Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Benchmark problems for reactive transport modeling of the generation and attenuation of acid rock drainage

Acid rock drainage (ARD) is a problem of international relevance with substantial environmental and economic implications. Reactive transport modeling has proven a powerful tool for the process-based assessment of metal release and attenuation at ARD sites. Although a variety of models has been used to investigate ARD, a systematic model intercomparison has not been conducted to date. This contribution presents such a model intercomparison involving three synthetic benchmark problems designed to evaluate model results for the most relevant processes at ARD sites. The first benchmark (ARD-B1) focuses on the oxidation of sulfide minerals in an unsaturated tailing impoundment, affected by the ingress of atmospheric oxygen. ARD-B2 extends the first problem to include pH buffering by primary mineral dissolution and secondary mineral precipitation. The third problem (ARD-B3) in addition considers the kinetic and pH-dependent dissolution of silicate minerals under low pH conditions. The set of benchmarks was solved by four reactive transport codes, namely CrunchFlow, Flotran, HP1, and MIN3P. The results comparison focused on spatial profiles of dissolved concentrations, pH and pE, pore gas composition, and mineral assemblages. In addition, results of transient profiles for selected elements and cumulative mass loadings were considered in the intercomparison. Despite substantial differences in model formulations, very good agreement was obtained between the various codes. Residual deviations between the results are analyzed and discussed in terms of their implications for capturing system evolution and long-term mass loading predictions.

The relationship between enterotoxigenic {\it Escherichia coli\/} infection and environmental risk factors in Bilbeis, Egypt, 1981--1983

Diarrheal disease associated with enterotoxigenic Escherichia coli (ETEC) infection is one of the major public health problems in many developing countries, especially in infants and young children. Because tests suitable for field laboratories have been developed only relatively recently, the literature on the environmental risk factors associated with ETEC is not as complete as for many other pathogens or for diarrhea of unspecified etiology.^ Data from a diarrheal disease surveillance project in rural Egypt in which stool samples were tested for a variety of pathogens, and in which an environmental questionnaire was completed for the same study households, provided an opportunity to test for an association between ETEC and various risk factors present in those households. ETEC laboratory-positive specimens were compared with ETEC laboratory-negative specimens for both symptomatic and asymptomatic children less than three years of age at the individual and household level using a case-comparison design.^ Individual children more likely to have LT infection were those who lived in HHs that had cooked food stored for subsequent consumption at the time of the visit, where caretakers used water but not soap to clean an infant after a diarrheal stool, and that had an indoor, private water source. LT was more common in HHs where the caretaker did not clean an infant with soap after a diarrheal stool, and where a sleeping infant was not covered with a net. At both the individual and HH level, LT was significantly associated with good water supply in terms of quantity and storage.^ ST was isolated more frequently at the individual level where a sleeping infant was covered with a net, where large animals were kept in or around the house, where water was always available and was not potable, and where the water container was not covered. At the HH level, the absence of a toilet or latrine and the indiscriminate disposal of animal waste decreased risk. Using animal feces for fertilizer, the presence of large animals, and poor water quality were associated with ST at both the individual and HH level.^ These findings are mostly consistent with those of other studies, and/or are biologically plausible, with the obvious exception of those from this study where poorer water supplies are associated with less infection, at least in the case of LT. More direct observation of how animal ownership and feces disposal relates to different types of water supply and usage might clarify mechanisms through which some ETEC infection could be prevented in similar settings. ^

STRATEGIES FOR THE TRANSFER OF APPROPRIATE TECHNOLOGY TO DEVELOPING COUNTRIES: THE IMPLEMENTATION AND DEVELOPMENT OF ENVIRONMENTAL HEALTH PROGRAMS IN TUNISIA

