AAMI News September 2016

Deadline Looms for UDI Implementation

With some medical device manufacturers struggling to comply and a deadline approaching at the end of the month, both industry and the Food and Drug Administration (FDA) are looking to clarify the use and application of the unique device identifier (UDI) system.

UDIUDIs are made up of two distinct components: a “device identifier” that indicates the version or model of the device and at least one “production identifier,” such as the batch number, the expiration date, or the date the device was manufactured. According to the FDA, this information must be presented in two formats: an “easily readable plain-text form” and a machine-readable version.

Starting Sept. 24, the labels and packages of Class II medical devices must display a UDI, and product information must be entered into the Global Unique Device Identification Database (GUDID). Class II devices are associated with moderate risk and include infusion pumps and powered wheelchairs. This is the third step in phasing in the UDI system, a process scheduled to conclude in September 2020.

According to an unscientific survey of approximately 120 medical device industry professionals responsible for product labeling—conducted by USDM Life Sciences, a professional services firm, and Loftware, Inc., which provides enterprise labeling solutions—just 15% of respondents say their products are compliant with the next phase of implementation. More than one-third cited difficulty understanding and applying the regulation as a limiting factor. Other challenges included compiling the necessary data and using more than one barcode labeling software.

“Many device manufacturers are struggling to meet the FDA UDI compliance timelines; however, the overriding issue to UDI compliance is in developing and implementing a sustainable, extendable UDI program and understanding that UDI is and will be a constantly growing and evolving process,” said Jay Crowley, vice president of UDI services and solutions for USDM Life Sciences, in a statement. Crowley formerly worked at the FDA and is widely recognized as the author of the agency’s UDI rule.

In a move intended to clarify the components and presentation of UDIs beyond what was described in its 2013 final rule, the FDA released a draft guidance document in late July—Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). In this draft, the agency specified how UDI information should be ordered. For example, the device identifier should come before production identifiers, and UDI information should precede any non-UDI information, such as the quantity.

The FDA also stated that the machine-readable version, which should be positioned near the plain-text version, should be able to be scanned by a barcode reader or another device so it can be added automatically to a patient’s electronic health record (EHR) or another computer system.

The UDI system is part of a larger initiative by the FDA to more closely and efficiently track medical devices throughout their life cycle. In a recent editorial published in the Journal of the American Medical Association (JAMA), FDA Commissioner Robert Califf and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren renewed their call for the establishment of a national medical device evaluation system that would draw upon existing clinical data sources, such as EHRs, insurance claims data, and registries, to support the pre- and postmarket evaluation of medical devices.

A key component of this system is the incorporation of UDIs into EHRs and insurance claims forms. Although EHR vendors are expected to offer software that is capable of capturing and recording UDIs by 2018, the inclusion of UDIs in insurance claims forms is not a done deal.

In a letter dated July 13, Califf and Andrew M. Slavitt, acting administrator for the Centers for Medicare & Medicaid Services, called for the device identifier of implantable devices to be included in insurance claims forms as part of an update to a health data exchange standard for medical claims. The next version of the claims form is expected to be released in December for public comment.

In this letter, the executives asserted that including UDI information in claims forms would “improve device oversight and monitoring and support more robust research.” However, they acknowledged that adding UDI information would require changes in workflow and updates to billing and claims processing systems. As a result, the U.S. Department of Health and Human Services only supports adding UDIs to claims “if sufficient funding and resources are provided to make the necessary Medicare claims processing system changes.”