| 翻訳と辞書 |
| Single Use Medical Device Reprocessing ： ウィキペディア英語版 |
Single Use Medical Device Reprocessing
Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used, (or, in some cases, a device opened from its original packaging but unused), medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use. Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled “Single Use Device” (SUDs), is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing. Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified third-party vendor. The U.S. revenue for reprocessed SUDs is estimated to be around $400 million annually.
==History of reprocessing in the United States==
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. After a thorough review by the U.S. FDA in 1999 and 2000,〔 the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, under the condition that third-party reprocessors would be treated as the manufacturer and would meet the same criteria as the original equipment manufacturers (OEMs) of the medical device.〔 Following the implementation of FDA regulation, the U.S. Congress codified these standards and other requirements in the Medical Device User Fee Act of 2002.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
■ウィキペディアで「Single Use Medical Device Reprocessing」の詳細全文を読む
スポンサード リンク
| 翻訳と辞書 : 翻訳のためのインターネットリソース |
Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.
|
|