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Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here are four important things you need to know about particulate testing on medical devices. First, while there are some device-specific...
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...
Deciding which disinfection level applies to your non-critical device can be tricky. Non-critical devices are defined as devices that will either only contact intact skin but do not penetrate it, or which have no direct patient contact but may become...
On May 20, 2021, FDA published a document (“Safety of Metals and Other Materials Used in Medical Devices”) requesting input regarding the best methods to use in conveyance of material information for a broader range of medical devices to both...
FDA’s guidance on reprocessing re-usable medical devices[1] indicates that in addition to reprocessing instructions that allow for thorough cleaning, an appropriate microbicidal process should be in place. Which terminal processing step should be included will depend on the device’s potential...
