scholarly journals Skin Reaction Report Form: Development and Design of a Standardized Report Form for Skin Reactions Due to Medical Devices for Diabetes Management

2020 ◽  
pp. 193229682091110 ◽  
Author(s):  
Guido Freckmann ◽  
Sina Buck ◽  
Delia Waldenmaier ◽  
Eva Zschornack ◽  
Manuela Link ◽  
...  
Keyword(s):  
Medical Devices ◽  
Diabetes Management ◽  
Daily Practice ◽  
General Information ◽  
Skin Reactions ◽  
Standardized Report ◽  
Diabetes Technology ◽  
Standardized Documentation ◽  
The One ◽  
Form Development

Background: Skin reactions due to medical devices for diabetes management have become a common problem in diabetes technology. There is a varying degree in how detailed skin reactions are described in scientific literature and diabetes practice, and no uniform structured documentation is given. Whereas most articles only describe findings, some others already document final diagnoses, such as contact dermatitis. Furthermore, inconsistent wordings for comparable issues were used. Methods: A more detailed and standardized documentation, possibly facilitated by a generally accepted guideline for structured descriptions, of skin reactions could be helpful to enable better differentiations between the described skin reactions. Therefore, a report form to assess skin reactions due to medical devices in diabetes therapy was developed and will be presented in this article. Results: The one-page report form is divided into four categories and a separate instruction paper. Beside general information the form includes the location, size, severity and duration of skin appearances, the grading of itching, and suspected diagnoses. Conclusion: A consistent use of the form in daily practice and clinical trials could facilitate a fast and standardized documentation and help to evaluate the occurrence and severity of different skin reactions due to medical devices in diabetes management.

scholarly journals Countrywide survey on utilization of medical devices by GPs in Hungary: advantages of the cluster-practice model

2021 ◽  
Vol 22 ◽  
Author(s):  
Katalin Dózsa ◽  
Fruzsina Mezei ◽  
Tamás Tóth ◽  
Ábel Perjés ◽  
Péter Pollner
Keyword(s):  
Medical Devices ◽  
Point Of Care ◽  
Daily Practice ◽  
Evidence Based ◽  
Self Assessment ◽  
Practice Model ◽  
Practice Models ◽  
Integrate State ◽  
The Relationship ◽  
Further Development

Abstract Background: Expectations towards general practitioners (GPs) are continuously increasing to provide a more systematic preventive- and definitive-based care, a wider range of multidisciplinary team-based services and to integrate state-of-the-art digital solutions into daily practice. Aided by development programmes, Hungarian primary care is facing the challenge to fulfil its role as the provider of comprehensive, high quality, patient-centred, preventive care, answering the challenges caused by non-communicable diseases (NCDs). Aim: The article aims to provide an insight into the utilization of simple, digital, medical devices. We show the relationship between the primary health care (PHC) practice models and the used types of devices. We point at further development directions of GP practices regarding the utilization of evidence-based medical technologies and how such devices support the screening and chronic care of patients with NCDs in everyday practice. Methods: Data were collected using an online self-assessment questionnaire from 1800 Hungarian GPs registered in Hungary. Descriptive statistics, Wilcoxon’s test and χ2 test were applied to analyze the ownership and utilization of 32 types of medical devices, characteristics of the GP practices and to highlight the differences between traditional and cluster-based operating model. Findings: Based on the responses from 27.7% of all Hungarian GPs, the medical device infrastructure was found to be limited especially in single GP-practices. Those involved in development projects of GP’s clusters in the last decade reported a wider range and significantly more intensive utilization of evidence-based technologies (average number of devices: 5.42 versus 7.56, P<.001), but even these GPs are not using some of their devices (e.g., various point of care testing devices) due to the lack of financing. In addition, GPs involved in GPs-cluster development model programmes showed significantly greater willingness for sharing relatively expensive, extra workforce-demanding technologies (χ2 = 24.5, P<.001).

scholarly journals Implant Surgery Using Bio-compatible Guides

2018 ◽  
Vol 55 (1) ◽  
pp. 38-41
Author(s):  
Serban Talpos ◽  
Tareq Hajaj ◽  
Costin Timofte ◽  
Mircea Rivis ◽  
Felicia Streian ◽  
...  
Keyword(s):  
Primary Stability ◽  
Daily Practice ◽  
Implant Placement ◽  
Surgical Guides ◽  
Technological Advances ◽  
Tissue Healing ◽  
The Future ◽  
Oral Tissue ◽  
The One ◽  
User Friendly

