Adverse events with medical devices in anesthesia and intensive care unit patients recorded in the French safety database in 2005-2006.

BACKGROUND: French regulations require that adverse events involving medical devices be reported to the national healthcare safety agency. The authors evaluated reports made in 2005-2006 for patients in anesthesiology and critical care. METHODS: For each type of device, the authors recorded the severity and cause of the event and the manufacturer's response where relevant. The authors compared the results with those obtained previously from the reports (n = 1,004) sent in 1998 to the same database. RESULTS: The authors identified 4,188 events, of which 91% were minor, 7% severe, and 2% fatal. The cause was available for 1,935 events (46%). Faulty manufacturing was the main cause of minor events. Inappropriate use was the cause in a significantly larger proportion of severe events than minor events (P < 0.001) and was usually considered preventable via improved knowledge or device verification before use. Compared to with that in 1998, the annual number of reported events doubled and the rate of severe events decreased slightly (12-10%, P = 0.03). The rate of events related to manufacturing problems remained stable (59-60%, P = nonsignificant), and the rate of events caused by human errors was 32-42% (P = 0.01). There were no changes in the mortality rate (2% in both studies). CONCLUSIONS: The number of adverse events related to medical devices indicates a need for greater attention to these complex pieces of equipment that can suffer from faulty design and manufacturing and from inappropriate use. Improvements in clinician knowledge of medical devices, and to a lesser extent improvement in manufacturing practices, should improve safety.

Changes in R-Wave amplitude in DII lead is less sensitive than pulse pressure variation to detect changes in stroke volume after fluid challenge in ICU patients postoperatively to cardiac surgery.

OBJECTIVE: The amplitude of R-wave in DII lead (RDII) has been shown to correlate to central blood volume in animal and healthy volunteers. The aim of this study was to assess if change in RDII (DeltaRDII) after passive leg rise (PLR) and fluid loading would allow detecting preload dependence in intensive care ventilated patients. This parameter was compared to concomitant changes in pulse arterial pressure (DeltaPP). METHODS: Observational study in 40 stable sedated and ventilated cardiac surgery patients studied postoperatively. In line with our routine practice we performed a 45 degrees passive leg rise (PLR1) to detect preload dependence. If cardiac index or DeltaPP rose more than 12 and 13%, respectively, the patient was declared as non-responder (NR) to fluid loading. If these criteria were not met, they were declared as responders (R) and received a 500 ml of gelatin fluid loading (FL) followed by a second passive leg rise (PLR2). Hemodynamic parameters were assessed during each maneuver using their indwelling Swan-Ganz and radial catheter. RESULTS: We identified 16 R and 24 NR whose hemodynamic parameters did not differ at basal condition, except DeltaPP (19% +/- 7 in R vs. 7% +/- 4 in NR, P < 0.001). PLR1 did not elicit any hemodynamic change in NR. In R, DeltaPP decreased and SV rose, both significantly (P < 0.001) whereas DeltaRDII did not vary. FL induced a more pronounced change in these parameters. CONCLUSIONS: DeltaRDII in response to PLR does not successfully help identifying preload dependent patients contrarily to DeltaPP or change in stroke volume.

Written information that relatives of adult intensive care unit patients would like to receive--a comparison to published recommendations and opinion of staff members.

OBJECTIVE: Information booklets have not been assessed by the families of intensive care unit (ICU) patients. This study explored the information that the relatives of adult ICU patients wanted to find in the information booklets. DESIGN: Multicenter survey. SETTING: Twenty-three French ICUs. SUBJECTS: One close relative of each of 250 consecutive adult patients. METHODS: Relatives were asked about the desirability of finding information on each of the 24 topics identified by ICU physicians and listed in guidelines as deserving inclusion in information booklets. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The 250 patients (61% men) had a mean age of 60 +/- 18 years and a mean Simplified Acute Physiology Score II of 48 +/- 19; 57% had chronic comorbidities and 41% were surgical patients. At least 72% of the relatives felt that booklets should discuss nosocomial infections, treatment-limitation decisions, access to medical information on the patient, access to medical records, and the meaning of medical terms. Overall, relatives wanted more information than that anticipated by ICU physicians, suggested in guidelines, or found in booklets. However, for at least one of the 24 topics, 38% of relatives indicated that fear or poor comprehension made them unwilling to receive written information. These relatives were younger and had fewer years of formal education than did the other relatives, and they were more likely to be visiting conscious unrestrained patients. CONCLUSIONS: Opinions of relatives should be taken into account when designing ICU information booklets. Relatives want more information than that anticipated by physicians or suggested in guidelines, but the youngest or the less-educated ones may respond less favorably to written information.

Measuring disease-specific quality of life in rare populations: a practical approach to cross-cultural translation.

BACKGROUND: Disease-specific quality of life (QoL) measures have enhanced the capacity of outcome measures to evaluate subtle changes and differences between groups. However, when the specific disease is rare, the cohort of patients is small and international collaboration is often necessary to accomplish meaningful research. As many of the QoL measures have been developed in North American English, they require translation to ensure their usefulness in a multi-cultural and/or international society. Published guidelines provide formal methods to achieve cross-culturally comparable versions of a QoL tool. However, these guidelines describe a rigorous process that is not always feasible, particularly in rare disease groups. The objective of this manuscript is to describe the process that was developed to achieve accurate cross-cultural translations of a disease-specific QoL measure, to overcome the challenges of a small sample size, i.e. children with a rare disorder. PROCEDURE: A measurement study was conducted in the United Kingdom (UK), France, Germany and Uruguay, during which the validated measure was translated into the languages of the respective countries. RESULTS: This is a report of a modified, child-centric, cross-cultural translation and adaptation process in which culturally appropriate and methodologically valid translations of a disease-specific QoL measure, the Kids' ITP Tools (KIT), were performed in children with immune thrombocytopenic purpura (ITP). The KIT was translated from North American English into UK English, French, German, and Spanish. CONCLUSION: This study was a successful international collaboration. The modified process through which culturally appropriate and methodologically valid translations of QoL measures may be achieved in a pediatric population with a relatively rare disorder is reported.

The virulence variability of different Acinetobacter baumannii strains in experimental pneumonia.

OBJECTIVES: Our objective was to compare the virulence of 5 strains of Acinetobacter baumannii by using a mouse model of pneumonia. METHODS: Six-week old female C3H/HeN mice were used. The pneumonia was inducted by intra-tracheal inoculation of 5.10(6) bacteria. Spontaneous outcome was evaluated by mortality, mice weight variations, and a clinical score. Bacterial counts in lungs, spleen and blood, and inflammatory response in lungs (dosages of tumor necrosis factor-alpha and macrophage inflammatory protein-2) were also measured. Lastly, a histological examination of lungs was performed for 3 strains, giving a histological score. RESULTS: Global mortality varied from 13% to 79% (P<10(-4)). Bacterial counts in lungs within the 4 days following inoculation varied significantly according to different strains. The evolution curves of bacterial counts were also different. There was a significant correlation between the clinical score and mortality (P<0.05) but not between bacterial counts in lungs and mortality. The increase of pro-inflammatory mediator production in lungs and the histological score also varied according to strains. CONCLUSIONS: These results demonstrate the variability of the virulence between strains, and suggest that bacterial proliferation is not the only virulence factor responsible for the pathogenesis in A. baumannii pneumonia.