Research and Reflection on Reprocessed Medical Devices Supervision.
10.3969/j.issn.1671-7104.2018.04.016
- Author:
Xiaodong YANG
1
;
Wei XU
1
;
Yuji WANG
1
;
Jiaxin TIAN
1
Author Information
1. Center for Medical Device Evaluation, CFDA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
medical device;
reprocessing;
supervision
- MeSH:
Equipment Reuse;
Equipment Safety;
United States
- From:
Chinese Journal of Medical Instrumentation
2018;42(4):286-288
- CountryChina
- Language:Chinese
-
Abstract:
Under the precondition of ensuring safety and effectiveness, whether to reuse reprocessed medical devices to reduce the medical expenses has become the focus of the relevant regulatory authorities in our country. In this paper, we studied the regulatory policy for reprocessed medical devices in major international economies, such as United States, Japan, European Union and so on. From the regulatory and technical level, we thought about the risks of supervising reprocessed medical devices, and analyzed the ideas and risk concerns of supervising reprocessed medical devices to provide reference for regulation of such devices in our country.