This dissertation focuses on Project HOPE, an American medical aid agency, and its work in Tunisia. More specifically this is a study of the implementation strategies of those HOPE sponsored projects and programs designed to solve the problems of high morbidity and infant mortality rates due to environmentally related diarrheal and enteric diseases. Several environmental health programs and projects developed in cooperation with Tunisian counterparts are described and analyzed. These include (1) a paramedical manpower training program; (2) a national hospital sanitation and infection control program; (3) a community sewage disposal project; (4) a well reconstruction project; and (5) a solid-waste disposal project for a hospital.^ After independence, Tunisia, like many developing countries, encountered several difficulties which hindered progress toward solving basic environmental health problems and prompted a request for aid. This study discusses the need for all who work in development programs to recognize and assess those difficulties or constraints which affect the program planning process, including those latent cultural and political constraints which not only exist within the host country but within the aid agency as well. For example, failure to recognize cultural differences may adversely affect the attitudes of the host staff towards their work and towards the aid agency and its task. These factors, therefore, play a significant role in influencing program development decisions and must be taken into account in order to maximize the probability of successful outcomes.^ In 1969 Project HOPE was asked by the Tunisian government to assist the Ministry of Health in solving its health manpower problems. HOPE responded with several programs, one of which concerned the training of public health nurses, sanitary technicians, and aids at Tunisia's school of public health in Nabeul. The outcome of that program as well as the strategies used in its development are analyzed. Also, certain questions are addressed such as, what should the indicators of success be, and when is the time right to phase out?^ Another HOPE program analyzed involved hospital sanitation and infection control. Certain generic aspects of basic hospital sanitation procedures were documented and presented in the form of a process model which was later used as a "microplan" in setting up similar programs in other Tunisian hospitals. In this study the details of the "microplan" are discussed. The development of a nation-wide program without any further need of external assistance illustrated the success of HOPE's implementation strategies.^ Finally, although it is known that the high incidence of enteric disease in developing countries is due to poor environmental sanitation and poor hygiene practices, efforts by aid agencies to correct these conditions have often resulted in failure. Project HOPE's strategy was to maximize limited resources by using a systems approach to program development and by becoming actively involved in the design and implementation of environmental health projects utilizing "appropriate" technology. Three innovative projects and their implementation strategies (including technical specifications) are described.^ It is advocated that if aid agencies are to make any progress in helping developing countries basic sanitation problems, they must take an interdisciplinary approach to progrm development and play an active role in helping counterparts seek and identify appropriate technologies which are socially and economically acceptable. ^

AN INVESTIGATION OF THE EFFECT OF FORMALDEHYDE SPECIES ON ENVIRONMENTAL MEASUREMENT METHODS UNDER AMBIENT CONDITIONS

Species variations in formaldehyde solutions and gases were investigated by means of infrared spectral analysis. Double beam infrared spectrometry in conjunction with sodium chloride wafer technique and solvent compensation technique were employed. Formaldehyde species in various solutions were investigated. Formalin 37% was stable for many months. Refrigeration had no effects on its stability. Spectral changes were detected in 1000 ppm formaldehyde solutions. The absorbances of very diluted solutions up to 100 ppm were lower than the detection limit of the instruments. Solvent compensation improved resolution, but was associated with an observed lack of repeatability. Formaldehyde species in animal chambers containing animals and in mobile home air were analyzed with the infrared spectrophotometer equipped with a 10 cm gas cell. Spectra were not different from the spectrum of clean air. A portable single beam infrared spectrometer with a 20 meter pathlength was used for reinvestigation. Indoor formaldehyde could not be detected in the spectral; conversely, an absorption peak at 3.58 microns was found in the spectra of 3 and 15 ppm formaldehyde gas in animal chambers. This peak did not appear in the spectrum of the control chamber. Because of concerns over measurement bias among various analytical methods for formaldehyde, side-by-side comparisons were conducted in both laboratory and field measurements. The chromotropic acid method with water and 1% sodium bisulfite as collection media, the pararosaniline method, and a single beam infrared spectrometer were compared. Measurement bias was elucidated and the extent of the effects of temperature and humidity was also determined. The problems associated with related methods were discussed. ^

Long-term environmental time series of continuously collected data in hydroelectric reservoirs in Brazil

