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. ^

Special report of the medical division on teletherapy design problems: Cs¹³⁷ /

AEC Report No. TID-5086 (1st REV).

Medical mycology; an introduction to its problems.

Includes bibliography.

Administration of medical care; problems and issues, based on an analysis of the medical-dental care program for the recipients of old-age assistance in the state of Washington, 1941-1945.

Mode of access: Internet.

Clinical relationships and ethical problems in primary care, Sao Paulo, SP, Brazil

Objectives: Main Objective: to identify ethical problems in primary care according to nurses` and doctors` perceptions. Secondary Objective: to know ethical issues of patient-professional relationships in primary care. Design: Synthesis to integrate and reinterpret primary results of qualitative studies. Setting: Primary healthcare centers, Sao Paulo, SP, Brazil. Participants and/or context: Incidental sample of 34 nurses and 36 medical doctors working in primary healthcare centers selected by convenience. Methods: Individual, semi-structured interviews to identity situations considered as sources of ethical problems. The sample is socially representative of primary care health centers and professionals. Data collection assured discourse saturation. Hermeneutic-dialectical discourse analysis was used to study the results. Results: Patient-professional relationships and team work were the main sources of ethical problems. The most important problems were patient information, privacy, confidentiality, interpersonal relationship, linkage and patient autonomy. These issues reflect the recent changes in clinical relation ships and show the peculiarities of primary care with its continuous care which lasts a long time. Healthcare involves multiprofessional team work in the midst of the patient claims for autonomy. Good care of patients needs requires a relationship based on communication and cooperation, and includes feelings and values, with communication skills. Conclusions: Ethical problems in primary care are common situations. For quality and humane primary care the relationship should consist of dialogue, trust and cooperation. (C) 2009 Elsevier Espana, S.L. All rights reserved.

The role of legal coercion in the treatment of offenders with alcohol and heroin problems

This article discusses the ethical justification for and reviews the American evidence on the effectiveness of; treatment for alcohol and heroin dependence that is provided under legal coercion to offenders whose alcohol and drug dependence has contributed to the commission of the offence with which they have been charged or convicted. The article focuses on legally coerced treatment for drink-driving offenders and heroin-dependent property offenders. it outlines the various arguments that have been made for providing such treatment under legal coercion, namely. the over-representation of alcohol and drug dependent persons in prison populations; the contributory causal role of alcohol and other drug problems in the offences that lead to their imprisonment; the high rates of relapse to drug use and criminal involvement after incarceration; the desirability of keeping injecting heroin users out of prisons as a way of reducing the transmission of infectious diseases such as HIV and hepatitis; and the putatively greater cost-effectiveness of treatment compared with incarceration. The ethical objections to legally coerced drug treatment are briefly discussed before the evidence on the effectiveness of legally coerced treatment for alcohol and other drug dependence is reviewed. The evidence, which is primarily from the USA, gives qualified support for some forms of legally coerced drug treatment provided that these programs are well resourced, carefully implemented, and their performance is monitored to ensure that they provide a humane and effective alternative to imprisonment. Expectations about what these programs can achieve also need to be realistic.

The Building Partnerships Program: An Approach to Community-based Learning for Medical Students in Australia

The Building Partnerships Program at the University of Queensland, Australia seeks to address the dual challenge of preparing doctors who are responsive to the community while providing a meaningful context for social sciences learning. Through partnerships with a diverse range of community agencies, the program offers students opportunities to gain non-clinical perspectives on health and illness through structured learning activities including: family visits; community agency visits and attachments; and interview training. Students learn first-hand about psychosocial influences on health and how people manage health problems on a day-to-day basis. They also gain insights into the work of community agencies and how they as future doctors might work in partnership with them to enhance patient care. We outline the main components of the program, identify challenges and successes from student and community agency perspectives, and consider areas that invite further development.

Attitudes of paediatric medical ward staff to a dog visitation programme

No previous studies regarding either structured, strictly controlled pet visitation programmes in paediatric hospital wards or hospital staff attitudes towards them have been conducted in Australia. Information regarding these is essential in order to minimize problems during implementation of such programmes. The aim of the study was to analyse hospital staff perceptions regarding the introduction of a pet visitation programme in an acute paediatric medical ward prior to and following implementation of the programme and to compare attitudes between the various professional groups. The study consisted of two cross-sectional surveys. A total of 224 anonymous questionnaires were distributed to administrators, doctors, nursing staff and therapists 6 weeks before and 195 were distributed 12 weeks after the introduction of a pet visitation programme. Responses were received from 115 respondents (before the programme introduction) and 45 respondents (after the programme introduction). Prior to the introduction of the dog visitation programme, there were high staff expectations that the programme would distract children from their illness, relax children and that it was a worthwhile project for the hospital to undertake. Following implementation of the programme these expectations were strongly endorsed, in addition to the perception that the ward was a happier place, the work environment was more interesting and that nurses accepted the dogs. After implementation staff were less concerned about the possibility of dog bites and dogs doing damage to equipment. Allied health staff and non-clinical staff were more positive about the programme with respect to ward climate and acceptance than were doctors and nurses. We conclude that well-planned dog visitation programmes result in positive anticipation among staff and high levels of satisfaction following programme impact.

