The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Paul C. D. Bank ◽  
Leo H. J. Jacobs ◽  
Sjoerd A. A. van den Berg ◽  
Hanneke W. M. van Deutekom ◽  
Dörte Hamann ◽  
...  
Keyword(s):  
Clinical Practice ◽  
The Netherlands ◽  
Medical Devices ◽  
Task Force ◽  
Large Impact ◽  
Guidance Document ◽  
Scientific Societies ◽  
Clinical Laboratories ◽  
The Impact

AbstractThe in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.

Legal and Normative Requirements Related to Medical Devices for Individual Supply in Clinical Practice

2021 ◽  
Vol 23 (5) ◽  
pp. 381-387
Author(s):  
Marcin Zaczyk
Keyword(s):  
Clinical Practice ◽  
Medical Devices ◽  
End Users ◽  
Medical Centers ◽  
Council Directive ◽  
In Vitro Diagnostic ◽  
Normative Requirements ◽  
Medical Directives ◽  
Special Order

This article has the form of a communication presenting recent legal changes in relation to medical devices. Until 26 May 2021, three medical directives were in force, namely Directive 98/79 / EC, Council Directive 93/42/ EEC and Council Directive 90/385 / EEC. They have been replaced by two regulations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The article presents the reasons for introducing the changes and the new obligations that these changes bring for manufacturers of medical devices, in particular, products manufactured individually on a special order as necessary for the implementation of personalized therapies in clinical practice. There are also forecasts for the industry and end users of medical devices manufactured to order and used individually at medical centers.

Impact of Tracheoesophageal Puncture Prosthesis Airway Resistance on In-Vivo Phonatory Performance

1986 ◽  
Vol 51 (1) ◽  
pp. 88-91 ◽  
Author(s):  
Bernd Weinberg ◽  
Jerry B. Moon
Keyword(s):  
Clinical Practice ◽  
Airway Resistance ◽  
Voice Production ◽  
Tracheoesophageal Puncture ◽  
The Impact

Substantial differences have been established among in-vitro airway resistance properties of tracheoesophageal (TE) puncture prostheses (Weinberg & Moon, 1984). In this report, the impact of these in-vitro differences on the actual, in-vivo process of TE voice production is made explicit. Variation in in-vitro airway resistance among TE puncture prostheses is shown to exert substantial effects upon in-vivo phonatory mechanism opposition to flow, aerodynamic power required to initiate and sustain TE voice production, and TE phonatory efficiency. Individuals responsible for defining TE puncture options for laryngectomized patients are encouraged to consider these effects in clinical practice.

scholarly journals Malaria diagnosis in a malaria non-endemic high-resource country: high variation of diagnostic strategy in clinical laboratories in the Netherlands

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Marrit B. Boonstra ◽  
Rob Koelewijn ◽  
Eric A. T. Brienen ◽  
Welmoed Silvis ◽  
Foekje F. Stelma ◽  
...  
Keyword(s):  
The Netherlands ◽  
Quality Assessment ◽  
Thick Film ◽  
Microscopic Examination ◽  
Intestinal Parasites ◽  
Diagnostic Strategy ◽  
Screening Assay ◽  
High Resource ◽  
Clinical Laboratories ◽  
The Impact