Long-term environmental time series of continuously collected data are fundamental to identify and classify pulses and determine their role in aquatic systems. This paper presents a web based archive for limnological and meteorological data collected by integrated system for environmental monitoring (SIMA). The environmental parameters that are measured by SIMA are: chlorophyll-a (µg/L), water surface temperature (ºC), water column temperature by a thermistor string (ºC), turbidity (NTU), pH, dissolved oxygen concentration (mg/L), electric conductivity (µS/cm), wind speed (m/s) and direction (º), relative humidity (%), short wave radiation (W/m**2), barometric pressure (hPa). The data are collected in preprogrammed time interval (1 hour) and are transmitted by satellite in quasi-real time for any user in a range of 2500 km from the acquisition point. So far 11 hydroelectric reservoirs being monitored using the SIMA buoy. A basic statistics (mean and standard deviation) for some parameters and an example of time series were displayed. The main observed problem are divided into sensors and satellite. The sensors problems is due to the environmental characteristics of each water body. In acid waters the sensors of water quality rapidly degrade, and the collected data are invalid. Another problem is the infestation of periphyton in the sensor. SIMA buoy makes the parameters readings every hour, or 24 readings per day. However, not always received all readings because the system requires satellites passing over the buoy antenna to complete the transfer and due to the satellite constellation position, some locations inland are not met as often as necessary to complete all transmissions. This is the more often causes for lack in the time series.

Practical case with regard to applying the functional and environmental method to low crest level, detached breakwaters

The research work as presented in this article covers the design of detached breakwaters since they constitute a type of coastal defence work with which to combat many of the erosion problems found on beaches in a stable, sustainable fashion. The main aim of this work is to formulate a functional and environmental (but not structural) design method, enabling the fundamental characteristics of a detached breakwater to be defined as a function of the effect it is wished to induce on the coast, and taking into account variables of a different nature (climate, geomorphology and geometry) influencing the changes the shoreline undergoes after its construction. With this article, it is intended to submit the final result of the investigation undertaken, applying the detached breakwater design method as developed to solving a practical case. Thus it may be shown how the method enables a detached breakwater’s geometric pre-sizing to be tackled at a place on the coast with certain climate, geomorphology and littoral dynamic characteristics, first setting the final state of equilibrium it is wanted to obtain therein after its construction.

An example of integration between en economic and an hydrologic model in the framework of water resource management problems

Growing scarcity, increasing demand and bad management of water resources are causing weighty competition for water and consequently managers are facing more and more pressure in an attempt to satisfy users? requirement. In many regions agriculture is one of the most important users at river basin scale since it concentrates high volumes of water consumption during relatively short periods (irrigation season), with a significant economic, social and environmental impact. The interdisciplinary characteristics of related water resources problems require, as established in the Water Framework Directive 2000/60/EC, an integrated and participative approach to water management and assigns an essential role to economic analysis as a decision support tool. For this reason, a methodology is developed to analyse the economic and environmental implications of water resource management under different scenarios, with a focus on the agricultural sector. This research integrates both economic and hydrologic components in modelling, defining scenarios of water resource management with the goal of preventing critical situations, such as droughts. The model follows the Positive Mathematical Programming (PMP) approach, an innovative methodology successfully used for agricultural policy analysis in the last decade and also applied in several analyses regarding water use in agriculture. This approach has, among others, the very important capability of perfectly calibrating the baseline scenario using a very limited database. However one important disadvantage is its limited capacity to simulate activities non-observed during the reference period but which could be adopted if the scenario changed. To overcome this problem the classical methodology is extended in order to simulate a more realistic farmers? response to new agricultural policies or modified water availability. In this way an economic model has been developed to reproduce the farmers? behaviour within two irrigation districts in the Tiber High Valley. This economic model is then integrated with SIMBAT, an hydrologic model developed for the Tiber basin which allows to simulate the balance between the water volumes available at the Montedoglio dam and the water volumes required by the various irrigation users.

