Open AccessApplication of Processing Guidance: Case Study of Cleaning Validations on Flexible Endoscopes
Author(s) -
Nupur Jain,
Samaniego Chávez,
Alpa V. Patel
Publication year - 2021
Publication title -
biomedical instrumentation and technology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.206
H-Index - 28
eISSN - 1943-5967
pISSN - 0899-8205
DOI - 10.2345/0899-8205-55.s3.12
Subject(s) - icon , citation , download , computer science , information retrieval , world wide web , multimedia , database , programming language
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.