1. The Unique Device Identifier (UDI) (FDA, Sept. 24, 2013) is intended to track a medical device through its entire lifecycle. Most of the healthcare industry saw UDI as a labeling and supply chain regulation. It has now become apparent that it will be used throughout the continuum of care due to its adoption in electronic health records (EHRs) and claims payment systems.
Implications: There is strong industry support for UDIs to be integrated into claims payment systems. This will improve the transparency of costs and reduce overpayments by ensuring that device costs are reimbursed by specific device rather than by device type.
2. The Global Unique Device Identifier Database (GUDID), maintained by the U.S. Food and Drug Administration (FDA), only contains the DI (device identifiers); all production-level data remain with the manufacturer. The GUDID is not intended to replace recordkeeping done by device manufacturers.
Implications: Medical Device Reports (MDRs) on adverse events require that the UDI be reported. Once a signal has been identified by FDA, the manufacturer/labeler will be contacted to gather production identification (PI) information, so that warnings and recalls can be targeted more directly by lot or batch. (GUDID Guidance, FDA, June 27, 2014) With this greater level of detail now available, recalls can be micro-managed, resulting in fewer device shortages. (Pew Trusts, June 13, 2013)
3. Since the GUDID is a new database, certain fields that show change of ownership have not yet been implemented. Once the FDA releases new database fields for manufacturers to indicate a change of ownership, then both the firm selling the line of devices and the acquiring firm will have to take steps to update the GUDID so that there are links between the records. The UDI label must change because the manufacturer/labeler has changed, but it will be vital for the FDA to see that the device is the same so that the true scope of the problem (number and severity of instances) is evident.
Implications: If an enforcement action is to occur, the FDA will need to include all the devices that may have patient safety issues. According to Avalere, manufacturers should maintain information regarding change of ownership in their records and prepare internal systems to have the capability to report the previous UDI, when the FDA implements the forthcoming change of ownership process in GUDID.
4. CMS reliance on the UDI will increase once the Class II roll-out takes place, because much of the fraud, waste, and abuse in the medical device arena is with durable medical equipment.
Implications: With a greater number of devices containing UDI on the market, it will be more difficult for Medicare fraudsters to bill both Medicare and Medicaid for the same devices or to even bill one single device to multiple Medicare recipients. UDI is intended to help CMS and health plans eliminate fraudulent payments in excess of tens of billions of dollars per year. (Goldman, T.R., July 31, 2012)
5. Combination products have different requirements based on how the products are packaged: whether it is considered a “single-entity” combination product, or whether a device component is co-packaged with the drug component.
Implications: Pre-filled syringes are a good example of a combination product that has been problematic in the past. Full scale recalls were required when it wasn’t apparent whether the device or the drug/biologic caused the malfunction or injury. This resulted in drug shortages when sometimes it was the device that was the issue. Now that UDI will be on the device and will be trackable, the FDA hopes to reduce the number of shortages by honing in on the various parts of the combination product.
6. Pre-packaged device kits require a UDI, but devices within the kits do not need individual UDIs.
Implications: Once devices within kits have been separated from their packaging, they will no longer have a UDI. If it is determined that claims payments will be made on the entire kit, then business processes may have to change to record the UDI before it is separated from the device(s).
7. Devices intended to be sterilized and re-used are required to have a permanent UDI (direct marking).
Implications: Most manufacturers that will have to begin direct marking their devices have not done so in the past. This will be both a manufacturing step and a labeling step. The good news for manufacturers is that many devices indicated for direct marking in the proposed rule were exempted by the time the UDI Final Rule was released.
8. Radio Frequency ID (RFID) can be used in addition to standard labeling (bar code or 2D), but cannot be the only label (because it is not human-readable) and cannot be attached to the device, only to the package. This is because there is no obvious way to know when an RFID has been attached to a device and because an RFID cannot be “turned off” prior to a device being implanted in a patient.
Implications: As consumer technology improves, if RFID were to be used to manage and track implanted devices, there could be potential issues with Protected Health Information (PHI) of individuals. In this scenario, anyone with an RFID reader would be able to determine the devices that were implanted in an individual.
9. Several EHR companies have already started modifying their interfaces to allow for the entry of UDI in patient records. The FDA engaged with Mercy Health System in a demonstration project in 2013 to record the UDI of implanted cardiac stents in Mercy’s EHR. The EHR was then linked to the risk management system to spontaneously transmit adverse events to the FDA if a device issue caused a negative outcome.
Implications: EHR companies have not been quick to make these changes. This is because, until they receive guidance from the Centers for Medicare & Medicaid Services (CMS) on when UDIs should be recorded, they are uncertain of how many UDI fields could potentially be needed for a single patient encounter. Would CMS require only the UDI of the implanted device, or would they also want to track which additional devices, such as ventilators and catheters, had been used? (Pew Trusts, Aug. 6, 2014)
10. The serial number of a medical device is considered to be protected health information, so it is redacted in the outward-facing GUDID file that will be made publicly available by FDA. For this same reason, the serial number is also redacted in medical device adverse event reports that are publicly available.
Implications: If the serial numbers were not redacted, the combination of information gathered in a disease/device registry combined with the UDI in an adverse event report could inadvertently identify an individual.
For more information about UDI, please contact Madris Tomes at MTomes@Avalere.com.
This article was coauthored by Virna Dapic, Manager.