FDA has been working to release a rule that will require that each medical device be uniquely identified by an identification number and bar code. This will enable each device to be targeted in case there are any issues at a later point. This requires that as the medical devices are made, they need to be tracked in a database somewhere that will inform where the device was made and under what conditions.
There are obvious advantages from the patient point of view, safety, traceability, reporting, reviewing of adverse event reports, documentation of device use for electronic medical records and distrubution chain but obviously there will also be consequences for the manufacturer now in additional cost in tracking each one of the devices that are made since it is not just a general bar code number but each label that will have to be customized. Good thing for label makers! This cost will be soon passed on to the patients or the insurers. FDA is asking for comments but you can get more information from the FDA website or the link for the proposed rule for the PDF file.