It’s make or break time for UDI compliance

In late September 2013, the FDA published its final rule requiring most medical devices to carry a unique device identifier (UDI) and be stored in the FDA’s Global Unique Device Identification Database (GUDID) in order to better track and monitor medical devices. With this ruling, the overall aim is that healthcare providers and manufacturers of said devices will be able to work in unison to better manage quality and expedite necessary recalls, and eventually help put an end to counterfeit devices. Companies that adopt a technology that will capitalize on streamlined operations and improved traceability in order to comply quickly with the FDA’s new ruling for UDI compliance will be at an advantage to their counterparts who struggle to find a solution.
 

Where it starts

UDI initiatives begin far before a product goes to market. In addition, there are many stakeholders that play a role during the time leading up to UDI adoption, as indicated in this UDI adoption chain.

First (1), the three accredited issuing agencies – GS1, HABCC, and ICCBBA – must produce device identification (DI) codes. Next (2), the medical device manufacturers’ (MDM) working groups must identify a database to store device and product data (DI and PI), and (3) assign unique codes to all items. Once this has been done, a manufacturer is responsible for (4) the labeling function, meaning the package/product is both machine and human readable. Where applicable, manufacturers (5) are responsible for direct part marking. The medical UDI information is required to be submitted to the FDA’s GUDID prior to manufacturing. A product’s assigned UDI might not be permanent, as certain changes made to a device could require an update or refile for a new UDI.

For Class I (low risk) medical devices, the UDI’s product identifier must include the expiration date and/or manufacturing date. UDIs for Class II (a/b) devices must include lot and batch numbers. Class III (high-risk) devices will need to include batch/lot numbers or a serial number in the UDI. While lower-risk devices can include more information than is necessary, such as that required for a Class III device, high-risk devices cannot include less than is required.

All labels and packages of Class III medical devices – the most critical class – and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI by Sept. 24, 2014, just one year after the final FDA rule was published (and just 8 months from now). While the turnaround time for critical devices to comply with the FDA’s ruling is tight, the final date for required Class I devices to be labeled with a UDI is Sept. 24, 2020, as indicated in the UDI implementation timeline.
 

Avoiding a disconnect

Currently, most medical device manufacturers are using their own processes and proprietary identifiers to monitor products. The systems used to track a product as it moves throughout a complex web of sub-contractors, outsourced manufacturers, levels of distribution channels, health care providers, and the final patient are often abundant, disparate, unique, and disconnected.

As these systems are not correlated, the issue arises of not knowing where a final product is, should there be a recall. This disconnect often leads to performance deficiencies, a decrease in product quality, and an increase in adverse events – all of which negatively affect the end patient and decrease safety.

Implementing an additional system to assign a unique number to every participant in the value chain of a device (the UDI), then properly labeling products in order to comply with the FDA’s UDI ruling, could result in a costly and challenging endeavor for device manufacturers. Manufacturers that do not already have a UDI system in place to help ensure compliance with the FDA’s final rule will suffer the consequences.

The most important element and one of the most technically challenging tasks is master data management, where many of the nearly 60 necessary data elements reside and are readily accessible by all stakeholders. There must be a data repository to manage the UDI data life cycle; without this capability, any UDI submission management would be manual and likely result in errors and missed deadlines. Do you really want to take that chance when business and patient safety are on the line?

While the window left by the FDA for manufacturers to implement and comply with the final ruling may be small, the consequences for not having a UDI system in place within the FDA’s timeline are grave.

Manufacturers unable to comply before the specified deadline will simply not be able to sell their product¹, which could ultimately lead to bankruptcy. Alternatively, patients in need of medical devices whose manufacturers have not been able to comply with the FDA’s final rule by their prescribed deadline will also suffer, as the medical devices they need may not be readily available for use.

The UDI mandate currently applies only to the device manufacturers that market their products in the United States. The European Union has published preliminary recommendations for EU-wide UDI that uses the same framework as the FDA’s guidelines. However, Deborah Rosenfelder, clinical research associate with Paragon Biomedical, notes that implications of UDI compliance for medical device manufacturers pursuing European CE Marking, FDA 510(k) clearance, or other market registrations will be significant:

“Although medical device manufacturers should expect some degree of variance between [the European Union and the U.S. markets] in terms of UDI compliance, they now have a good idea of broad device identification requirements they’ll need to meet once these systems are brought online.”²

Additionally, the International Medical Device Task Force (IMDTF), which includes regulatory bodies from 16 countries, has adopted a similar framework with the intent to implement a globally harmonized identification system, although it may not be identical. No timeline has been stated, but the FDA is a trailblazer, and compliance to GUDID will provide a common core data source to use as a standard for compliance with EU and IMDTF regulatory bodies when the time comes.
 

Improving safety

The recent ruling from the FDA requiring medical device companies to include UDI comes, in part, as more nontraditional medical devices become mainstream, forcing regulators to implement a system to improve patient safety by increasing the quality of information in medical device adverse reports.

It’s unusual to see a software platform get classified as a Class II device, as was the case with the one Verizon Wireless app created for chronic disease management. Although the solution is not intended for use in clinical settings, it collects and monitors sensitive patient information, leaving it to fall under the nontraditional medical device category. With the FDA’s ruling, Verizon must implement a Quality Management System to regularly evaluate the operational success of its software platform, ensure it is being used as intended, and to keep up with the FDA’s Quality System Regulations (QSR). However, UDI is not applicable to these types of Class II devices because they are not tangible medical devices; rather, they are smartphone apps that are more lifestyle oriented and enhance user experiences related to healthcare or remote health monitoring, as opposed to medically invasive or diagnostic purposes.

UDI is more than just compliance; it is intended to enhance patient safety, improve the effectiveness during a product recall so every relevant stakeholder is aware of the whereabouts of the recalled product, and provide advanced information to healthcare providers so they can keep the unsafe or questionable devices from being implanted or removed when necessary. As previously stated, the FDA’s final UDI rule is all about patient safety first and foremost.

While the healthcare industry is still short of realizing a fully identified and logged pool of medical devices, the FDA’s final rule on UDI is a step in the right direction toward better monitoring and tracking of medical devices, which will ultimately increase quality and patient safety. Additionally, manufacturers that are quick to implement a UDI system to aid the transition will be better positioned for success than those that do not.

Sparta Systems Inc.
www.spartasystems.com

About the author: Mohan Ponnudurai is an industry solution director at Sparta Systems Inc. Mohan can be emailed at mohan.ponnudurai@spartasystems.com.

¹http://www.labelingnews.com/2013/09/what-you-need-to-know-about-udi/

²http://www.clinipace.com/building-perspective-on-pending-fda-regulations-for-a-medical-device-udi-system