Work to establish device ID numbers to reduce the risk of counterfeit products being used..members include the AHA, Catholic Health Association and more...letter send to the FDA...BD
A coalition of provider, consumer, research and quality organizations has sent a letter to Food and Drug Commissioner Andrew von Eschenbach asking for a timeline for when the agency will publish a rule to mandate a unique identification system for medical devices.
The FDA has been consulting with industry stakeholders on such a rule since 2005 and in recent months has come under pressure to finish the task. Legislation enacted last fall to revamp the FDA mandates a unique identifier on the label of medical devices. The law, however, does not specify what types of medical devices would fall under the regulations......“A national UDI standard has great potential for our entire healthcare system. It will improve patient safety while increasing efficiency for manufacturers by reducing the potential for counterfeit products being used on a patient.
0 comments :
Post a Comment