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  1. Book ; Online ; Thesis: Qualität der Kundeninformationen von Herstellern bei korrektiven Maßnahmen von Medizinprodukten zu In-vitro Diagnostika

    Hannig, Jürgen [Verfasser]

    Analyse der vom BfArM 2005 bis 2014 publizierten Daten

    2018  

    Author's details Jürgen Hannig
    Keywords Naturwissenschaften ; Science
    Subject code sg500
    Language German
    Publisher Universitäts- und Landesbibliothek Bonn
    Publishing place Bonn
    Document type Book ; Online ; Thesis
    Database Digital theses on the web

    Full text online

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  2. Article: Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    Hannig, Jürgen / Siekmeier, Rüdiger

    Advances in experimental medicine and biology

    2015  Volume 861, Page(s) 31–41

    Abstract: The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing ... ...

    Abstract The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of MEDDEV 2.12-1 rev 8. However, there are differences between German and English FSN, e.g. regarding the distribution to persons needing awareness, missing statement that the Competent Authority was informed and missing customer confirmation. Due to the importance of FSN for reduction of product related risks in FSCA type and content of FSN should be further improved.
    MeSH term(s) Equipment and Supplies/adverse effects ; Humans ; Patient Safety ; Pulmonary Medicine/instrumentation
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article
    ISSN 2214-8019 ; 0065-2598
    ISSN (online) 2214-8019
    ISSN 0065-2598
    DOI 10.1007/5584_2015_133
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

    Hannig, Jürgen / Siekmeier, Rüdiger

    Advances in experimental medicine and biology

    2015  Volume 873, Page(s) 87–100

    Abstract: The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance ... ...

    Abstract The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent FSCA were product modifications and customer information. The data suggest that there is an annually increasing number of FSCA on devices included in our study. Most FSN fulfill the criteria of MEDDEV 2.12-1 rev. 8. However, there are differences between German and English FSN, e.g., regarding the distribution to persons needing awareness, missing statement that a CA was informed, and missing customer confirmation. Due to the importance of FSN for reduction of product related risks in FSCA, the type and content of FSN should be further improved.
    MeSH term(s) Equipment Failure/statistics & numerical data ; Equipment and Supplies/statistics & numerical data ; Germany ; Guideline Adherence ; Humans ; Product Surveillance, Postmarketing ; Respiratory Tract Diseases/therapy ; Safety ; United Kingdom ; Ventilators, Mechanical/statistics & numerical data
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article
    ISSN 2214-8019 ; 0065-2598
    ISSN (online) 2214-8019
    ISSN 0065-2598
    DOI 10.1007/5584_2015_165
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Does customer information fulfill MEDDEV criteria in cases of product problems of in vitro diagnostics for infection testing?

    Hannig, Jürgen / Siekmeier, Rüdiger

    Advances in experimental medicine and biology

    2015  Volume 835, Page(s) 23–30

    Abstract: The European Directive 98/79/EC on in vitro diagnostics (IVD) regulates marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform responsible ...

    Abstract The European Directive 98/79/EC on in vitro diagnostics (IVD) regulates marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform responsible competent authority (CA) and public by field safety notices (FSN). We analyzed FSCA and FSN of IVD for infection testing (culture media, reagents, kits, control materials, as well as culture-based analyzers and their general consumables) published by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany in 2005-2012 in regard to the European Regulatory Framework of Medical Devices (MEDDEV). One hundred and sixty-nine FSCA were published and German and English FSN were found in 157 and 154 cases, respectively. FSN were clearly characterized as FSN in 110 German and 134 English cases and product names were provided in 157 and 154 cases, respectively. Lot numbers and other information for product characterization were available in 146 and 137 cases, respectively. The information regarding FSCA and product malfunction was provided in 157 and 151 and 144 and 136 cases and that regarding the product related risks with continued use of affected IVD in 116 and 116 cases, respectively. In 156 German and 152 English cases, manufacturers provided the information for risk mitigation, including retesting in 69 and 75 cases, respectively. Requests to pass FSN to persons needing awareness were found in 108 and 87 cases, and contact data were provided in 127 and 131 cases, respectively. We conclude that most FSN fulfilled the MEDDEV criteria. However, type and content of FSN should be improved to ensure a better mitigation of risks due to product failure.
    MeSH term(s) Communicable Diseases/diagnosis ; Consumer Product Safety ; Diagnostic Equipment/utilization ; Humans ; Molecular Diagnostic Techniques/ethics ; Molecular Diagnostic Techniques/standards ; Practice Guidelines as Topic ; Reagent Kits, Diagnostic/ethics ; Reagent Kits, Diagnostic/standards
    Chemical Substances Reagent Kits, Diagnostic
    Language English
    Publishing date 2015
    Publishing country United States
    Document type Journal Article
    ISSN 2214-8019 ; 0065-2598
    ISSN (online) 2214-8019
    ISSN 0065-2598
    DOI 10.1007/5584_2014_24
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Book: Die Saarregion

    Hannig, Jürgen

    Zeugnisse ihrer Geschichte

    (Quellenleseheft zur Regionalgeschichte)

    1995  

    Author's details hrsg. von Jürgen Hannig. Unter Mitarb. von Hildegard Ames
    Series title Quellenleseheft zur Regionalgeschichte
    Keywords Geschichtsunterricht ; Saarland
    Language German
    Size 151 S, Ill, 23 cm
    Publisher Diesterweg
    Publishing place Frankfurt am Main
    Document type Book
    ISBN 3425072250 ; 9783425072258
    Database Former special subject collection: coastal and deep sea fishing

