Medical device technologies: Who is the user?

A myriad of medical devices deployed by many users play an essential role in healthcare, and they, and their users, need to be defined, classified and coded effectively. This study provides definitions of terms frequently employed to describe the users of medical device technologies (MDT) as well as a classification of such users. Devices are widely used, developed and assessed by many others than clinicians. Thus, users of medical devices need to be classified in various relevant ways, such as primary and secondary users; user groups such as healthcare professionals, patients, carers, persons with disabilities, those with special needs, as well as professionals allied with healthcare. Proper definition and classification of MDT users is particularly important for integrating the users’ perspectives in the process of MDT development and assessment, as well as in relation to the regulatory, health and safety, and insurance perspectives concerning MDT

Benefits of and barriers to involving users in medical device technology development and evaluation

Objectives: This study investigated the benefits of, and barriers to user involvement in medical device technology development and evaluation. Methods: A structured review of published literature in peer-reviewed journals. Results: This review revealed that the main benefits of user involvement were an increased access to user needs, experiences and ideas; improvements in medical device designs and user interfaces; and an increase in the functionality, usability and quality of the devices. On the other hand, resource issues, particularly those of time and money were found the key impediments to involving users in the development and evaluation of medical device technologies. This study has categorised both the benefits and barriers to user involvement also. Conclusions: The involvement of users in MDTD&E requires resources, which are limited; however, it is essential from both users and manufacturers perspectives

Investigation of practices and procedures in the use of therapeutic diathermy: A study from the physiotherapists' health and safety perspective

Background and Purpose. The safe use of therapeutic diathermy requires practices and procedures that ensure compliance to professional guidelines and clinical evidence. Inappropriate use may expose physiotherapists and other people in the vicinity of operating diathermy devices to stray radiofrequency electromagnetic fields, which can be a source of risk and may lead to adverse health effects. The aim of the present study was to investigate practices and procedures for therapeutic diathermy from a health and safety perspective. Method. A cross-sectional research design was used, this included a postal survey using a self-administered questionnaire and semi-structured observational visits to 46 physiotherapy departments in National Health Service (NHS) hospitals located in the south-east and south-west of England, including Greater London. Results. Microwave diathermy was not available in the departments surveyed. Pulsed shortwave diathermy was available and was used more commonly than continuous shortwave diathermy. There were metallic objects in treatment cubicles used for pulsed shortwave diathermy and continuous shortwave diathermy. Shortwave diathermy devices created electromagnetic interference with a variety of electrical and medical devices. Physiotherapists reported that they did not stay in the treatment cubicle during the entire period of electrotherapy with pulsed shortwave diathermy or continous shortwave diathermy; pregnant physiotherapists reported that they did not use these devices. Electrotherapy with pulsed shortwave diathermy and continuous shortwave diathermy was not always administered on a wooden couch or chair. Electrotherapy was highest in those departments with the fewest physiotherapists. Conclusions. Departments report good practices and procedures regarding the use of therapeutic diathermy devices. However, field observations of practices and procedures, and the working environment, have identified issues with a potential to create health and safety problems, and these should be addressed. Copyright (c) 2007 John Wiley & Sons, Ltd

User involvement in healthcare technology development and assessment: Structured literature review

Purpose – Medical device users are one of the principal stakeholders of medical device technologies. User involvement in medical device technology development and assessment is central to meet their needs. Design/methodology/approach – A structured review of literature, published from 1980 to 2005 in peer-reviewed journals, was carried out from social science perspective to investigate the practice of user involvement in the development and assessment of medical device technologies. This was followed by qualitative thematic analysis. Findings – It is found that users of medical devices include clinicians, patients, carers and others. Different kinds of medical devices are developed and assessed by user involvement. The user involvement occurs at different stages of the medical device technology lifecycle and the degree of user involvement is in the order of design stage > testing and trials stage > deployment stage > concept stage. Methods most commonly used for capturing users’ perspectives are usability tests, interviews and questionnaire surveys. Research limitations/implications – We did not review the relevant literature published in engineering, medical and nursing fields, which might have been useful. Practical implications – Consideration of the users’ characteristics and the context of medical device use is critical for developing and assessing medical device technologies from users’ perspectives. Originality/value – This study shows that users of medical device technologies are not homogeneous but heterogeneous, in several aspects, and their needs, skills and working environments vary. This is important consideration for incorporating users’ perspectives in medical device technologies. Paper type: Literature review

