AMDR Submits Comments to FDA’s Reprocessing of Reusable Medical Devices Docket

On September 26, 2011, AMDR submitted comments to FDA’s docket seeking input on the reprocessing of reusable medical devices:

In AMDR’s August 1, 2011 comments, we highlighted that FDA’s experience in regulating the reprocessors of SUDs applies to its current efforts to identify factors affecting the reprocessing of reusable devices.  As we explained, FDA already has in place a long-standing, stringent regulatory framework for reprocessors of SUDs.  The result of FDA’s regulatory requirements for SUD reprocessors is that reprocessed SUDs are as safe and effective as original devices and pose no increased risk to patients.  In addition to the decade of safe clinical use, both FDA and the independent U.S. Government Accountability Office (GAO) have concluded that there is no evidence of harm to patients from FDA-regulated reprocessed SUDs.[1]

AMDR is proud to have worked with FDA to ensure that our reprocessed SUDs are safe and effective for clinicians and patients.  The leadership demonstrated by FDA in choosing to legitimize the third-party SUD reprocessing industry through regulation is now looked at as a model.  AMDR believes that FDA is again poised to demonstrate such leadership with these new activities aimed at encouraging proper reprocessing of reusable devices….