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Medical Device Endotoxin Testing for ANSI/AAMI ST72:2011/2016

#1
Good morning! We make a sterile class II device that collects a patients blood and then can be used to reinfuse that blood into the patient. We currently perform endotoxin testing on samples from each lot in order to comply with ANSI/AAMI ST72:2011/2016 and USP<85>. Here are my questions:

  • When I read the standard it is unclear whether or not it allows reduced testing (alternatives to testing every lot) for our type of product. The standard clearly allows alternatives to testing every lot if certain criteria are met (there's an entire section discussing this). What's unclear because of the wording, is whether or not a product intended to hold blood for reinfusion can be tested at a reduced level (less than lot by lot). What are your thoughts?
  • Have any of you justified doing a reduced endotoxin testing plan for a sterile class ll medical device. Have you been able to successfully explain and defend this approach?
 
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