Tecnologia di tracciabilità dei prodotti di controllo del Fentanyl Huolingniao: guidare lo sviluppo dell'industria attraverso RFID+ algoritmo e costruire una nuova linea di difesa per la sicurezza pubblica.

Introduction: 特殊药物管理的时代命题 在全球范围内，芬太尼等强效麻醉药物的滥用已成为对公共健康和公共安全的双重严重挑战。根据世界卫生组织（WHO）的统计，全球因阿片类药物滥用导致的死亡人数每年超过150,000，其中芬太尼因其强烈的成瘾性和隐蔽性而成为监管领域的关键目标。作为全球麻醉药物的主要生产和使用国，中国始终将特殊药物的监管视为国家安全战略的重要组成部分。2023年，公安部发布的《芬太尼药物特殊智能柜通用技术规范》（GA/T 2015-2023）标志着中国在特殊药物管理领域进入了智能化和标准化的新阶段。在此背景下，深圳火灵鸟科技有限公司凭借其自主研发的“RFID+算法”单一芬太尼追溯技术，成为行业技术突破的标杆，为医疗机构和监管部门提供从技术标准到应用场景的完整解决方案。值得一提的是，作为行业首家源头制造商，火鸟公司已两次获得芬太尼药物控制柜的准入证书，并且两批产品已获得公安部的检测和认证报告。其根据医院试用反馈改进的第二代产品在平台管理与控制及单支追溯的要求上显著提升了产品性能指标。 网络接入注册证书1（如下图所示） 网络接入注册证书2（如下图所示） 公安部第一批检测报告（如下图所示） 公安部第二批检测报告（如下图所示）。

首先，技术核心：RFID+算法构建了一个全链条可追溯系统，产品已获得公安部第一研究所的权威认证。火灵鸟技术的核心在于RFID（射频识别）与智能算法的深度融合，形成覆盖药物全生命周期的可追溯闭环。该技术系统突破了传统药物管理中“人工登记+条形码扫描”的局限，实现了从生产、流通到使用的实时动态监管。目前，中国对芬太尼药物的生产、管理、运输、使用、进出口实施动态全流程监控和闭环管理，以进一步有效防止芬太尼药物的流失。具体措施包括：对生产环节实施企业定点和年度计划管理；对经营环节实施企业定点和限量流通管理；严格执行医疗机构对使用环节的管理措施；对出口环节实施许可管理。然而，由于中国医疗机构信息管理水平差异较大，出现了同一家医院药物持续过量使用、多个医院药物过量使用、同一人持续过量使用药物、医疗机构药物过度采购以及前药物使用者大量采购药物的情况。为了解决这些问题，推动麻醉药物控制柜的应用是医疗机构的重要工具，通过整合物联网、信息智能和身份识别等技术，实现药物的精准控制（单药追溯）和可追溯性（平台实时数据记录）。 (1) RFID标签：药物的“数字身份证”。火灵鸟为每种芬太尼制剂配备了UHF RFID电子标签。该标签具有以下特点：微型化设计：标签尺寸微小，可以嵌入单一药物的包装中，有效避免人为损坏或替换。抗液体干扰：采用特殊材料包装，确保药物在各种环境中仍能稳定读取信息。多频段兼容性：支持860-960MHz国际通用频段，并兼容全球不同地区的监管系统。加密存储：采用国家秘密SM4算法对药物信息进行加密，防止数据被篡改或伪造。 (II) 智能算法：火灵鸟自主研发的可追溯算法平台包括三个核心模块：时空轨迹分析：通过RFID读写器网络，实时记录药物在医疗机构中的流通路径，生成可视化轨迹图。例如，系统可以准确追踪芬太尼从药房到手术室的全过程，时间戳精确到秒，空间定位精确到厘米。行为模式识别：基于机器学习算法，分析医务人员的操作习惯，识别异常行为（如未经授权人员接触、药物过量等）。某3A医院的试点数据显示，系统的误报率低于0.01%，异常行为识别的准确率为99.99%。库存预测模型：结合历史使用数据和季节波动，动态预测药物需求，优化库存周转率。在某省癌症医院应用后，芬太尼药物的库存周转天数从14天缩短至7天，过期药物的损失率下降了82%. (3) 私有网络加密数据存储：防篡改监督链火灵鸟系统通过公共安全无线加密私有网络通信模块实时将药品追溯数据上传至国家麻药追溯控制系统，并构建覆盖全链的信任机制：数据碎片存储：药品信息被分割成多个数据块，分别存储在医疗机构和监管部门的数据网络中。智能合约审计：通过预设规则自动验证药品流通的合规性，例如，当系统检测到某部门使用芬太尼超过阈值时，自动触发监管部门的审计流程。跨机构协作：支持卫生健康委员会、食品药品监督管理局、公共安全等部门之间的数据共享，实现“一次录入、在线查询”。其次，标准指导：全面满足公共安全行业标准。

