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Tuesday, October 17, 2006

Reprocessing and re-use of single use medical devices

Problem:
Single use medical devices cannot be re-used without FDA compliant reprocessing procedures. Essentially reprocessing a single use device constitutes manufacturing it which requires conmpliance with FDA medical device manufacturing regulations. Appropriate cleaners must be chosen and cleaning validations done.

Solution:
Alconox, Inc. cleaners can be used for medical device reprocessing cleaning. Alconox provides technical bulletins, books, and support for the use and validation of their cleaners. See the medical device validation section by clicking on the related Pharmaceutical Cleaning Validation link located at the upper right hand corner of the page and then clicking on the "see printable version" button on the upper right hand corner which will take you to http://www.alconox.com/downloads/pdf/PCV42301.PDF. This document contains information about identifying residues on medical devices, selecting residue detection methods, selecting medical device surface sampling methods, establishing acceptable residue limits, validation of the methods, writing standard operating procedures, traning operators to follow the procedures, and a directory of analytical methods to use to detect specific Alconox brand detergents on the surface of a medical device that is being cleaned for re-processing. Alconox cleaners are both efficient at the removal of post use residues on medical devices as well as having the documentation and support needed for compliance with FDA regulations governing medical device re-use and reprocessing

1 comment:

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