Cleaning Validation for Reusable Medical Devices
Cleaning Validation for Reusable Medical Devices Published: March 20, 2025 Author: Anne M. Schuler Topics: reusable medical devices, cleaning validations, reprocessing of reusable medical devices, end-of-life conditioning, AAMI ST98, ISO 17664, medical device IFU, protein analysis, hemoglobin analysis Related Services: End-of-life conditioning, 21 CFR 801, instruction for use development Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients. If they are not properly reprocessed between use, there is a greater likelihood of microbial transmission and a high risk of infection. Cleaning is the physical removal of soil and contaminants, according to the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff effective cleaning should: