“2023年11月30日，美国食品药品监督管理局（FDA）发布了一份安全通讯《评估中国制造的塑料注射器的潜在设备故障：FDA安全沟通》，通知消费者、医疗保健提供者和医疗保健机构，FDA正在评估中国制造的注射器可能出现的设备故障（如泄漏、破损、注射器中的颗粒和其他问题）。”
2023年11月30日，美国食品药品监督管理局（FDA）发布了一份安全通讯《评估中国制造的塑料注射器的潜在设备故障：FDA安全沟通》《Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication》，通知消费者、医疗保健提供者和医疗保健机构，美国食品和药物管理局正在评估中国制造的注射器可能出现的设备故障（如泄漏、破损、注射器中的颗粒和其他问题）。
该机构收到了与几家中国注射器制造商有关的质量问题的信息。因此，美国食品药品监督管理局担心，某些在中国生产的注射器可能无法提供一致和充分的质量或性能。
以下是通信全文：
The U.S. Food and Drug Administration (FDA) is informing consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China. The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
FDA正在通知消费者、医疗保健提供者和医疗保健机构，FDA 正在评估中国制造的塑料注射器出现设备故障（如泄漏、破损和其他问题）的可能性。FDA正在收集和分析数据，以评估中国制造的用于向体内注射液体或从体内抽取液体的塑料注射器。目前，该问题不包括玻璃注射器、预充式注射器或用于口服或局部目的的注射器。
The FDA received information about quality issues associated with several Chinese manufacturers of syringes. We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance.
FDA收到了有关几家中国注射器制造商的质量问题的信息。FDA担心中国制造的某些注射器可能无法提供一致和足够的质量或性能。
Recommendations for Consumers, Health Care Providers, and Facilities
At this time, while the FDA continues its evaluation of plastic syringes made in China:
Check the manufacturing location for syringes you use or have in your inventory by reviewing the labeling, outer packaging, or contacting your supplier or group purchasing organization.
Consider using syringes not manufactured in China, if possible. At this time, glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not included.
If you only have syringes manufactured in China, then continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems.
对消费者、医疗保健提供者的设施和建议
当美国食品药品监督管理局对注射器进行评估时，鼓励进行以下操作：：
– 通过查看标签、外包装或联系您的供应商或团购组织，检查您使用或库存中注射器的生产地点。
– 如果可能的话，考虑使用非中国制造的注射器。目前，不包括玻璃注射器、预充式注射器或用于口服或局部目的的注射器。
– 如果您只有中国制造的注射器，请根据需要继续使用，直到您能够使用替代注射器并密切监测泄漏、破损和其他问题。
Device Description
Generally, a syringe is used to inject fluid into, or withdraw fluid from, the body and can be used in a variety of clinical and home health settings. Some syringes may also be used with infusion pumps to deliver fluids into the body in a controlled manner.
设备说明
通常，注射器用于将液体注射到身体中或从身体中抽取液体，并可用于各种临床和家庭健康环境中。一些注射器也可以与输注泵一起使用，以受控的方式将流体输送到体内。
Potential Syringe Failures
To date, the FDA is aware of quality issues from recent syringe recalls, Medical Device Reports (MDRs), and additional complaints about syringes made at various manufacturing sites in China. Quality issues reported have included leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions. These quality issues may affect the performance and safety of the syringes including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.
潜在的注射器故障
到目前为止，FDA已经意识到最近的注射器召回、医疗器械报告（MDR）以及有关中国各个生产基地生产的注射器的其他投诉中的质量问题。报告的质量问题包括制造商更改注射器尺寸后的泄漏、破损和其他问题。这些质量问题可能会影响注射器的性能和安全性，包括它们在单独使用或与其他医疗设备（如输液泵）一起使用时提供正确剂量药物的能力。
FDA Actions
The FDA is working with federal partners to further test syringes manufactured in China. The FDA plans to work with manufacturers to ensure adequate corrective actions are taken, and, as necessary, may prevent syringes made in China from entering the United States.
In addition, the FDA will continue monitoring reports of problems with syringes manufactured in China.
We will keep the public informed as additional information becomes available.
FDA的行动
FDA正在与联邦合作伙伴合作，进一步测试中国生产的注射器。FDA计划与制造商合作，确保采取适当的纠正措施，并在必要时阻止中国制造的注射器进入美国。
此外，FDA将继续监测有关中国生产的注射器问题的报告。
当有更多信息可用时，FDA将及时向公众通报情况。
建议广大注射器制造商密切关注近期出货美国的注射器质量情况，和在地经销商密切沟通保持联系，如有不良事件尽快解决与FDA沟通保持联系，在FDA重点关注期间保持产品质量稳定性
Reporting Problems to the FDA
If you think you had a problem with a syringe, or any medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
If you are experiencing supply issues for syringes, or other devices, you may contact the FDA about a medical device supply chain issue. Reporting supply chain issues to the FDA helps inform actions to prevent shortages and protect patient health.
向FDA报告问题
如果认为您的注射器或任何医疗设备有问题，美国食品药品监督管理局鼓励通过MedWatch自愿报告表报告问题。
受FDA用户机构报告要求约束的机构雇用的卫生保健人员应遵守其机构制定的报告程序。
如果遇到注射器或其他设备的供应问题，您可以就医疗设备供应链问题联系美国食品药品监督管理局。向FDA报告供应链问题有助于为防止短缺和保护患者健康的行动提供信息。
社会反响
传染病委员会副主席James D.Campbell医学博士说：“作为儿科医生，注射器当然是预防和治疗儿童疾病的重要工具。”。“它们的质量至关重要，我们很高兴看到美国食品药品监督管理局正在仔细审查这些潜在设备故障的报告。”
伯朗氏公众号将继续讨论注射器引发的安全问题，探讨注射器中的颗粒来源和解决方式，敬请关注！
