BackgroundPostmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting.MethodsQualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions.ResultsTwenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes.ConclusionsThere may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.

BackgroundLittle research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options.MethodsA descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team.ResultsTwenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications.ConclusionsThis study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.Electronic supplementary materialThe online version of this article (10.1186/s12911-017-0577-3) contains supplementary material, which is available to authorized users.

ObjectivesPhysician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed.DesignA descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team.ResultsTwenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as “symbiotic”, but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness.ConclusionsGiven the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Using data from interviews with Health Technology Assessment (HTA) professionals in Canada, this paper shows their views of the appropriate role of, and evidence required for, HTA are associated with values and norms. Recognizing HTA as a moral economy helps to explain when and why HTA professionals’ views of what HTA should and can do are mutable, and may specifically help to explain why there is resistance among some HTA professionals to the inclusion of ethical issues and patients or the public in technology assessment. The moral economy framework furthermore sheds light on the nature of objectivity in contemporary HTA.

The advent of 'smart' technologies has already transformed urban life, with important consequences for physical, mental, and social well-being. Population health and equity have, however, been conspicuously absent from much of the 'smart cities' research and policy agenda. With this in mind, we argue for a re-conceptualization of 'digital divides' in terms of socioeconomic gradients at the individual level, and we draw attention to digitally mediated connections as crucial elements for health promotion at an institutional level and for remedying inequities. We do so in part by reporting on a recent symposium. Overall, we begin to integrate the 'healthy cities' tradition with the current interest in 'smart cities'. Résumé Le déploiement des technologies numériques a d'ores et déjà transformé la vie urbaine, et entraîné des conséquences importantes sur le bien-être physique, mental et social. La santé des populations et l'équité sont cependant restées largement absentes des discussions politiques et académiques sur les « villes intelligentes ». Afin de contribuer à instruire ce débat, nous proposons de reconceptualiser la notion de « fracture numérique » en l'associant, à l'échelle de l'individu, à l'idée de gradients socio-économiques. De plus, nous transposons cette notion à l'échelle des organisations engagées dans la promotion de la santé et dans la lutte contre les inégalités, et pour qui l'accès aux technologies numériques et aux données est un enjeu de plus en plus décisif. Ce travail s'appuie sur les réflexions engagées lors d'un colloque organisé récemment, qui a permis d'esquisser un rapprochement entre le champ bien établi des « villes en santé » et l'intérêt actuel pour les « villes intelligentes ».

From embodied risk to embodying hope: therapeutic experimentation and experiential information sharing in a contested intervention for Multiple Sclerosis People who pursue unproven therapies are often portrayed as 'desperate' individuals duped by medical racketeers peddling 'false hope'. These patients, in contrast, present themselves as empowered citizens who have taken an informed decision to pursue an experimental therapy. This paper explores the latter perspective through the case of the so-called 'liberation procedure': a controversial endovascular intervention proposed as a treatment for Multiple Sclerosis (MS). Drawing on interviews with 48 people affected by MS, we analyse the decision-making processes and justifications thereof of those who had the procedure (n=31). While the decision to have the intervention might not have been justified according to the standards of evidence-based medicine, it was nonetheless premised on a shared 'experiential logic'-conceptualised as a logic of embodied risk/hope-that extends beyond the specific condition and therapy in question. The paper explicates this logic, concentrating on patients' negotiations of: a) risk and uncertainty; b) expertise and evidence; c) hope and experiment. In particular, we foreground how, through a combination of therapeutic experimentation and experiential information sharing, patients turn their own bodies into (contested) sources of hope for themselves and others, which, in turn, shapes their embodied experiences of living with MS in the present.

BackgroundConcern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.Methods/DesignOur study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.Ethics - beneficence, non-maleficence, autonomy, justice.Economics - scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.DiscussionThe significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.

These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.