Abstract Background Microscopic examination of thick and thin blood films is the gold standard in current guidelines for the diagnosis of malaria, but guidelines do not uniformly agree on which combination of other methods should be used and when. Methods Three questionnaires were sent between March 2018 and September 2019 to laboratories subscribing to the external quality assessment scheme for the diagnosis of blood and intestinal parasites of the Dutch Foundation for Quality Assessment in Medical Laboratories in order to investigate how much variation in the laboratory diagnosis of malaria between different clinical laboratories is present in the Netherlands. Results The questionnaires were partially or fully completed by 67 of 77 (87%) laboratories. Only 9 laboratories reported 10 or more malaria positive patients per year. Most laboratories use a different diagnostic strategy, within office versus outside office hours depending on the screening assay result. Within office hours, 62.5% (35/56) of the responding laboratories perform an immunochromatographic test (ICT) in combination with microscopic examination of thick and thin blood films without additional examinations, such as Quantitative Buffy Coat and/or rtPCR analysis. Outside office hours 85.7% (48/56) of laboratories use an ICT as single screening assay and positive results are immediately confirmed by thick and thin blood films without additional examinations (89.6%, 43/48). In case of a negative ICT result outside office hours, 70.8% (34/48) of the laboratories perform microscopic examination of the thick film the next morning and 22.9% (11/48) confirm the negative ICT result immediately. Furthermore, substantial differences were found in the microscopic examinations of thick and thin blood films; the staining, theoretical sensitivity of the thick film and determination of parasitaemia. Conclusions This study demonstrated a remarkably high variation between laboratories in both their diagnostic strategy as well as their methods for microscopic examination for the diagnosis of malaria in a clinical setting, despite existing national and international guidelines. While the impact of these variations on the accuracy of the diagnosis of malaria is yet unknown, these findings should stimulate clinical laboratories to critically review their own diagnostic strategy.

Iodinated poly(p-dioxanone) as a facile platform for X-ray imaging of resorbable implantable medical devices

2020 ◽  
Vol 35 (1) ◽  
pp. 39-48
Author(s):  
Fan Zhao ◽  
Haiyan Xu ◽  
Wen Xue ◽  
Yan Li ◽  
Jing Sun ◽  
...  
Keyword(s):  
Medical Devices ◽  
Melt Spinning ◽  
Imaging Techniques ◽  
Fibrous Materials ◽  
Hybrid Fibers ◽  
Implantable Medical Devices ◽  
X Ray ◽  
The Impact

Currently, implantable fibrous medical devices still suffer from invisibility under current clinical imaging techniques. To address this problem, 2, 3, 5-triiodobenzoic acid (TIBA) was recruited as a contrast agent, and then a set of iodinated poly( p-dioxanone) (PPDO) fibers was fabricated via melt-spinning hybrid blends of PPDO with TIBA (PPDO/TIBA). The impact of TIBA content on the rheological behavior of blends was evaluated firstly. The physical, chemical, and thermal properties of PPDO/TIBA fibers were investigated accordingly by SEM, FTIR, DSC, and TGA. Moreover, the radiopaque property of PPDO/TIBA hybrid fibers as a potential radio-opacifying platform for medical devices was verified in vitro and in vivo. Finally, the accumulated release results of the hybrid fibers during in vitro degradation indicate the continual X-ray visibility of the hybrid fibers maintains for 22 days. This intriguing iodinated platform may pave the way for constructing fibrous materials with in-situ X-ray tracking property.

scholarly journals Monitoring asthma in childhood: symptoms, exacerbations and quality of life

2015 ◽  
Vol 24 (136) ◽  
pp. 187-193 ◽  
Author(s):  
Paul L.P. Brand ◽  
Mika J. Mäkelä ◽  
Stanley J. Szefler ◽  
Thomas Frischer ◽  
David Price
Keyword(s):  
Quality Of Life ◽  
Clinical Practice ◽  
Asthma Control ◽  
Task Force ◽  
Night Time ◽  
Frequent Use ◽  
Reliever Medication ◽  
Children With Asthma ◽  
The Impact

Monitoring asthma in children in clinical practice is primarily performed by reviewing disease activity (daytime and night-time symptoms, use of reliever medication, exacerbations requiring frequent use of reliever medication and urgent visits to the healthcare professional) and the impact of the disease on children's daily activities, including sports and play, in a clinical interview. In such an interview, most task force members also discuss adherence to maintenance therapy and the patients' (and parents') views and beliefs on the goals of treatment and the amount of treatment required to achieve those goals. Composite asthma control and quality of life measures, although potentially useful in research, have limited value in clinical practice because they have a short recall window and do not cover the entire spectrum of asthma control. Telemonitoring of children with asthma cannot replace face-to-face follow-up and monitoring because there is no evidence that it is associated with improved health outcomes.

