September 15, 2021
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...
See BlogSeptember 8, 2021
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...
See BlogSeptember 1, 2021
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...
See BlogAugust 25, 2021
ISO17664:2017[1] notes that disinfection can be carried out concurrently with manual cleaning of a medical device but does not provide any additional guidance. On the other hand, FDA specifies that cleaning steps should be validated separately and independently from disinfection...
See BlogAugust 18, 2021
The ISO 17664 series[1][2] as well as the FDA guidance for reprocessing medical devices in health care settings[3] specify that processing instructions should include the required quality of any water that is used for preparing solutions or for rinsing. A...
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