Assessment of Prospect of Textile Technologies for Medical Devices

Struszczyk, M. H.; Olejnik, M.

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Tytuł artykułu

Assessment of Prospect of Textile Technologies for Medical Devices

Autorzy

Struszczyk M. H. , Olejnik M.

Treść / Zawartość

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Warianty tytułu

Ocena perspektyw technologii włókienniczych wyrobów medycznych

Języki publikacji

Abstrakty

This article includes the assessment of fibrous medical devices as well as borderline products from the point of view of expenditures necessary for the realisation of research and implementation in industrial and clinical practices, the range of practice implementation benefits as well as potential barriers restricting studies and implementation. The scale of investment necessary for the realisation of research and implementation in industrial practices in relation to the benefits of implementing them in practice as well as the limitations that restrict the research and implementation of selected fibrous technologies for medical devices are discussed in detail.

W artykule omówiono technologie włókienniczych wyrobów medycznych biorąc pod uwagę poziom koniecznych nakładów na realizację badań oraz wdrożenie rezultatów tych badań, skalę korzyści wdrożenia do praktyki oraz ewentualne, zidentyfikowane zgodnie z obecnym stanem wiedzy, bariery ograniczające procesy badawcze oraz komercjalizacyjne. Oszacowano także obecny stan zaawansowania badań nad włókienniczymi wyrobami medycznymi w kraju i za granicą wraz z próbą oceny stopnia ich gotowości do wdrożenia do praktyki i przewidywanego okresu komercjalizacji.

Słowa kluczowe

medical devices textile technologies foresight dressing implants

wyroby medyczne technologie włókiennicze ubieranie implanty

Wydawca

Sieć Badawcza Łukasiewicz - Łódzki Instytut Technologiczny

Czasopismo

Fibres & Textiles in Eastern Europe

Rocznik

2012

Tom

Vol. 20, no. 6A (95)

Strony

28--36

Opis fizyczny

Bibliogr. 33 poz.

Twórcy

autor

Struszczyk M. H.

autor

Olejnik M.

