A Comparison of the Opinions of Nurses and Emergency Medical Workers regarding Medical Device Usability

2002 ◽  
Vol 46 (16) ◽  
pp. 1477-1481 ◽  
Author(s):  
Laurie Reed ◽  
Jennifer Fisher
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Technology ◽  
Critical Care Nurses ◽  
Emergency Medical Technicians ◽  
Emergency Medical ◽  
Similarities And Differences ◽  
General Product ◽  
Two Populations

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.

scholarly journals Downtime after Critical Incidents in Emergency Medical Technicians/Paramedics

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Janice Halpern ◽  
Robert G. Maunder ◽  
Brian Schwartz ◽  
Maria Gurevich
Keyword(s):  
Critical Incidents ◽  
Stress Disorder ◽  
Emergency Medical Technicians ◽  
Depression Symptoms ◽  
Emotional Symptoms ◽  
Emergency Medical ◽  
Acute Distress ◽  
Optimal Period ◽  
Perceived Helpfulness

Effective workplace-based interventions after critical incidents (CIs) are needed for emergency medical technicians (EMT)/paramedics. The evidence for a period out of service post-CI (downtime) is sparse; however it may prevent posttraumatic stress disorder (PTSD) and burnout symptoms. We examined the hypothesis that downtime post-CI is associated with fewer symptoms of four long-term emotional sequelae in EMT/paramedics: depression, PTSD, burnout, and stress-related emotional symptoms (accepted cut-offs defined high scores). Two hundred and one paramedics completed questionnaires concerning an index CI including downtime experience, acute distress, and current emotional symptoms. Nearly 75% received downtime; 59% found it helpful; 84% spent it with peers. Downtime was associated only with lower depression symptoms, not with other outcomes. The optimal period for downtime was between<30 minutes and end of shift, with>1 day being less effective. Planned testing of mediation of the association between downtime and depression by either calming acute post-CI distress or feeling helped by others was not performed because post-CI distress was not associated with downtime and perceived helpfulness was not associated with depression. These results suggest that outcomes of CIs follow different pathways and may require different interventions. A brief downtime is a relatively simple and effective strategy in preventing later depression symptoms.

scholarly journals ATTITUDES OF ORTHOPEDIC SPECIALISTS TOWARD EFFECTS OF MEDICAL DEVICE PURCHASING

2017 ◽  
Vol 33 (1) ◽  
pp. 46-53 ◽  
Author(s):  
Myriam Lingg ◽  
Everth Merida-Herrera ◽  
Kaspar Wyss ◽  
Luis Durán-Arenas
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Primary Stability ◽  
Cross Sectional Study ◽  
End Users ◽  
Purchasing Decisions ◽  
Cross Sectional ◽  
Orthopedic Surgeons ◽  
Purchasing Process

Objectives: The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes.Methods: We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico.Results: We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments.Conclusions: To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement.

scholarly journals Digital process chains for patient specific medical devices

2020 ◽  
Vol 6 (3) ◽  
pp. 357-359
Author(s):  
Michael Wehmöller ◽  
Michael Utz ◽  
Valentine Gesche
Keyword(s):  
Advisory Committee ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Technology ◽  
Patient Specific ◽  
Medical Technology Advisory Committee ◽  
Development Framework ◽  
Process Chains

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.

Usability of Emergency Medical Devices: Assessment and Design Implications

2002 ◽  
Vol 46 (16) ◽  
pp. 1491-1495
Author(s):  
Jennifer Fisher ◽  
Beth Loring
Keyword(s):  
Medical Devices ◽  
Medical Equipment ◽  
Public Organizations ◽  
Emergency Medical Technicians ◽  
Suburban Areas ◽  
Emergency Medical ◽  
Private And Public

The goal of this study was to assess the usability of portable electronic emergency medical equipment. The study consisted of field interviews conducted with emergency medical workers, including emergency medical technicians (EMTs), paramedics, and firefighters. We sampled a varied population, including workers from urban and suburban areas as well as private and public organizations. Equipment manufacturers can use the results of this study to enhance the usability, efficiency, and acceptability of future emergency medical devices.

scholarly journals 24. Comparison of a Transillumination Versus Direct Visualization for Endotracheal Intubation by Basic Emergency Medical Technicians

1996 ◽  
Vol 11 (S2) ◽  
pp. S29-S29
Author(s):  
Juan A. March ◽  
Eric Manring ◽  
Scott Lovelace ◽  
Lawrence H. Brown ◽  
Kimmie Yarborough
Keyword(s):  
Endotracheal Intubation ◽  
Further Education ◽  
Emergency Medical Technician ◽  
Emergency Medical Technicians ◽  
Direct Visualization ◽  
Emergency Medical ◽  
Skills Retention ◽  
Or Practice ◽  
Short And Long Term

Purpose: The new Emergency Medical Technician (EMT) basic curriculum includes an optional session on intubation. Unfortunately little data is available regarding retention of endotracheal intubation skills by basic EMTs. The objective of this study was to examine endotracheal intubation skills by basic EMTs, and compare skills retention for a transillumination (TI) versus a direct visualization (DV) technique.Methods: A prospective, randomized trial was conducted over a five week period during a basic EMT class. EMT classes were randomized to train students to perform endotracheal intubation using either a transillumination or a direct visualization technique. Initial education was performed using an airway mannequin during a modified, accelerated three hour course, consisting of both a didactic and skills session. To assess performance, participants were tested using an airway mannequin and checklist currently implemented by our flight nurse program. Without further education or practice, students were then tested one week and five weeks later to assess short and long term retention.

Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic

2021 ◽  
Vol 47 (2-3) ◽  
pp. 291-326
Author(s):  
Katelynn Maxwell
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Antibody Test ◽  
Public Health Emergency ◽  
Long Term Results ◽  
Regulatory Oversight ◽  
Speed Up ◽  
Harsh Criticism ◽  
Medical Device Regulation

The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA’s credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA’s public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.

scholarly journals Functional Safety Concept EGAS for Medical Devices

2021 ◽  
Vol 7 (2) ◽  
pp. 739-742
Author(s):  
Benjamin Alexander Paulsen ◽  
Sandra Henn ◽  
Georg Männel ◽  
Philipp Rostalski
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Technology ◽  
Heterogeneous Systems ◽  
Functional Safety ◽  
Safety Concept ◽  
Automotive Safety ◽  
Design Concepts ◽  
Regulatory Landscape

Abstract For patient safety, it is important that a medical device can safely and reliably perform its intended purpose. The challenge in medical technology is that medical devices are heterogeneous systems and thus no widely applicable standard concepts for functional safety exist in medical technology. This is also reflected in the regulatory landscape, with its rather generally applicable standards. Patient safety is currently achieved by performing continuous risk management with an acceptable level of residual risk. Functional safety and its design concepts, as applied in other industries, have so far found little application in the field of medical technology. In this paper, the automotive safety concept "EGAS" is analyzed with regard to its applicability for medical devices. Based on the investigated example of a medical ventilator, important parallels were found between the automotive and the medical device sector, indicating the possibility of successfully applying the EGAS safety concept to medical devices.

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