Stakeholder challenges in purchasing medical devices for patient safety.

OBJECTIVE: This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. METHODS: Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. RESULTS: The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. CONCLUSIONS: The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

Exploring an effective model of new product development in medical devices: A knowledge cluster approach

This study proposes a new product development (NPD) model that aims to improve the effectiveness of innovative NPD in the medical devices. By adopting open innovation theory and applying an in-depth investigation methodology, this paper proposes a knowledge cluster that improves the integration of interdisciplinary human resources and enhances the acquirement of innovative technologies. A knowledge cluster approach helps gather, organise, synthesise, and accumulate knowledge in order to become the impetus for innovation. Although enterprises are no longer the principals of research and development, they should still be capable of integrating professional physicians, external groups, and individuals through the knowledge cluster platform. However, in order to support an effective NPD model, enterprises should provide adequate incentives and trust to external individuals or groups willing to contribute their expertise and knowledge to this knowledge cluster platform. Copyright © 2013 Inderscience Enterprises Ltd.

Development of a nanoporous and multilayer drug-delivery platform for medical implants.

Biodegradable polymers can be applied to a variety of implants for controlled and local drug delivery. The aim of this study is to develop a biodegradable and nanoporous polymeric platform for a wide spectrum of drug-eluting implants with special focus on stent-coating applications. It was synthesized by poly(DL-lactide-co-glycolide) (PLGA 65:35, PLGA 75:25) and polycaprolactone (PCL) in a multilayer configuration by means of a spin-coating technique. The antiplatelet drug dipyridamole was loaded into the surface nanopores of the platform. Surface characterization was made by atomic force microscopy (AFM) and spectroscopic ellipsometry (SE). Platelet adhesion and drug-release kinetic studies were then carried out. The study revealed that the multilayer films are highly nanoporous, whereas the single layers of PLGA are atomically smooth and spherulites are formed in PCL. Their nanoporosity (pore diameter, depth, density, surface roughness) can be tailored by tuning the growth parameters (eg, spinning speed, polymer concentration), essential for drug-delivery performance. The origin of pore formation may be attributed to the phase separation of polymer blends via the spinodal decomposition mechanism. SE studies revealed the structural characteristics, film thickness, and optical properties even of the single layers in the triple-layer construct, providing substantial information for drug loading and complement AFM findings. Platelet adhesion studies showed that the dipyridamole-loaded coatings inhibit platelet aggregation that is a prerequisite for clotting. Finally, the films exhibited sustained release profiles of dipyridamole over 70 days. These results indicate that the current multilayer phase therapeutic approach constitutes an effective drug-delivery platform for drug-eluting implants and especially for cardiovascular stent applications.

Biofunctionalization of PET/SiO2 surfaces for single molecule experiments and medical applications

PET/SiO2 layers were chemically modified to maintain immobilization of functional single molecules. GFP molecules provide an ideal system due to their stability and intrinsic fluorescence. GFP in vivo biotinylated within its NH2-terminal region and attached on the substrate via the biotinstreptavidin bond was further investigated with confocal microscopy, atomic force microscopy (AFM) and spectroscopic ellipsometry (SE). AFM revealed monolayered donut-like structures representing assemblies of biotinstreptavidinbiotinGFP immobilized onto PET/SiO2 surfaces via mPEG. In particular, regions with an approximate height of 12 nm, which approaches the molecular dimensions of the above complex given by molecular modeling, could be detected. The dimensions of the donut-like structures suggest a close-to-each-other positioning of the GFP molecules - which, however, retain their functionality, as evidenced by confocal microscopy. © 2011 World Scientific Publishing Company.

Correlation between initial chromatid damage and survival of various cell lines exposed to heavy charged particles

The biophysical characteristics of heavy ions make them a rational source of radiation for use in radiotherapy of malignant tumours. Prior to radiotherapy treatment, a therapeutic regimen must be precisely defined, and during this stage information on individual patient radiosensitivity would be of very great medical value. There are various methods to predict radiosensitivity, but some shortfalls are difficult to avoid. The present study investigated the induction of chromatid breaks in five different cell lines, including one normal liver cell line (L02), exposed to carbon ions accelerated by the heavy ion research facility in Lanzhou (HIRFL), using chemically induced premature chromosome condensation (PCC). Previous studies have reported the number of chromatid breaks to be linearly related to the radiation dose, but the relationship between cell survival and chromatid breaks is not clear. The major result of the present study is that cellular radiosensitivity, as measured by D-0, is linearly correlated with the frequency of chromatid breaks per Gy in these five cell lines. We propose that PCC may be applied to predict radiosensitivity of tumour cells exposed to heavy ions.

Hypothesis Formation and Evaluation in Medical Diagnosis

This thesis describes some aspects of a computer system for doing medical diagnosis in the specialized field of kidney disease. Because such a system faces the spectre of combinatorial explosion, this discussion concentrates on heuristics which control the number of concurrent hypotheses and efficient "compiled" representations of medical knowledge. In particular, the differential diagnosis of hematuria (blood in the urine) is discussed in detail. A protocol of a simulated doctor/patient interaction is presented and analyzed to determine the crucial structures and processes involved in the diagnosis procedure. The data structure proposed for representing medical information revolves around elementary hypotheses which are activated when certain disposing of findings, activating hypotheses, evaluating hypotheses locally and combining hypotheses globally is examined for its heuristic implications. The thesis attempts to fit the problem of medical diagnosis into the framework of other Artifcial Intelligence problems and paradigms and in particular explores the notions of pure search vs. heuristic methods, linearity and interaction, local vs. global knowledge and the structure of hypotheses within the world of kidney disease.

