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    Assessment of files of in vitro diagnostic devices for self-testing

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    Authors
    van Drongelen AW
    de Vries CGJCA
    Pot JWGA
    Series/Report no.
    RIVM report 360050017
    Type
    Report
    Language
    en
    
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    Title
    Assessment of files of in vitro diagnostic devices for self-testing
    Translated Title
    Beoordeling van dossiers van in-vitro diagnostische zelftesten
    Publiekssamenvatting
    Steeds vaker voeren mensen medisch-diagnostische testen uit zonder begeleiding van een arts. De testen en de gebruiksaanwijzing zijn echter niet altijd goed afgestemd op de gebruiker, wat kan leiden tot onjuiste testuitslagen. Dit blijkt uit onderzoek van het RIVM naar medisch-diagnostische zelftesten, gebaseerd op door de desbetreffende fabrikanten aangeleverde documentatie. Het gaat om ovulatietes-ten, bloedglucosemeters voor diabetici en een test voor de geslachtsziekte Chlamydia. Fabrikanten van dergelijke testen zijn verplicht de risico's van hun producten systematisch te signaleren en analyseren. Zonodig moeten zij hun product verbeteren of informatie verstrekken over risico's die samenhangen met het gebruik van het product.
    Tekortkomingen zijn gevonden in de manier waarop fabrikanten de risicoanalyse uitvoeren. Zo worden ervaringen met een product en incidenten onvoldoende in de risicoanalyse verwerkt. Daarnaast staan in de gebruiksaanwijzing risico's die niet in de risicoanalyse zijn vermeld maar daarin wel horen te staan. Omgekeerd staan niet alle risico's die volgens de risicoanalyse in de gebruiksaanwijzing moeten staan, er daadwerkelijk in. Verder bleek de opzet van studies onder leken niet altijd geschikt om de bruik-baarheid van het product voor de Nederlandse markt te testen.
    Het RIVM heeft de kwaliteit van dossiers van acht medisch-diagnostische zelftesten onderzocht. Van de opgevraagde dossiers voor zogeheten hoogrisicotesten (HIV, prostaatkanker en Chlamydia) is slechts een dossier voor Chlamydiatesten ontvangen en beoordeeld. De totale respons was 57 procent van de in het onderzoek opgenomen fabrikanten. Het onderzoek is uitgevoerd in opdracht van de In-spectie voor de Gezondheidszorg.

    An increasing number of people are now using medical diagnostic devices without having consulted a physician. Incorrect results could be obtained using these devices because they are not always suitable for the user and the instructions for use are not always clear. This is the outcome of an RIVM investigation into medical diagnostic self-tests, based on the documentation submitted by their manufacturers. The investigation concerned ovulation tests, blood glucose meters for diabetics and a self-test for the sexually transmitted disease Chlamydia. Manufacturers of such devices are required to systematically identify and analyse the risks associated with these devices. The product has to be improved or infor-mation about its use and related risks provided to the user wherever necessary.
    Shortcomings were found in the way that the risk analyses were carried out by the manufacturers. An issue is that experiences with the product and related incidents have been insufficiently incorporated into the risk analyses. Moreover, risks mentioned in the instructions for use were not always present in the risk analysis, as they should be. Vice versa, the residual risks, identified in the risk analysis for in-corporation into the instructions for use, were not always included in the instructions for use. A further shortcoming related to the fact that lay user studies performed by the manufacturer did not always ap-pear suitable for testing the usability of the self-test for the Dutch market.
    The quality of files of eight medical diagnostic self-tests was assessed by the RIVM. Of the requested high risk self-tests (e.g. HIV, prostate cancer and Chlamydia) only one file (a Chlamydia self-test) was received. The total response was only 57% of all included manufacturers. This investigation was conducted by order of the Dutch Health Care Inspectorate.
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
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    IGZ
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