Poland, Łódź, The Institute of Security Technology MORATEX

Bibliografia

1. Struszczyk MH, et al, Research report technological subject – T10. Medical Textile Products, Institute of SecurityTechnologies ‘MORATEX’, Łódź, 2010.
2. MEDDEV 2.1/3 rev.3, Borderline products,drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative,December 2009, http://ec.europa.eu/health/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf[2011-12-10].
3. Common Technical Document for the Registration of Pharmaceuticals for Human Use.-Quality Overall Summary of Module 2 and Module 3: Quality, July 2003, http://www.tga.gov.au/pdf/euguide/eumod3.pdf [2011-12-10].
4. Wilson L, et. al. Annual direct cost of urinary incontinence. Obstet & Gynaecol 2001; 98: 398-406.
5. US Surgical Sutures Market: Surgical Procedures Growth to Drive Demand,Aug-2009.
6. The EU market for wound care and wound closure products, CBI Market Survey, 2009, http://www.icci.com.pk/data/downloads/10/1169838317_1.pdf[2011-12-10].
7. Cody J, et al. Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape (TVT)for treatment of urinary stress incontinence.Report commissioned by NHS R&D HTA Programme on behalf of the national Institute for Clinical Excellence 2002, http://www.hta.ac.uk/pdfexecs/summ721.pdf [2011-12-10].
8. Albert D, et al. Biological Evaluation Of Medical Devicesthe Role Of Chemical And Material Characterisation, Business Briefing: Medical Device Manufacturing& Technology, 2004, 48-51.
9. Struszczyk MH. Vascular Prostheses –Harmonized Standards, MedTex 2005, Proceedings of Vth International Scientific Conference, ISBN 83-911012-3-1,32.
10. Struszczyk MH. Introduction of Chitin and its Derivatives for the Design of Medical Devices Based on the Requirements of EU Directive 93/42/EWG, Proceedings of the 8th International Conference of the European Chitin Society,ed. S. Senel, K.M. Varum, M. Sumnu,A. Hinncal, ISBN 978-975-491-250-0,2007, 186-192
11. MEDDEV 2.1/3 rev. 3, Borderline products, drug-delivery products and medical devices incorporating, as integralpart, an ancillary medicinal substanceor an ancillary human blood deriva tive, December 2009, http://ec.europa.eu/health/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf [2011-12-10].
12. Struszczyk MH, et al. Synthetic Vascular Prosthesis, Polimery w Medycynie,2002; 37 (1-2): 13-22.
13. Struszczyk MH, et al. Synthetic Vascular Prostheses - Presence and Future of Vascular Surgery, IV Medical Textile Conference MEDTEX 2002 , Lodz 2002,ISBN 83-89003-41-4, pp. 87-93.
14. Struszczyk MH, et al. Surgical Meshes– Physiological Aspects, MedTex 2005, Proceedings of the Vth International Scientific Conference, ISBN 83-911012-3-1, 112.
15. US Markets for Wound Management Products, Medtech Insight, RP-181303.
16. All Change in the Advanced Wound CareMarket 2009, A complete guide to this dynamic market sector, Espicom Business Intelligence Ltd, May 2009,
17. Chilarski A, et al. Novel Dressing Materials Accelerating Wound Healing Made from Dibutyrylchitin, Fibres & Textiles in Eastern Europe 2007; 15, 4 (63), 77-81.
18. Chakft N, et al. Impregnated Polyester Arterial Prostheses: Performance and Prospects, Ann Vasc Surg 1999; 13:509-523
19. Czaja W, et al. Microbial cellulose—the natural power to heal wounds, Biomaterials,2006; 27: 145–151.
20. Ciechanska D. Multifunctional Bacterial Cellulose/Chitosan Composite Materials for Medical Applications, FIBRES &TEXTILES in Eastern Europe 2004; 12, 4 (48): 69-72.
21. Niekraszewicz A, Kucharska M, Wawro D, Struszczyk MH, Rogaczewska A.Partially resorbable hernia meshes, Progress on chemistry and application of chitin and its derivatives, vol. XII, ed.by M. Jaworska, Polish Chitin Society,2007, 109-114.
22. Niekraszewicz A, Kucharska M, Wawro D, Struszczyk MH, Kopias K, Rogaczewska A. Development of a Manufacturing Method for Surgical Meshes Modified by Chitosan, Fibres & Textiles in Eastern Europe, 2007; 15, 3(62): 105-109.
23. Niekraszewicz A, Kucharska M, Struszczyk MH, Rogaczewska A, Struszczyk K.Investigation into Biological, Composite Surgical Meshes, Fibres & Textiles in Eastern Europe, 2008; 16, 6(71): 117-121.
24. Mazalevska O, Struszczyk MH, Chrzanowski M, Krucińska I. Application of Electrospinning for Vascular Grafts Performing– Preliminary Results, Fibres &Textiles in Eastern Europe, 2011; 19,4(87): 46–52.
25. Struszczyk MH, Komisarczyk A,Krucińska I, Kowalski K, Kopias K. Ultra-Light Knitted Structures for Application in Urologinecology and General Surgery – Optimization of Structure, FiberMed11 28-30 June 2011, Tampere, Finland,ISBN 978-952-15-2607-7
26. Ramos-e-Silva M, et al. New Dressings,including tissue-engineered living skin.Clin. Dermatol. 2002; 20: 715-723.
27. BioTissue Technologies AG, The Wall Street Transcript, July 22, 2002.
28. Petkow L, et al. Nowoczesne opatrunki w leczeniu przewlekłych ran i owrzodzeń podudzi ze szczególnym uwzględnieniem opatrunków hydrokoloidowych,Przegląd Flebologiczny,2002; 10(4): 101 – 105.
29. Goldstein HS. Selecting The Right Mesh, Hernia, 1999; 3: 23-26.
30. Niekraszewicz A, et al. Research into Developing Antibacterial Dressing Materials,Fibres & Textiles in Eastern Europe,2007; 15, 1(60): 99-103.
31. Shuangyun L, et al. Construction, application and biosafety of silver nanocrystalline chitosan wound dressing, Burns, 2008; 34: 623-628.
32. Kostanek K, Struszczyk MH, Domagała W, Krucińska I. Surface Modification of the Implantable Knitted Structures for Potential Application In Laparoscopic Hernia Treatments, FiberMed11 28-30 June 2011, Tampere, Finland, ISBN 978-952-15-2607-7.
33. Struszczyk MH, Gutowska A, Kowalski K, Kopias K, B Pałys, Komisarczyk A, Krucińska I. Ultra-Light Knitted Structures for Application in Urologinecology and General Surgery, – Optimization of Structure in the Aspect of Physical Parameters,Fibres & Textiles in Eastern Europe 2011; 19, 5(88): 92-98.

Typ dokumentu

Bibliografia

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