COVID-19
COVID-19 PANDEMIC
As COVID-19 continues to be top of mind for many in the U.S. and worldwide, we’d like to share the measures that California Transplant Services, Inc. is taking to ensure the health and well-being of […]
skull flap
hospitals
Technical Bulletin – Labeling
Please remind your operating room staff: Do not provide any additional labeling on the tissue packaging other than the provided label. These can only be “labeled” as sterile if they have completed sterility testing under […]
FDA regulations
Autologous Recordkeeping Q & A
We were recently asked by a hospital if they really need to keep the pink copy of the Autologous Tissue Preservation form. The question was: The information form we fill out in the autologous […]
FDA regulations
FDA Proposed Guidance for Same Surgical Procedure Exemption
A DRAFT guidance for industry was published in October 2014 by the FDA for Same Surgical Procedure Exemption. I highlighted the line 171 which establishes the need for hospitals to register with the FDA as […]