What is a RENALIN Certification Agreement?
A. As directed by the US Food and Drug Administration, (FDA) in their 518(a) order, Minntech Renal Systems is required to obtain a signed agreement by all dialysis facilities using RENALIN Cold Sterilant, to ensure that they conform with the 1986 Association for the Advancement of Medical Instrumentation Recommended Practice for Reuse of Hemodialyzers (AAMIROH-1986) and Minntech Renal System’s guidelines. The FDA prohibits the sale of RENALIN Cold Sterilant to dialysis facilities which have not returned a signed copy of this agreement. The agreement covers five different categories of RENALIN Cold Sterilant usage. The customer needs to determine which category or categories accurately describe their RENALIN Cold Sterilant usage. All centers that are RENALIN customers as of April 1, 1993 have a signed Certification Agreement on file. New customers are requested to send a Certification Agreement, signed by their Medical Director or Administrator.
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