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召回后:在一家大型儿童医院重新检查多次磁铁摄入。

After the Recall: Reexamining Multiple Magnet Ingestion at a Large Pediatric Hospital.

机构信息

Division of Pediatric Emergency Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Pediatrics, University of Toronto, Toronto, ON, Canada.

Department of General Surgery, University of Toronto, Toronto, ON, Canada.

出版信息

J Pediatr. 2017 Jul;186:78-81. doi: 10.1016/j.jpeds.2017.02.002. Epub 2017 Mar 10.

Abstract

OBJECTIVES

To evaluate the effectiveness of a mandatory product recall on the frequency of multiple mini-magnet ingestion at a large tertiary pediatric hospital, and to examine the morbidity and mortality associated with these ingestions.

STUDY DESIGN

In this retrospective chart review, we searched our institution's electronic patient record for patients aged <18 years who had been diagnosed with ingested magnetic foreign bodies between 2002 and 2015, a period that included the mandatory product recall. We compared the frequency and character of ingestions before and after the recall.

RESULTS

Comparing the postrecall years (January 1, 2014, to December 31, 2015) with the 2 years immediately preceding the recall year (January 1, 2011, to December 31, 2012) yields an incidence rate ratio of 0.34 (95% CI, 0.18-0.64) for all magnet ingestions and 0.20 (95% CI, 0.08-0.53) for ingestion of multiple magnets. Based on the Fisher exact test, the incidence of both magnet ingestion (P < .001) and multiple magnet ingestion (P < .001) decreased, and the morbidity associated with magnet ingestion decreased. There were no deaths in either study period.

CONCLUSION

There was a significant decrease in multiple mini-magnet ingestion following a mandatory product recall. This study supports the effectiveness of the recall, which should bolster efforts to keep it in place in jurisdictions where it is being appealed. More broadly, the result provides general evidence of a recall helping decrease further harm from a product that carries a potential hazard.

摘要

目的

评估在一家大型儿科三级医院实施强制性产品召回对多次微型磁铁摄入频率的影响,并研究这些摄入物相关的发病率和死亡率。

研究设计

在这项回顾性图表研究中,我们在机构的电子病历中搜索了 2002 年至 2015 年间被诊断为摄入磁性异物的<18 岁患者,这一时期包括强制性产品召回。我们比较了召回前后摄入的频率和特征。

结果

与召回年前的 2 年(2011 年 1 月 1 日至 2012 年 12 月 31 日)相比,在召回年后(2014 年 1 月 1 日至 2015 年 12 月 31 日),所有磁铁摄入的发生率比为 0.34(95%CI,0.18-0.64),多次磁铁摄入的发生率比为 0.20(95%CI,0.08-0.53)。根据 Fisher 确切检验,磁铁摄入(P<0.001)和多次磁铁摄入(P<0.001)的发生率均下降,且与磁铁摄入相关的发病率下降。在两个研究期间均无死亡病例。

结论

在实施强制性产品召回后,多次微型磁铁摄入明显减少。本研究支持召回的有效性,这应支持在有吸引力的司法管辖区保留召回的努力。更广泛地说,这一结果提供了召回有助于减少具有潜在危险的产品造成的进一步伤害的一般证据。

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