Implants and biomaterials used in hard and soft oral tissue augmentation are very complex, but predictable to use nowadays, as the technological advances haven�t skipped this field of medicine. Cases that were impossible to treat with implant retained fixed prosthesis some years ago, have become the daily practice of oral surgeons and dentists around the world. The new user-friendly products, together with simplified protocols, increased the practitioners� predictability and success rate, thus the biomaterial industry took a huge leap forward. As the biomaterial industry keeps developing continuously, making better and safer products, the surgical and prosthetic protocols evolve and change as well. On this matter, the implant placement has become safer, using digital surgical guides. Guided implant placement doesn�t just allow the practitioner place the implant in the patient�s bone, but, moreover, it helps him place it in the correct, 3D, prosthetic position. And, thus, guiding the future bone augmentation and regeneration as well, accordingly. So, the implant placement has shifted from bone-orientated to prosthetic-orientated, offering at the same time a better primary stability for the implants, due to the prior planning. The present clinical study aims to analyze the outcome of the digital guided protocol. Unlike the free-handed surgery, the digital guided surgery allows dentists and oral surgeons to place implants according to the future prosthetic position of the crowns, even in conditions of alveolar ridges with bone resorption. Moreover, it makes possible the �one day implant� concept, the dental technician being able to create the provisional crown/s in advance, knowing precisely the future position of the implant placement. So, at the time of the surgery, the provisional crown is also put in place, guiding the soft and hard tissue healing and also giving the patient a greater satisfaction.

Non-Invasive Data Acquisition and Measurement in Bio-Medical Technology

2016 ◽  
pp. 27-45 ◽  
Author(s):  
H. G. Sandeep Patil ◽  
Ajit N. Babu ◽  
P. S. Ramkumar
Keyword(s):  
Health Care ◽  
Infectious Diseases ◽  
Medical Devices ◽  
Care Delivery ◽  
Non Invasive ◽  
Technological Advances ◽  
Mathematical Techniques ◽  
The One ◽  
Insight Into ◽  
Technology Trends

Non-invasive medical measurements have expanded into several types of diagnostic and monitoring activities in health care delivery. They are being used in handling a number of non-infectious diseases such as diabetes, asthma, hypertension, congestive heart failure, cardiac arrhythmia, etc., as well as infectious diseases such as cholera, malaria, etc.. Non-Invasive Medical Devices (NIMDs) are naturally preferred over invasive methods considering patient convenience, reduced patient risk, increased speed, and operational simplicity. However non-invasive methods are often perceived to be less accurate than their invasive counterparts. Over the last decade, technological advances and mathematical techniques have improved significantly, challenging this perception across the board. The chapter will discuss this important transformation in health care diagnostics and monitoring. The chapter will also provide further insight into some of the currently available non-invasive measurement products and explore how futuristic techniques and technology trends which have great potential to transform healthcare into a significantly different paradigm than the one we experience today.

scholarly journals The earlier, the better or the worse? Towards accurate management of patients with arthralgia at risk for RA

2020 ◽  
Vol 79 (3) ◽  
pp. 312-315 ◽  
Author(s):  
Annette van der Helm-van Mil ◽  
Robert B M Landewé
Keyword(s):  
Daily Practice ◽  
Long Term Results ◽  
Current Status ◽  
Controlled Trials ◽  
Future Studies ◽  
Clinical Arthritis ◽  
The One ◽  
Firm Evidence ◽  
Early Phases

The favourable long-term results of early treatment in patients with classified rheumatoid arthritis have resulted in an increasing interest in the diseases phases preceding clinical arthritis. The hypothesis to test is that an intervention in these early phases may better prevent or reduce disease persistence than an intervention when arthritis has become clinically manifest. While several placebo-controlled trials are still ongoing, to date there is no firm evidence that this hypothesis truly holds. Therefore, it is important to reflect on the current status of arthralgia preceding clinical arthritis. Inherent to every new field of research, attitudes are conflicting, with opinions propagating innovation (based on the fear of undertreatment) on the one hand, and critical sounds pleading for more restraint (fear of overtreatment) on the other hand. In this Viewpoint, we will examine these divergent opinions, relate them to a preferred ultimate scenario and provide considerations for future studies and daily practice.

scholarly journals Extraction With Sweat-Sebum Emulsion as a New Test Method for Leachables in Patch-Based Medical Devices, Illustrated by Assessment of Isobornylacrylate (IBOA) in Diabetes Products