Intention and Causation in Medical Non-Killing: The impact of criminal law concepts on euthanasia and assisted suicide

null RAE2008

By the equator's snowy peak a record of medical missionary work and travel in British East Africa by E May Crawford

http://www.archive.org/details/equatorssnowype00crawuoft

How far to the nearest doctor? Stories of medical missions around the world, by Edward M. Dodd.

http://www.archive.org/details/howfartotheneare012020mbp

Rule Extraction, Fuzzy ARTMAP, and Medical Databases

This paper shows how knowledge, in the form of fuzzy rules, can be derived from a self-organizing supervised learning neural network called fuzzy ARTMAP. Rule extraction proceeds in two stages: pruning removes those recognition nodes whose confidence index falls below a selected threshold; and quantization of continuous learned weights allows the final system state to be translated into a usable set of rules. Simulations on a medical prediction problem, the Pima Indian Diabetes (PID) database, illustrate the method. In the simulations, pruned networks about 1/3 the size of the original actually show improved performance. Quantization yields comprehensible rules with only slight degradation in test set prediction performance.

A medical study on wireless inertial measurement technology as a tool for identifying patients at risk of death or imminent clinical deterioration

This paper provides a system description and preliminary results for an ongoing clinical study currently being carried out at the Mid-Western Regional Hospital, Nenagh, Ireland. The goal of the trial is to determine if wireless inertial measurement technology can be employed to identify elderly patients at risk of death or imminent clinical deterioration. The system measures cumulative movement and provides a score that will help provide a robust early warning to clinical staff of clinical deterioration. In addition the study examines some of the logistical barriers to the adoption of wearable wireless technology in front-line medical care.

The evolution of the medical professions in eighteenth-century Ireland: An institutional perspective

Ireland, in the eighteenth century, followed the classic tripartite division of regular medical practitioners into physicians, surgeons and apothecaries. At the beginning of the century surgeons and apothecaries were regarded as mere tradesmen, but by the end of the century both were regarded as professionals and had the right to regulate their respective professions. Practitioners in different regions of Europe developed in a different manner, and eighteenth-century practitioners in Ireland developed independently from their English counterparts. In common with Britain and Europe in the eighteenth century, the total number of practitioners increased in Ireland, and by the end of the century, apothecaries were the largest group in Dublin, closely followed by the surgeons. Surgeons and apothecaries at the start of the eighteenth century belonged to the same guild. However in mid-century, St Luke's guild of apothecaries was established and this provided the apothecaries with a new identity that allowed them to pursue auto regulation, rather than hitherto, when they had been regulated by the physicians. This was vital to the apothecaries as they were in direct commercial competition with both the physicians and the surgeons and faced increasing pressure from both druggists and the disparate group of practitioners known as the irregulars. The 1765 County Infirmaries Act established a hospital in virtually every county in Ireland, and cast the surgeon as the primary medical officer in the countrywide network of hospitals. This legislation, which was unique in Europe, had the unintended consequence of elevating the status of the surgeons, as prior to this physicians were always in the ascendancy in the voluntary hospitals in Ireland and Britain, in contrast to France. The status of the surgeons was further enhanced by the establishment of the College of Surgeons in Ireland in 1784, which provided them with a new corporate identity, the authority to regulate the profession countrywide, and, also, the ability to educate surgeons in Ireland. The establishment of the College of Surgeons placed further pressure on the apothecaries to demonstrate that they also had a recognisable identity, and the authority to regulate their own profession. This was achieved with the 1791 Apothecaries Act which established the Apothecaries Hall and give the apothecaries the right to regulate themselves. This innovative legislation deemed the apothecaries a profession, and was enacted twenty-four years prior to similar legislation in Britain. Commercial pressure from druggists and, probably, irregulars expedited the requirement of the apothecaries to establish a new corporate identity, in order to distance themselves from these groups. The changing status of both apothecaries and surgeons had little effect on the physicians as a group, and, despite being the beneficiaries of a generous bequest from Sir Patrick Dun in 1711 to provide medical chairs in Dublin, the physicians displayed an inertia during the eighteenth century that was not in keeping with the developments that occurred in the contemporary Dublin medical world. The fact that it took ninety-five years, and that five acts of parliament, two House of Commons enquiries and a House of Lords enquiry were required to ensure that Dun's wishes were brought to fruition demonstrates that the physicians did not develop at the same pace as the other medical groups in the city. Had Dun’s bequest been implemented as he desired, Dublin, with a number of voluntary hospitals, would have been well placed to provide comprehensive tuition for medical students in the eighteenth century. It was not until the nineteenth century that the city, and the populace, benefited from this legacy. This thesis will trace these developments in the context of changes that occurred in contemporary medical education and diagnosis in Ireland, Britain and France. It will demonstrate that Irish practitioners developed independently, influenced mainly by local issues, but also by those who had travelled abroad and returned to Ireland with new concepts and ideas, ensuring that Irish medical practitioners had the institutional structure that could encompass the diagnostic and regulatory changes that would become accepted in the nineteenth century.