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UDI rule is final, now what

Publish Date: 10/2/2013

4 keys to UDI implementation

The same technology used to track grocery store purchases will now be required in health care, following publication of the FDA’s final rule requiring mandatory use of unique device identification (UDI) for medical products. The rule is intended to increase patient safety and reduce medical errors by making it possible to better identify medical devices and facilitate more accurate reporting of adverse events related to medical devices.

“UDI gives health care leaders the opportunity to essentially have the same access to medical product data as a grocery story produce manager has to track orders and purchases of every kind of apple,” explains Claire Karas, BSN, RN, CNOR. “With UDI, instead of saying ‘we spent $5 million on suture this year,’ you will be able to identify suture size, cost, brand, use patterns, outcomes, etc … all through one unique identifier.”

She says this final rule on UDI “has been seven years in the making, and aligns with government and health care work toward electronic medical record documentation.”

The FDA is also creating the Global Unique Device Identification Database (GUDID) to include a standard set of basic identifying elements for each device with a UDI. Karas says, “Ideally, users will be able to access this database and act fast when a product issue such as a recall emerges.”

Karas is an experienced perioperative nurse and AORN legislative state coordinator for Tennessee. She worked closely with AORN to shape the association’s comments on the UDI proposed rule last fall.

UDI in the perioperative setting

Perioperative nurses will start seeing the impact of the multi-phase UDI rule by October 24, 2014, when all Class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. Manufacturers will be required to register to receive a unique UDI they can place on their products.

The immediate burden of UDI implementation will fall to manufacturers who must plan for staff resources and costs associated with this new process, Karas acknowledges. However, she also stresses that plans for appropriately documenting UDI in facility and patient documentation will require careful planning, education, and potentially new technology purchases if facilities want to incorporate UDI into their electronic medical records systems.

Karas suggests 4 considerations for successful UDI implementation in the health care setting:

1. Coordinate technology implementation to support UDI
Plan now and include key players
Although implementation will be incremental over a 7-year period, perioperative leaders, supply chain leaders and health IT leaders should start working together now (if they haven’t already) to make sure their UDI plan is in place over the next year.

Here are a few conversation starters:

  • How will our IT system accommodate the UDI standard date format, which will comply with the International Standards Organization 8601 requirements to be listed as YYYY-MM-DD (for example, 2013-10-02)?
  • If we won’t have electronic documentation in place, how will we track UDI through paper documentation?
  • What technology purchases, such as bar scanners, will we need to purchase to best accommodate efficient UDI use in practice settings?
2. Educate along the supply chain
Consider how UDI implementation will impact every link in the supply chain
Users are the best experts to share how UDI implementation will impact workflow. The RN Circulator plays a critical role in this chain as the last connection between a product and a patient. So …

Perioperative nurses should share input on how to streamline UDI documentation at point of use. Consider:

  • Will the UDI bar scanner be wireless and universal so it can also allow for the acceptance of different codes, such as medication delivery, blood transfusion administration, or scanning sterile lap sponges with an RFID tag?
Supply chain leaders should also share input on how to streamline the acceptance of UDI as products enter the supply chain. Consider:

  • How will products that should have UDI, but don’t have to be reported to FDA be managed internally to prevent interruption of supply chain flow?
3. Communicate with industry partners
Consider costs and point-of-use efficiencies for ideal UDI implementation
Manufacturers and health care providers will be learning together as UDI implementation becomes reality. Collaborate to share information and concerns in broader efforts to ensure smooth UDI implementation. Consider:

  • Will UDI implementation incur manufacturer costs that will be passed along to health care facilities?
  • Are there UDI design and placement considerations (within mandatory parameters) that can support efficiency in the health care practice setting?
4. Stay informed
Look to barcode and IT experts for best practices that can be applied to UDI use

  • Experts from GS1 (the international organization responsible for creating barcodes) and those working with GS1 will have valuable information that can be applied to efficient UDI implementation.
  • Nursing informaticists and health care IT experts will also be great “go-to” experts for brainstorming UDI use.
    • For example, informatics perioperative nursing specialists from the AORN SYNTEGRITY® team are already hard at work to understand the details of the FDA’s final UDI rule so UDI use can be incorporated into the SYNTEGRITY Standardized Perioperative Framework used in perioperative electronic documentation systems across the country.
Although some initial costs and planning will be required for UDI implementation, Karas stresses the long-term pros far outweigh the short-term cons.

“Unified data is to everyone's advantage,” she notes. “When we can make OR charges as easy as checking out at the grocery, the efficiencies will give circulators more time for patient care.”

Additional Resources

Bookmark this FDA webpage to learn more about:
  • UDI Rule and GUDID Guidance
  • Benefits of Unique Device Identification
  • Compliance Dates for UDI Requirements
  • Accredited Issuing Agencies

Guidelines for Perioperative Practice


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