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UDI – If You Do It, With They Use It?

UDI: If You Do It, Will They Use It?

By Karen Conway, Executive Director, Industry Relations, GHX

We are about the cross the second major milestone for healthcare manufacturers when it comes to compliance with the US FDA’s Unique Device Identification Rule. That rule requires manufacturers to assign and label their products with UDI-compliant codes and to publish additional data on those products to the FDA’s Global UDI Database (GUDID).   The deadline to comply for Class III products was September 2014, and this September all implantable products regardless of class (as well as products deemed to be “life saving and life sustaining”) were to have met the first two requirements.  Due to some technical problems with the GUDID submission process, manufacturers have until October 24, 2015 to publish product attributes to the database.  Many of those products falling under this second group of products are Class II devices, although the FDA has published a complete list at By the time the next deadline rolls around in September 2016, covering all remaining Class II devices, more than half of medical devices sold in the U.S. should have UDIs.

So now what?

Many have asked, what will the FDA and others do with the UDIs and the data being provided to the FDA? To answer that question, it’s important to remember, why the FDA created the UDI rule in the first place. The rule stems from the 1999 To Err is Human report, which documented nearly 100,000 deaths due to preventable medical errors. That led to publication of the pharmaceutical barcode rule based on the national drug code (NDC) but the FDA Center for Devices and Radiological Health realized in the process that it did not have a corresponding code for medical devices.  The UDI fills that gap.  But as the FDA learned from relatively slow uptake in hospital use of barcodes on medications, just having a code is not enough.  That’s why the UDI is central to the FDA’s plan to strengthen post market surveillance, including capturing UDIs in electronic health records. It’s also why the former head of the UDI team, Terrie Reed, has returned to CDRH to focus solely on provider adoption.  After all, if we don’t actually use the UDIs, we will lose out on all the intended value. 

There is some movement afoot to require providers to use UDIs. Currently, providers must use the UDI (if available) when reporting adverse events involving serious injury or death.  As I write this, the Office of the Management and Budget (OMB) is reviewing the proposed final rule Stage 3 of Meaningful Use, which could include requirements for providers to use UDIs when documenting and sharing data on a patient’s implantable devices and to access additional data on those products in the GUDID.   Meaningful use of EHRs is something that healthcare providers must prove in order to avoid additional reductions in reimbursements from the federal government.

Meanwhile, some hospitals and healthcare systems are not waiting for the government to tell them what they have to do. As an example, Franciscan Missionaries of Our Lady Health System (FMOLHS) is working with a number of its supplier and technology partners to incorporate product identifiers and other data standards into its systems and processes as part of a corporate wide initiative to better manage to declining reimbursement levels.  This includes efforts to transact using the product standards with suppliers and incorporating UDIs into various systems, including its enterprise resource planning and revenue cycle systems, as well as its EHR.  For providers, the biggest challenge is being able to capture and share data across its various technology systems, to understand the relationship between the products used in patient care, the outcomes achieved and the costs involved.  As FMOLHS Vice President for Materials Management Bill Mosser explains: “I want to know when spending more on supplies yields better results, and when it doesn’t.” 

Based on its work, FMOLHS has published a step-by-step instructional guide to implementing GS1 data standards for other healthcare organizations to follow, which includes its work with suppliers.  FMOLHS and Cook Medical recently presented a webinar on a pilot project they conducted as part of the FMOLHS initiative.  You can access the recording here.