At last week’s GS1 Global Healthcare Conference, Jay Crowley, the FDA’s point man for the unique device identification (UDI) system, said he expects (but don’t hold him to it) the proposed UDI rule to be out in June. Those who are counting on the regulation to finally get the healthcare industry to move forward with standards for product identification have questioned why it has taken the FDA so long, given that legislation calling a UDI system was passed in 2007. But a closer look at what the FDA and regulators from other countries have been up to for the past four years demonstrates a deliberate attempt to ensure the regulation’s success on a global level.
Jay and his counterpart from the European Commission, Rodolphe Muñoz, both made the case at the GS1 conference for a globally applicable UDI System without regional adaptations. They encouraged attendees and other interested parties to review and provide comments by April 30, 2011 on a draft UDI document issued by the Global Harmonization Task Force (GHTF). The document is designed to provide guidance to regulators around the world on how to establish a UDI system for medical devices. The hope is that, if multiple countries follow the same guidelines, they can reduce variation in how such systems are set up and minimize the costs of regulatory compliance for global suppliers who often have to comply with inconsistent and at times conflicting regulations in different countries.
One of the biggest challenges, according to Muñoz, has been gaining agreement on how many and which data attributes need to be provided on the various devices that are covered under a UDI regulation. The concern is that if too much information is required, it will be harder for suppliers to comply, but if not enough information is required, some countries may decide that they need to go it alone and add additional data attributes, defeating the purpose of global harmonization. For example, there is general agreement that manufacturers should report whether products are sterile or not, but one country has also requested information on the method of sterilization.
The primary purpose of a UDI system is to make it easier to track medical products through distribution and use. Better tracking is particularly important for regulators who want a more effective way to deal with adverse events and recalls. While not their primary intent, regulators also believe a UDI can yield additional benefits in terms of supply chain efficiency and data capture to better understand the efficacy of products used in patient care.
I encourage you to take the time to review and comment on the draft document. It’s also a great place for manufacturers to start thinking about how they will prepare for the UDI, even in advance of the issuance of the proposed rule. The document provides a good overview of what a UDI system in the US will look like and what manufacturers will need to do to be in compliance. For those who want to know more, plan to join GHX and Crowley for a webinar on preparing for the UDI, scheduled for May 24 at 11 am ET. If you would like to be notified when you can register for the event, contact Nancy Pakieser at firstname.lastname@example.org.