The role of the user within the medical device design and development process: medical device manufacturers' perspectives

Copyright @ 2011 Money et al.Background: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so.Methods: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process.Results: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process.Conclusions: Medical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised.This study was in part funded by grant number Ref: GR/S29874/01 from the Engineering and Physical Sciences Research Council. This article is made available through the Brunel University Open Access Publishing Fund

Adherence to the medical regimen during the first two years after lung transplantation

BACKGROUND: Despite the importance of adherence to the medical regimen for maximizing health after lung transplantation, no prospective studies report on rates or risk factors for nonadherence in this patient population. Whether adherence levels differ in lung versus other types of transplant recipients is unknown. METHODS: A total of 178 lung recipients and a comparison group of 126 heart recipients were enrolled. Adherence in nine areas was assessed in separate patient and family caregiver interviews 2, 7, 12, 18, and 24 months posttransplant. Potential risk factors for nonadherence were obtained at the initial assessment. RESULTS: Cumulative incidence rates of persistent nonadherence (i.e., nonadherence at 0.05) in lung recipients than heart recipients for taking immunosuppressants (13% nonadherent vs. 21%, respectively), diet (34% vs. 56%), and smoking (1% vs. 8%). Lung recipients had significantly higher persistent nonadherence to completing blood work (28% vs. 17%) and monitoring blood pressure (70% vs. 59%). They had a high rate of spirometry nonadherence (62%; not measured in heart recipients). The groups did not differ in nonadherence to attending clinic appointments (27%), exercise (44%), or alcohol limitations (7%). In both groups, poor caregiver support and having only public insurance (e.g., Medicaid) increased nonadherence risk in all areas. CONCLUSIONS: Lung recipients were neither uniformly better nor worse than heart recipients in adhering to their regimen. Lung recipients have particular difficulty with some home monitoring activities. Strategies to maximize adherence in both groups should build on caregiver support and on strengthening financial resources for patient healthcare requirements

Cuidados de enfermagem na prevenção da insuficiência renal provocada por contraste após cateterismo Cuidados de enfermagem na prevenção da insuficiência renal provocada por contraste após cateterismo Nursing care in the prevention of renal failure caused by post-catheterism contrast

O estudo teve como objetivo identificar produções científicas de enfermagem sobre insuficiência renal aguda provocada por contraste iodado após cateterismo cardíaco, no período de 2002 a 2007, analisando sua aplicabilidade à prática. Foi realizada ainda uma análise crítica das produções científicas selecionadas, delineando os cuidados de enfermagem. Este estudo é uma pesquisa bibliográfica de artigos de enfermagem, encontrados através de busca computadorizada. Dos 47 artigos encontrados, 10 foram selecionados por terem atendido os critérios de inclusão. Após a análise dos artigos, verificamos a importância da atuação do enfermeiro na prevenção da insuficiência renal aguda provocada por contraste. Além disso, evidenciamos a melhor prática de enfermagem para a prevenção da insuficiência renal aguda provocada por contraste.<br>El presente estudio tuvo como objetivo identificar producciones científicas de enfermería sobre la insuficiencia renal aguda provocada por contraste yodado después del cateterismo cardíaco, en el período de 2002 a 2007, analizando su aplicabilidad a la práctica. Se realizó además el análisis crítico de las producciones científicas seleccionadas, delineando los cuidados de enfermería. Este estudio es una investigación bibliográfica de artículos de enfermería, encontrados por medio de búsqueda computarizada. De los 47 artículos encontrados, 10 fueron seleccionados por haber atendido a los criterios de inclusión. Después del análisis de los artículos, verificamos la importancia de la actuación del enfermero en la prevención de la insuficiencia renal aguda provocada por contraste. Además de lo referido, evidenciamos una mejor práctica de enfermería para la prevención de la insuficiencia renal aguda provocada por contraste.<br>The purpose of this study was to identify the nursing scientific production on acute renal failure caused by post-catheterism iodized cardiac contrast, from 2002 to 2007, by analyzing its practical application. A critical analysis was further performed of the selected scientific production outlining nursing care. This study is a literature review of nursing articles, found through computerized search. Out of the 47 articles found, ten were selected because they met the inclusion criteria. After the analysis of the articles, we checked the importance of the nurse's performance in the prevention of acute renal failure caused by contrasts. In addition, we noted the best nursing practices for prevention of acute renal failure caused by contrasts

Development, preliminary usability and accuracy testing of the EBMT ‘eGVHD App’ to support GvHD assessment according to NIH criteria—a proof of concept

The EBMT Complications and Quality of Life Working Party has developed a computer-based algorithm, the 'eGVHD App', using a user-centered design process. Accuracy was tested using a quasi-experimental crossover design with four expert-reviewed case vignettes in a convenience sample of 28 clinical professionals. Perceived usefulness was evaluated by the technology acceptance model (TAM) and User satisfaction by the Post-Study System Usability Questionnaire (PSSUQ). User experience was positive, with a median of 6 TAM points (interquartile range: 1) and beneficial median total, and subscale PSSUQ scores. The initial standard practice assessment of the vignettes yielded 65% correct results for diagnosis and 45% for scoring. The 'eGVHD App' significantly increased diagnostic and scoring accuracy to 93% (+ 28%) and 88% (+ 43%), respectively (both P < 0.05). The same trend was observed in the repeated analysis of case 2: accuracy improved by using the App (+ 31% for diagnosis and + 39% for scoring), whereas performance tended to decrease once the App was taken away. The 'eGVHD App' could dramatically improve the quality of care and research as it increased the performance of the whole user group by about 30% at the first assessment and showed a trend for improvement of individual performance on repeated case evaluation