimates of ablation zones in the acute group increased in an ablation time-dependent (1-10 min) manner, whereas macroscopy-based estimates showed an increasing trend in ablation zone size. CONCLUSION: The NEUWAVE FLEX and MONARCH devices were safely used to perform single or multiple RAB MWAs. The preclinical procedural safety profile of RAB MWA supports clinical research of both devices to investigate efficacy in select patients with oligometastatic disease or primary NSCLC.

[Analysis of Radio Frequency Identification Immunity Standard for Medical Equipment].

Aiming at the increasing application of RFID technology in the medical environment, this study introduces the foreign requirements for RFID immunity test of medical devices, compares them with the current immunity test requirements of medical devices in China, and puts forward the necessity of establishing relevant test specifications in China.

3 Tesla magnetic resonance imaging in patients with cardiac implantable electronic devices: a single centre experience.

AIMS: Three Tesla (T) magnetic resonance imaging (MRI) provides critical imaging information for many conditions. Owing to potential interactions of the magnetic field, it is largely withheld from patients with cardiac implantable electronic devices (CIEDs). Therefore, we assessed the safety of 3T MRI in patients with '3T MRI-conditional' and 'non-3T MRI-conditional' CIEDs. METHODS AND RESULTS: We performed a retrospective single-centre analysis of clinically indicated 3T MRI examinations in patients with conventional pacemakers, cardiac resynchronization devices, and implanted defibrillators from April 2020 to May 2022. All CIEDs were interrogated and programmed before and after scanning. Adverse events included all-cause death, arrhythmias, loss of capture, inappropriate anti-tachycardia therapies, electrical reset, and lead or generator failure during or shortly after MRI. Changes in signal amplitude and lead impedance were systematically assessed. Statistics included median and interquartile range. A total of 132 MRI examinations were performed on a 3T scanner in 97 patients. Thirty-five examinations were performed in patients with 'non-3T MRI-conditional' CIEDs. Twenty-six scans were performed in pacemaker-dependent patients. No adverse events occurred during or shortly after MRI. P-wave or R-wave reductions ≥ 50 and ≥ 25%, respectively, were noted after three (2.3%) scans, all in patients with '3T MRI-conditional' CIEDs. Pacing and shock impedance changed by ± 30% in one case (0.7%). Battery voltage and stimulation thresholds did not relevantly change after MRI. CONCLUSION: Pending verification in independent series, our data suggest that clinically indicated MRI scans at 3T field strength should not be withheld from patients with cardiac pacemakers or defibrillators.

Ingestible light source for intragastric antibacterial phototherapy: a device safety study on a minipig model.

Helicobacter pylori gastric infections are among the most diffused worldwide, suffering from a rising rate of antibiotic resistance. In this context, some of the authors have previously designed an ingestible device in the form of a luminous capsule to perform antibacterial photodynamic inactivation in the stomach. In this study, the light-emitting capsules were tested to verify the safety of use prior to perform clinical efficacy studies. First, laboratory tests measured the capsule temperature while in function and verified its chemical resistance in conditions mimicking the gastric and gut environments. Second, safety tests in a healthy minipig model were designed and completed, to verify both the capsule integrity and the absence of side effects, associated with its illumination and transit throughout the gastrointestinal tract. To this aim, a capsule administration protocol was defined considering a total of 6 animals with n = 2 treated with 8 capsules, n = 2 treated with 16 capsules and n = 2 controls with no capsule administration. Endoscopies were performed in sedated conditions before-after every capsule administration. Biopsies were taken from the corpus and antrum regions, while the gastric cavity temperature was monitored during illumination. The bench tests confirmed a very good chemical resistance and a moderate (about 3 °C) heating of the capsules. The animal trials showed no significant effects on the gastric wall tissues, both visually and histologically, accompanied with overall good animal tolerance to the treatment. The integrity of the administered capsules was verified as well. These encouraging results pose the basis for the definition of successive trials at the clinical level.

History of ultrasound in obstetrics and gynaecology from 1971 to 2021 on occasion of the 50 years anniversary of EFSUMB.