Systematic literature review of adverse reproductive outcomes associated with physiotherapists' occupational exposures to non-ionising radiation

This article is available through open access and can be accessed at the link below.Objectives: To review empirical research on adverse health and pregnancy outcomes associated with physiotherapists' occupational exposure to radiofrequency electromagnetic fields (RF EMFs) from shortwave (SWD) and microwave (MWD) diathermy devices. Methods: A systematic review of peer reviewed literature published from 1990 to 2010 in the English language searched in eight online bibliographic databases: CINAHL, EBSCOhost, ISI Web of Knowledge, Medline, OSH UPDATE, PubMed Central, ScienceDirect, and Scopus. Results: Findings suggest that physiotherapists' occupational exposure to SWD was statistically significantly associated with delayed time to pregnancy (>6 months), still birth, altered gender ratio (low ratio of boys to girls), congenital malformations and low birth weight (<2,500 g) among physiotherapists' offspring. Physiotherapists' exposure to MWD was also found to be statistically significantly associated with spontaneous abortion. However, causal mechanisms for these statistical associations are unknown. The present systematic review has found these adverse reproductive outcomes and health effects associations with RF EMFs from therapeutic diathermy devices to be inconsistent. Conclusions: A number of studies did not find statistically significant results to replicate associations with such adverse outcomes, and therefore further research, preferably prospective studies of cohorts of physiotherapists, is warranted.This is extended version of a study funded by the Health and Safety Executive (Project No: R47.022

Availability and use of electrotherapy devices: a survey

This item is published and the copyright holder of this article is the International Journal of Therapy and Rehabilitation © 2010 MA Healthcare Limited, http://www.ijtr.co.uk/. The article is available here with the permission of the copyright holder. Any use of the article from this site for personal use is permitted; however, if it is to be used for any other purpose, or reproduced in part or in full, the copyright holder must be contacted.Electrophysical agents such as radiofrequency electromagnetic fields (shortwave and microwave), ultrasound, laser and electrical stimulation are used for therapeutic purpose in physiotherapy departments. They are primarily used for treating a wide range of musculoskeletal injuries. This study investigated the availability and use of therapeutic diathermy, ultrasound, laser, transcutaneous electrical nerve stimulation (TENS) and interferential equipment in 46 physiotherapy departments in NHS hospitals in the south of England, using a self-administered questionnaire. Results indicated that therapeutic ultrasound was the most commonly available and most often used modality by surveyed departments. Pulsed shortwave diathermy, interferential, and laser were available to a lesser degree and also used less often. Continuous shortwave diathermy was used rarely and only in larger departments. Microwave diathermy was not available in any of the surveyed departments. The level of non-use of equipment despite availability was highest for continuous shortwave diathermy followed by pulsed shortwave diathermy and then laser. The rare use and total non-use of some of the modalities, despite availability of equipment, may have implications for purchasers of this expensive equipment. While the findings of this study show a regional trend in NHS physiotherapy departments, this may not be generalizable to a national level.This study was funded by the Health and Safety Executive, UK, (Grant No. 4371/R47.022

Factors determining patients’ intentions to use point-of-care testing medical devices for self-monitoring: The case of international normalised ratio self-testing

