Challenges Associated with the Safety Signal Detection Process for Medical Devices.

BACKGROUND: Previous safety issues involving medical devices have stressed the need for better safety signal detection. Various European Union (EU) national competent authorities have started to focus on strengthening the analysis of vigilance data. Consequently, article 90 of the new EU regulation states that the European Commission shall put in place systems and processes to actively monitor medical device safety signals. METHODS: A systematic literature review was conducted to synthesize the current state of knowledge and investigate the present tools used for medical device safety signal detection. An electronic literature search was performed in Embase, Medline, Cochrane, Web of science, and Google scholar from inception until January 2017. Articles that included terms related to medical devices and terms associated with safety were selected. A further selection was based on the abstract review. A full review of the remaining articles was conducted to decide on which articles finally to consider relevant for this review. Completeness was assessed based on the content of the articles. RESULTS: Our search resulted in a total of 20,819 articles, of which 24 met the inclusion criteria and were subject to data extraction and completeness scoring. A wide range of data sources, especially spontaneous reporting systems and registries, used for the detection and assessment of product problems and patient harms associated with the use of medical devices, were studied. Coding is remarkably heterogeneous, no agreement on the preferred methods for signal detection exists, and no gold standard for signal detection has been established thus far. CONCLUSION: Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to signal detection. The new safety surveillance system will be able to use real-world evidence to support regulatory decision-making across all jurisdictions.

Methodological complexities and the use of GIS in conducting a community needs assessment of a large U.S. municipality.

Reliable assessment of health and social needs within a community ensures that local input drives strategic planning and programmatic decisions. Results are used to determine the priorities and focus of local public health departments and to support the activities of health and social service agencies. We utilized a geographic information system in the planning, administration, and analysis of a recent community needs assessment to ensure a reliable and randomly distributed sample of a diverse urban population and to allow for small geographic area analysis of disease prevalence data. Collection of location data at the time of the 3,361 face-to-face assessment interviews allowed for the association of spatial data with measures of health conditions and behaviors. Results of the assessment indicated a need for public health programs designed to address emerging public health concerns in the community. Incorporating a spatial component in analyses of morbidity and needs assessment data allows for efficient integration of demographic and socio-economic census data and permits ad hoc analyses of varied and changing geographic strata.

Assessment of physician preparedness and response capacity to bioterrorism or other public health emergency events in a major metropolitan area.

BACKGROUND: The role of physicians in the detection, reporting, and response to infectious disease outbreaks, anomalous biologic events, or other public health emergencies is critical to the community's safety. OBJECTIVE/METHOD: In an effort to assess the level of preparedness of local physicians to respond to such events, the City of Fort Worth Public Health Department, the Fort Worth/Tarrant County Health Authority, and the Tarrant County Medical Society collaborated in designing and administering a cross-sectional study in spring 2006. RESULTS: The results serve as a baseline of the local clinical community's preparedness, with 91% of local physicians reporting their knowledge as "fair-poor," 80% desiring more information, and 83% favoring more training opportunities. CONCLUSION: Information obtained through this assessment is used to help cultivate educational interventions that will enhance the participation, integration, and mobilization of clinicians in the event of a community emergency.