DOI: 10.1097/SGA.0b013e3181abb55c
,
,
PMID: 19506444
Issn Print: 1042-895X
Publication Date: 2009/05/01
Facebook
Twitter
LinkedIn
Email
 |
Checking for direct PDF access through Ovid | |
Excerpt
Critical Medical Devices refer to instruments that may be introduced directly into the bloodstream or into other normally sterile areas of the body (American Society for Testing and Materials [ASTM], 2000). These devices break the mucus membrane and/or come into contact with sterile tissue or the vascular system.
Reusable Device refers to an instrument designed and validated by the manufacturer to be used more than once, provided that after each use, an appropriate reprocessing protocol and functionality check is performed (ASTM, 2000).
Reuse refers to the repeated use or multiple use of any medical device including devices intended for reuse or single use, with reprocessing (cleaning, disinfection, or sterilization) between uses (United States Food and Drug Administration [FDA], 2001).
Reprocessed is defined as follows:
Single-Use Device (SUD) refers to an instrument designed for one-time use only, on one patient, during a single procedure. SUDs are not designed by their manufacturers to be reprocessed and/or used on another patient. The manufacturer's label on these devices does not include reprocessing instructions and may or may not identify the device as an SUD (FDA, 2000). SUDs are also referred to as disposable devices (FDA, 2000).