2020 ◽  
pp. 193229682090865
Author(s):  
Herbert Fink ◽  
Nuno M. de Barros Fernandes ◽  
Jörg Weissmann ◽  
Manfred Frey
Keyword(s):  
Medical Devices ◽  
Insulin Pump ◽  
Water Solution ◽  
Glucose Monitoring ◽  
Stable Solution ◽  
Test Method ◽  
Skin Reactions ◽  
Extraction Solvent ◽  
Targeted Analysis ◽  
Allergenic Potential

Background: The increasing offering of patch-based medical devices is accompanied by growing numbers of reported adverse skin reactions. Procedures for testing leachables according to ISO 10993 may not be optimal for lipophilic substances that can be mobilized on skin by sweat and sebum. We propose an improved extraction method for targeted analysis of leachables using low volumes of a sweat-sebum emulsion. The approach is illustrated by the analysis of isobornylacrylate (IBOA), a compound found in some devices and suspected for allergenic potential. Method: Three patch-based products were tested: an implantable device for continuous glucose monitoring (CGM), an intermittently scanned CGM (isCGM) device, and a micro-insulin pump. Quantification of IBOA was performed by gas chromatography and allergenic potential of IBOA levels was assessed by the KeratinoSens cell assay. Different combinations were used for extraction solvent (isopropanol, 5% ethanol-water solution, and sweat-sebum emulsion), extraction volumes (complete immersion vs partial immersion in 2 mm of solvent), and extraction time (3, 5, and 14 days). Results: Isobornylacrylate was only found in the isCGM device. About 20 mg/L IBOA were eluted after 3 days in isopropanol but only about 1 mg/L in ethanol-water. Sweat-sebum emulsion dissolves IBOA better and gives a more stable solution than ethanol-water. Decomposition of IBOA solutions requires adjusted extraction timing or correction of results. In the sweat-sebum extract, IBOA levels were about 20 mg/L after 3 days and about 30 mg/L after 5 days, clearly above the threshold found in the KerationSens assay for keratinocyte activation (10 mg/L). Conclusion: Extraction by low volumes of sweat-sebum emulsion can be a superior alternative for the targeted simulating-use assessment of leachables in patch-based medical devices.

scholarly journals Improving patient self-care using diabetes technologies

2019 ◽  
Vol 10 ◽  
pp. 204201881882421 ◽  
Author(s):  
Valeria Alcántara-Aragón
Keyword(s):  
Cost Effectiveness ◽  
Unmet Needs ◽  
Diabetes Management ◽  
Glycated Hemoglobin ◽  
Diabetes Education ◽  
Self Care ◽  
Use Of Technology ◽  
Diabetes Technology ◽  
Improve Patient ◽  
And Training

Diabetes technologies are an unstoppable phenomenon. They offer opportunities to improve patient self-care through empowerment. However, they can be a challenge for both patients and clinicians. Thus, the use of technology may empower or burden. To understand and benefit from the use of diabetes technologies, one must understand the currently unmet needs in diabetes management. These unmet needs call for perspectives beyond glycated hemoglobin and an evaluation of technology solutions. Optimal use of these technologies is necessary to obtain benefits and achieve cost-effectiveness; this process depends on diabetes education and training. This review evaluates clinician and patient perspectives regarding diabetes technologies, followed by an evaluation of technology solutions. Diabetes technology solutions are evaluated according to available results about their effectiveness and their potential to empower people living with diabetes.

Biological Properties of Ti-Si-C-O-N Thin Films

2009 ◽  
Vol 6 ◽  
pp. 99-114
Author(s):  
Mariana Henriques ◽  
Maria Susano ◽  
Isabel Carvalho ◽  
Isabel Ferreri ◽  
Sandra Carvalho ◽  
...  
Keyword(s):  
Thin Films ◽  
Medical Devices ◽  
Staphylococcus Epidermidis ◽  
Biofilm Formation ◽  
Surface Characterization ◽  
Biological Properties ◽  
Nitrogen Partial Pressure ◽  
Reactive Magnetron ◽  
The One ◽  
Ti Content

The main aim of this work was to study the feasibility of new coatings for medical devices. Ti-Si-C-O-N films were deposited by DC unbalanced reactive magnetron sputtering, using different oxygen and nitrogen partial pressure ratios (pO2/pN2). Surface properties were also analysed. Staphylococcus epidermidis was used to study biofilm formation and cytotoxicity was determined using fibroblasts. Surface morphology changed with the increase of pO2/pN2. Samples of high hydrophobicity displayed opposite behaviour in terms of biofilm formation, presenting the highest and lowest biomass. Moreover, the sample with the highest Ti content was the one, with the lowest biofilm amount, raising the possibility of a correlation between Ti and biofilm formation capability. In fact, this sample also displayed the highest degree of cytotoxicity (near 35%). This work shows the feasibility of the proposed coatings and highlights the importance of joining together both biological properties (biofilm formation and cytotoxicity) with the surface characterization.

