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We evaluated three oximeters from three manufacturers. We based our ratings on operator safety, ability to report all parameters, alarm features, and human factors design. All units are rated Conditionally Acceptable. They are Acceptable on the condition that users assume the responsibility for taking appropriate infection control measures to minimize exposure to potentially infectious blood samples.
BACKGROUND: Sputum induction (SI) has proved to be a reliable non-invasive tool for sampling inflammatory airway contents in asthma, with distinct advantages over collection of expectorated sputum (ES) and bronchoalveolar lavage (BAL). A study was undertaken to evaluate the safety of SI and to assess if it might be an equally valuable outcome tool in patients with cystic fibrosis (CF). METHODS: The safety of the procedure was examined and sample volume, cell counts, cytokine concentrations, and bacterial culture results obtained by SI, spontaneous ES, and fibreoptic bronchoscopy were compared in 10 adults with CF. RESULTS: SI was well tolerated and was preferred to BAL by all subjects. The mean (SE) sample volume obtained by SI was significantly greater than ES (6.74 (1.46) ml v 1.85 (0.33) ml, p = 0.005). There was no significant difference in the number of cells per ml of sample collected. There was a difference in the mean (SD) percentage of non-epithelial, non-squamous cells collected (67 (28)%, 86 (21)%, and 99 (1)% for ES, SI, and BAL, respectively). These percentage counts were different between ES and both SI and BAL (p=0.03 and p=0.006, respectively). Cell differential counts (excluding squamous cells) from all collection methods were similar (mean (SD) 84 (9)%, 87 (7)%, and 88 (11)% polymorphonuclear cells for ES, SI, and BAL, respectively). The concentrations of interleukin (IL)-8 and tumour necrosis factor (TNF)-alpha were the same in all three samples when corrected for dilution using urea concentration. The test specific detection rate for recovery of bacteriological pathogens was 79% for SI, 76% for ES, and 73% for BAL. CONCLUSION: SI offers safety advantages over BAL and may be a more representative airway outcome measurement in patients with CF.
The JEV widely is used in Asian countries each year and is an important vaccine for travelers to the East from other parts of the world. JE virus is a zoonotic disease with natural reservoirs and cannot be eliminated. Although a declining incidence of JE has been observed in Asia because of reduced transmission by agricultural approaches and vaccination, the most important control measure now, and in the future, is vaccination of humans against JE. The inactivated vaccine, produced from infected mouse-brain-derived tissue, is the only commercially available vaccine. There are several concerns with the use of this vaccine. It is expensive, requires two or three doses to achieve protective efficacy, and, in practice, requires further booster doses to maintain immunity. The apparent increase in allergic reactions in the first part of the 1990s has set focus on the safety of the JEV. A cheap, live attenuated SA 14-14-2 vaccine is used almost exclusively in China and parts of Korea, but there have been no trials of SA 14-14-2 vaccine outside JE endemic countries. The vaccine seems to be highly efficient, and few adverse events have been observed; however, PHK cells are used for the production of this vaccine, and these cells are not approved by the WHO. A satisfactory cell substrate is needed. A committee under the WHO has proposed that for the live JEV, there should be validity of the assays for retrovirus when applied to PHK cell substrate and validity of the mouse assays for neurovirulence. Further information should be reviewed on the long-term follow-up of recipients of the vaccine. Several new types of vaccines have reached the phase of clinical trials; however, studies remain to be completed. Until a new vaccine is available, the priority of surveillance of adverse events and the continuous reporting of such events to the users of the vaccines must be of importance. This fact is highlighted by the possibility of the varying frequency of adverse events with different batches over the years. The WHO offers information and recommendations for vaccines in the EPI and issues a series of updated papers on other vaccines that are of international public health importance (eg, JEV). The development of alternative efficient, safe, and appropriately priced JEVs is recommended, as is intensified surveillance of adverse events. Prospective vaccine studies of safety may be limited because of sample size and because rare adverse events may not be detected. Several new initiatives have been taken to improve surveillance of adverse events to vaccines within the past 10 years. In Japan, there is an increasing awareness of the importance of efforts taken to improve vaccine safety, and surveillance of adverse events and possibilities of compensation for vaccine-related injuries are in place. In Vietnam, a database to detect adverse events after vaccination has been established; the project involves active visits to data collectors at the vaccination sites. Comparative studies of adverse events, such as one recent study from Japan and the United States, are important for the evaluation of the reporting systems. The reporting rate for JEV adverse events from Japan was approximately one order of magnitude lower than that in the United States. Japan had strict predefined reporting criteria and time limits for observations. If time limits for the observation are too strict (eg, defining a possible neurologic reaction to occur within 1 week after vaccination), later reactions will not be included (eg, if ADEM is elicited by a vaccine, the