Standard lists of medical devices and a strategic maintenance plan: tools for appropriate medical technology

2002 ◽  
Author(s):  
A. Mboule
Heart ◽  
2018 ◽  
Vol 104 (22) ◽  
pp. 1817-1822 ◽  
Author(s):  
Peter H Groves ◽  
Chris Pomfrett ◽  
Mirella Marlow

The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system. Diagnostic guidance is published for diagnostic technologies if they have the potential to improve health outcomes, but if their introduction may be associated with an increase in overall cost to the NHS. Medtechinnovation briefings provide evidence-based advice to those considering the implementation of new medical devices or diagnostic technologies. This review provides reference to all of the guidance and briefing medical technology documents that NICE has published that are relevant to the heart and circulation and reflect on their diverse recommendations. The interaction of MTEP with other NICE programmes is integral to its effectiveness and the means by which consistency is ensured across the different NICE programmes is described. The importance of the input of clinical experts from the cardiovascular professional community and the engagement by NICE with cardiovascular professional societies is highlighted as being fundamental to ensuring the quality of guidance outputs as well as to promoting their implementation and adoption.


2009 ◽  
Vol 6 (2) ◽  
pp. 197-205 ◽  
Author(s):  
Ajay Mahal ◽  
Anup K Karan

Author(s):  
Laurie Reed ◽  
Jennifer Fisher

In this study critical care nurses and emergency medical workers (including firefighters, emergency medical technicians (EMTs), and paramedics) were surveyed regarding their opinions of medical device usability. The goal of the study was to determine how the two populations fared in terms of general product understanding, proficiency, usability, and functionality. Furthermore, the study identified similarities and differences between the two populations, and explored areas of medical technology design upon which manufacturers can improve. Results showed that a major concern of both populations was training; nurses and emergency medical workers felt that workloads do not allow time for sufficient mastery of the devices. The respondents also felt that medical devices could be more consistent and less complex. Both groups indicated that it is most important to design products that are easy to learn, easy to use upon first use, and efficient to use long-term.


2020 ◽  
Vol 6 (3) ◽  
pp. 357-359
Author(s):  
Michael Wehmöller ◽  
Michael Utz ◽  
Valentine Gesche

AbstractThe Medical Technology Advisory Committee of the VDI Society develops a guideline for the implementation of digital process chains for patient-specific medical devices. The underlying medical device constitutes the basis for each individualized medical device. It serves as the development framework for manufacturing.


2021 ◽  
Vol 7 (2) ◽  
pp. 807-810
Author(s):  
Matthias Reisemann ◽  
Angelina Krupp

Abstract Product development in medical technology is largely governed by Regulatory Affairs. In contrast, for consumer products Human-Centred Design (HCD) is the guiding principle. Both approaches are laid down in international standards and overlap many aspects such as procedure, applied methodologies and development activities. For medical devices patient safety and therefore risk management is the guiding development goal. In HCD the focus lies on User Experience (UX), a positive experience throughout the entire product life cycle. The question arises whether UX could play a more important role in medical device development, particularly considering the similarities of the two development processes


Healthcare ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 23 ◽  
Author(s):  
David Johansson ◽  
Patrik Jönsson ◽  
Bodil Ivarsson ◽  
Maria Christiansson

Objective: Segmentation is one way of improving data protection. The aim of this study was to investigate Information Technology (IT) and Medical Technology (MT) personnel’s perception in relation to ongoing segmentation of medical devices and IT infrastructure in the healthcare sector. Methods: Focus group interviews with 9 IT and 9 MT personnel in a county council in southern Sweden were conducted. The interviews focused on two areas: Positive expectations and misgivings. Digital recordings were transcribed verbatim and analyzed using qualitative content analysis. Results: Responses related to 2 main areas: Information security and implementation of segmentation. Informants stated that network segmentation would increase the overall level of cybersecurity for medical devices, addressing both insider and outsider threats. However, it would also increase the need for administration and the need for knowledge of the communication patterns of medical devices from the manufacturer’s perspective. Conclusion: IT and MT personnel in a county council in southern Sweden believed that segmentation would increase cybersecurity but also increase administration and resource needs, which are important opinions to take into consideration. The present study can be used as a model for others to increase awareness of opinions of healthcare organizations.


2015 ◽  
Vol 31 (5) ◽  
pp. 297-303 ◽  
Author(s):  
Matthew D. Haydock ◽  
Anubhav Mittal ◽  
Carissa F. Wilkes ◽  
David H. Lim ◽  
Elizabeth Broadbent ◽  
...  

Objectives: Medical technology is a large and expanding industry. Introducing new medical devices is important but several challenges exist in implementing the optimal method of evaluation. Both objective and subjective measures can be used for evaluation. The former is the mainstay of evaluation, yet subjective assessment is often the basis for the introduction of new medical technology. The aim of this study was to determine the interaction and concordance between objective and subjective assessment of new medical technology.Methods: This study used both objective performance measures and subjective user perceptions in the evaluation of a new medical device designed to improve the accuracy of gravity-assisted delivery of intravenous fluids, compared with the current, widely used “roller-clamp” device. The concordance of objective and subjective assessments was evaluated using comparative analysis.Results: Objective assessment of the accuracy of intravenous fluid delivery revealed no difference between the two devices (p = .636). Subjective assessment revealed that the new device was perceived to be significantly more accurate (p = .001). This lack of concordance can be partially explained by both device and demand characteristics.Conclusions: This case study reveals a significant discordance between the objective and subjective assessments. It provides some explanation for why new medical devices are adopted without objective evidence of benefit. This phenomenon has been termed “persuasive design” and its influence should be controlled for in the evaluation, purchase and introduction of new medical devices. This should help reduce the risk and associated cost of premature introduction.


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