This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. - Copyright @ 2012 Dove Medical Press LtdThis article has been made available through the Brunel Open Access Publishing Fund.Purpose: To identify factors that determine patients' intentions to use point-of-care medical devices, ie, portable coagulometer devices for self-testing of the international normalized ratio (INR) required for ongoing monitoring of blood-coagulation intensity among patients on long-term oral anticoagulation therapy with vitamin K antagonists, eg, warfarin. Methods: A cross-sectional study that applied the technology-acceptance model through a self-completed questionnaire, which was administered to a convenience sample of 125 outpatients attending outpatient anticoagulation services at a district general hospital in London, UK. Data were analyzed using descriptive statistics, factor analyses, and structural equation modeling. Results: The participants were mainly male (64%) and aged ≥ 71 years (60%). All these patients were attending the hospital outpatient anticoagulation clinic for INR testing; only two patients were currently using INR self-testing, 84% of patients had no knowledge about INR self-testing using a portable coagulometer device, and 96% of patients were never offered the option of the INR self-testing. A significant structural equation model explaining 79% of the variance in patients’ intentions to use INR self-testing was observed. The significant predictors that directly affected patients' intention to use INR self-testing were the perception of technology (β = 0.92, P < 0.001), trust in doctor (β = −0.24, P = 0.028), and affordability (β = 0.15, P = 0.016). In addition, the perception of technology was significantly affected by trust in doctor (β = 0.43, P = 0.002), age (β = −0.32, P < 0.001), and affordability (β = 0.23, P = 0.013); thereby, the intention to use INR self-testing was indirectly affected by trust in doctor (β = 0.40), age (β = −0.29), and affordability (β = 0.21) via the perception of technology. Conclusion: Patients’ intentions to use portable coagulometers for INR self-testing are affected by patients' perceptions about the INR testing device, the cost of device, trust in doctors/clinicians, and the age of the patient, which need to be considered prior to any intervention involving INR self-testing by patients. Manufacturers should focus on increasing the affordability of INR testing devices for patients’ self-testing and on the potential role of medical practitioners in supporting use of these medical devices as patients move from hospital to home testing.This study is funded by the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) program (EPSRC grant EP/GO12393/1)

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

Patients' perspectives on self-testing of oral anticoagulation therapy: Content analysis of patients' internet blogs

<p>Abstract</p> <p>Background</p> <p>Patients on oral anticoagulant therapy (OAT) require regular testing of the prothrombin time (PT) and the international normalised ratio (INR) to monitor their blood coagulation level to avoid complications of either over or under coagulation. PT/INR can be tested by a healthcare professional or by the patient. The latter mode of the testing is known as patient self-testing or home testing. The objective of this study was to elicit patients' perspectives and experiences regarding PT/INR self-testing using portable coagulometer devices.</p> <p>Methods</p> <p>Internet blog text mining was used to collect 246 blog postings by 108 patients, mainly from the USA and the UK. The content of these qualitative data were analysed using XSight and NVivo software packages.</p> <p>Results</p> <p>The key themes in relation to self-testing of OAT identified were as follows: Patient benefits reported were time saved, personal control, choice, travel reduction, cheaper testing, and peace of mind. Equipment issues included high costs, reliability, quality, and learning how to use the device. PT/INR issues focused on the frequency of testing, INR fluctuations and individual target (therapeutic) INR level. Other themes noted were INR testing at laboratories, the interactions with healthcare professionals in managing and testing OAT and insurance companies' involvement in acquiring the self-testing equipment. Social issues included the pain and stress of taking and testing for OAT.</p> <p>Conclusions</p> <p>Patients' blogs on PT/INR testing provide insightful information that can help in understanding the nature of the experiences and perspectives of patients on self-testing of OAT. The themes identified in this paper highlight the substantial complexities involved in self-testing programmes in the healthcare system. Thus, the issues elicited in this study are very valuable for all stakeholders involved in developing effective self-testing strategies in healthcare that are gaining considerable current momentum particularly for patients with chronic illness.</p

User needs elicitation via analytic hierarchy process (AHP). A case study on a Computed Tomography (CT) scanner

Background: The rigorous elicitation of user needs is a crucial step for both medical device design and purchasing. However, user needs elicitation is often based on qualitative methods whose findings can be difficult to integrate into medical decision-making. This paper describes the application of AHP to elicit user needs for a new CT scanner for use in a public hospital. Methods: AHP was used to design a hierarchy of 12 needs for a new CT scanner, grouped into 4 homogenous categories, and to prepare a paper questionnaire to investigate the relative priorities of these. The questionnaire was completed by 5 senior clinicians working in a variety of clinical specialisations and departments in the same Italian public hospital. Results: Although safety and performance were considered the most important issues, user needs changed according to clinical scenario. For elective surgery, the five most important needs were: spatial resolution, processing software, radiation dose, patient monitoring, and contrast medium. For emergency, the top five most important needs were: patient monitoring, radiation dose, contrast medium control, speed run, spatial resolution. Conclusions: AHP effectively supported user need elicitation, helping to develop an analytic and intelligible framework of decision-making. User needs varied according to working scenario (elective versus emergency medicine) more than clinical specialization. This method should be considered by practitioners involved in decisions about new medical technology, whether that be during device design or before deciding whether to allocate budgets for new medical devices according to clinical functions or according to hospital department