symptoms cannot be expected to occur until weeks after the vaccination). The passive surveillance systems have limitations with an underreporting of adverse events, depending on clinical seriousness, temporal proximity to vaccination, awareness of healthcare workers, and tradition of reporting particular events. In developed countries, surveillance of adverse events is formalized, although not necessarily optimal. An increase in reporting would be expected when the reporting of adverse events is mandatory. Reports have been sent to VAERS, the Vaccine Safety Datalink Project, and the European Union Pharmacovigilance System. A Brighton collaboration has been implemented to enhance comparability of vaccine safety data. Public health authorities in specific countries, such as the CDC in the United States and the National Advisory Committee in Canada, regularly have published information on the JE situation in Asia and the preventive measures to be taken, including information on the vaccines and adverse reactions. The conventional recommendation is that travelers should be vaccinated if they will spend more than 1 month in a JE endemic area or in areas with epidemic transmission with even shorter periods. Although the risk for JE for short-term travelers is considered small (1 case per 1 million travelers per year), sporadic cases, including deaths, have been reported among tourists traveling to endemic areas. Risk for travelers in rural districts in the season of risk is considerably higher (range, 1 case per 5000 travelers to 1 case per 20,000 travelers per week). Doctors who advise travelers should be updated on the latest JE occurrences in Asia. Updates on the JE situation can be found on bulletins at http://www.promedmail.org or are available from the WHO or CDC. The allergic reactions primarily described after vaccination with the inactivated mouse-brain-derived JEV have been observed in several countries during the 1900s. Allergic reactions, including the mucocutaneous and neurologic reactions reported after JE vaccination, may vary in frequency, and these reactions should be evaluated meticulously yearly. This step enables recommendations, including information on possible side effects, to be given in an optimal way.
BACKGROUND: In April 1991, an excess of bladder cancer cases among workers employed at a chemical manufacturing facility in Niagara Falls, NY, was reported. This excess was primarily confined to 708 workers who had ever been employed in the rubber chemicals manufacturing area of the plant, where the aromatic amines aniline and o-toluidine have historically been used. PURPOSE: An environmental and biological monitoring survey was conducted to evaluate current exposures to aniline and o-toluidine in the rubber chemicals department. METHODS: Personal air sampling for aniline and o-toluidine was conducted with the use of a modified Occupational Safety and Health Administration (OSHA) 73 method. Urine samples were collected before and after work (i.e., pre-shift and post-shift, respectively) and stored at -70 degrees C. Base hydrolysis was used to convert acetanilide and N-acetyl-o-toluidine, metabolites of aniline and o-toluidine present in the urine, to the parent compounds. The parent compounds were extracted from the alkaline urine into butyl chloride and then back-extracted from the butyl chloride into aqueous hydrochloric acid. An aliquot of each acidic extract was subjected to ion-interaction reversed-phase liquid chromatography with coulometric electrochemical detection. Hemoglobin (Hb) was extracted from blood and stored at -70 degrees C. For the measurement of adducts of aniline, o-toluidine, and 4-aminobiphenyl (4-ABP), precipitated Hb was dissolved in 0.1 M sodium hydroxide in the presence of recovery standards, and the hydrolysate was extracted with hexane, derivatized with pentafluoropropionic anhydride, and analyzed by gas chromatography-mass spectrometry with negative chemical ionization. RESULTS: A total of 73 workers, including 46 of 64 exposed workers who were employed in the rubber chemicals department and had the potential for exposure to aniline and o-toluidine and 27 of 52 unexposed workers employed in other departments where aniline and o-toluidine were not used or produced, had data available for both aniline and o-toluidine and Hb adducts; 28 of the workers in the former group also had personal air-sampling data. Personal air sample measurements showed that airborne concentrations of aniline and o-toluidine were well within the limits allowed in the workplace by OSHA. Urinary aniline and o-toluidine levels, however, were substantially higher among exposed workers than among unexposed control subjects. The most striking differential was for post-shift urinary o-toluidine levels, which averaged (+/- standard deviation) 2.8 micrograms/L (+/- 1.4 micrograms/L) in unexposed subjects and 98.7 micrograms/L (+/- 119.4 micrograms/L) in exposed subjects (P = .0001). Average aniline-Hb and o-toluidine-Hb adduct levels were also significantly higher (P = .0001) among exposed workers than among unexposed control subjects. Average levels of adducts to 4-ABP, a potential contaminant of process chemicals, were not significantly different (P = .48), although three exposed workers had 4-ABP levels above the range in unexposed workers. CONCLUSIONS: The adduct data suggest that, among current workers, o-toluidine exposure substantially exceeds aniline exposure and that 4-ABP exposure, if it occurs at all, is not widespread. These data support the conclusion that occupational exposure to o-toluidine is the most likely causal agent of the bladder cancer excess observed among workers in the rubber chemicals department of the plant under study, although exposures to aniline and 4-ABP cannot be ruled out.
