Tissue Engineered Medical Products (TEMPs): A prelude to risk management
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Series / Report no.
Open Access
Type
Report
Language
en
Date
2001-07-16
Research Projects
Organizational Units
Journal Issue
Title
Tissue Engineered Medical Products (TEMPs): A
prelude to risk management
Translated Title
Tissue Engineered Medical
Products
Published in
Abstract
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.
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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