After the FDA issues the proposed UDI rule, the agency will hold a three-month public comment period, after which the agency will incorporate feedback into the final rule. It is expected to be published a year after the proposed rule comes out.

Jay Crowley

While there will be no immediate regulatory impact on device identification for providers, the proposed rule will mark the first major step in the launch of the UDI system and establish a timeline for the healthcare industry to transition from proprietary product identifiers to UDIs. Since healthcare providers will need to identify products using the UDI system once it is established, Crowley recommends that providers make their voices heard by providing input to the FDA on the proposed rule.

"The real benefits of UDI only accrue if everyone in the supply chain participates so we have been working with not only suppliers, but also distributors, hospitals and others to understand the issues associated with adoption and implementation and welcome anyone’s input during this next phase of the initiative," said Crowley.

Providers should also starting thinking now about how they will comply with a likely requirement that UDIs be documented in electronic health records, probably as part of Phase 2 or 3 of meaningful use.

The final UDI regulation will likely be rolled out in the following steps:

Development of the UDI: Device manufacturers will assign UDIs to their covered medical devices. The UDI will identify the manufacturer, make and model and the device’s serial number, lot number, expiration date or manufacturing date.

UDI Application: Manufacturers will apply the UDIs to all levels of packaging down to the lowest unit of use. They will place the UDI on the label in both human readable format and in some form of automatic identification technology (barcode, RFID).

Creating and Maintaining a UDI Database: Manufacturers will publish UDIs to a database, which will be owned and maintained by the FDA, to facilitate product identification. There will be a number of ways that manufacturers will be able to enter their data into the database. For example, if the manufacturer uses GS1 Global Trade Item Numbers (GTINs) for its UDIs, then it can publish its UDIs to the UDI database through a GS1 Global Data Synchronization Network (GDSN) certified data pool. Manufacturers that use the Health Industry Business Communications Council’s (HIBCC) HIBC-Labeler Identification Codes (LICs) or GS1 GTINs also have the option to publish their data directly to the database.

While the UDI system is intended to uniquely identify all medical devices, the FDA is proposing that the regulation be implemented in a phased fashion, starting with the highest risk devices. Class III devices (e.g., some implants) will be required to bear a unique device identifier 12 months following issuance of the FDA’s final UDI rule, Class II devices (e.g., hospital based equipment) 36 months following the final rule and Class I devices (e.g., many disposables) 60 months following the final rule.

Crowley notes that for some low-risk devices that are packaged together in a shelf pack, such as bandages, a UDI might not be required for each individual product. Rather, a manufacturer would only mark the UDI on the higher level of packaging (box of 10) and not on each unit.

When most of us think of medical devices, we think of traditional, hospital-based equipment, such as patient monitors, catheters and surgical instruments. But the definition of medical device is much broader, from multi-parameter patient monitors in a critical care unit to lipid analyzers in a clinical lab to wound care products used in a long-term care facility.