The FDA final ruling on a Unique Device Identification (UDI) system issued on September 24th, 2013 initially had the biggest impact on medical device labelers. How the Unique Device Identification system will ultimately impact hospitals and surgery centers has not come into full focus. But based on the stated goals of the initiative, it appears that it will be necessary for healthcare facilities to invest in IT solutions that will allow them to:
- Capture, track, store, retrieve, and relay Unique Device Identification data
- Leverage the new Unique Device Identification database for information on devices and device recalls
- Take advantage of device labeling and marking changes in a way that promotes patient safety, reduces costs, and improves efficiency
This means UDI data capture will have to be integrated into electronic healthcare record (EHR) systems, as well as other administrative, supply chain, billing, and clinical support applications. Specifically, these systems will need to be able to provide:
- A field to capture UDI information
- The ability to scan, enter, and store UDIs
- The ability to internally transmit UDI information to supply chain and billing systems once a device has been used at the point of care
- The ability to transmit UDI information from eHRs to patients, registries, and payers
- The capability for patients, registries, and payers to access UDI information throughout a universal provider system1
As Central Sterile Supply Departments (CSSDs), and ORs move from manual to electronic instrument and device management systems, CSSDs will want to invest in software functionality that not only captures FDA accredited UDI label formats, but also provides reporting capabilities related to UDI data. Additionally, in order to have standardized processes related to reprocessing, CSSDs will need to consider a methodology for marking their “pre” UDI inventory of reuseable devices and instruments with an “internal” unique identifier that can also be captured by the asset management software. This way whether an instrument or device came from the manufacturer with a UDI or the unique identifier mark was added later by the hospital, the technician can capture each reprocessing step of an asset in the same manner, and the facility can realize all the safety and efficiency benefits associated with UDI for the majority of their reusable assets.
Here are 5 items for healthcare facilities to consider now to meet anticipated UDI expectations:
1. Choose an asset management automation solution that can capture an FDA accredited data carrier or barcode, (i.e. GS1 format).
2. Invest in scanners capable of reading 2D data matrix barcodes for scanning instruments.
3. Choose an asset management automation solution that can link a device to a patient case, and can also retrieve device history easily. (This will be important when investigating cases where a surgical site is suspected or if there is a device recall of any kind.)
4. Partner with a vendor that has a solution to mark, track, and manage existing or “pre” UDI instruments and devices.
5. Plan and budget for costs associated with marking existing instrument and device inventory. A do-it-yourself approach to instrument marking can extend associated costs out over a longer period, but lengthen project completion time. Using a professional service to mark instrument inventory shortens implementation and avoids costs associated with staff learning curves, but needs to be included in budget planning.
Preparing for the impact of the UDI initiative is an on-going process. It will be important for hospital and surgery centers to be aware of the upcoming challenges and timelines associated with UDI in order to make effective purchasing decisions related to IT systems’ ability to meet UDI expectations.
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1Workgroup for Electronic Data Interchange Foundation. Unique Device Identifiers: Facilitating the Capture and Transmission of UDI. http://www.pewtrusts.org/~/media/assets/2014/04/07/wedi_udi_white_paper_04072014.pdf
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