The role of rehabilitation of building in the urban integration, social cohesion and environmental responsibility

In the framework ofthe National Research Plan2008-2011, our research poses estrategy for the design and evaluation of plans and programmes of urban integrated regeneration. The objective is to develop a study on the role of rehabilitation of buildings in concepts like urban integration, social cohesion and environmental responsibility. The research proposes a methodological tool for evaluating urban regeneration processes from a holistic perspective that can serve as a guide for governments and technical teams to address intervention in consolidated urban areas with physical and socio-economic problems. The development of the tool has inevitably led to delve into different areas where you can intervene but has not lost sight of the complex interplay of factors involved in the process.It is an open source tool to visualize Urban Integrated Rehabilitation processes.

The environmental and economic effects of innovative measures in urban parcels delivery

The main scope of this research is to identify and evaluate solutions to redesign the parcels delivery logistic process to achieve higher level of quality, lower operational costs, energy consumptions and air pollution. The study is starting from the analysis of the delivery process managed by a leader company operating in Rome. Main delivery flows, personnel and fleet management costs, quality performances and environmental impacts are investigated. The results of this analysis are benchmarked with other European situations. On the basis of the feedback of this analysis, a set of operational measures, potentially able tackle the objectives, are identified and assessed by means of a simulative approach. The assessment is based on environmental and economic indicators allowing the comparison between new and reference scenarios from the viewpoints of the key players: operator, customer and Society. Moreover, the operational measures are combined into alternative packages by looking for the sets capable to maximize the benefits for the key players. The methodology, tested on Rome case study, is general and flexible enough to be extended to parcels delivery problem in different urban contexts, as well as to similar urban distribution problems (e.g. press, food, security, school)

Environmental Wireless Sensor Network Deployment in Food Industry: from Theory to Practice

The difficulty behind Wireless Sensor Network deployments in industrial environments not only resides in the number of nodes or the communication protocols but also in the real location of the sensor nodes and the parameters to be monitored. Sensor soiling, high humidity and unreachable locations, among others, make real deployments a very difficult task to plan. Even though it is possible to find myriad approaches for floor planners and deployment tools in the state of the art, most of these problems are very difficult to model and foresee before actually deploying the network in the final scenario. This work shows two real deployments in food factories and how their problems are found and overcome.

Plasma Spectroscopic Techniques Applied to Biological and Environmental Matrices

The purpose of this research was to apply the use of direct ablation plasma spectroscopic techniques, including spark-induced breakdown spectroscopy (SIBS) and laser-induced breakdown spectroscopy (LIBS), to a variety of environmental matrices. These were applied to two different analytical problems. SIBS instrumentation was adapted in order to develop a fieldable monitor for the measurement of carbon in soil. SIBS spectra in the 200 nm to 400 nm region of several soils were collected, and the neutral carbon line (247.85 nm) was compared to total carbon concentration determined by standard dry combustion analysis. Additionally, Fe and Si were evaluated in a multivariate model in order to determine their impacts on the model's predictive power for total carbon concentrations. The results indicate that SIBS is a viable method to quantify total carbon levels in soils; obtaining a good correlation between measured and predicated carbon in soils. These results indicate that multivariate analysis can be used to construct a calibration model for SIBS soil spectra, and SIBS is a promising method for the determination of total soil carbon. SIBS was also applied to the study of biological warfare agent simulants. Elemental compositions (determined independently) of bioaerosol samples were compared to the SIBS atomic (Ca, Al, Fe and Si) and molecular (CN, N2 and OH) emission signals. Results indicate a linear relationship between the temporally integrated emission strength and the concentration of the associated element. Finally, LIBS signals of hematite were analyzed under low pressures of pure CO2 and compared with signals acquired with a mixture of CO2, N2 and Ar, which is representative of the Martian atmosphere. This research was in response to the potential use of LIBS instrumentation on the Martian surface and to the challenges associated with these measurements. Changes in Ca, Fe and Al lineshapes observed in the LIBS spectra at different gas compositions and pressures were studied. It was observed that the size of the plasma formed on the hematite changed in a non-linear way as a function of decreasing pressure in a CO2 atmosphere and a simulated Martian atmosphere.

A study of vegetation problems associated with refuse landfills /

Mode of access: Internet.

Read this if you plan to breathe this summer : advisory for those with asthma & breathing problems and for children, older adults, and people who work outdoors.

Mode of access: Internet.