Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jan 2015
[Patient safety in Sweden].
This article describes the patient safety work in Sweden and the cooperation between the Nordic countries in the area of patient safety. It depicts the national infrastructure, methods and partners in patient safety work as well as the development in key areas. Since 2000, the interest in patient safety and quality issues has significantly increased. ⋯ The Nordic collaboration in this field currently focuses on the development of indicators and quality measurement with respect to nosocomial infections, harm in inpatient somatic care, patient safety culture, hospital mortality and polypharmacy in the elderly. The Nordic collaboration is driven by the development, exchange and documentation of experiences and evidence on patient safety indicators. The work presented in this article is only a part of the Swedish and the Nordic efforts related to patient safety and provides an interesting insight into how this work can be carried out.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jan 2015
[Systemic error analysis as a key element of clinical risk management].
Systemic error analysis plays a key role in clinical risk management. This includes all clinical and administrative activities which identify, assess and reduce the risks of damage to patients and to the organization. The clinical risk management is an integral part of quality management. ⋯ It focuses on the analysis of the following contributory factors: patient factors, task and process factors, individual factors, team factors, occupational and environmental factors, psychological factors, organizational and management factors and institutional context. Organizations can only learn from mistakes by analyzing these factors systemically and developing appropriate corrective actions. This article describes the fundamentals and implementation of the method at the University Medical Center Hamburg-Eppendorf.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Dec 2014
[Safe reprocessing of medical devices with a view of the entire process chain. Recommendations of the VDI 5700 guidelines].
The reprocessing of medical devices for low pathogen or sterile use is in itself potentially risky even though the aim of reprocessing is the avoidance of hygienic or technically functional risks. The methodological principles of risk management for medical devices are described in the standard DIN EN ISO 14971. ⋯ The aim was a practical combination of the normative risk management methodology with the process-oriented KRINKO/BfArM recommendations, which has provided an interdisciplinary group of experts moderated by the Association of German Engineers (VDI). The main contents of the VDI 5700 guidelines on "hazards associated with the reprocessing--risk management in the reprocessing of medical devices--measures for risk control" and the process of the development of these guidelines is described.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Dec 2014
[Future trend medical apps. From the apps store directly into medical practice?].
In day to day medical care, patients, nursing staff and doctors currently face a bewildering and rapidly growing number of health-related apps running on various "smart" devices and there are also uncountable possibilities for the use of such technology. Concerning regulation, a risk-based approach is applied for development and use (including safety and security considerations) of medical and health-related apps. Considering safety-related issues as well as organizational matters, this is a sensible approach but requires honest self-assessment as well as a high degree of responsibility, networking and good quality management by all those involved. ⋯ This can for example result in unwanted advertising or unauthorized access to the stored data by third parties; therefore, local, regional and international regulatory measures need to be applied in order to ensure safe use of medical apps in all possible areas, including the operating room (OR) with its highly specialized demands. Lawmakers need to include impulses from all stakeholders in their considerations and this should include input from existing private initiatives that already deal with the use and evaluation of apps in a medical context. Of course, this process needs to respect pre-existing national, European as well as international (harmonized) standards.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Nov 2014
Randomized Controlled Trial Multicenter StudyCollection of vaccination data in the German National Cohort : Findings of a feasibility study in three study centers.
Data about the vaccination status of participants are required in epidemiological cohort studies whenever infection or immunity is considered as potential exposure or outcome. Within Pretest 2 of the German National Cohort (GNC) we therefore investigated the acceptance and feasibility of extracting vaccination status from vaccination certificates provided by the participants of the study. ⋯ The reliable documentation of vaccinations within the context of the GNC proved to be feasible and thus recommendable at a large scale within the GNC as participants showed high willingness and compliance in providing available vaccination documents. An additional validation by means of documents provided by physicians seems to be possible for more than a quarter of participants. In order to maximize the likelyhood of participants' of bringing their vaccination certificates it would be sufficient to send a reminder card together with the appointment letter.