Message from Michigan: Reprocess SUD’s ONLY with FDA Registered Reprocessors

On March 26, 2010, the State of Michigan Legislature enacted a bill amendment that in essence limits the reprocessing of single use devices only to formally cleared Medical Device Reprocessors who strictly adhere to the guidelines and protocols issued by the FDA. The language of this bill outlines the restrictions and possible penalties to healthcare facilities who attempt to reprocess their own Single Use Devices. For example, a Michigan-based facility which reprocesses Phaco Tips on their own could be subject to a $50,000 fine and up to 10 Years in prison.

Healthcare facilities are, in turn, encouraged to use a Medical Device Reprocessor who is registered with and regulated by the FDA, such as MEDISISS.

To read the enacted bill, click here.