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  6. Book ; Thesis: Elektroporation von Lipidvesikeln und Erythrozyten

    Hannig, Jürgen

    elektrooptische Parameter der Adsorption von Makromolekülen und des Membrantransports

    1993  

    Author's details Jürgen Hannig
    Keywords Erythrozyt ; Elektroporation ; Liposom
    Language Undetermined
    Size 71 Bl, graph. Darst
    Document type Book ; Thesis
    Thesis / German Habilitation thesis @Bielefeld, Univ., Diss. : 1993
    Note Mikroreprod. e. Ms. 71 Bl. : graph. Darst
    Database Former special subject collection: coastal and deep sea fishing

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  7. Book ; Thesis: Elektroporation von Lipidvesikeln

    Hannig, Jürgen

    elektrooptische Parameter der Adsorption von Makromolekülen und des Membrantransports

    1993  

    Author's details von Jürgen Hannig
    Language German
    Size 71 S, graph. Darst
    Edition [Mikrofiche-Ausg.]
    Document type Book ; Thesis
    Thesis / German Habilitation thesis @Bielefeld, Univ., Diss
    Note Mikrofiche-Ausg.: 1 Mikrofiche : 24x
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  8. Book ; Thesis: Consensus fidelium

    Hannig, Jürgen

    frühfeudale Interpretationen des Verhältnisses von Königtum und Adel am Beispiel des Frankenreiches

    (Monographien zur Geschichte des Mittelalters ; 27)

    1982  

    Author's details von Jürgen Hannig
    Series title Monographien zur Geschichte des Mittelalters ; 27
    Keywords Constituent power (Germanic law)/History ; Franks/Kings and rulers ; Franks/Nobility/History ; Law, Medieval ; Consensus fidelium ; Capitulare ; Verfassungsrecht ; Staatsrecht ; König ; Adel ; Fränkisches Reich
    Language German
    Size VIII, 343 S., 25 cm
    Publisher Hiersemann
    Publishing place Stuttgart
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Univ., Diss.--Saarbrücken, 1977
    ISBN 3777282189 ; 9783777282183
    Database Former special subject collection: coastal and deep sea fishing

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  9. Book ; Thesis: Consensus fidelium

    Hannig, Jürgen

    frühfeudale Interpretationen des Verhältnisses von Königtum und Adel am Beispiel des Frankenreiches

    (Monographien zur Geschichte des Mittelalters ; 27)

    1982  

    Author's details von Jürgen Hannig
    Series title Monographien zur Geschichte des Mittelalters ; 27
    Keywords Constituent power (Germanic law)/History ; Franks/Kings and rulers ; Franks/Nobility/History ; Law, Medieval ; Consensus fidelium ; Capitulare ; Verfassungsrecht ; Staatsrecht ; König ; Adel ; Fränkisches Reich
    Language German
    Size VIII, 343 S., 25 cm
    Publisher Hiersemann
    Publishing place Stuttgart
    Document type Book ; Thesis
    Thesis / German Habilitation thesis Univ., Diss.--Saarbrücken, 1977
    ISBN 3777282189 ; 9783777282183
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  10. Article: Direct observation of poloxamer 188 insertion into lipid monolayers.

    Maskarinec, Stacey A / Hannig, Jürgen / Lee, Raphael C / Lee, Ka Yee C

    Biophysical journal

    2002  Volume 82, Issue 3, Page(s) 1453–1459

    Abstract: P188, a triblock copolymer of the form poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) helps seal electroporated cell membranes, arresting the leakage of intracellular materials from the damaged cells. To explore the nature of the ... ...

    Abstract P188, a triblock copolymer of the form poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) helps seal electroporated cell membranes, arresting the leakage of intracellular materials from the damaged cells. To explore the nature of the interaction between P188 and cell membranes, we have constructed a model system that assesses the ability of P188 to insert into lipid monolayers. Using concurrent Langmuir isotherm and fluorescence microscopy measurements, we find that P188 changes the phase behavior and morphology of the monolayers. P188 inserts into both dipalmitoylphosphatidlycholine and dipalmitoylphosphatidylglycerol monolayers at surface pressures equal to and lower than approximately 22 mN/m at 30 degrees C; this pressure corresponds to the maximal surface pressure attained by P188 on a pure water subphase. Similar results for the two phospholipids indicate that P188 insertion is not influenced by headgroup electrostatics. Because the equivalent surface pressure of a normal bilayer is on the order of 30 mN/m, the lack of P188 insertion above 22 mN/m further suggests the poloxamer selectively adsorbs into damaged portions of electroporated membranes, thereby localizing its effect. P188 is also found to be "squeezed out" of the monolayers at high surface pressures, suggesting a mechanism for the cell to be rid of the poloxamer when the membrane is restored.
    MeSH term(s) Cell Membrane/metabolism ; Dose-Response Relationship, Drug ; Lipid Metabolism ; Lipids/chemistry ; Micelles ; Poloxamer/chemistry ; Surface-Active Agents/chemistry ; Time Factors
    Chemical Substances Lipids ; Micelles ; Surface-Active Agents ; Poloxamer (106392-12-5)
    Language English
    Publishing date 2002-02-22
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 218078-9
    ISSN 1542-0086 ; 0006-3495
    ISSN (online) 1542-0086
    ISSN 0006-3495
    DOI 10.1016/S0006-3495(02)75499-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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