可编程注射泵以低输注速率输送药物时（特别是向婴幼儿患者和危重患者输送时）存在严重风险，美国食品药品监督管理局（FDA）于上周四（2016年8月25日）就与可编程注射泵相关联的严重不良事件向医疗服务提供者发出警告。
对此，FDA要求这些器械的制造商在使用说明书中加入新的警告和注意事项，以降低风险。FDA还指出，想要用不同于已经提供的表述对器械标签进行修改时，制造商应就这些变化向FDA提交新的510(k)申请。
注射泵
可编程注射泵是一种医疗机构用到的输液泵，以不同输注速率向患者输送多种药物。FDA将可编程注射泵作为II类医疗器械进行监管。一般情况下，这些器械用于向婴幼儿患者或有液量限制的患者输送“高浓度”药物。
FDA指出，“当流率小于每小时5mL时，特别是当流率小于每小时0.5mL时，注射泵可能引起由流量连续性不足带来的严重临床后果，从而导致治疗延误、过度输注或输注不足。”
据FDA透露，在过去三年时间里，FDA收到了超过300份与可编程注射泵相关的医疗器械不良事件报告（MDR），其中许多不良事件报告与流量率引起的问题相关。“在提供了输注速率信息的100份医疗器械不良事件报告中，绝大多数报告所提及的输注速率为每小时≤5mL（包括低至每小时0.06mL的输注速率）。”
正因为如此，FDA建议医疗服务提供者慎重考虑与器械一同使用的注射器及其附件（如管道和过滤器），以将不合理流量的风险降至最低。
但是，在FDA指出这类问题“可能延伸至所有能够以低输注速率输送药物的可编程注射泵”的同时，FDA也告诫人们不能仅仅以此确定问题的根源，因为医疗器械不良事件报告（MDR）有其固有的局限性，与器械一同使用的注射器大小也各有不同，而且患者也会存在并发症。
FDA指出，除了查看医疗器械不良事件报告（MDR）之外，其还查阅了相关文献并进行了医院调查，以就器械如何使用以及器械造成的风险收集更多的信息。
英语原文
FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates
Posted 25 August 2016 By Michael Mezher
The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients.
In response, FDA has provided manufacturers of the devices with new language to add to their instructions for use that includes a list of warnings and considerations to mitigate the risks. The agency also says that companies wishing to modify their labels with language other than what it has provided should submit a new 510(k) for the changes.
Syringe Pumps
Programmable syringe pumps are a type of infusion pump used in healthcare settings to administer a wide array of drugs to patients at various rates, and are regulated as Class II devices by FDA. These devices are also commonly used to deliver "highly concentrated" drugs to infants or patients with fluid restrictions.
According to FDA, the syringe pumps can cause "serious clinical consequences from lack of flow continuity resulting in delay of therapy, over-infusion or under-infusion," when operating at a rate of less than 5 mL per hour, "and especially at flow rates of less than 0.5 mL per hour."
Over the last three years, FDA says it has received more than 300 medical device reports (MDRs) related to programmable syringe pumps, many of which were related to issues with the devices' flow rate. "Of the 100 MDRs that provided information on the infusion rates, the majority of those MDRs noted infusions at rates of 5 mL per hour or less, including rates as low as 0.06 mL per hour."
As such, FDA is advising healthcare providers to carefully consider the syringes and accessories, such as tubing and filters, used with the devices in order to minimize the risk of inconsistent flow.
However, while FDA says the issues "may extend to all programmable syringe pumps capable of delivering at low infusion rates," it cautions that it is not able to definitively single out the root cause of the issues due to the limitations inherent with MDRs, varying syringe sizes used with the devices and presence of patient comorbidities.
In addition to reviewing the MDRs, FDA says it conducted a literature review and a hospital survey to gather more information on how the devices are used and the risks they pose.

来自：FDA

版权声明：本网站所有内容，凡注明来源为“寻医问药网-医脉”，版权均归寻医问药网所有，欢迎转载，转载请注明作者和出处，否则将追究法律责任。本网注明来源为其他媒体的内容为转载，版权归原作者所有，如有侵犯版权，请及时联系我们。