Nonimmune hydrops fetalis can be caused by fetal chromosomal, hematologic, cardiac, or infectious conditions. A fetal blood sample obtained from percutaneous ultrasound-guided fetal blood sampling can offer vital information about the underlying cause of nonimmune hydrops fetalis, and perinatal management can be planned accordingly. Ten cases of nonimmune hydrops fetalis were investigated with percutaneous ultrasound-guided fetal blood sampling and subsequent fetal blood analysis. Nine were proved to be Bart's hemoglobin hydrops fetalis, with 78.2% to 99% of Bart's hemoglobin in the fetal blood. Terminations of pregnancy were undertaken immediately, resulting in a lowered maternal morbidity rate. Free cord loops or an intra-abdominal portion of the dilated umbilical vein can be used for percutaneous fetal blood sampling in nonimmune hydrops fetalis when the placental cord insertion is difficult to visualize. Percutaneous ultrasound-guided fetal blood sampling and subsequent fetal blood analysis will eventually play a key role in the management of the puzzling nonimmune hydrops fetalis if the safety of ultrasound-guided fetal blood sampling can be verified by further clinical studies.
The purpose of this study was to describe the epidemiology of injuries in children of adolescent mothers (< 18 years old at delivery), in Baltimore, MD, and to explore the relationship between maternal receipt of home safety information and child injury. A random sample of 363 adolescent mothers and their children were followed longitudinally by home interview at 3 and 15 months postpartum. Receipt of home safety information and information source were assessed at the 3-month interview. Injuries requiring medical attention were assessed at the 15-month interview. Sixty-eight children sustained injuries during follow-up and 14% required hospitalization. Falls and burns predominated as the cause of injury, with burns much more common in girls. The children of mothers who received home safety information from family and community-based sources by 3 months postpartum had significantly lower risk of injury during follow-up than children of mothers who had not received home safety information. As the number of information sources increased, the injury rate decreased. Further work is needed to examine the most appropriate timing, repetition, format, and content of injury prevention education.
Perfluorooctanoic acid is a completely fluorinated carboxylic acid that is usually used in the ammonium salt form as a processing aid in the production of many fluoropolymers and fluoroelastomers. Ammonium perfluorooctanoate readily dissociates in water to give the ammonium and perfluorooctanoate ions. Perfluorooctanoate has been reported to be present in low levels in human serum in the United States and Europe. This study reports on the development and validation of a method for the determination of perfluorooctanoic acid in air samples. This method uses the Occupational Safety and Health Administration (OSHA) Versatile Sampler (OVS) with a nominal 0.3 micro m filter and polystyrene resin sorbent (XAD-2 or XAD-4) followed by determination of the perfluorooctanoate anion by liquid chromatography mass spectrometry. The method was validated in the range of 0.474 to 47.4 microg/m3 for a 480-L sample. Breakthrough studies showed samples could be collected at 1 L/min for 24 hours or at 15 L/min up to 8 hours without breakthrough. Extract storage stability tests showed that sample extracts in methanol remain stable in glass autosampler vials for up to 13 days following initial injection. Perfluorooctanoic acid stability on OVS tubes was unaffected at both refrigerated and ambient temperatures. The overall average retention efficiency was 92.1% with a pooled RSD95 of 5.8% at five concentration levels (0.474 microg/m3 to 47.4 microg/m3).
