‘‘The Gray Sheet’® m e d i c a l d e v i c e s a n d d i a g n o s t i c s April 4, 2016 UDI and submit their data to GUDID. The second phase re- TALK quired implantable, life-supporting and life-sustaining devices to bear a UDI by September 2015. Guest Column: Labeling, Packaging It also mandated that life-supporting and life-sustaining devices intended to be used more than once must include a Front-And-Center As Unique permanent marking on the devices themselves. In all cases, Device Identifiers Move Forward, once again, UDI-labeled devices were required to submit rel- evant data to GUDID. Survey Shows As a majority of manufacturers already know, FDA set out As expected, the majority of its framework for establishing a Unique Device Identifi- respondents whose companies cation system in 2013 to identify medical devices through their distribution and use. The system, which is being phased implemented UDI found the process in over several years, requires that by 2020 most products will to be challenging. need to include a UDI in human- and machine-readable form. Device labelers must also submit mandatory data about each device to the FDA/National Library of Medicine’s Global So what have we learned from the process so far, and Unique Device Identification Database (GUDID), enabling the what does this mean for manufacturers facing the 2016 dead- public and health-care stakeholders to access and download line? In the final quarter of 2015, Prisym ID conducted a poll device information. of the industry to find out how the new UDI regulations had FDA’s introduction of the UDI system has a number of impacted medical device organizations. goals, including driving more accurate reporting and analysis The survey sample included companies directly affected of adverse events, ensuring problem devices can be quickly by the first two phases of implementation, as well as early identified and rectified; reducing medical errors by giving adopters not yet mandated by FDA’s timetable. Forty-one per- health-care professionals key information about specific de- cent of respondents had not yet been required to meet UDI vices; enhancing market analysis with access to real-world requirements, while interestingly, 8% were unsure whether data on device usage; providing a standard identifier to help they had. The overall results provide a good barometer of cur- manufacturers, distributors and health-care providers to man- rent feelings regarding UDI across the sector and highlight age product recalls efficiently; and offering a platform for a some key findings that can inform strategies for organiza- secure global supply chain that protects against counterfeit- tions yet to make the leap. ing and can respond effectively in a medical emergency. FDA’s definition of a UDI and guidelines on its use are out- lined in the sidebar below. The complexities of the new system About The Author mean that, for many companies, managing the transition to UDI compliance can be a challenging process that touches all Kevin Grygiel is VP of US parts of the organization. Critically, the implications for label- Sales at device-labeler ing operations are significant and require all manufacturers to Prisym ID. Kevin has more examine their current infrastructure and, in many cases, adapt than 15 years’ experience it to enable more holistic label lifecycle management. in software development and implementation. What Have We Learned Thus Far? He holds a master’s from Harvard. The first two phases of UDI implementation are now complete. By September 2014, Class III devices and devices licensed un- der the Public Health Service Act were required to include a Reprinted with Permission from “The Gray Sheet.” Please see Copyright Notice on the end page.
TheGraySheet.com As expected, the majority of respondents whose compa- nies implemented UDI found the process to be challenging. UDI Definitions & Guidelines Fifty-eight percent described implementation as “difficult” with a further 4% regarding it “extremely difficult.” Encour- agingly, however, just over one-third (34%) reported mini- A UDI is a unique numeric or alphanumeric code that mal challenges and 4% described the process as “easy.” consists of two parts: The challenges were widely anticipated. Almost two-thirds Device identifier (DI): A mandatory, fixed portion of of respondents (63%) stated that the impact of UDI imple- a UDI that identifies the labeler and the specific ver- mentation on business operations had matched their ex- sion or model of a device pectations – though almost one-fifth (18%) said it had had Production identifier (PI): A conditional, variable a “massive impact.” portion of a UDI that identifies one or more of the following when included on the label of a device: Labeling At The Center Of Troubles ● The lot or batch number within which a device was The introduction of UDI capabilities is undoubtedly a cross- manufactured; functional challenge for all medical device manufacturers. ● The serial number of a specific device; The poll shows that UDI implementation caused reverbera- ● The expiration date of a specific device; tions in manufacturing, quality, operations and distribution. ● The date a specific device was manufactured; and Likewise, UDI projects also tend to involve IT and regulatory teams, meaning they permeate almost every department and ● The distinct identification code required by system within an organization. This naturally dictates a col- §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device. laborative approach where implementation decisions cannot be made or managed in isolation. Each UDI must be provided in a plain-text version However, the poll shows unequivocally that the biggest and in a form that uses automatic identification and impact of UDI implementation is typically felt in labeling and data capture (AIDC) technology. packaging. Eighty-five percent of respondents reported that The UDI will also be required to be directly marked labeling, packaging & design were affected the most. This is on a device that is intended for more than one use, and intended to be reprocessed before each use. further underlined by data that reveals that companies experi- enced more issues around their labeling capabilities than any Dates on device labels and packages are to be pre- sented in a standard format that is consistent with other area. international standards and international practice. Validation is a critical aspect of the mission of data to GUDID. This separate process requires the labeling process. Companies need to submission of data covering a total of 62 fields – with data not be able to prove that an action has only coming from the label itself but from various locations across the organization. taken place and demonstrate the outcome it yielded. Label Lifecycle Management The impact of UDI regulations on labeling operations is a Building and implementing an appropriate labeling system major reason why label lifecycle management (LLM) is now was cited as the single biggest issue, with 23% of respondents regarded as a must-have capability for global medical de- encountering difficulties. Alongside this, almost one-fifth vice manufacturers. LLM encompasses the full range of dis- (19%) found getting a UDI onto the device label their biggest ciplines, processes and controls that go into the preparation, challenge, while 9% reported troubles when adding a UDI to production and audit of every single label. device packaging. This data shows that, when asked to name Unlike traditional labeling systems that focus purely on the their biggest issue around UDI compliance, more than half of final output – the label itself – an LLM system focuses on data, all respondents cited issues related to labeling. supporting the end-to-end management of labeling across its This is not surprising. Making the move to UDI compliance entire lifecycle. It gives companies full visibility of all their data requires manufacturers to ensure device labels not only in- assets, as well as editing tools and vision control to help main- clude a device identifier (DI), production identifier (PI) and tain data integrity. Crucially, an LLM system assures robust associated barcodes, but also include 13 additional pieces of data validation and reinforces it with transparent audit tools information. These requirements represent a major shift and that can supply objective evidence in the event of internal or necessitate a labeling system that can capture these datasets regulatory inspection. accurately and efficiently, and configure them to the appropri- These capabilities are crucial if organizations are to meet ate label design. Ideally, the labeling system would be able to the regulatory requirements of UDI. However, Prisym ID’s sur- communicate seamlessly with systems that support the sub- vey shows that only 40% of companies polled are confident Reprinted with Permission from “The Gray Sheet.” Please see Copyright Notice on the end page.