Huolingniao technology strictly follows the GA/T 2015-2023 standard, and achieves comprehensive benchmarking in hardware design, software function and data security. (1) Hardware standard: Design of intelligent cabinet with full-dimensional protection from equipment to environment: The cabinet body is made of SPCC+aluminum alloy, which has passed IP65 protection level test and can resist violent damage. Equipped with electromechanical double lock structure, it needs two-person two-factor identification (fingerprint/face/password/ID card) to open it. Built-in temperature and humidity sensor to monitor the storage environment in real time. Reader network: Self-developed UHF RFID reader is deployed, and the reading speed is ≥200 tags/second. Support LAN high-speed networking, reduce wiring cost and adapt to complex cabinet structure. (2) Software standard: the whole process control function module from operation to audit: drug warehousing: automatically scanning RFID tags, comparing the batch number and expiration date of drugs, and automatically intercepting abnormal drugs. Prescription matching: interface with HIS system to verify the authenticity of prescription and prevent over-prescribing. Recovery of residual liquid in empty bottles: identify residual liquid in empty bottles by RFID/ one-dimensional code, and record information such as destruction time and operators. Audit log: record all operations (taking medicine, returning medicine, taking inventory, etc.) and keep it for ≥10 years. Support multi-dimensional query by time, personnel, drugs, etc., and the audit response time is ≤1 second. (III) Security standard: full chain protection data encryption from data to system: SM4 symmetric encryption algorithm is adopted to protect the transmitted data, and the key length is 256 bits. Sensitive data (such as patient information) are desensitized when stored, which meets the requirements of the Personal Information Protection Law. System security: it meets the requirements of equal security certification and has security protection capabilities such as DDoS attack and SQL injection. Conduct vulnerability scanning and penetration testing regularly, and the repair period shall be ≤72 hours. Third, industry application: from pilot to popularization, Huolingniao technology has been applied in dozens of medical institutions in many provinces across the country, covering multi-level scenes such as top three hospitals, specialist hospitals and primary medical institutions. (1) Typical case: Implementation background of a provincial cancer hospital: the annual consumption of fentanyl exceeds 50,000, and the traditional management method has problems such as overstock and difficulty in traceability. A loss of fentanyl occurred in 2022, which attracted the attention of the regulatory authorities. Solution: Deploy 20 intelligent firebird cabinets, covering key departments such as operating room, ICU and pain department. Integrate hospital HIS and LIS systems to realize real-time interaction between drug circulation and diagnosis and treatment data. Implementation effect: the drug inventory time was shortened from 24 hours/time to 15 minutes/time. The early warning accuracy of drugs in the near term was 100%, and the loss rate of expired drugs decreased by 95%. IV. Industry Impact: From technological breakthrough to ecological reconstruction, the popularization of Huolingniao technology not only improved the management level of special drugs, but also promoted the digital transformation of the whole industry. (1) Policy promotion: Help the regulatory standards to be upgraded. Huolingniao actively participates in the group standard of single fentanyl drug coding, and incorporates RFID traceability technology into the recommended standards. Promote multi-local health and health committees to incorporate fentanyl control smart cabinet configuration into hospital grade evaluation indicators, and accelerate technology popularization. (2) Industrial synergy: build an open ecosystem, strengthen in-depth exchanges with pharmaceutical manufacturers such as Renfu, Sinopharm and Enhua, and promote the traceability of drugs from factory/distribution to use. Docking the "National Traceability Control System of Hemp Fine Drugs" of the Ministry of Public Security to provide data support for drug control work. (III) Social benefits: The pilot data of a city guarding the public security defense line shows that after the application of Huolingniao technology, the loss rate of fentanyl drugs decreased by 95%. Through accurate medication management, adverse drug reactions can be reduced and the safety level of patients can be improved. V. Future Outlook: Technology Iteration and Global Layout Huolingniao is continuously increasing investment in R&D to promote the evolution of technology to a higher dimension: (1) Technology upgrading direction AI visual recognition: combining 360 panoramic space imaging camera and AI algorithm, it can realize 360 supervision and real-time risk analysis of drug deposit and withdrawal process without dead angle. (2) Market expansion plan to deepen the domestic market: covering 80% of the country's top three hospitals and sinking to county-level medical institutions. Explore the international market: cooperate with WHO to promote the application of technology in the "Belt and Road" countries. Conclusion: Protecting life safety with leading technological innovation Huolingniao technology not only solves the technical problems of fentanyl management, but also builds a public safety protection network covering the whole society through the deep integration of "RFID+algorithm". Guided by the strategy of "Healthy China 2030", Huolingniao will continue to be driven by innovation and guided by standards, contribute China wisdom to the global special drug management, and protect the dignity and safety of every life. As its corporate mission says: "Let every drug have a trace to follow, and make every medication safe and reliable." This is not only the promise of technology, but also the awe of life. Pay attention to replay Share praise Close watch more exit full screen switch to vertical screen full screen exit full screen Firebird technology has paid attention to sharing videos. 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