1.
Biomed Instrum Technol
; 55(s3): 12-16, 2021 Mar 01.
Article
in English
| MEDLINE
| ID: mdl-34153992
ABSTRACT
In 2015, the Food and Drug Administration (FDA) updated its guidance on test methods for cleaning validations for reusable medical devices. The changes include the condition and contamination of devices, test samples and controls, cleaning process performed during validation, extraction methods, and endpoints. This article reviews the FDA's changes to cleaning validations. Examples are presented using flexible endoscopes in order to provide a practical guide to performing cleaning validations.