Peripheral intravenous catheter use in Europe: towards the use of safety devices

Background: Peripheral intravenous catheters are among the most widely used medical devices in the world. European patients are increasingly aware of the risk of health care associated infections and the role catheters play in their facilitation.
Aims: We intend to show that European health care providers are increasingly aware of the occupational risks of bloodborne infections such as HIV and hepatitis which can be transmitted by the needles from catheters and that the political will is building to take action to ensure safer devices are provided.
Methods: We review the wide variety of peripheral intravenous catheters which are specially engineered to reduce these risks.
Results: Available safety devices include spring-loaded retractable needles, guards that shield the dangerous tips and closed, needle-free access valves for intravenous sets.
Conlusions: It is no longer necessary for patients and professionals to take risks to health and life when solutions which minimize these risks are at hand.     

Study of biological safety of scaffold material with heterologous deproteinized bone

Objective: To evaluate the biological safety of manufactured heterologous deproteinized bone and to provide an experimental basis for clinical applications. Methods: Deproteinized bone (10 mm) and leaching liquor were made from pig ribs with a series of physical and chemical methods, then were evaluated through acute and subacute toxicity test, hemolysis test, pyrogen test, intracutaneous test, intramuscular implantation test and cytotoxity test. Results: No obvious toxicity, hemolysis, pyrogenic characteristics, skin irritation, inflammatory reaction after intramuscular implantation and cytotoxity were observed. Conclusions: The heterologous deproteinized bone has good biological safety and meets all the demands of scaffold material for tissue engineering.     

磷酸钙与聚甲基丙烯酸甲酯制备复合型骨水泥的生物安全性研究

目的探讨磷酸钙(CPC)和聚甲基丙烯酸甲酯(PMMA)按不同比例混合而制备复合型骨水泥(CPC/PMMA)的方法及评价其生物安全性。方法制备CPC/PMMA复合型骨水泥试件并分组,共分为CPC(100%)组、CPC/PMMA(75%、67%、50%、33%、16.7%、9.1%、6.25%、4.8%)组、PMMA(100%)组;通过急性毒性实验、全身亚急性毒性实验、热源实验、致敏实验、溶血实验检测CPC/PMMA复合型骨水泥的生物安全性。结果 CPC(100%)组、CPC/PMMA(75%)组、CPC/PMMA(67%)组、CPC/PMMA(50%)组OD值两两比较差异无统计学意义(P0.05),细胞毒分级为1级,无细胞毒性。CPC/PMMA(50%)组与对照组、CPC(100%)组、PMMA(100%)组小鼠的血常规检、生化检查、脏器湿重、体重变化差异无统计学意义(P0.05)。实验组的组织病理学检查、热源实验、致敏实验、溶血实验未出现异常。结论复合型骨水泥CPC/PMMA制备过程简便可靠,具有良好的生物安全性、血液与组织相容性,无毒性及致敏性。     

肾移植中生物免疫制剂应用与术后肺部感染的关系

目的探讨肾移植中巴利昔单抗(舒莱)、抗Tac单抗(赛尼哌)、抗胸腺细胞球蛋白(ATG)等生物免疫制剂应用与术后肺部感染的关系。方法2003年至2005年间肾移植患者417例,男249例,女158例。年龄17～64岁,平均41岁。比较分析生物免疫抑制剂组、环孢素组和他克莫司(FK506)组术后肺部感染的发生率,以及不同生物免疫制剂组间肺部感染发生率的差异。结果417例患者术后发生肺部感染38例(9.1%)。环孢素组(n=224)、FK506组(n=118)和生物制剂组(n=75)肺部感染发生率分别为8.0%、9.3%、12.0%,组间差异无统计学意义(P>0.05)。舒莱组(n=25)、赛尼哌组(n=14)、ATG诱导组(n=16)和ATG治疗组(n=20)肺部感染发生率分别为8.0%、7.1%、6.3%、25.0%,差异无统计学意义(P>0.05)。急性排斥组与未出现排斥组肺部感染发病率分别为20.5%、7.9%,差异有统计学意义(P<0.01),其中单纯应用甲泼尼龙冲击治疗组(n= 19)与ATG治疗组(n=20)间肺部感染发病率分别为15.8%,25.0%,差异无统计学意义(P>0.05)。结论生物免疫制剂舒莱、赛尼哌和ATG并不增加肾移植后肺部感染的危险性。     

Analysis of adverse events in pediatric surgery using criteria validated from the adult population: justifying the need for pediatric-focused outcome measures

Introduction

Little is known regarding the incidence and financial impact of adverse events associated with the surgical care of children. The purpose of this study was to characterize the epidemiology and resource utilization associated with these events using definitions validated from the adult population.

Methods

We conducted a 6-year audit (Jan 2003-Dec 2008) of adverse events associated with the 100 most common general pediatric surgical procedures from the Pediatric Health Information System database. We audited 23 events as defined by the National Surgical Quality Improvement Project and modified Agency for Healthcare Research and Quality Patient Safety Indicators. Excess length of stay and total hospital charges attributable to events were determined for each procedure after adjusting for confounders.

Results

Overall 30-day incidence of any adverse event was 10.3% in our sample of 331,093 patients. The most common events were transfusions (30% of all events), wound complications (15%), and events associated with central access (11%). The cumulative incidence of serious events including cardiac arrest, stroke, deep venous thrombosis and pulmonary embolish was less than 0.3%. Ten procedures accounted for 62% of all events, and all 10 were associated with significant (P < .01) increases in length of stay and total hospital charges when any event occurred. Circumcisions, soft-tissue biopsies, pyloromyotomies, and repair of abdominal wall hernias accounted for only 3% of events despite comprising nearly 25% of operative volume.

