Single-use Medical Devices Re-processing: Regulatory Status Quo / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 210-214, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-689830
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
United States
/
China
/
Equipment Reuse
/
Risk Assessment
/
Equipment and Supplies
/
Equipment Safety
Type of study:
Etiology study
/
Risk factors
Country/Region as subject:
North America
/
Asia
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2018
Type:
Article
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