Category Archives: Microbiology

Bioburden Basics for Sterile Medical Devices

Bioburden Basics for Sterile Medical Devices
Author: Laura Lakemeyer, Senior Microbiology and Quality Consultant Assessing bioburden is a critical process monitoring step in the manufacturing of sterile medical devices. A product’s natural bioburden is an estimation of the microbiological contamination level of the device and is usually measured once manufacturing has been complete, but, prior to the sterilization process. Failure to…
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Microbiology
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Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements

Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements
By: Laura Lakemeyer, Senior Microbiology and Quality Consultant Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances The American National Standards Institute (ANSI) and the Advancement of Medical Instrumentation (AAMI) recently released substantial revisions to the updated standard ANSI/AAMI ST72:2019, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing.…
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Microbiology, Regulatory Affairs
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New study indicates Coronavirus can linger for three days on plastic and stainless steel

New study indicates Coronavirus can linger for three days on plastic and stainless steel
What should we do if a returned product comes back  potentially contaminated? What if an employee tests positive for COVID-19? In the wake of the coronavirus pandemic, clients have been contacting QA Consulting over the past few weeks with important questions. If your company receives a medical device shipment back from a customer such as…
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Microbiology, Quality Systems, Safety
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Dissecting the FDA’s Expectations for Biocompatibility of Medical Devices: Five Key Considerations

The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process replacing the historical "Blue Book Memorandum #G95-1" (1995). The new guidance, released in June, is a substantial upgrade from its predecessor and serves the purpose of guiding…
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Microbiology
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