A method for detection of Escherichia coli O157 in beef and poultry is presented. The method is antibody-based and uses a patented antibody-specific metal-plating procedure for the detection of E. coli O157 in enriched meat samples. Both raw ground beef and raw ground poultry were tested as matrixes for the organism. The sensitivity and specificity of the assay were 98 and 90%, respectively. The accuracy of the assay was 96%. Overall, the method agreement between the E. coli O157 Detex assay and the U.S. Department of Agriculture/Food Safety Inspection Service method was 96%. Sample temperature upon loading of the apparatus was critical to the observed false-positive rate of the system.
Nitrates and glycoalcaloids (TGA) content in mature tubers of 29 potato table cultivars of different earliness were examined during 1992-1998. Excess of nitrates (more than 250 mg NaNO3/kg of product--the upper limit for food safety in Poland) was found in 24 tuber samples what makes 16% of total number (154) tested samples. Samples with the highest amounts of nitrates belonged mainly to very early and early cultivars. TGA concentrations lower than the upper limit TGA for food safety (200 mg/kg of product) were estimated in all 129 tested tuber samples. Only in 8 samples TGA content was between 100 and 140 mg/kg of product what could cause bitter taste.
In the last years the standards for professional handling of hazardous material as well as health and safety in the veterinary practice became considerably more stringent. This is expressed in various safety regulations, particularly the decree of hazardous material and the legislative directives concerning health and safety at work. In part 1, a definition based on the law for hazardous material was given and the potential risks were mentioned. The correct documentation regarding the protection of personal and the purchase, storage, working conditions and removal of hazardous material was explained. General rules for the handling of hazardous material were described. In part 2, partial emphasis is put on the handling of flammable liquids, disinfectants, cytostatica, pressurised gases, liquid nitrogen, narcotics, mailing of potentially infectious material and safe disposal of hazardous waste. Advice about possible unrecognized hazards and references are also given.
A single-dose study and a multiple-dose study of the safety and pharmacokinetics of ruprintrivir, a new selective irreversible inhibitor of human rhinovirus 3C protease, were conducted with healthy adult volunteers. Both studies were double-blind, randomized, placebo-controlled, parallel-group investigations of ruprintrivir administered intranasally at two dose levels. The parent drug and its acid metabolite, AG7185, were measured in plasma samples and nasal washings, and the safety of the treatments was monitored. Intranasal ruprintrivir, administered as single doses of 4 and 8 mg or every 3 h, six times per day, for 7 days was safe and well tolerated. Adverse events were mild, short-lived, and confined to the upper respiratory tract (i.e., nose and throat, taste and smell perceptions). Adverse events were similar after placebo and after single or multiple doses of active drug. Systemic exposure to ruprintrivir was rarely detectable with the highest measured concentration of < or =0.52 ng/ml; the assay had a lower limit of quantification of 0.2 ng/ml. Systemic exposure to the metabolite was also low, with a highest measured concentration of 3.25 ng/ml. Concentrations of AG7185 observed during multiple dosing were higher than those observed after the first dose but were no more than predicted from the single-dose study. Substantial amounts of ruprintrivir were observed intranasally for at least 9 h after multiple doses of ruprintrivir.
OBJECTIVE: This study assessed the efficacy of instructions to drop 'safety behaviours' during exposure tasks in a cognitive-behaviour therapy (CBT) group treatment program for social phobia. METHOD: Fourteen subjects with social phobia received a standardised CBT treatment program and were compared to 16 subjects with social phobia who were given additional instructions to drop safety behaviours. RESULTS: Repeated measures of ANOVA between groups on a specific social phobia measure (SPAI) demonstrated significant benefit when instructions to drop safety behaviours were added to the treatment program. CONCLUSIONS: The addition of instruction to drop safety behaviours in exposure tasks in the course of CBT treatment for social phobia may be useful. This result supports the cognitive model of social phobia developed by Clark and Wells (1995), which postulates that anxiety and negative beliefs about social situations are in part maintained by engaging in safety behaviours. Further replication with larger samples is required and warranted on the basis of the present study.
