Reprocessing of Reusable Medical Devices
- Posted by Mark Goins
- On January 10, 2017
- microbiology
The FDA requires manufacturers of reusable medical devices to provide reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. Developing and validating these instructions can be a complex and highly specialized activity. Guidance on this process can be found in a document created by the FDA Center for Devices and Radiological Health entitled, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.” The guidance indicates, the labeling of a reusable medical device should clearly specify the appropriate material and equipment parameters to adequately reprocess the devices. Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection. The validation of the cleaning and disinfection process may also be a necessary part of Premarket Notification - also called PMN or 510(k). (more…)
ella contamination in dairy powder, paprika powder, black pepper, toasted oats cereal, peanut butter, and chia powder. Research has shown that while pathogens do not thrive in low moisture foods, they do survive very well in these dry environments when stored at room temperature or above. In the cases when the low moisture products are reconstituted, the bacteria proliferate when the moisture level is increased. Bacterial strains that survive in these dry products have proven to withstand low pH environments, such as the stomach, and therefore reach the intestines where they cause the most problems for the consumer. Due to their benign reputation, low moisture foods are often left off the list of matrices validated when rapid pathogen detection products are developed and approved. Therefore, a qualified laboratory must perform a validation study to indicate proficiency of a rapid method for these troublesome product types. 