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Fine-needle aspiration biopsy using a newly-developed pencil-grip syringe holder.

Until now, commercially available syringe holders for fine-needle aspiration (FNA) were designed to be held in a pistol-grip manner. A newly developed, pencil-grip syringe holder, the Tao Aspirator, was tested. The device is equipped with a release button for automatically drawing back the syringe plunger and a regulating knob for adjusting negative pressure for the aspiration. After direct smears were made for on-site examination, the remaining aspirated material was collected by rinsing the needle and syringe with CytoRich red fixative. Hettich cytocentrifuge preparations were then prepared. The quality of the first 150 FNA specimens procured by this device and prepared with liquid fixation was evaluated in terms of adequacy of specimen, amount of obscuring blood, preservation of cells, and ease of screening and interpretation. These 150 specimens included 32 from thyroids; 34 from breasts; 40 from lymph nodes; 24 from subcutaneous nodules; and 20 from salivary glands. There were no unsatisfactory specimens. In Hettich preparations, red blood cells were lysed, making interpretation easier. All cellular elements and tissue fragments were adequately fixed, showing excellent cellular morphology. Specimens fixed in liquid fixative yielded uniform cell suspensions, resulting in cytocentrifuge preparations with evenly distributed cells, and so the screening was also easier. The aspiration techniques using pistol-grip and pencil-grip FNA syringe holders were also compared in terms of control in tissue sampling, ease of use, and safety. The pencil-grip syringe holder allowed greater tactile sensation of the texture of the lesion, and enabled the operator to use a single hand to place a needle into a target lesion with minimal error. This device placed the hand relatively close to the needle tip while the hand was in a position of natural function, imparting more control in tissue sampling. It was more easily manipulated, and could prevent dripping when cystic fluid was aspirated. Specimen collection using the Tao Aspirator and processing with liquid fixation in addition to direct smear preparations allowed the laboratory to consistently produce adequate cytologic preparations and cell blocks.

Biopsy, Needle↗

Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis.

Two randomized, placebo-controlled, double-blind studies have shown clinical benefit with omalizumab (Xolair), a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody, at a dose of 300 mg every 3 or 4 weeks in patients with seasonal allergic rhinitis. The present open-label, 12-week study was designed to assess the safety and tolerability of retreatment with omalizumab in 287 patients previously treated with this agent in one of the latter studies. Omalizumab, 300 mg, was administered subcutaneously every 4 weeks (three injections) to patients with IgE levels < or = 150 IU/mL (n = 182) and every 3 weeks (four injections) to patients with IgE levels > 150 IU/mL (n = 105) at screening before retreatment. Reported adverse events were monitored and blood samples were analyzed for laboratory safety (hematology and serum chemistry) and IgE levels. Urinalysis also was completed as part of the laboratory safety evaluation. The overall incidence and pattern of adverse events were similar to those reported in the primary study. There were no severe or serious adverse events related to omalizumab treatment and no anti-omalizumab antibodies were detected in any patient. Two patients withdrew from treatment because of adverse events (skin rash and nausea; facial erythema and edema) related to study treatment. Free IgE levels decreased to the levels associated with symptom reduction in the core study. In summary, retreatment during a second pollen season with omalizumab, 300 mg every 3 or 4 weeks, was well tolerated and was not associated with any significant immunologic reactions.

Adolescent↗

Validity and reliability of responses to a self-report home safety survey designed for use in a community-based child injury prevention programme.

OBJECTIVE: To quantify the validity and reliability of responses to a self-report home safety survey designed for use in a community-based child injury prevention program. METHODS: A cross-sectional study of home-based injury risk factors and safety practices was administered to a random sample of households (n = 614) in two rural and remote communities in Queensland, Australia using a Computer Assisted Telephone Interview (CATI) survey. The survey was re-administered during subsequent home interviews with a sub-sample (n = 85) of CATI participants. RESULTS: For all self-reported hazards and safety practices, prevalence estimates obtained from the CATI survey were significantly different from those directly observed at the home interview with proportions of homes exposed to hazards between 10-21% under reported at CATI survey and safety practices over-reported at CATI survey by 17-24%. There was no statistically significant difference however between the estimates of prevalence of hazards and safety practices self-reported at CATI and home interview. Validity of the CATI survey was poor with sensitivity of the CATI question ranging from 0 to 71 and specificity from 32 to 97. While the marginal distribution of prevalences of hazard prevalences and safety practices were similar between CATI and home interviews, the low level of response concordance (kappa = -0.24 to 0.41) indicates that reliability of the responses to these questions was low. CONCLUSION: In view of these limitations in the accuracy of CATI risk factor surveys, their use for priority setting and evaluation in community-based injury prevention programs needs to be considered with caution.

