Análise legal das informações sobre instruções de uso presentes nas embalagens de limas K-File
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2010-06
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Resumo
Introduction: Anvisa classifies endodontic files as medical products
and, therefore, all commercial trademarks sold in Brazil must have an
adequate registration. To achieve this registration, several information
on the product should be available to consumers (dentists) in order
to allow its proper use and to avoid possible accidents. Objective:
To examine whether the information set forth in endodontic K-Files
packages, labels and instructions for use are in accordance with current
legislation, especially those established by Anvisa and the Consumer’s
Defense Code (CDC). Material and methods: 29 retail dental centers
were visited and 11 samples of different commercial trademarks of KFiles
first series (15-40) were obtained, and the information available
on them was submitted to an analysis based on legal orders. Results:
In all trademarks, there was no information available on how to use
the product and on the means of storing the files before/after use. Only
SybronEndo trademark warned about the risks of using the files and
reported criteria of number of use and disposal. Only Mani trademark
adequately informed on how to sterilize. Conclusion: It was verified
that certain rules established by Anvisa and CDC are being disregarded
concerning the display of certain necessary and required information
that should be included on labels, instructions for use or K-Files
commercial packages. Considering the large amount of information that
must be available for the proper use of endodontic files, it is important
that they are displayed preferably by means of instructions for use in
the commercial package to be acquired by dentists.
Descrição
Palavras-chave
Defesa do consumidor, Odontologia legal, Instrumentos odontológicos, Consumer advocacy, Dental instruments, Legal dentistry
Citação
SILVA, Rhonan Ferreira da et al. Análise legal das informações sobre instruções de uso presentes nas embalagens de limas K-file. RSBO: revista sul-brasileira de odontologia, Joinville, v. 7, n. 2, p. 200-207, jun. 2010.