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    Tissue Engineered Medical Products (TEMPs): A prelude to risk management

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    Authors
    Wassenaar C
    Geertsma RE
    Kallewaard M
    Type
    Report
    Language
    en
    
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    Title
    Tissue Engineered Medical Products (TEMPs): A prelude to risk management
    Translated Title
    Tissue Engineered Medical Products
    Publiekssamenvatting
    In de medische praktijk worden momenteel producten toegepast die gekweekte cellen bevatten. Deze producten kunnen 'Tissue Engineered Medical Products' (TEMPs) genoemd worden. Een literatuuronderzoek over de afgelopen 10 jaar is uitgevoerd om informatie te vergaren over de risico's die geassocieerd zijn met deze producten en om suggesties te leveren voor de ontwikkeling van strategie6n voor regelgeving. De informatie is gestructureerd door de EN-ISO 14971 norm voor risicomanagement toe te passen voor TEMPs. Regelgeving en standaarden voor andere medische producten, zoals geneesmiddelen, bloed/-producten en medische hulpmiddelen werden besproken in het licht van hun toepasbaarheid voor TEMPs. Producten die dierlijke cellen bevatten zijn buiten beschouwing gelaten. Gezien de grote hoeveelheid onderzoek die momenteel wordt uitgevoerd is het te verwachten dat in de komende jaren het aantal beschikbare producten zal toenemen. Vanwege de jonge historie van TEMPs zijn hun risico's nog niet goed bekend. Ervaringen met andere medische producten suggereren dat de belangrijkste risico's liggen op de terreinen van overdracht van ziekte, biocompatibiliteit en werkzaamheid. Alle betrokken partijen in de levenscyclus van TEMPs zullen besluiten nemen ten aanzien van de acceptatie van risico's. Deze afwegingen zijn bij voorkeur gebaseerd op vooraf vastgestelde standaarden. Voor TEMPs zijn deze momenteel niet beschikbaar, maar ze zullen naar verwachting in de komende jaren verschijnen. De meeste maatregelen voor risicomanagement die opgenomen zijn in de huidige regelgeving en normen voor bijvoorbeeld geneesmiddelen, bloed/-producten en medische hulpmiddelen worden in generieke vorm toepasbaar geacht voor TEMPs. Beheersmaatregelen dienen opgenomen te worden in regelgeving waarvan de structuur is afgestemd op en complementair is aan de bestaande Europese regelgeving voor medische producten.
    In medical practice products containing cultured cells have emerged. These products could be labelled Tissue Engineered Medical Products (TEMPs). A literature review covering the past ten years was carried out to collect information useful for the assessment of risks associated with these products and to provide suggestions on developing regulatory strategies. The information was structured according to the EN-ISO 14971 standard for risk management. Regulations and standards for other medical products, such as medicinal products, blood and blood products and medical devices were discussed as to their applicability for TEMPs. Products that contain cells of animal origin were excluded. In view of the large amount of research currently being carried out, the number of available products is expected to increase in the coming years. Due to the novelty of TEMPs, their risks have not been clearly identified yet. Experiences with other medical products indicate the most important risks as being related to transmission of disease, bio-compatibility and efficacy. All parties involved in the life cycle of TEMPs will take decisions on the acceptability of risks. These decisions are preferably based on pre-defined standards. Although these are not available for TEMPs at the moment, they can be expected in the (near) future. Most measures for risk control included in current regulations and standards covering products like medicinal products, blood and products and medical devices were found to be applicable in generic form to TEMPs. Control measures for TEMPs should be combined into a regulatory framework which is complementary to current European regulation on medical products and attuned to it.
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    URI
    http://hdl.handle.net/10029/259841
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