Accidents, Home↗

Chorion villi sampling (CVS) for prenatal diagnosis of genetic disorders: first results and future research.

Chorion villi sampling (CVS) in the first trimester of pregnancy has become available recently as an alternative method to second trimester amniocentesis for prenatal diagnosis of genetic defects. Currently there are six different tissue sampling techniques being investigated in different centers around the world, but there are very few trials in ongoing pregnancies. From chorionic villi material cytogenetic and biochemical studies as well as DNA analyses can be performed. Different methods of chromosome analysis are being investigated at the University of California San Francisco and elsewhere to determine the most efficient and reliable techniques. Larger studies will be needed to establish the efficacy and the safety of the chorionic villi sampling procedure for the mother and the developing fetus. Although CVS is preferable to amniocentesis for psychological and medical reasons (earlier elective termination of a fetus with a genetic disorder), many questions remain to be answered in carefully controlled studies.

Adult↗

Evaluation of indoor exposition to benzene, toluene, ethylbenzene, xylene, and styrene by passive sampling with a solid-phase microextraction device.

A solid-phase microextraction (SPME) sampling method is developed to evaluate indoor exposure to benzene, toluene, ethylbenzene, xylene, and styrene with gas chromatography and flame ionization detection for quantitative analysis. An SPME holder with a 100-pm polydimethylsiloxane (PDMS) and 65-pm PDMS-divinylbenzene fiber coating is tested in different air relative humidity conditions. The method gives good resolution, shows a linear response, is repeatable, and presents high sensitivity. This method is compared with National Institute of Occupational Safety and Health (NIOSH) active sampling.

Journal Article↗

Safety climate and attitude as evaluation measures of organizational safety.

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Accidents, Occupational↗

Evaluation of employee exposure to organic tin compounds used as stabilizers at PVC processing facilities.

Organic tin compounds are primary substances used as heat stabilizers by the polyvinyl chloride (PVC) industry. The use of these compounds in the PVC industry is generally well controlled, usually by automated processes. This study was conducted to provide an overview of worker exposure to organic tin compounds at PVC processing facilities and to verify that these exposures are below the threshold limit value (TLV((R))) set by the American Conference of Governmental Industrial Hygienists for organic tin. The basis of the TLV indicates the principal concern is to minimize adverse effects on immune function and the central nervous system from airborne exposure to organic tin. The TLV has a skin designation based on the potential for percutaneous absorption; the TLVs for inhalation exposures are based on the presumption that there is no concurrent exposure via the skin and oral ingestion routes. Personal exposure monitoring was conducted following the National Institute for Occupational Safety and Health (NIOSH) 5504 sampling method and a modified version of the NIOSH analytical method. The results were reported as"total tin."The data indicated no average exposure levels for individual tasks exceeded the organic tin TLV, and 96%of results the samples were less than 20%of the TLV. Only 1 sample of 102 exceeded the TLV, and the individual was wearing appropriate respiratory protection. Subsequent investigation indicated the highest exposures occurred while the operators were conducting tasks that included manual handling of the organic tin compounds. These data suggest manual operations may have a greater potential for organic tin exposure.

Environmental Monitoring↗

[Utility and safety endoscopic digestive procedure in pediatric age].

The aim of this study is to verify the utility and safety of endoscopic procedures in the evaluation of children with clinically-significant gastrointestinal symptomatology. We report our experience of 87 pediatric endoscopy procedures including esophagogastroduodenoscopy, colonoscopy and tissue biopsies performed in 85 infants, children and adolescent, 3 months-15 years old, over a two-year period, june 2002-november 2004 after complete history, physical examination and basic investigations. General anesthesia was used in all patients after informed consent obtained from parents. Non significant complications were observed in this series of patients. In 81 cases (92.5%) with clinical symptoms and laboratory indications for gastrointestinal disease, the endoscopy and bioptical samples confirmed the utility and safety of procedure. Coeliac disease (39 cases), gastritis (11 cases), esophagitis (6 cases) were the most common organic cause of upper gastrointestinal disease. Allergic and indeterminate colitis (7 cases) were the most common cause of lower gastrointestinal disease. In 4.7% the procedures appear to be particularly helpful in the diagnosis of inflammatory lesions of the esophagus and stomach. In summary, the data demonstrate that endoscopy techniques show low morbidity, provide important diagnostic informations in pediatric gastrointestinal diseases and can be done safely in patients over 3 months of age.