We have established a new simultaneous positive/negative selection procedure using the Baxter Isolex 300i system. We tested its tumor cell (TC) purging efficacy by tumor contamination tests ex vivo and its safety in a group of 17 breast cancer (BC) patients by measuring hematopoietic recovery after high-dose (HD) therapy and autologous stem cell rescue with the selected cells. Tumor contamination tests resulted in a TC depletion of 4.1-6.0 log steps. The CD34+ cell yield in this experimental setting was 38.9-91.5%, and the CD34+ cell purity was 86.0-96.0%. In a group of 17 BC patients (5 high-risk adjuvant, > or = 10 lymph nodes positive, and 12 metastatic), we processed leukapheresis products (LPs) by simultaneous positive/negative selection. In these clinical samples, the mean CD34+ cell yield was 56.2% (range, 14.0-80.1%), and the CD34+ cell purity was 94.5% (range, 69.0-99.8%). Additionally, we screened samples of the patients' LPs before and after the purging procedure for contaminating TC by immunocytochemistry. In 15 of 17 tested cases, TCs were detectable prior to the purging procedure. After the procedure, we could not detect residual TCs in 16 of 17 cases. In one case, we found a highly reduced number of TCs. Furthermore, we evaluated the times for hematopoietic reconstitution in a group of five BC patients in the high-risk adjuvant situation who underwent HD chemotherapy and hematopoietic rescue with positive/negative selected stem cells and compared it with our own data from 10 BC patients who, after identical HD therapy, received only positively selected CD34+ cells and 14 patients who, after identical HD therapy, received autografts purged by incubation with toxic ether lipids (ET-18-OCH3). In all groups, a leukocyte count of >2000 cells/microl was reached at day +10. A platelet count of > 50,000 cells/microl was reached at day +12 in the ET-18-OCH3 group and at day +14 in the other two groups. Furthermore, 12 patients with metastatic disease rescued with positive/negative selected stem cells after HD therapy also showed fast and comparable hematopoietic recovery. The new simultaneous immunomagnetic positive/negative selection using a closed system is effective and safe. Processing LPs leads to a similar CD34+ cell yield, a higher TC depletion compared to standard CD34+ cell selection, and no delay in hematopoietic recovery.
Toxicological evaluation of chemicals with thresholded effects involves the estimation of their acceptable daily intakes (ADI). The following steps are involved in the evaluation: judging the completeness of the available chemical and biological data, determination of the no-effect level (NEL), selection of an appropriate safety factor, and extrapolation of the NEL to the ADI using the selected safety factor. The relative insignificance of the sample size on the NEL, the advantages of body weight (compared to the body surface) as a basis for interspecies extrapolation, the size of the safety factor as a function of the nature of the toxic effects, and the multiplicity of the toxicological investigations, in addition to the conventional short-term and long-term toxicity studies, are described. In addition, the possible inadvisability of overemphasizing the importance of dose-response relationship at the expense of in-depth, relevant studies is discussed.
A number of protocols for the cultural detection of Escherichia coli O157:H7 in clinical fecal specimens have been proposed. In the present study direct plating of cattle feces was compared to three different broth enrichment protocols, i.e., a protocol with modified E. coli broth with novobiocin, a protocol with Trypticase soy broth with cefixime and vancomycin, and a protocol with Gram-Negative Broth with novobiocin, for their relative abilities to detect E. coli O157:H7 in feces. In all enrichment protocols, dilutions of the enrichment broths onto 150-mm sorbitol-MacConkey agar plates to which cefixime and tellurite were added were used along with reading of agar plates at both 24 and 48 h. Fecal samples came from a preharvest food safety project in which feces from New York cull dairy cattle from a northeastern packing plant along with experimentally inoculated adult dairy cow feces were tested. The performances of the broth enrichments were comparable to each other, but the broth enrichments were superior to direct plating in their ability to detect E. coli O157:H7. Regardless of the culture protocol used, recovery of E. coli O157:H7 is more likely from fresh fecal specimens than from frozen samples. An overall prevalence of E. coli O157:H7 fecal shedding by New York cull dairy cattle of 1.3% was found in specimens just before processing at the packing plant.
