International Journal of Risk & Safety in Medicine - Volume 2, issue 2-3
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: The physician's liability in Danish law is based on negligence, which is assessed by the courts largely on the basis of expert opinions. Such opinions are provided primarily by the Medico-Legal Council rather than by experts selected by the parties. The evaluation of negligence is based on a “reasonable man” standard and the performance expected of a competent colleague; a hospital will be responsible for the negligence of its employees. The burden of proof generally lies with the plaintiff; negligence will not be presumed and the assessment of the evidence of negligence will be adapted to the individual situation, e.g.…factors such as the degree of specialization involved, the time which the physician had at his disposal to make his decision and the resources available to him will be taken into consideration. The courts have shown themselves willing to allow for the fact that doctors differ, i.e. recognizing that there must be scope for reasonable discretion. Because the culpa principle is central, the standard applied to medical knowledge will be that which pertained at the time of the treatment. Where a non-specialist is confronted with a problem which may go beyond the knowledge of his limits and experience, he is under an obligation to refer the patient. The principle of informed consent to treatment is accepted in Danish law, but such consent will readily be considered to have been given tacitly.
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Keywords: Professional liability, Physician, Denmark
Abstract: The concept of “risk management” originally entered medicine in the United States from the insurance world as a consequence of the medical malpractice crisis. With the realization that much negligence-related injury in health care can be avoided, a positive concept of risk management has developed, complemented by a methodical approach to quality assurance. Risk management and quality assurance differ in their focus and methods, but they have in common the objective of identifying and eliminating risk factors and ensuring adequate standards of patient care. If risk management activities are to be fully accepted by health professionals it is important that…the latter be taught to understand that the process is not a witch-hunt but a genuine attempt to learn from errors and thereby improve the standard of practice.
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Keywords: Risk management, Medical care, Quality assurance, Definitions
Abstract: During the last 25 years, medical negligence claims in the United Kingdom have become increasingly frequent and problematical. In 1990, the Department of Health announced that district health authorities would assume vicarious liability for negligent acts by doctors in the course of their work for the National Health Service. A study of claims closed in the region covered by one Regional Health Authority shows that over a five-year period there were 7.8 claims per 100,000 population, levels in some other Regions ranging from 4.5 to 20.5 claims per 100,000, with a progressive increase. Obstetrics/Gynaecology and Anaesthetics are prominent areas for…claims. It has been suggested that by the mid 1990s some 12% of the United Kingdom's National Health Service Budget might be absorbed in indemnity payments. Negligence litigation provides signals to health care providers about where they should invest in risk reduction rather than in bearing the cost of successful claims. At the national level it can be of value to create computerized data bases' of medical mishaps. Among the various types of activity which seem more practicable and worth exploring at the local level are the positive development of a “culture of safety” in health care, the creation of risk management teams to examine and document medical misadventure, and the establishment of health care organizations which do not feel threatened by their failures but which can respond in a caring, compassionate and concerned fashion to patients' distress and deal fairly with economic losses.
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Keywords: Medical negligence claims, survey, United Kingdom, Remedial measures
Abstract: An analysis of 100 British cases of alleged medical negligence in the field of orthopaedics and trauma surgery shows that failure to take or to interpret an X-ray was the essence of the largest group of cases. Immediate settlement was advised in 56 cases, the majority of which involved errors made by junior hospital doctors and would have been avoided had a consultant been involved. Faults made in accident and emergency departments related largely to failure to refer the patient to other hospital departments for further management and follow up. Both diagnostic and operative errors were represented in the group.…A retrospective study such as this provides some important lessons, relating particularly to situations justifying the use of antibiotics, the need for selective referral, the taking and interpretation of X-rays, and above all to the value of establishing rules to ensure sufficient involvement of consultants.
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Abstract: When seeking a patient's informed consent to surgery, it is necessary to ensure that the extent of risk is explained, that the most common risks are described, and that the information given is recorded. Errors in performance of an agreed operation tend to be under-reported; acceptance of guidelines can reduce their incidence but will not eliminate them, and it is vital to deal understandingly with those which do occur.
Keywords: Surgery, Informed consent, Management of errors
Abstract: In the United Kingdom, claims relating to obstetrics and gynaecology account for a quarter of all medico-legal costs. Obstetric claims are relatively few, but damages awarded are high, partly because of the nature of the injuries suffered, such as brain damage to the infant. Claims often arise very late, and it is therefore advisable to keep obstetric records for long periods. In gynaecology by contrast, claims are more numerous but damages and legal costs are lower. The solutions to these problems must lie in well-conducted practice, sufficient involvement of senior specialists (with proper supervision of more junior staff) and the…keeping of good records. More basically one will have to strive for a society in which these issues are dealt with in a less adversarial manner.
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Abstract: When medical negligence claims in the fields of obstetrics and gynaecology are retrospectively analyzed, a distinction must be drawn between the categories of claims most likely to be submitted and those categories most likely to succeed. Although some types of injury may be difficult to avoid, too many successful claims are found to relate to medical acts and omissions which with due care could have been avoided. A programme of risk management should concentrate on improved communication with patients (including the correct transmission and assimilation of data), better counselling (including the advice and information underlying informed consent), measures to…ensure clinical competence (including caution in delegation to juniors and wider use of referral to senior staff) and the enforcement of well-devised rules for the maintenance of patient records.
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Keywords: Risk management, Communication, Patient consent, Clinical competence, Case records
Abstract: Retrospective assessment of claims handled in recent years by the Medical Defence Union in the United Kingdom underlines the fact that administrative negligence in the health services as well as claims relating to nursing and midwifery were not less prominent than claims relating to purely clinical fault. However, more systematic study is needed, not merely of actual claims and injuries but also of faults in any part of the health care system which could have led to injury, irrespective of whether or not they actually did so. Such investigations, including enquiry into causal factors, will be an essential element in…raising the awareness of health care staff to the possibility of inadvertent harm and in developing means to avoid and limit injury. On present evidence the prospects for an improvement in the overall situation and in a reduction in claims seem promising.
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Keywords: Risk assessment, Risk management, Health services
Abstract: Since dialysis was introduced thirty years ago, nephrologists have sought to diversify treatment strategies with the double aim of offering patients better psychosocial rehabilitation and containing the cost of treatment; this latter aim has been the cornerstone of development in haemodialysis, which in western countries now offers access to treatment for all patients with chronic renal insufficiency. The risk to life during a dialysis session is currently very small indeed. Such fatalities as do occur reflect on the one hand on various medical complications, the incidence of which is largely predictable because of the field involved, and on the other…hand on unforeseeable accidents which are highly exceptional. We consider that the risk is not significantly higher in the absence of a physician (as in extra-hospital dialysis procedures) or a nurse (as in home dialysis) than where treatment is given in a fully equipped dialysis centre, provided that there is a prior selection of patients both with respect to their age and their extra-renal pathology.
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Keywords: Haemodialysis centres, Extra-hospital dialysis, Limited-care dialysis, Home dialysis
Abstract: Editorial Note: Safety standards for hospital and medical electrical equipment are – or should be – an issue on which international change greatly accelerates progress. In the first issue of this Journal, Reidar Karlsen provided a Norwegian approach to the quality dilemma where medical devices are concerned, and in the second issue Cornelis van Gruting provided an analysis of public policies in the field. In this issue, we examine a complementary topic: the safety of electrical equipment as a whole in hospitals and clinics. The paper is published simultaneously in the Canadian Medical Association Journal and appears here with…the permission of the Canadian Medical Association.
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Keywords: Safety standards, Electrical equipment in hospitals