Adolescent↗

Fallopian tissue sampling with a cytobrush during hysteroscopy: a new approach for detecting tubal infection.

OBJECTIVE: To evaluate whether the transcervical approach for fallopian tissue sampling is a practicable and safe method to establish an etiologic diagnosis of salpingitis. DESIGN: Controlled clinical study. SETTING: Academic research environment. PATIENT(S): Twenty women with primary or secondary sterility undergoing hysteroscopy and laparoscopy. INTERVENTION(S): During hysteroscopy, fallopian tissue samples were obtained from the proximal parts of both tubes with a cytobrush inserted through the working channel of the hysteroscope. Diagnostic laparoscopy with assessment of tubal patency was performed in the same session. The specimens were split and used for chlamydial testing by both cell culture and polymerase chain reaction. Serum samples were evaluated for the presence of antichlamydial antibodies. MAIN OUTCOME MEASURE(S): Practicability and safety of the method. RESULT(S): The sampling procedure was performed in all patients without complications. Adequate samples were obtained from both tubes in all 20 patients. The fallopian specimens showed evidence of chlamydial infection in one patient. CONCLUSION(S): Those data indicate that transcervical fallopian tissue sampling with a cytobrush is a reliable and safe technique.

Cervix Uteri↗

A sample introduction technique for obtaining a multiphoton ionization spectrum using picogram quantities of analyte in supersonic jet spectrometry.

A new sample introduction techniquefor ensuring the safety of a researcher during the measurement of hazardous compounds, such as dioxins, by supersonic jet spectrometry is described. The solution containing the analyte is introduced beneath the nozzle through a narrow capillary with a glass frit at the end, which is formed to vaporize only the solvent and to deposit the analyte. The first laser, that is, the second harmonic emission of a Nd: YAG laser, vaporizes the analyte and entrains it into a supersonic jet. The analyte molecule is ionized by the second laser, that is, an optical parametric oscillator. Ion measurement is achieved by a time-of-flight mass spectrometer. The analyte molecule is localized in the jet, thus permitting the amount of sample to be minimized. The minimum amount of phenol necessary for measurement of a multiphoton ionization spectrum by scanning the wavelength of the ionization laser in the 3-nm range was 180 pg, which is similar to or slightly less than the tolerable daily intake (TDI) of dioxin.

Journal Article↗

RF safety of wires in interventional MRI: using a safety index.

With the rapid growth of interventional MRI, radiofrequency (RF) heating at the tips of guidewires, catheters, and other wire-shaped devices has become an important safety issue. Previous studies have identified some of the variables that affect the relative magnitude of this heating but none could predict the absolute amount of heating to formulate safety margins. This study presents the first theoretical model of wire tip heating that can accurately predict its absolute value, assuming a straight wire, a homogeneous RF coil, and a wire that does not extend out of the tissue. The local specific absorption rate (SAR) amplification from induced currents on insulated and bare wires was calculated using the method of moments. This SAR gain was combined with a semianalytic solution to the bioheat transfer equation to generate a safety index. The safety index ( degrees C/(W/kg)) is a measure of the in vivo temperature change that can occur with the wire in place, normalized to the SAR of the pulse sequence. This index can be used to set limits on the spatial peak SAR of pulse sequences that are used with the interventional wire. For the case of a straight resonant wire in a tissue with very low perfusion, only about 100 mW/kg/ degrees C spatial peak SAR may be used at 1.5 T. But for < or =10-cm wires with an insulation thickness > or =30% of the wire radius that are placed in well-perfused tissues, normal operating conditions of 4 W/kg spatial peak SAR are possible at 1.5 T. Further model development to include the influence of inhomogeneous RF, curved wires, and wires that extend out of the sample are required to generate safety indices that are applicable to common clinical situations. We propose a simple way to ensure safety when using an interventional wire: set a limit on the SAR of allowable pulse sequences that is a factor of a safety index below the tolerable temperature increase.

Electric Wiring↗

Pretransfusion testing without serologic crossmatch: approaches to ensure patient safety.

BACKGROUND AND OBJECTIVES: A crossmatch is usual in pretransfusion testing, but we eliminated it at our tertiary care university hospital. In place of the crossmatch, we have introduced a system where, if an antibody screen is negative, two technologists confirm the ABO of the same patient sample, and we release blood of the patient's type without a serologic or electronic crossmatch. MATERIALS AND METHODS: In 65,628 samples received for pretransfusion testing, we studied the effect of common errors that occur from the time of receipt of a sample until release of the blood unit, in order to decide if elimination of the serologic crossmatch would affect patient safety. All sample labels were inspected for acceptability. RESULTS: A total of 1,082 (1.64%) samples were rejected for mislabeling. Discordance in patient ABO typing results between two technologists was 0.43%. Such discrepancies were resolved before the release of blood units. No donor unit mislabeling or unit release errors were detected. CONCLUSION: Elimination of the crossmatch for red cell antibody-negative patients is safe provided a system of error detection is used. This enhances patient care through the quicker release of blood, increased laboratory efficiency and decreased costs.

ABO Blood-Group System↗

Chorion villus sampling versus amniocentesis for prenatal diagnosis.

BACKGROUND: Amniocentesis test results are usually available only after 18 weeks gestation. Chorion villus sampling (CVS) may be performed transabdominally or transvaginally, usually between 10 and 12 weeks gestation. OBJECTIVES: The objective of this review was to assess the safety and accuracy of chorion villus sampling compared to amniocentesis. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. SELECTION CRITERIA: Randomised trials comparing first trimester chorion villus sampling and second trimester amniocentesis. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. MAIN RESULTS: Three studies involving over 9000 women were included. The trials were generally of good quality. Compared to amniocentesis, chorion villus sampling was associated with more sampling and technical failures, and more false positive and false negative results. Pregnancy loss was more common after chorion villus sampling (odds ratio 1.33, 95% confidence interval 1.17 to 1.52). There is a suggestion (though not statistically significant) of an increase in stillbirths and neonatal deaths following chorion villus sampling. Maternal complications were uncommon. REVIEWER'S CONCLUSIONS: The increase in miscarriages after chorion villus sampling compared to amniocentesis appear to be procedure related. Second trimester amniocentesis appears to be safer than chorion villus sampling. The benefits of earlier diagnosis with chorion villus sampling must be set against the greater risk of pregnancy loss.

Chorionic Villi Sampling↗

Development of the Crash Injury Research and Engineering Network.

The Crash Injury Research and Engineering Network has developed a computer database and wide area network for data sharing and analysis among 8 trauma centers. The computer database extends the National Highway Traffic Safety Administration's National Automotive Sampling System with medical- and trauma-related variables in a relational/object database system. The medical data include injury location details, injury subclassification systems, and medical images for better biomechanical injury evaluation. Key data elements are migrated to a core repository so that all centers can review the status of case acquisition across the network. Cases, whole or in part, may be migrated between centers so that individual center expertise may be shared in evaluating the cause of injury. Electronic rounds, where cases are reviewed simultaneously across multiple centers, are possible.

Accidents, Traffic↗

Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques.

PURPOSE: A comparison was conducted of the levels of surface contamination with two commonly used antineoplastic drugs, cyclophosphamide and fluorouracil, on countertops, floors, and hood surfaces in three oncology pharmacies following preparation with standard hazardous drug (HD) preparation techniques, or a closed-system drug transfer device (CSTD) in conjunction with standard HD preparation techniques, or a CSTD in conjunction with standard HD preparation techniques but prepared on a countertop outside the biological safety cabinet (BSC). METHODS: Wipe samples of the various surfaces in each pharmacy were obtained biweekly for 12 weeks (six samples) to establish a baseline. Following implementation of the CSTD, an additional six biweekly samples were collected. The CSTD was then removed, and a final six samples were collected again using standard preparation techniques. During the CSTD Phase, fluorouracil was prepared on the countertop outside the BSC. RESULTS: During the 36-week study, 342 samples were collected. A total of 8% positive fluorouracil wipe samples were found in the three pharmacies. The proportion of positive fluorouracil samples was significantly less in the CSTD Phase than in the control phases (p = 0.0002). There were 324 (95%) positive cyclophosphamide wipe samples. The median surface contamination was significantly different across the three phases (p < 0.00001). This was consistent at all sites, for both the BSC work surfaces and countertops. Contamination on floors adjacent to the BSCs was not consistently reduced. CONCLUSION: The use of a CSTD in the BSC in conjunction with standard HD preparation techniques significantly reduced cyclophosphamide surface contamination as compared to standard techniques alone. Preparation of fluorouracil outside the BSC using the CSTD did not result in significant analytically detectable contamination on the countertops.

