TORONTO, ON--(Marketwired - October 14, 2016) - During a live broadcast industry expert Dr. Michael Brady, Director of Microbiology Services at Toxikon Corporation will aid medical device designers and manufacturers navigate the reprocessing requirements and successfully execute a manual cleaning validation.
Reusable medical devices (RMD) acquire varying levels of organic residue during clinical use. Prior to re-use, this residue must be removed as failure to effectively clean devices can result in loss of device function(s), the inability to subsequently disinfect or sterilize, and increased patient risk of infection. While the responsibility for ensuring reusable devices are effectively cleaned during reprocessing is shared, it begins with the device manufacturer. Manufacturers are required to provide the end-user with appropriate and validated cleaning instructions for use (IFU), increasingly under regulatory scrutiny.
Official guidance documents such as AAMI TIR12, AAMI TIR30, and the FDA's Reprocessing Medical Devices in Health Care Setting (2015) provide critical direction and considerations. However, reusable medical designs vary, devices have distinct classifications and clinical applications, and there are multiple reprocessing options. This complexity contributes to some uncertainty in the structure of a validated cleaning procedure and no single study design is appropriate for all device types. Proper selection of the most appropriate methodology is essential for a successful RMD manual cleaning validation.
This program will present various aspects of manual cleaning validation testing: overall considerations, selection of artificial test soil, soil challenge sites and dwell time, cleaning reagents, manual cleaning techniques, rinse requirements, and acceptance criteria. It will also cover life cycle considerations and challenges in the design of an appropriate validation study.
Join Dr. Michael Brady on Wednesday, October 26, 2016 at 11am EDT (4pm BST/UK). For more information or to register for this complimentary event, visit: Reprocessing Medical Devices: Approaches and Considerations for Manual Cleaning Validations
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