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.
该研究从监管机构组成及监管法令、不良事件报告形式及时限要求、不良事件数据库、不良事件报告分析评价以及不良事件反馈及控制方面对美国医疗器械不良事件监测体系进行介绍，同时对MAUDE数据库在医疗器械注册申报资料中的风险分析、物理和机械性能研究以及临床评价中的应用进行实例说明。以期建立以风险识别、风险控制为核心，贯穿医疗器械全生命周期的科学审评体系，实现对医疗器械风险精准控制。.

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.

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.
点阵激光治疗仪广泛使用基于模拟PID控制器的驱动器来控制振镜，将激光脉冲以点阵图形的方式扫描人体组织表面，以实现预期的治疗效果。然而，这类振镜驱动器由无源元件和运算放大器组成，它们只能单向接收点阵激光治疗仪中控系统的扫描定位指令，并且通常只能通过比较电路对振镜进行简单的故障诊断，这可能会降低点阵激光治疗仪的安全性。针对这些问题，该研究首先分析并总结了振镜可能出现的各种故障机理，以及这些故障对点阵激光治疗仪安全运行的影响。接着，在数字振镜驱动器的基础上，针对传统振镜系统故障诊断策略的不足，提出了自适应限位保护、线圈断路故障诊断、基于二次握手的通信超时故障诊断以及振镜控制超时故障诊断策略。这些策略的实施提高了点阵激光治疗仪扫描手具的整体安全性。最后，通过实验验证了这些保护策略的有效性。.

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 FiO2 assuming a minute ventilation of 5 L/min and 30% FiO2 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 FiO2 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 FiO2 to maintain an acceptable pulse oximetry saturation may need general anesthesia with tracheal intubation.

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.

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.
OBJECTIVE: 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.
CONCLUSIONS: 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.

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.

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.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: The proposed potential prevention strategies may facilitate clinicians in preventing recreational windsurfing-related acute injuries. Injury prevention for recreational windsurfing is under-researched. Future studies should focus on large prospective clinical trials evaluating the efficacy of prevention strategies for recreational windsurfing-related injuries.
UNASSIGNED: Le but de cette étude était d’identifier les stratégies de prévention existantes pour les blessures aiguës liées à la pratique récréative de la planche à voile et de fournir aux cliniciens une vue d’ensemble pratique des preuves actuelles soutenant les stratégies de prévention potentielles proposées.
UNASSIGNED: Une recherche documentaire a été effectuée jusqu’au 8 mars 2023, en utilisant des mots clés pertinents avec des opérateurs booléens, tels que “windsurfing” AND “injury prevention” (planche à voile ET prévention des blessures) et “windsurfing” AND “exercise interventions » (planche à voile ET prescriptions d’exercices) à partir des bases de données PubMed et Google Scholar. Seuls les articles en anglais examinés par des pairs ont été retenus.
UNASSIGNED: Les stratégies de prévention existantes, les règles de droit de passage, un nouvel ensemble proposé de huit stratégies potentielles de prévention primaire à tertiaire pour les blessures aiguës liées à la pratique de la planche à voile, et les définitions proposées des niveaux de prévention des blessures équivalentes à la matrice de Haddon ont été déterminés et présentés.
UNASSIGNED: Les stratégies de prévention potentielles proposées peuvent aider les cliniciens à prévenir les blessures aiguës liées à la pratique récréative de la planche à voile. La prévention des blessures liées à la pratique récréative de la planche à voile n’est pas suffisamment étudiée. Les études futures devraient se pencher sur de vastes essais cliniques prospectifs évaluant l’efficacité des stratégies de prévention des blessures liées à la pratique récréative de la planche à voile.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Because the use of abdominal rollers may result in extremely serious disabilities, it is necessary to emphasize the appropriate use of such equipment.