O'Day D M
Ophthalmology. 1985 Mar;92(3):309-15. doi: 10.1016/s0161-6420(85)34035-6.
A centralized registry of cases was established when it became apparent that an outbreak of Candida parapsilosis endophthalmitis in California was due to intrinsic contamination of a nationally distributed ocular irrigation solution. The purposes were to detect cases, to identify patients at risk, to collect and disseminate clinical information regarding the infection, and to make available information and experience regarding treatment. As a result of these efforts, all patients exposed to the solution were reviewed by their physicians and numerous cases of infection were detected. In contrast, Food and Drug Administration-mandated procedures, traditionally focused on manufacturing standards, were effective in recalling the contaminated solution but failed to provide physicians with adequate information to identify and care for patients at risk.
当发现加利福尼亚州发生的近平滑念珠菌性眼内炎暴发是由于一种全国性分发的眼用冲洗液的内在污染所致时,便建立了一个集中的病例登记处。其目的是检测病例、识别有风险的患者、收集和传播有关该感染的临床信息以及提供有关治疗的信息和经验。通过这些努力,所有接触过该冲洗液的患者都由其医生进行了复查,并检测出了许多感染病例。相比之下,美国食品药品监督管理局规定的程序传统上侧重于生产标准,虽然有效地召回了受污染的冲洗液,但未能向医生提供足够的信息以识别有风险的患者并对其进行护理。