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Author: Emily Mitzel





August 19, 2019

Successful Medical Device Cleaning Validations: What You Need to Know

Validating cleaning instructions for a tray of reusable orthopedic devices is an important milestone on the path to obtaining FDA clearance for those devices. Although the process of validation can seem daunting at first, medical device manufacturers seeking to successfully...

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October 25, 2017

2017 Fall AAMI Sterilization Standards Meetings Update

The AAMI Sterilization Standards Meetings were held on 16-18 October 2017.  There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance. One item of interest from USFDA/CDRH is that...

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April 3, 2017

2017 Spring AAMI Sterilization Standards Meeting Update

On March 20-23, 2017, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Committee Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF...

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March 10, 2017

Considerations for Third-Party Reprocessing of Single-Use Medical Devices

Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable health care providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection,...

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October 12, 2016

Reprocessing Single-Use Devices

Some devices that are marketed and validated for single use are now being used multiple times in clinical settings. To save money and to comply with green initiatives, hospitals are moving towards using third-party reprocessed single-use devices (SUDs). However, reusing...

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