Fourth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (Constituted by representatives of nine societies and by invited experts)

2007 ◽  
Vol 14 (2_suppl) ◽  
pp. E1-E40 ◽  
Author(s):  
Ian Graham ◽  
Dan Atar ◽  
Knut Borch-Johnsen ◽  
Gudrun Boysen ◽  
Gunilla Burell ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Czech Republic ◽  
Clinical Practice ◽  
The Netherlands ◽  
Disease Prevention ◽  
European Society ◽  
Task Force ◽  
Joint Task ◽  
Joint Task Force ◽  
European Society Of Cardiology

Other experts who contributed to parts of the guidelines: Edmond Walma, Schoonhoven (The Netherlands), Tony Fitzgerald, Dublin (Ireland), Marie Therese Cooney, Dublin (Ireland), Alexandra Dudina, Dublin (Ireland) European Society of Cardiology (ESC) Committee for Practice Guidelines (CPG):, Alec Vahanian (Chairperson) (France), John Camm (UK), Raffaele De Caterina (Italy), Veronica Dean (France), Kenneth Dickstein (Norway), Christian Funck-Brentano (France), Gerasimos Filippatos (Greece), Irene Hellemans (The Netherlands), Steen Dalby Kristensen (Denmark), Keith McGregor (France), Udo Sechtem (Germany), Sigmund Silber (Germany), Michal Tendera (Poland), Petr Widimsky (Czech Republic), José Luis Zamorano (Spain) Document reviewers: Irene Hellemans (CPG Review Coordinator) (The Netherlands), Attila Altiner (Germany), Enzo Bonora (Italy), Paul N. Durrington (UK), Robert Fagard (Belgium), Simona Giampaoli(Italy), Harry Hemingway (UK), Jan Hakansson (Sweden), Sverre Erik Kjeldsen (Norway), Mogens Lytken Larsen (Denmark), Giuseppe Mancia (Italy), Athanasios J. Manolis (Greece), Kristina Orth-Gomer (Sweden), Terje Pedersen (Norway), Mike Rayner (UK), Lars Ryden (Sweden), Mario Sammut (Malta), Neil Schneiderman (USA), Anton F. Stalenhoef (The Netherlands), Lale Tokgözoglu (Turkey), Olov Wiklund (Sweden), Antonis Zampelas (Greece)

VP70 Structuring The Process Of Innovation Uptake In Tunisia

2017 ◽  
Vol 33 (S1) ◽  
pp. 181-182
Author(s):  
Mouna Jameleddine ◽  
Asma Ben Brahem ◽  
Hela Grati ◽  
Hella Ouertatani ◽  
Wafa Allouche ◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Healthcare System ◽  
Medical Devices ◽  
Public Procurement ◽  
Flow Chart ◽  
Hospital Level ◽  
Specific Flow ◽  
Health Technologies ◽  
The Impact

INTRODUCTION:Tunisia recently implemented a Health Technology Assessment (HTA) agency (INASanté) to inform decisions around health technologies and to improve clinical practice by means of the elaboration of Clinical Practice Guidelines (CPG). However many decisions on new and emerging technologies, their implementation and coverage in the health care system are still taken at the hospital level without any structured process that informs the decisions. The aim of this project was to improve the methods and flow-chart of decision-making processes on innovation uptake in the Tunisia Healthcare System.METHODS:By means of the toolkit of EuroScan for the implementation of an early awareness and alert system (EAAS), and its checklist, it was discussed specifically within INASanté the characteristics of the Tunisia Healthcare System and its specificities regarding decisions on drugs and medical devices. The analysis included the process of innovation uptake at the hospital level and its specific flow-chart. In depth interviews and a devoted workshop were performed with personal in INASanté: two physicians (one involved in CPG elaboration and the second in accreditation), three pharmacists (HTA), one nutritionist (HTA), two librarians and other stakeholders, including the Directorate of Hospitals.RESULTS:The uptake of innovations in Tunisia does not follow a structured process. In fact, there is no central purchase of medical devices in Tunisia and most medical devices are purchased by hospitals within a tender process in accordance with the Tunisian public procurement law. The main pitfalls are: lack of awareness around innovations that could impact the system, non-structured process of information sharing among the different decision-makers that promotes inequity in access to technologies and services, and lack of explicit criteria that determine decisions around health technologies.CONCLUSIONS:Tunisia requires a structured and informed process on decisions around innovation uptake in the healthcare system. The principles that should govern this system are: anticipation of the impact of new health technologies, establishing priorities and criteria for decision making in all places of decision. The decisions should be recorded and publicly shared to avoid inequities in the access to technologies.

