Literature DB >> 22588587

Regulation of medical devices used in diabetology in Europe: time for reform?

A J M Boulton, S Del Prato.   

Abstract

Mesh：

Year:  2012        PMID： 22588587     DOI： 10.1007/s00125-012-2580-7

Source DB:  PubMed          Journal:  Diabetologia        ISSN： 0012-186X            Impact factor:   10.122


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  16 in total

1.  The PIP mammary prosthesis: a product recall study.

Authors:  M G Berry; Jan J Stanek
Journal:  J Plast Reconstr Aesthet Surg       Date:  2012-03-09       Impact factor: 2.740

2.  Here we go again--another failure of postmarketing device surveillance.

Authors:  Robert G Hauser
Journal:  N Engl J Med       Date:  2012-02-14       Impact factor: 91.245

Review 3.  Management of diabetes mellitus: is the pump mightier than the pen?

Authors:  John C Pickup
Journal:  Nat Rev Endocrinol       Date:  2012-02-28       Impact factor: 43.330

Review 4.  Emerging diabetes therapies and technologies.

Authors:  Emily G Moser; Audrey A Morris; Satish K Garg
Journal:  Diabetes Res Clin Pract       Date:  2012-02-29       Impact factor: 5.602

5.  Pendra goes Dutch: lessons for the CE mark in Europe.

Authors:  I M E Wentholt; J B L Hoekstra; A Zwart; J H DeVries
Journal:  Diabetologia       Date:  2005-05-04       Impact factor: 10.122

Review 6.  Clinical use of real-time continuous glucose monitoring.

Authors:  Tadej Battelino; Jan Bolinder
Journal:  Curr Diabetes Rev       Date:  2008-08

7.  Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia.

Authors:  J C Pickup; H Keen; J A Parsons; K G Alberti
Journal:  Br Med J       Date:  1978-01-28

8.  A multicenter, randomized efficacy study of the EndoBarrier Gastrointestinal Liner for presurgical weight loss prior to bariatric surgery.

Authors:  Ruben Schouten; Carianne S Rijs; Nicole D Bouvy; Wim Hameeteman; Ger H Koek; Ignace M C Janssen; Jan-Willem M Greve
Journal:  Ann Surg       Date:  2010-02       Impact factor: 12.969

9.  Severe hyperkalaemia and ketoacidosis during routine treatment with an insulin pump.

Authors:  G Knight; A M Jennings; A J Boulton; S Tomlinson; J D Ward
Journal:  Br Med J (Clin Res Ed)       Date:  1985-08-10

10.  Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads.

Authors:  Robert G Hauser; Raed Abdelhadi; Deepa McGriff; Linda Kallinen Retel
Journal:  Heart Rhythm       Date:  2012-03-23       Impact factor: 6.343
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  4 in total

Review 1.  Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations.

Authors:  Guido Freckmann; Christina Schmid; Annette Baumstark; Malte Rutschmann; Cornelia Haug; Lutz Heinemann
Journal:  J Diabetes Sci Technol       Date:  2015-04-14

2.  Considerations for an institution for evaluation of diabetes technology devices to improve their quality in the European Union.

Authors:  Lutz Heinemann; Guido Freckmann; Theodor Koschinsky
Journal:  J Diabetes Sci Technol       Date:  2013-03-01

Review 3.  Self-monitoring of blood glucose in diabetes: from evidence to clinical reality in Central and Eastern Europe--recommendations from the international Central-Eastern European expert group.

Authors:  Leszek Czupryniak; László Barkai; Svetlana Bolgarska; Agata Bronisz; Jan Broz; Katarzyna Cypryk; Marek Honka; Andrej Janez; Mladen Krnic; Nebojsa Lalic; Emil Martinka; Dario Rahelic; Gabriela Roman; Tsvetalina Tankova; Tamás Várkonyi; Bogumił Wolnik; Nadia Zherdova
Journal:  Diabetes Technol Ther       Date:  2014-04-09       Impact factor: 6.118

4.  Insulin Infusion Set Use: European Perspectives and Recommendations.

Authors:  Dorothee Deiss; Peter Adolfsson; Marije Alkemade-van Zomeren; Geremia B Bolli; Guillaume Charpentier; Claudio Cobelli; Thomas Danne; Angela Girelli; Heiko Mueller; Carol A Verderese; Eric Renard
Journal:  Diabetes Technol Ther       Date:  2016-08-15       Impact factor: 6.118
  4 in total

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