Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research

摘要: Background Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose this study was identify optimal surveillance strategies medical and surgical devices. Methods Qualitative methods were used sampling, data collection analysis. Stakeholders from Canada USA representing different roles perspectives first interviewed examples characteristics strategies. These stakeholders others they recommended then assembled at 1-day nominal group meeting discuss prioritise components device system, needed achieve system. Results Consultations held 37 participants, 47 participants attended meeting. They multicomponent system including reporting by facilities, clinicians patients, supported some external validation real-time trials high-risk devices. Many considerations identified that constitute desirable of, means which implement An overarching network envisioned broker linkages, establish shared minimum dataset, support communication decision making. Numerous questions identified, could be pursued in tandem phased implementation system. Discussion findings provide unique guidance establishing safety based on existing initiatives, expanded evaluated prospective, fashion as it developed.