THE MDEPINET MEDICAL COUNTER MEASURES STUDY

项目摘要。医疗器械性能的系统性审批后评估在很大程度上依赖于 对不断扩大的观测数据和全球连接数据的分析。因为医学 应对措施(MCM)设备需要快速评估和批准，以确保有效的公共卫生 在大流行或化学、生物、辐射或核威胁(CBRN)事件中的反应，利用 常规护理中观察到的信息提供了一种机制，向监管机构和患者通报MCM- 相关设备的安全性和有效性。然而，预测医疗设备对CBRN威胁的脆弱性 需要了解设备故障的潜在模式以及特定事件发生的可能性 引发这样的失败。虽然上市前和上市后的信息可以帮助解决这些预测问题， 需要严格的分析方法来处理数据的独特特征。我们建议开发和开发 说明在整个产品生命周期中综合信息以进行风险评估的现代方法。 目标1开发和说明了连接MCM上市前和上市后证据的方法- 相关设备的安全性和有效性。我们将推广和应用方法来概括临床研究结果。 通过使用后验预测将研究水平和个人水平的数据结合在一起，对常规护理环境进行试验 针对多达9个设备领域的方法、微模拟建模技术和网络元分析。目标 2重点是开发一个概率风险评估框架，以量化特定的 设备到CBRN事件。我们将为多达5个与MCM相关的设备开发和应用贝叶斯方法 考虑到混杂因素选择中的不确定性以及患者、医生、 和设备异构性。AIM 3实施MCM优先医疗的上市后监测方法 设备。我们将购买17个地理位置的急诊科数据库和住院患者数据库 不同的州建立对患有特殊疾病的患者提出诊断的基线期望 设备曝光。这将为未来的监测工作提供基线比率，以检测隐秘的CBRN事件 或估计事件的潜在公共健康风险。目标4促进与利益相关者的沟通，并 通过出版物对与MCM相关的医疗器械监测和科学战略进行教育推广， 科学演示，以及2个针对利益攸关方的讲习班。 我们将利用我们目前由FDA资助的医疗设备中存在的关系和专业知识 流行病学网络方法学中心，以补充科学和临床基础 做决定。我们将建立一个由临床研究人员和生物医学工程师组成的网络，以研究特定的 设备及其对潜在CBRN事件的脆弱性。与FDA调查人员一起，这些专家将 提供有关医疗设备漏洞范围的指导，以及将风险降至最低的策略 医疗器械和依赖它们的患者面临这样的潜在威胁。

Project Summary. A systematic post-approval assessment of medical device performance depends heavily on the analysis of an expanding universe of observational and globally connected data. Because medical countermeasures (MCM) devices require rapid assessment and approval to ensure an effective public health response in the event of a pandemic or a chemical, biological, radiological, or nuclear (CBRN) threat, exploiting information observed in routine care provides a mechanism to inform regulators and patients about MCM- related device safety and effectiveness. However, predicting vulnerabilities of medical devices to CBRN threats requires an understanding of potential modes of device failure and the likelihoods that specific events would trigger such failures. While premarket and postmarket information can help with these prediction problems, rigorous analytical methods are required to address unique features of the data. We propose to develop and illustrate modern methodology to synthesize information for risk assessment across the total product life cycle. Aim 1 develops and illustrates methodology to bridge premarket and postmarket evidence of MCM- related device safety and effectiveness. We will extend and apply methods to generalize findings from clinical trials to routine care settings by combining study-level and individual-level data using posterior predictive approaches, micro-simulation modeling techniques, and network meta-analyses for up to 9 device areas. Aim 2 focuses on developing a probabilistic risk assessment framework for quantifying the vulnerability of specific devices to CBRN events. We will develop and apply Bayesian methods for up to 5 MCM-related devices to estimate effectiveness accounting for uncertainty in the selection of the confounders and for patient, physician, and device-heterogeneity. Aim 3 implements approaches to postmarket surveillance of MCM-priority medical devices. We will purchase emergency department databases and inpatient databases for 17 geographically diverse states to establish baseline expectations of presenting diagnoses in patients who have had a particular device exposure. This will provide future surveillance efforts with baseline rates to detect occult CBRN events or to estimate the potential public health risk of events. Aim 4 promotes communication with stakeholders and educational outreach of MCM-related medical device surveillance and scientific strategies through publications, scientific presentations, and 2 stakeholder targeted workshops. We will capitalize on relationships and expertise existing in our currently FDA-funded Medical Device Epidemiological Network Methodology Center in order to supplement the scientific and clinical grounding for decision making. We will create a network of clinical investigators and biomedical engineers to study specific devices and their vulnerability to potential CBRN events. Together with FDA investigators, these experts will provide guidance regarding the scope of medical device vulnerabilities, and strategies to minimize the risks to medical devices and the patients who depend on them to such potential threats.