We analyzed raw ground beef testing data to determine whether a decrease in the rate of Escherichia coli O157:H7-positive raw ground beef samples has occurred since the inception of Food Safety and Inspection Service (U.S. Department of Agriculture) regulatory actions and microbiological testing concerning this commodity and pathogen. A main effects log-linear Poisson regression model was constructed to evaluate the association between fiscal year and the rate of E. coli O157:H7-positive raw ground beef samples while controlling for the effect of season for the subset of test results obtained from fiscal year (FY)2000 through FY2003. Rate ratios were used to compare the rate of E. coli O157:H7-positive raw ground beef samples between sequential years to identify year-to-year differences. Of the 26,521 raw ground beef samples tested from FY2000 through FY2003, 189 (0.71%) tested positive for E. coli O157:H7. Year-to-year comparisons identified a 50% reduction in the rate of positive ground beef samples from FY2002 to FY2003 when controlling for season (95% CI, 10 to 72% decrease; P = 0.02). This decrease was the only significant year-to-year change in the rate of E. coli O157:H7-positive raw ground beef samples but was consistent in samples obtained from both federally inspected establishments and retail outlets. We believe this decrease is attributed to specific regulatory actions by Food Safety and Inspection Service and subsequent actions implemented by the industry, with the goal of reducing E. coli O157:H7 adulteration of raw ground beef. Continued monitoring is necessary to confirm that the decrease in the rate of E. coli O157:H7 in raw ground beef samples we observed here represents the beginning of a sustained trend.
Many residential hazards are disproportionately concentrated in older, urban dwellings and share common underlying causes, such as uncorrected moisture problems and inadequate maintenance and cleaning. Comprehensive and affordable approaches to remediation are needed, but the feasibility and efficacy of such approaches has not been well documented. To address this gap, a multihazard, multimethod intervention, addressing deteriorated lead-based paint and lead dust, vermin, mold, and safety hazards was pilot-tested in a sample of 70 pre-1940 dwellings. Dwellings received paint stabilization, dust lead cleaning, integrated pest management (IPM), mold cleaning, and safety devices, as needed. The median remediation cost for labor and materials was 864.66 dollars (range: 120.00-5235.33 dollars) per dwelling. Environmental conditions were evaluated prior to, immediately following, and an average of 5 months after remediation. Between the baseline and 5-month follow-up periods, significant reductions were achieved in the number of dwellings with multiple (i.e., three or four) problems (75% vs. 23%, P<0.0001); high levels of dust lead on floors and window sills (67% and 46% declines, P<0.01); evidence of cockroaches or rodents (43% and 36% declines, P<0.01); and fire, electrical and/or fall hazards (between 67% and 88% declines, P<0.01). Significant reductions were also observed in the geometric mean (GM) dust lead levels on floors and window sills (13.3 vs. 5.0 microg/ft2 and 210.6 vs. 81.0 microg/ft2, respectively, P<0.0001) and Blatella germanica (Blag1) levels among dwellings with elevated baseline levels (7.7 vs. 0.09 U/g, P<0.0001). Reductions in mold dust levels were of borderline statistical significance (50% decline, P=0.07). The greatest declines in dust lead and Blag1 levels occurred in dwellings having the highest baseline levels and, for Blag1, in dwellings in which occupants attended training sessions. These results indicate that a comprehensive approach to hazard remediation can be highly effective and cost efficient and that overall improvements can be maintained. Further research is needed to clarify the most effective sampling strategies, educational and behavioral interventions, and optimal intervention frequency.
A population-based cross-sectional study was conducted in Pelotas, southern Brazil, focusing on the determinants and patterns of bicycle use as a mode of commuting by workers. Accidents during commuting and use of safety equipment were also studied. The sample included 1,705 workers (> 15 years of age) living in the urban area of Pelotas and using various modes of transportation during commuting. Crude and adjusted analyses were performed using Poisson regression, taking the design effect into account. Prevalence of bicycle use was 17.2% (95%CI: 15.4%-19.0%). Male workers and those with low schooling and low income presented higher prevalence. Less than 1.0% of the bicycles featured the safety equipment required by the Brazilian Traffic Code, and 15.0% did not even have brakes. Nearly 6.0% of workers who commuted by bicycle had suffered accidents resulting in injuries during the previous 12 months. The authors conclude that bicycling workers are a priority for interventions aimed at reducing traffic accidents.