Antineoplastic Agents↗

ECT Treatment of Demented Elderly Patients with Major Depression: A Retrospective Study of Efficacy and Safety.

Retrospective analysis of a 4-year sample of demented patients who had major depression and who were treated with electroconvulsive therapy (ECT) showed that they responded as well to ECT as did a previously studied group of elderly depressed subjects from our institution. Cardiac side effects were no greater in this group, but some patients did have transitory increased confusion. ECT is a safe and effective therapy for the demented patient who has concomitant major depression and who has proven to be resistant to tricyclic antidepressant drug therapy, is intolerant of such medicines, or requires emergency treatment.

Journal Article↗

Residential and commercial painters' exposure to lead during surface preparation.

The California Painters Project was a 2-year intervention research project aimed at preventing lead poisoning among a group of residential and commercial painters in San Francisco, Calif. As part of this project 12 contractors invited project staff to conduct employee exposure monitoring. Twenty-five full-shift samples were collected, with 8-hr TWA results ranging from 0.8 to 550 microg/m3 (arithmetic mean: 57 microg/m3). Six of the 25 samples (24%) were above the Occupational Safety and Health Administration (OSHA) permissible exposure limit; all of these involved dry manual sanding or uncontrolled power sanding. Fifty-eight 30-minute task-specific samples also were collected. The arithmetic mean concentration results for heat gun use, wet sanding, and open flame burning were all under 10 microg/m3; the mean concentration for HEPA-exhausted power sanding was 33 microg/m3; dry manual scraping, 71 microg/m3; dry manual sanding, 420 microg/m3; and uncontrolled power sanding, 580 microg/m3. Analysis and modeling based on the 30-min results for dry manual sanding and uncontrolled power sanding indicate that painters' full-shift exposures often exceed 500 microg/m3 and the OSHA assigned level of protection for a half-mask air-purifying respirator. These results are cause for concern because both of these surface preparation methods are widely performed wearing half-mask respirators. The data show that HEPA-exhausted power sanding reduces paint dust exposure levels by approximately 80 to 90%. These tools should be more widely promoted as a safer alternative work method.

Air Pollutants, Occupational↗

Effect of temperature on the breakthrough of a charcoal tube during vinyl chloride monomer sampling.

This study evaluated the effects of temperature on breakthrough of two standard collection media at various concentrations during vinyl chloride monomer (VCM) sampling. The National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) methods were evaluated. To determine whether breakthrough of VCM would occur at the extremes of exposure and temperature that might be encountered in some workplaces, air samples containing 4 ppm (10.24 mg/m3), 8 ppm (20.45 mg/m3), 16 ppm (40.98 mg/m3), and 32 ppm (81.80 mg/m3) of VCM were collected at temperatures of 4, 22, and 40 degrees C. Five liters of air was sampled at the rate of 0.05 L/min for 100 min using the activated charcoal tube recommended by NIOSH. A second tube was added to the sampling train to collect any VCM that might not have been absorbed in the first tube. To collect VCM air samples by the OSHA method, two carbon molecular sieve tubes were connected serially and 3 L of air was sampled at the rate of 0.05 L/min for 60 min. A gas chromatograph with a flame ionization detector and ultra 2 capillary column was used to analyze VCM. Significant breakthrough was found when sampling at higher temperatures with the NIOSH method. No breakthrough was found when samples were collected using the OSHA media at different temperatures and concentrations. Therefore, under hot ambient conditions (>22 degrees C), the possibility of breakthrough should be considered when sampling VCM by the NIOSH method.

Air Pollutants, Occupational↗