Mortality problems in Brazil and in Germany: past-present-future. Learning from each other?

This article was written by a Swiss-German historical demographer after having visited different Brazilian Universities in 1984 as a guest-professor. It aims at promoting a real dialog between developed and developing countries, commencing the discussion with the question: Can we learn from each other? An affirmative answer is given, but not in the superficial manner in which the discussion partners simply want to give each other some "good advice" or in which the one declares his country's own development to be the solely valid standard. Three points are emphasized: 1. Using infant mortality in S. Paulo from 1908 to 1983 as an example, it is shown that Brazil has at its disposal excellent, highly varied research literature that is unjustifiably unknown to us (in Europe) for the most part. Brazil by no means needs our tutoring lessons as regards the causal relationships; rather, we could learn two things from Brazil about this. For one, it becomes clear that our almost exclusively medical-biological view is inappropriate for passing a judgment on the present-day problems in Brazil and that any conclusions so derived are thus only transferable to a limited extent. For another, we need to reinterpret the history of infant mortality in our own countries up to the past few decades in a much more encompassing "Brazilian" sense. 2. A fruitful dialog can only take place if both partners frankly present their problems. For this reason, the article refers with much emprasis to our present problems in dealing with death and dying - problems arising near the end of the demographic and epidemiologic transitions: the superanuation of the population, chronic-incurable illnesses as the main causes of death, the manifold dependencies of more and more elderly and really old people at the end of a long life. Brazil seems to be catching up to us in this and will be confronted with these problems sooner or later. A far-sighted discussion already at this time seems thus to be useful. 3. The article, however, does not want to conclude with the rather depressing state of affairs of problems alternatingly superseding each other. Despite the caution which definitely has a place when prognoses are being made on the basis of extrapolations from historical findings, the foreseeable development especially of the epidemiologic transition in the direction of a rectangular survival curve does nevertheless provide good reason for being rather optimistic towards the future: first in regards to the development in our own countries, but then - assuming that the present similar tendencies of development are stuck to - also in regard to Brazil.

Comparative evaluation of underlying causes of death processed by the Automated Classification of Medical Entities and the Underlying Cause of Death Selection Systems

INTRODUCTION: The correct identification of the underlying cause of death and its precise assignment to a code from the International Classification of Diseases are important issues to achieve accurate and universally comparable mortality statistics These factors, among other ones, led to the development of computer software programs in order to automatically identify the underlying cause of death. OBJECTIVE: This work was conceived to compare the underlying causes of death processed respectively by the Automated Classification of Medical Entities (ACME) and the "Sistema de Seleção de Causa Básica de Morte" (SCB) programs. MATERIAL AND METHOD: The comparative evaluation of the underlying causes of death processed respectively by ACME and SCB systems was performed using the input data file for the ACME system that included deaths which occurred in the State of S. Paulo from June to December 1993, totalling 129,104 records of the corresponding death certificates. The differences between underlying causes selected by ACME and SCB systems verified in the month of June, when considered as SCB errors, were used to correct and improve SCB processing logic and its decision tables. RESULTS: The processing of the underlying causes of death by the ACME and SCB systems resulted in 3,278 differences, that were analysed and ascribed to lack of answer to dialogue boxes during processing, to deaths due to human immunodeficiency virus [HIV] disease for which there was no specific provision in any of the systems, to coding and/or keying errors and to actual problems. The detailed analysis of these latter disclosed that the majority of the underlying causes of death processed by the SCB system were correct and that different interpretations were given to the mortality coding rules by each system, that some particular problems could not be explained with the available documentation and that a smaller proportion of problems were identified as SCB errors. CONCLUSION: These results, disclosing a very low and insignificant number of actual problems, guarantees the use of the version of the SCB system for the Ninth Revision of the International Classification of Diseases and assures the continuity of the work which is being undertaken for the Tenth Revision version.

