RTI Expanded Use Of BioCleanse To Soft Tissues Spurred By CDC Report
This article was originally published in The Gray Sheet
Executive Summary
Regeneration Technologies, Inc. plans to be fully processing its soft tissue product lines with BioCleanse by late August
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CryoLife Reviewing Tissue Sterilization Process In Wake Of Warning Letter
FDA is increasing its scrutiny over validation of tissue processing practices, as evidenced by a June 17 warning letter to CryoLife
CryoLife tissue infections
CDC issues morbity and mortality report identifying cases of allograft-associated bacterial infection March 14. Of 26 named cases, 14 were identified as using CryoLife-processed tissues. "Some of the infections are likely not due to the tissue," CryoLife President/CEO Steven Anderson maintained during a March 15 teleconference downplaying the report and emphasizing that it is a summary of previously released information. Though a measure of increased oversight by FDA is anticipated, the firm says it is not aware of "serious" infections of the rare bacterium Clostridium sordellii since a 23-year old Minnesota knee surgery patient implanted with Cryolife-processed human donor condyle tissue died Nov. 11, 2001 (1"The Gray Sheet" Dec. 24, 2001, In Brief)...