scholarly journals Influence of Inflammation on Cytochromes P450 Activity in Adults: A Systematic Review of the Literature

2021 ◽  
Vol 12 ◽  
Author(s):  
Camille Lenoir ◽  
Victoria Rollason ◽  
Jules A. Desmeules ◽  
Caroline F. Samer
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Case Reports ◽  
Cytochromes P450 ◽  
Convincing Evidence ◽  
Pharmacokinetic Parameters ◽  
Published Data ◽  
Resolution Of Inflammation ◽  
The Impact

Background: Available in-vitro and animal studies indicate that inflammation impacts cytochromes P450 (CYP) activity via multiple and complex transcriptional and post-transcriptional mechanisms, depending on the specific CYP isoforms and the nature of inflammation mediators. It is essential to review the current published data on the impact of inflammation on CYP activities in adults to support drug individualization based on comorbidities and diseases in clinical practice.Methods: This systematic review was conducted in PubMed through 7th January 2021 looking for articles that investigated the consequences of inflammation on CYP activities in adults. Information on the source of inflammation, victim drugs (and CYPs involved), effect of disease-drug interaction, number of subjects, and study design were extracted.Results: The search strategy identified 218 studies and case reports that met our inclusion criteria. These articles were divided into fourteen different sources of inflammation (such as infection, autoimmune diseases, cancer, therapies with immunomodulator…). The impact of inflammation on CYP activities appeared to be isoform-specific and dependent on the nature and severity of the underlying disease causing the inflammation. Some of these drug-disease interactions had a significant influence on drug pharmacokinetic parameters and on clinical management. For example, clozapine levels doubled with signs of toxicity during infections and the concentration ratio between clopidogrel’s active metabolite and clopidogrel is 48-fold lower in critically ill patients. Infection and CYP3A were the most cited perpetrator of inflammation and the most studied CYP, respectively. Moreover, some data suggest that resolution of inflammation results in a return to baseline CYP activities.Conclusion: Convincing evidence shows that inflammation is a major factor to be taken into account in drug development and in clinical practice to avoid any efficacy or safety issues because inflammation modulates CYP activities and thus drug pharmacokinetics. The impact is different depending on the CYP isoform and the inflammatory disease considered. Moreover, resolution of inflammation appears to result in a normalization of CYP activity. However, some results are still equivocal and further investigations are thus needed.

Translating Principles of Speech Science to Clinical Practice: Current and Future Trends in Craniofacial Disorders

2008 ◽  
Vol 18 (1) ◽  
pp. 31-40 ◽  
Author(s):  
David J. Zajac
Keyword(s):  
Clinical Practice ◽  
Speech Intelligibility ◽  
Current Practice ◽  
Computer Assisted ◽  
Behavioral Management ◽  
Single Word ◽  
Future Directions ◽  
Speech Science ◽  
The Impact ◽  
Opinion Article

Abstract The purpose of this opinion article is to review the impact of the principles and technology of speech science on clinical practice in the area of craniofacial disorders. Current practice relative to (a) speech aerodynamic assessment, (b) computer-assisted single-word speech intelligibility testing, and (c) behavioral management of hypernasal resonance are reviewed. Future directions and/or refinement of each area are also identified. It is suggested that both challenging and rewarding times are in store for clinical researchers in craniofacial disorders.

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