[Single-use Medical Devices Re-processing: Regulatory Status Quo].
Zhongguo Yi Liao Qi Xie Za Zhi
; 42(3): 210-214, 2018 May 30.
Article
em Zh
| MEDLINE
| ID: mdl-29885131
ABSTRACT
Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Reutilização de Equipamento
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Equipamentos e Provisões
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Segurança de Equipamentos
Idioma:
Zh
Ano de publicação:
2018
Tipo de documento:
Article