American cutaneous leishmaniasis: presentation and problems of patient management

We report our experience with the diagnosis and treatment of 60 patients with American cutaneous leishmaniasis. They were infected in Panama (55), Brazil (4) or Colombia (I). Among 35 patients with a 3 week exposure in Panama, the mean maximum incubation period was 33 days (range 4-81 days). Diagnosis was delayed an average of 93 days after onset of skin lesions, due to the patient's delay in seeking medical attention (31 days), medical personnel's delay in considering the diagnosis (45 days), and the laboratory's delay in confirming the diagnosis (17 days). Forty-four patients (73%) developed ulcers typical of cutaneous leishmaniasis. Sixteen additional patients (27%) had atypical macular, papular, squamous, verrucous or acneiform skin lesions that were diagnosed only because leishmanial cultures were obtained. Of the 59 patients treated with pentavalent antimonial drugs, only 34 (58%) were cured after the first course of treatment. Lesions which were at least 2 cm in diameter, ulcerated, or caused by Leishmania braziliensis were less likely to be cured after a single course of treatment than were lesions smaller than 2 cm, nonulcerated or caused by Leishmania mexicana or Leishmania donovani.

Problems and perspectives for Chagas disease control: in search of a realistic analysis

Chagas disease was an important medical and social problem in almost all of Latin America throughout the twentieth century. It has been combated over a broad swath of this continent over recent decades, with very satisfactory results in terms of vector and transfusional transmission. Today, a surveillance stage still remains to be consolidated, in parallel with appropriate care required for some millions of infected individuals who are today living in endemic and non-endemic areas. Contradictorily, the good results attained have generated excessive optimism and even disregard among health authorities, in relation to this disease and its control. The loss of visibility and priority may be a logical consequence, particularly in Latin American healthcare systems that are still disorganized and overburdened due to insufficiencies of financial and human resources. Consolidation of the victories against Chagas disease is attainable but depends on political will and continual attention from the most consequential protagonists in this struggle, especially the Latin American scientific community.

The general practitioner and the surgeon: stereotypes and medical specialties

OBJECTIVE: To investigate and characterize the professional stereotypes associated with general medicine and surgery among Brazilian medical residents. METHODS: A randomized sample of residents of the General Medicine and Surgery Residence Programs were interviewed and their perceptions and views of general and surgical doctors were compared. RESULTS: The general practitioner was characterized by the residents in general to be principally a sensitive and concerned doctor with a close relationship with the patient; (45%); calm, tranquil, and balanced (27%); with intellectual skills (25%); meticulous and attentive to details (23%); slow to resolve problems and make decisions (22%); and working more with probabilities and hypotheses (20%). The surgeon was considered to be practical and objective (40%); quickly resolving problems (35%); technical with manual skills (23%); omnipotent, arrogant, and domineering (23%); anxious, stressed, nervous, and temperamental (23%); and more decided, secure, and courageous (20%). Only the residents of general medicine attributed the surgeon with less knowledge of medicine and only the surgeons attributed gender characteristics to their own specialty. CONCLUSION: There was considerable similarity in the description of a typical general practitioner and surgeon among the residents in general, regardless of the specialty they had chosen. It was interesting to observe that these stereotypes persist despite the transformations in the history of medicine, i.e. the first physicians (especially regarding the valorization of knowledge) and the first surgeons, so-called "barber surgeons" in Brazil (associated with less knowledge and the performance of high-risk procedures).

Does readiness to change predict subsequent alcohol consumption in medical inpatients with unhealthy alcohol use?

We studied whether readiness to change predicts alcohol consumption (drinks per day) 3 months later in 267 medical inpatients with unhealthy alcohol use. We used 3 readiness to change measures: a 1 to 10 visual analog scale (VAS) and two factors of the Stages of Change Readiness and Treatment Eagerness Scale: Perception of Problems (PP) and Taking Action (TA). Subjects with the highest level of VAS-measured readiness consumed significantly fewer drinks 3 months later [Incidence rate ratio (IRR) and 95% confidence interval (CI): 0.57 (0.36, 0.91) highest vs. lowest tertile]. Greater PP was associated with more drinking [IRR (95%CI): 1.94 (1.02, 3.68) third vs. lowest quartile]. Greater TA scores were associated with less drinking [IRR (95%CI): 0.42 (0.23, 0.78) highest vs. lowest quartile]. Perception of Problems' association with more drinking may reflect severity rather than an aspect of readiness associated with ability to change; high levels of Taking Action appear to predict less drinking. Although assessing readiness to change may have clinical utility, assessing the patient's planned actions may have more predictive value for future improvement in alcohol consumption.

Zerebrale Probleme in der pädiatrischen Intensivmedizin [Cerebral problems in pediatric intensive care]

This paper presents a review of different methods enabling the monitoring of cerebral function in neonatal and paediatric intensive care. EEG, evoked potentials, conventional radiological studies, computerized tomography, ultrasound, intracranial pressure measurements, nuclear magnetic resonance, Doppler ultrasound, radioisotope studies, angiography, infra-red spectral analysis and last, but not least, clinical examination produce information regarding the neurological state of the patient which must be critically analysed in order to ensure optimal management of the case. Unfortunately, and in spite of impressive progress in non-invasive monitoring of the cerebral function, we are still forced to make important medical and ethical decisions without precise information about the neurological state of our patients.