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Nicholas Brydon

Head of Sterilization at NextBeam

Nicholas Brydon is currently the Head of Sterilization at NextBeam. He has a background as a leader and scientist, showcasing a diverse range of expertise in his field. His professional activities include engaging in discussions about sterilization validation and presenting at industry meetings, such as the Council of Ionizing Radiation Measurements and Standards.123

Brydon is affiliated with the University of Florida, indicating a strong academic foundation that complements his professional roles.1 His LinkedIn profile highlights his commitment to advancing practices in sterilization, reflecting his leadership in the sector.12

Highlights

May 7 · linkedin

If you have something to say about #medicaldevices #sterilization and #endotoxin, this is a great time to get involved!

Endotoxin of terminally sterilized devices has been getting a lot more attention since the updated FDA guidance on premarket submissions for sterile devices added "implants" to the list of products in scope for endotoxin limit criteria. There is some explanation in past versions of ST72 for the historical exclusion of orthopedic devices from endotoxin testing.

There are a few current and upcoming projects for updating endotoxin standards:

  • AAMI/ST72:2019 is under review by AAMI ST/WG08 to look at updating the standard for better alignment with ISO 11737-3 and (possibly) to include some information on recombinant endotoxin testing as an alternative to LAL and (hopefully) to update some of the language related to sterilization effect on endotoxin based on some recent papers
  • ISO 11737-3 - published in 2023, this should come up for review next in 2028. Updates to the international standard are a bit harder to predict that far out and with more people involved but there is a good possibility that some of the updates going through now in ST72 will be reflected in future versions of the international standard.
  • USP <86> new general chapter "Bacterial endotoxin test using recombinant reagents". The latest news release I've seen on this has the expert committee voting around the last week of June with possible publication between November 2024 and May 2025 if approved.
Feb 1 · linkedin

For any fans of #medicaldevices and #endotoxin there is a MASSIVE new paper demonstrating reduction in bacterial endotoxin activity following sterilization. Link to paper in comments -

The paper tested a variety of relevant medical device materials (stainless steel, glass, nylon, polyethylene, and titanium alloy) in dry heat, moist heat, EO and electron beam and also included several types of endotoxin.

Results? All four sterilization technologies demonstrated reduction in endotoxin activity with some variation on different material substrates and source of endotoxin. This is a substantial development because so many papers and books have said for years - always without data or supporting references - that various sterilization methods do not reduce endotoxin. Some device manufacturers have looked into this in the past but I'm not aware of any that have previously published test results. Massive thanks to #jnj and the study team Dr. Gerald McDonnell Allan Kimble Jim Hauschild for bringing this to light.

Hopefully this will help drive updates to USP <85> and <161>, ST72, and ISO 11737-3 to recognize the impact of sterilization on endotoxin.

Related Questions

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Nicholas Brydon
Nicholas Brydon, photo 1
Nicholas Brydon, photo 2
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