After its investigation of cross-contamination from arthroscopic shavers, the US Food and Drug Administration issued an alert to hospitals about medical device reprocessing methods. In response to this, a team of risk management and instrument room personnel at a university hospital undertook a project that tested the manufacturer's recommended cleaning methods for surgical instruments with the objective of determining the efficacy of automated instrument reprocessing and identifying a process that would produce a verifiably clean instrument after the cleaning process is performed. The quality improvement project focused on suction tips because they are used in most surgical procedures, are exposed to high levels of organic debris, and are difficult to clean. A variety of suction tips were cleaned and tested with a variety of processes and products to determine best instrument cleaning practices. Results of the project were eye-opening--debris was found where debris should not be, and the manufacturer's recommended cleaning methods--the current practices-were not effective.
We examined the effects of atomoxetine in Latino (n = 108) versus Caucasian (n = 1090) pediatric outpatients (aged 6 to <18 years) during the first 10-11 weeks of treatment in two multicenter, open-label trials. Mean modal doses were not significantly different in Latinos (1.22 mg/kg per day) versus Caucasians (1.27 mg/kg per day; p = 0.22). Both groups showed significant and similar improvements: Mean ADHD Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-P:I) scores decreased by 54% in Latinos (40.9-18.9; p < 0.001) and by 52% in Caucasians (37.7-18.2; p < 0.001). Other efficacy measures, such as Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) and Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S), demonstrated similar and significant decreases. The only significant between-group difference was a greater decrease in the ADHDRS-IV-P:I Hyperactive/Impulsive subscale at weeks 8-11 for Latinos; however, Latinos had higher baseline scores compared with Caucasians. This was not demonstrated in the CPRS-R:S Hyperactivity subscale. There was a significantly higher frequency of CYP2D6 slow metabolizers in Caucasians compared with Latinos. Caucasians reported significantly more abdominal and throat pain, whereas Latinos reported more decreased appetite and dizziness, but no differences in other common adverse events were reported. No suicidal behavior was reported in either group. We found that Latino and Caucasian children with attention-deficit/hyperactivity disorder (ADHD) exhibit a similar pattern of efficacy and tolerability with atomoxetine. The lack of placebo controls was a limitation of this study.
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