Societas Scientiarum Fennica

1938 ◽  
Vol 1 (2) ◽  
pp. 60-62
Keyword(s):  
Natural History ◽  
Royal Society ◽  
Scientific Literature ◽  
Modern Science ◽  
General Information ◽  
The Other ◽  
Physical Sciences ◽  
Académie Des Sciences ◽  
The One ◽  
Large Output

An important event of the present year has been the attainment of its centenary by the Societas Scientiarum Fennica, the Finnish equivalent of the Royal Society or the Académie des Sciences—though indeed of wider scope than these, including as it does a Humanistic section in addition to those concerned with Mathematics and Physical Sciences on the one hand and Natural History on the other. The Society, during the century of its existence, has been responsible for a large output of scientific literature, its main publications being subdivided, on very much the same plan as those of the Royal Society, into (1) Transactions (Acta), which of recent years (1930-38) have been arranged in separate volumes for the physico-mathematical and biological subjects; (2) Proceedings (Ofversigt), which from 1923 onwards are arranged in three parallel series of 'Commentationes’ corresponding to the main sections of the Society’s activities, and (3) an annual 'Arsbok' containing general information, reports of lectures, and obituary notices. The pages of these several publications provide impressive testimony to the importance of the Societas Scientiarum Fennica in the march of modern science.

Surgical and audiological evaluation of the Baha BA400

2015 ◽  
Vol 129 (1) ◽  
pp. 32-37 ◽  
Author(s):  
M Iseri ◽  
K S Orhan ◽  
M H Yarıktaş ◽  
A Kara ◽  
M Durgut ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Surgical Technique ◽  
Hearing Aid ◽  
Tertiary Care ◽  
Case Series ◽  
Retrospective Case ◽  
Skin Reactions ◽  
Bone Anchored Hearing Aid ◽  
The One ◽  
Tissue Reduction

AbstractObjective:Despite extensive soft tissue reduction, the most common complications associated with bone-anchored hearing aid systems, also known as bone-anchored hearing implants, are related to adverse skin reactions around the abutment. The necessary soft tissue reduction also adds complexity to the surgical procedure. This study aimed to evaluate the surgical and audiological outcomes of a new connective interface of the Cochlear™ Baha® BA400 device implanted using the one-stage surgical technique.Method:A multicentre, retrospective case series is presented, including data collected from three tertiary care institutions.Results:In total, 16 patients who had undergone bone-anchored hearing aid surgery over a 10- to 12-month period were assessed for hearing performance, implant stability and surgical complications.Conclusion:This case series indicates that new abutments with a hydroxyapatite coating can be implanted percutaneously without soft tissue reduction. Furthermore, device implantation using this surgical technique may have some advantages compared with a conventional device and procedure combination over 12- to 16-months of follow up.

scholarly journals Bendamustine in the treatment of B-cell non-Hodgkin lymphoma

2018 ◽  
Vol 20 (4) ◽  
pp. 41-46
Author(s):  
L G Babicheva ◽  
I V Poddubnaya
Keyword(s):  
Clinical Data ◽  
Therapeutic Index ◽  
Daily Practice ◽  
Phase Iii ◽  
Cross Resistance ◽  
Skin Reactions ◽  
Non Hodgkin Lymphoma ◽  
Antiemetic Prophylaxis ◽  
Mantle Cell ◽  
Phase Iii Trials

Bendamustine is a uniquely structuredalkylating agent that lacks cross-resistance with other alkylators. This agent has a high degreeof activity against a variety of tumor cell lines.Based on clinical data from randomized phase III trials, bendamustine, with or without rituximab, hasbeen shown to be an appropriate option for first-line treatment or treatment of relapsed/refractory patients with indolent non-Hodgkin’s lymphoma or elderly patients with mantle cell lymphoma. Bendamustine treatment is associated with abetter therapeutic index and offers an improved overall quality of life compared to R-CHOP or R-CVP. It is now often used as achemotherapy backbone for combination with novel drugs including ibrutinib or idelalisib. This article provides a comprehensivesummaryof the clinical data along with practical adviceonhowto optimallymanagepatients with bendamustine therapy, includingdose recommendations, antiemetic prophylaxis, prevention of infusion and skin reactions, as well as prophylaxis of opportunisticinfections. This information might be helpful for clinicians using bendamustine in their daily practice.

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