Conclusions

A relatively small number of pediatric surgical procedures contribute to a disproportionate share of adverse events. Although the National Surgical Quality Improvement Project and Agency for Healthcare Research and Quality criteria can identify pediatric procedures associated with a significant risk of morbidity, the relatively high 30-day event rates captured for some procedures may be heavily influenced by underlying co-morbidity profiles not related to the surgical disease or intervention. Furthermore, the validity of applying adult-focused “adverse” event definitions for the pediatric population should be further explored. Collaborative efforts will be needed to develop more clinically meaningful outcome measures for the purpose of quality improvement end points.     

Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: an exploratory analysis of the outcomes of elderly patients in the RECORD-1 Trial

Background

Elderly patients with metastatic renal cell carcinoma (mRCC) may require special treatment considerations, particularly when comorbidities are present. An understanding of the efficacy and safety of targeted agents in elderly patients with mRCC is essential to provide individualized therapy.

Objective

To evaluate the efficacy and safety of everolimus in elderly patients (those ≥65 and ≥70 yr of age) enrolled in RECORD-1.

Design, setting, and participants

The multicenter randomized RECORD-1 phase 3 trial (Clinicaltrials.gov identifier, NCT00410124; http://www.clinicaltrials.gov) enrolled patients with mRCC who progressed during or within 6 mo of stopping sunitinib and/or sorafenib treatment (n = 416).

Intervention

Everolimus 10 mg once daily (n = 277) or placebo (n = 139) plus best supportive care. Treatment was continued until disease progression or unacceptable toxicity.

Measurements

Median progression-free survival (PFS), median overall survival (OS), and time to deterioration in Karnofsky performance status (TTD-KPS) were assessed using the Kaplan-Meier method; the log-rank test was used to compare treatment arms. Other outcomes evaluated included reduction in tumor burden, overall response rate (ORR), and safety.

Results and limitations

In RECORD-1, 36.8% of patients were ≥65 yr and 17.5% were ≥70 yr of age. PFS, OS, TTD-KPS, reduction in tumor burden, and ORR were similar in the elderly and the overall RECORD-1 population. Everolimus was generally well tolerated in elderly patients, and most adverse events were grade 1 or 2 in severity. The toxicity profile of everolimus was generally similar in older patients and the overall population; however, peripheral edema, cough, rash, and diarrhea were reported more frequently in the elderly regardless of treatment. The retrospective nature of the analyses was the major limitation.

Conclusions

Everolimus is effective and tolerable in elderly patients with mRCC. When selecting targeted therapies in these patients, the specific toxicity profile of each agent and any patient comorbidities should be considered.     

声门上气道装置在困难气道处理中的应用及相关问题

背景 声门上气道装置(supraglottic airway devices,SAD)在困难气道患者的处理中发挥着重要作用,并且许多气道管理指南推荐应用SAD处理发生在手术室和院前的困难气道. 目的 介绍SAD在困难气道处理不同方面的应用情况及其存在的可能问题. 内容 包括SAD的分类、SAD在困难气道处理中的作用、困难气道处理时采用SAD进行通气管理或通过SAD实施气管插管、SAD在院前困难气道处理中的应用、SAD在困难气道处理中应用的相关问题等. 趋势 目前的主要问题是大多数的SAD研究是人体模型研究,仅有少数随机对照临床研究在困难气道患者比较了SAD的应用情况.由于最安全的数据是来自于广泛地临床应用,因此认为在困难气道处理中SAD有效和安全的断言必须慎重解释.     

Survey: retrospective survey of monitoring/safety devices and incidents of cardiopulmonary bypass for cardiac surgery in France

Several surveys showed that cardiopulmonary bypass (CPB) is associated with incidents that negatively affect outcome and suggested that improved monitoring and safety could be associated with a decreased rate of incidents. In 2004, the French "Haute Autorité de Santé" (an independent French government advisory agency) and the French College of Perfusion issued recommendations concerning safety and monitoring devices for CPB. The aims of this study were to investigate the difference between the recommendations and the clinical practice of CPB shortly after publication of the recommendations and compare the 2005 situation with the results of a previous survey performed in France and to investigate the rate of perfusion incidents and their outcome. A 62-item questionnaire was sent in January 2006 to all 66 centers performing cardiac surgery and CPB in France. The survey investigated the use of safety and monitoring devices as well as perfusion incidents for 2005. Fifty-seven centers (response rate, 86%) returned the questionnaire, totaling 34,496 CPB procedures. There was a wide difference between the recommendations and the reported use of safety and monitoring devices with no clinically relevant change from the previous French survey concerning 2001. An incident was reported for every 198 CPB procedures with death at a frequency of 1:4864 and permanent sequelae of 1:11,349, respectively (a permanent injury or death in 1:3220 procedures). The three most frequent perfusion incidents were adverse effects to protamine (1:1702), dissection at the arterial cannulation site (1:1792), and coagulation of the circuit (1:4864). In conclusion, this survey showed that an important effort must be made in France to implement into clinical practice the recommendations concerning CPB monitoring and safety devices. The analysis of CPB-related incidents suggest that, with the exception of protamine adverse effects, the majority of deaths and severe permanent injuries in this survey could probably be avoided by improved use of the monitoring and safety devices.