How You Can Stay Compliant With UDI

Want a sustainable, extendable UDI program? Here are five reasons why your medical device company needs to implement an Enterprise Labeling Solution.

Laura Johnson, Loftware

With a goal of improving patient safety, the FDA initially implemented the Unique Device Identification rule in 2013. UDI labeling regulations are being phased in through 2020 in a concerted effort to provide a comprehensive methodology for medical practitioners, caregivers, and patients to identify, track and monitor the safety and efficacy of medical devices. However, as showcased in a recent Qmed article, UDI is presenting some substantial challenges for medical device companies, which are struggling to stay ahead of compliance deadlines.

Compliance with the UDI rule requires a significant investment of time and resources on the part of medical device manufacturers. Just how much, and the return on investment, depends in large part on an understanding of the original intent of the rule. How you and your customers can best utilize UDIs and the insights they generate into your product lifecycle is key. Acknowledging the lack of readiness and the ensuing struggles these companies are facing, the FDA has recently extended the deadline for certain Class II medical devices packaged in convenience kits or non-implantable single use devices.

So the question remains: How can medical device companies achieve value while addressing the challenges of UDI?

Adhering to regulations that define how products are developed, marketed, shipped, and disposed of is essential to avoid fines, retain customers, enter new markets, and in some cases, stay in business. Labeling continues to play a crucial role in meeting evolving standards, especially those like UDI where labeling and identifying parts and packages is critical for consumer's safety.

There is actually a silver lining to the UDI rules going into effect, because a label containing necessary information about a product can be leveraged as it moves through the supply chain. Individualized labels can contain such important information as how the product was made, what it contains, how it should be handled, and how it should be disposed.

In fact, one of the best ways to achieve a sustainable, extendable UDI program is to implement an Enterprise Labeling Solution, which integrates production labeling and business processes to support mission-critical labeling. This dynamic and data-driven approach allows businesses to react to evolving customer, regional, and most importantly, regulatory requirements such as UDI. This approach also ensures consistency across a global supply chain, enabling companies to meet performance and scalability requirements with the flexibility to sustain complex, high volume labeling requirements.  

Enterprise Labeling Solutions enable customers to quickly and efficiently make changes to meet regulatorystandards.   

Here are five things that Enterprise Labeling Solutions can help companies achieve:

1. Simplify the Label Printing Process

Many companies are faced with error-prone manual barcode printing processes and often need to build custom printing applications in an attempt to streamline processes and ensure that users are printing the right labels. Custom applications can enable companies to meet the requirements of a single, ad hoc labeling process, but they quickly become difficult and costly to maintain especially with evolving regulations such as UDI.  The right Enterprise Labeling Solution offers the necessary level of control for data input and enables users to create and manage complex applications dramatically faster and easier by eliminating the need for customers to build their own user interfaces for on-demand label printing.

2. Keep Pace with Evolving Regulations and Standards

In the U.S., there's UDI compliance issues, as well as Title 21 of the Code of Federal Regulations (CFR) Part 11, which provides guidance for electronic records and eSignatures to streamline workflows. Many global companies are looking for a solution that eliminates paper-based approvals and printed first article inspections, which involve endless stacks of paper and require time consuming filing processes and additional warehousing. Instead they are now relying on electronic records that can be easily accessed or linked directly to the electronic batch records. Enterprise Labeling Solutions, which offer workflow and eSignature capabilities provide a new level of visibility and control for managing labels in highly regulated industries and facilitates 21 CFR Part 11 compliance for labeling in the medical device and pharmaceutical companies.

3. Enter New Markets

Market expansion is essential for success. The faster you can satisfy local language, shipping, and regulatory demands with your labels, the faster you can drive revenue. UDI requirements, which address issues such as traceability, are impacting both U.S. companies and multinationals that market in the U.S.

Utilizing this type of dynamic, data-driven labeling enables companies to rapidly respond to changing regional and international regulatory requirements for labeling, including those mandated by the FDA's UDI Systems. 

4. Automate the Print Process

An automated process allows business users to initiate labeling from the ERP system and eliminate the need to manually input UDI or serial number data. Additionally, an automated process allows companies to achieve significant printing performance gains, allowing labeling to keep up with production. Most importantly, with this type of labeling platform medical device companies are able to initiate print jobs and produce labels anywhere in the global landscape. Labels are based on approved templates, using a common labeling infrastructure.

5. Integrate with Business Processes

A centralized Enterprise Labeling approach allows companies to integrate with their existing ERP, PLM or other validated environments to drive data from "sources of truth," which offers greater control. By using a central database companies can avoid the need to replicate data, which reduces errors and offers improved labeling consistency for deployment to other plants and distribution partners internationally. This ultimately provides a new level of consistency, simplifies troubleshooting and streamlines labeling while adhering to a sustainable UDI program.

Ultimately, labeling is essential to smooth the flow within the medical device supply chain, where problems can arise at any juncture, or may "wait" to manifest in a finished product.How quickly and accurately companies respond to customer requests to meet evolving regulatory requirements such as UDI and respond to unique labeling requirements can mean a huge difference in time to market, customer satisfaction, and cost savings.

To find out more about how Enterprise Labeling can help medical device company's improve labeling practices go to Loftware's medical device page or click on the following link to access Loftware's on-demand webinar "Addressing the Challenges of UDI with Enterprise Labeling" with customer, Greatbatch Medical.

Laura Johnson is a senior account executive for Loftware (Portsmouth, NH). She has over 20 years of expertise working with both pharmaceutical and medical device manufacturers to improve processes and meet regulatory requirements such as serialization, UDI, and secure supply chain.

[Image courtesy of Loftware]