A. Overview of Reprocessing 「再處理」概述

Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. Reprocessing of reusable devices encompasses appropriate steps that begin in close proximity to the point of use of the device and, in general, involves the following three steps in sequence:
「再處理」定義為 已被使用或受到染污的醫材，經過再處理的確效程序後，該醫材適合用於單次使用。這些處理的設計目的是透過清潔程序，移除醫材上的污物和污染物；並透過消毒或滅菌程序殺死微生物(inactivate microorganisms)。可重複使用醫材的再處理，從醫材的使用點(point of use)開始，一般來說，按順序包括以下三個步驟：

1. Point-of-Use Processing 使用點處理:
   Reprocessing begins with processing at the point of use (i.e., close proximity to the point of use of the device), to facilitate subsequent cleaning steps. We define this as point-of-use processing, which includes prompt, initial cleaning steps and/or measures to prevent drying of soil and contaminants in and on the device.
   「再處理」開始於使用點處理（即，最接近醫材的使用點），以便於後續的清潔步驟。我們定義「使用點處理」包括：迅速的開始清潔步驟和措施，以防止醫材內和醫材上的污物和污染物乾燥。
    
2. Thorough Cleaning 徹底清潔:
   The device should be thoroughly cleaned after the point-of use processing. Generally, thorough cleaning is done in a dedicated cleaning area.
   在使用點處理後，應徹底清潔醫材。通常，在專用清潔區域進行徹底清潔。
    
3. Disinfection or Sterilization 消毒或滅菌:
   Depending on the intended use of the device, the device should be disinfected or sterilized, and routed back into use.
   根據醫材的預期用途，進行醫材的消毒或滅菌，然後重新使用。

資料來源:
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling_ Guidance for Industry and Food and Drug Administration Staff (March 17, 2015; US FDA)