Diagnostic ultrasound in obstetrics and gynaecology has experienced a fantastic evolution during the past seven decades. Initial steps with A-mode technology were followed by B-mode and B-mode real-time imaging, then by Doppler and colour Doppler ultrasound, and finally by 3D/4D ultrasound. Other evolutionary steps were the development of high-resolution transabdominal and transvaginal transducers providing high quality images in the first, second and third trimesters of pregancy, as well as in gynaecology and breast imaging.The progression from two-dimensional (2D) to three-dimensional ultrasound (3D) and 3D real-time imaging (4D) has brought new options in displaying anatomical structures. In comparison with CT or MRI, it is not a static but functional technique, cheap and safe, and applicable at any time.

Warning and active steering rollover prevention control for agricultural wheeled tractor.

Tractor rollover is regarded as the most fatal incident in agricultural production, but some of which can be avoided by timely anti-rollover warning and active control. There have been a lot of researches on the tractor rollover model building and rollover protective structure designing but few on the anti-rollover control. The purpose of this study is to develop a cheaper and practical anti-rollover control system based on active steering technique and to prove the efficiency of the proposed scheme for the wheeled tractors. A three-degree-of-freedom rollover dynamics model including automatic steering system is established. A control scheme by adjusting the roll angle to keep the stability based on the adaptive sliding mode control is proposed with the estimated lateral velocity according to the feedback correction principle. Front wheel angle tracking controller is designed adopting internal model control (IMC) theory. Simulation results exhibit that the active anti-rollover control can calculate the stability index in real time and can keep it within the stable range by adjusting the front steering wheel angle. It is prospective for the proposed scheme to provide a valuable reference to reduce tractor rollover accidents.

Singular secular Kuznets-like period realized amid industrial transformation in US FDA medical devices: a perspective on growth from 1976 to 2020.

INTRODUCTION: Since inception, the United States (US) Food and Drug Administration (FDA) has kept a robust record of regulated medical devices (MDs). Based on these data, can we gain insight into the innovation dynamics of the industry, including the potential for industrial transformation?. AREAS COVERED: Using premarket notifications (PMNs) and approvals (PMAs) data, it is shown that from 1976 to 2020 the total composite (PMN+PMA) metric follows a single secular period: 20.5 years (applications - peak-to-peak: 1992-2012; trough: 2002) and 26.5 years (registrations - peak-to-peak: 1992-2019; trough: 2003), with a peak-to-trough relative percentage difference of 24% and 28%, respectively. Importantly, PMNs and PMAs independently present as an inverse structure. EXPERT OPINION: The evidence suggests that MD innovation is driven by a singular secular Kuznets-like cyclic phenomenon (independent of economic crises) derived from a fundamental shift from simple (PMNs) to complex (PMAs) MDs. Portentously, while the COVID-19 crisis may not affect the overriding dynamic, the anticipated yet significant (~25%) MD innovation drop may be potentially attenuated with attentive measures by MD stakeholders. Limitations of this approach and further thoughts complete this perspective.

Improving Tractor Safety: A Comparison between the Usability of a Conventional and Enhanced Rear-Mounted Foldable ROPS (FROPS).

Tractor rollover is the main cause of both fatal and non-fatal injuries in agriculture. The foldable rollover protective structure (FROPS) can help to prevent these injuries. However, in many cases, the FROPS is left in a folded-down position. Human factor and rear-mounted FROPS technical characteristics influence operators' behavior in roll-bar handling. To improve the FROPS's comfortable use, the prototype of an enhanced handling system was developed, and its usability was tested and compared with a conventional FROPS. Usability was assessed with 93 novice tractor users through an ad hoc questionnaire (investigating perceived effort, time demand, the posture adopted and satisfaction) and observations (investigating effectiveness and efficiency) during lowering and raising tasks. For both tasks, the participants perceived significantly less effort, less physical discomfort, a higher level of satisfaction and less time demand while operating the enhanced FROPS. Observations showed that the critical issues that emerged for the conventional FROPS were eliminated by adopting the developed and implemented handling system. The developed handling system showed itself to be usable and effective in making the FROPS easier and safer to be operated.