The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
ISO 17664:2017[1] as well as FDA[2] state that if a medical device is intended to be sterilized, at least one validated sterilization method must be specified in the IFU. Consequently, if devices are intended to be steam sterilized, at least...
The FDA guidance on reprocessing medical devices in health care settings: validation methods and labeling states, that when performing cleaning validations, the artificial test soil that is chosen should allow for at least two clinically relevant soil components to be...
ISO 17664[1] and ISO17664-2[2] clearly state that all reprocessing instructions provided in the Instructions For Use (IFU) document must be validated; and FDA[3] as well as other guidance documents provide information on how these validations should be performed. However, that...
It is important that all reprocessing instructions included in the Instructions For Use document are validated to ensure patient safety and minimize healthcare-acquired infections; however, validating the reprocessing instructions for every device is a costly affair. Luckily, when an array...
Choosing a chemical disinfectant will depend on a combination of considerations with regards to the reprocessing instructions, location of the users, possible adverse effects on biocompatibility/patient safety and device materials. Reprocessing instructions A first consideration when selecting the proper disinfectant...
