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出自识林

2015-11-16 FDA Voice

聚焦质量行动：与利益攸关方共同努力，提高针对患者的医疗器械安全性
FDA Voice 2015年11月12日
作者：
FDA负责全球监管运作与政策的副局长 Howard Sklamberg, J.D.；:FDA器械与放射医学中心（CDRH）主任 Jeffrey Shuren, M.D., J.D.；FDA负责监管事务的副局长 Melinda K. Plaisier, M.S.W.

在整个FDA，我们正投入巨大的努力，与各个利益攸关方合作，致力于推动和提高产品与制造质量的行动。我们认为，通过密切关注数据以及一致审查和分析这些数据，能够量化质量，从而促进公司的质量规范与质量文化。

量度与评价工具开发是聚焦质量行动（the Case for Quality，CfQ）的关键部分。我们正在与范围广泛的利益攸关方合作，这些利益攸关方包括医疗器械行业、患者、其它政府和学术界同僚和医保支付方/提供方，确定和推广将会产生出品质更佳医疗器械的实践规范。

2011年10月发起聚焦质量行动（CfQ），深入审查器械质量数据和来自于FDA和多个产业利益攸关方的反馈。通过分析，FDA醒目地标记出制造质量风险，对在整个组织全面推进质量的公司显示出巨大的效益。与竞争对手相比，这些公司收到的投诉减少，每批制造的器械内部调查下降，质量管理人员更为精简，质量成本更低。

在分析得出结论后的4年来，FDA 一直注意到，需要FDA采取正式行动检查所占百分比保持平稳，同样的问题通常年复一年地重复发生。鉴于一直注意到这样的现象，除了FDA定期检查医疗器械企业之外，我们正在考虑超越于检查和传统的监管途径的其它支持质量改进的方法。

FDA发起聚焦质量行动（CfQ），是为了帮助医疗器械制造商提升关注点，除了遵守法规的基本要求之外，还应该关注制造商可以独立实施改进质量的具有预见性和主动性的方法。聚焦质量行动（CfQ）也为FDA提供了改变路径的机会，更多地专注于保证产品和制造质量和患者安全性的重中之重的方面。

为解决这些确定的障碍，聚焦质量行动（CfQ）有3个要点：

1. 聚焦质量。FDA与聚焦质量行动（CfQ）的利益攸关方认为，合规是底线，并将我们的关注点更多地转移到日常的医疗器械设计和生产中所体现出的与更高品质的产出相关的特性和实践规范方面。通过聚焦质量行动（CfQ），我们正在与内部和外部客户合作，确定对具体的医疗器械质量至关重要的特性。这将导致对患者安全最为重要的产品特性和制造工艺的共同认识。

2. 利益攸关方参与。 FDA与医疗器械行业和广泛的用户团体在聚焦质量行动（CfQ）上密切合作，征集反馈意见。通过这项工作，认识并确认监管机构、产业界、患者、医疗保险提供方和支付方的参与和共识能够对医疗器械质量产生的非凡影响。

3. 数据透明。FDA收到范围广泛的质量相关数据，包括来自于召回与不良事件报告的信息。为了支持医疗器械质量，FDA在open.fda.gov网址公布医疗器械数据（联邦法律、法规不允许我们披露的数据除外）。

聚焦质量行动（CfQ）的成果将使得利益攸关方能够将资源集中到保证患者和用户得到高品质医疗器械产生最大影响的行动方面。这项工作汇集了量度、成功的质量实践规范以及与利益攸关方的合作，促进医疗器械产业的质量和精益求精。反映了我们确保医疗器械性能符合预期、实现FDA保护和促进公众健康的使命的承诺。 聚焦质量行动（CfQ）计划的工作信息，请访问： http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm.

翻译：识林-Kapok
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The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients Posted on November 12, 2015 by FDA Voice
By: Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W.

Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

The metrics and assessment tools being developed are key parts of the Case for Quality (CfQ). We are working with a wide variety of stakeholders–including the medical device industry, patients, other governmental and academic colleagues, and payer/provider counterparts–to identify and promote practices that will result in higher quality devices.

The CfQ was launched in October 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. FDA's analysis flagged manufacturing quality risks and showed tremendous benefits for firms that drive quality organization-wide. They receive fewer complaints and internal investigations per batch of devices manufactured, often house smaller quality staffs, and have lower quality-related costs, compared with competitors.

In the four years since the conclusion of the analysis, FDA has continued to observe that the percentage of inspections calling for official action by FDA has remained static, with the same issues recurring frequently year after year. Given this observation, in addition to FDA inspecting device firms on a regular basis, we are thinking about other ways to support quality beyond inspections and traditional regulatory approaches.

FDA introduced the CfQ in an effort to help device manufacturers elevate their focus from the baseline requirements of compliance with regulations alone, and instead focus on predictive and proactive measures they can take independently to improve quality. CfQ also provides FDA the opportunity to change our approach to focus more on what matters most in assuring product and manufacturing quality and safety for patients.

The CfQ has three priorities for addressing the barriers that were identified:

1. Focus on Quality. FDA and CfQ stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. Through the CfQ, we are collaborating with internal and external customers to identify characteristics that are critical to the quality of a particular device. This will result in a shared understanding of product features and manufacturing processes most important to patient safety.

2. Stakeholder engagement. FDA works closely with the device industry and a broad group of customers to collaborate on CfQ and solicit feedback. This effort recognizes the extraordinary impact that engagement and agreement among regulators, industry, patients, providers, and payers can have on device quality.

3. Data transparency. FDA receives a broad array of quality-related data, including information from recalls and adverse event reports. To support device quality, FDA has made device data (except certain information that we are prevented by federal law and regulations from disclosing) available on open.fda.gov.

The outcomes of the CfQ will allow stakeholders to focus resources on activities with the greatest impact on assuring that patients and users receive high-quality devices. This effort brings together metrics, successful quality practices, and our partnerships with stakeholders to promote quality and excellence in the medical device industry. It reflects our commitment to ensuring that devices perform as intended, meeting FDA’s mission of protecting and promoting public health.

For more on the Case for Quality initiative, visit http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm.