Blossom David, Noble-Wang Judith, Su John, Pur Stacy, Chemaly Roy, Shams Alicia, Jensen Bette, Pascoe Neil, Gullion Jessica, Casey Eric, Hayden Mary, Arduino Matthew, Budnitz Daniel S, Raad Isaam, Trenholme Gordon, Srinivasan Arjun
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Arch Intern Med. 2009 Oct 12;169(18):1705-11. doi: 10.1001/archinternmed.2009.290.
To investigate clusters of Serratia marcescens (SM) bloodstream infections (BSIs) at health care facilities in several states and determine whether contaminated prefilled heparin and isotonic sodium chloride solution (hereinafter, saline) syringes from a single manufacturer (company X) were the likely cause, we performed an outbreak investigation of inpatient and outpatient health care facilities from October 2007 through February 2008.
Active case finding for clusters of SM BSIs. Information on SM BSIs was obtained, and SM blood isolates were sent to the Centers for Disease Control and Prevention (CDC). Culture specimens were taken from various lots of prefilled heparin and saline syringes by health care facilities and the CDC to test for the presence of SM. The SM isolates from syringes and blood were compared by pulsed-field gel electrophoresis.
A total of 162 SM BSIs in 9 states were reported among patients at facilities using prefilled heparin and/or saline syringes made by company X. Cultures of unopened prefilled heparin and saline syringes manufactured by company X grew SM. Of 83 SM blood isolates submitted to the CDC from 7 states, 70 (84%) were genetically related to the SM strain isolated from prefilled syringes. A US Food and Drug Administration inspection revealed that company X was not in compliance with quality system regulations.
A multistate outbreak of SM BSIs was associated with intrinsic contamination of prefilled syringes. Our investigation highlights important issues in medication safety, including (1) the importance of pursuing possible product-associated outbreaks suggested by strong epidemiologic data even when initial cultures of the suspected product show no contamination and (2) the challenges of medical product recalls when production has been outsourced from one company to another.
为调查几个州的医疗机构中粘质沙雷氏菌（SM）血流感染（BSI）的聚集情况，并确定来自单一制造商（X公司）的预充式肝素和等渗氯化钠溶液（以下简称生理盐水）注射器受到污染是否可能是病因，我们于2007年10月至2008年2月对住院和门诊医疗机构进行了一次暴发调查。
对SM BSI聚集情况进行主动病例搜索。获取了有关SM BSI的信息，并将SM血液分离株送至疾病控制与预防中心（CDC）。医疗机构和CDC从不同批次的预充式肝素和生理盐水注射器中采集培养标本，以检测是否存在SM。通过脉冲场凝胶电泳比较注射器和血液中的SM分离株。
在使用X公司生产的预充式肝素和/或生理盐水注射器的医疗机构中，共报告了9个州的162例SM BSI。X公司生产的未开封预充式肝素和生理盐水注射器培养物中生长出SM。从7个州提交给CDC的83株SM血液分离株中，70株（84%）在基因上与从预充式注射器中分离出的SM菌株相关。美国食品药品监督管理局的检查显示，X公司不符合质量体系规定。
多州的SM BSI暴发与预充式注射器的内在污染有关。我们的调查突出了药物安全中的重要问题，包括（1）即使疑似产品的初始培养物未显示污染，根据强有力的流行病学数据追查可能与产品相关的暴发的重要性，以及（2）当生产从一家公司外包给另一家公司时医疗产品召回的挑战。
