The U.S. Food and Drug Administration created its framework for the Unique Device Identifier system in 2013 as a way to promote unification in medical device identification throughout the entire supply chain. Regulators are phasing out this process until 2020, where during this time, medical device manufacturers must attain compliance through including a UDI that is readable in machine and human-form. The new standardization's goals are to reduce labeling errors, help manufacturers handle recalls more efficiently and improve the global supply chain overall.
New study finds UDI compliance to be significant challenge for medical device manufacturers
While many find the new requirements to be beneficial, a recent study published by PRISYM ID, a designer and provider of turn-key label lifecycle management solutions, highlighted many of the key challenges facing medical device packaging and labeling operations throughout Europe and North America. Their findings revealed that 40 percent of pharmaceutical and medical device company respondents said that label defect control is one of the main problems facing the industry today. Meanwhile, for 40 percent of medical device companies, UDI labeling compliance was a significant difficulty.
"The results of these findings are not particularly surprising, however what is a concern is that 40 percent of those surveyed still do not have a solution in place to control these issues," Warren Ward-Stacey, senior vice president of global sales at PRISYM ID, explained. "A streamlined end-to-end label lifecycle management solution that enables companies to effectively manage data and ensure a single version of the truth is vital to help reduce unnecessary product recall, increase profit and improve supply chain efficiency. It is clear that a complete label lifecycle management solution that meets country specific requirements, supports expansion and communicates coherently, is crucial for ensuring regulatory compliance and efficiency gains."
"Manufacturers must take proactive steps to avoid compliance failure."
Overall, the study found that a large portion of medical device organizations view UDI compliance and other challenges as the cause of lost profits and time, lowered marketplace respectability, patient safety concerns and unnecessary waste. As the rest of the requirements unfold over the coming years, manufacturers must take a strategic approach to investing in quality packaging and labeling materials to maintain compliant with UDI and other similar regulations.
How can manufacturers take a strategic approach to labeling medical devices?
As new regulations unfold and are introduced each day, manufacturers must take proactive steps to avoid compliance failure and lost profits. As many of these labeling requirements are here to stay, manufacturers can change their best practices to best adhere to new these standards. Here are a few ways manufacturers who approach medical device labeling strategically can thrive in an increasingly challenging marketplace:
- Maintain a consistent brand: Brand names that remain consistent and unified find the most success – even in a competitive market. Multi billion dollar fast-food chains such as McDonalds or shoe apparel organizations like Nike did not rise to the top of their respective industries due to disjointed labeling or branding practices. Manufacturers that want to promote brand recognition that is synonymous with patient safety, innovation and expertise must take a strategic approach to brand labeling.
- Avoid conflicting label data or inefficiencies: As many organizations operate with global supply chains in today's economy, with manufacturers in one country and suppliers in another in certain cases, ensuring that medical devices are correctly labeled is key to success and patient safety. Through fully complying with UDI regulations, among many others, manufacturers can ensure that their device labels won't offer disparate data from one location to the next, thus improving their bottom line.
- Cut high regulatory costs: Each year, new requirements are introduced in the medical device labeling industry, which means that companies must keep up with these changing standards or risk losing business or recalling outdated equipment. As soon as new standards are implemented, manufacturers must quickly design and create compliant labels and get them approved and implemented to not waste any additional time or resources.
- Showcase high-quality and reliable products: Manufacturers that show regulators and their customers that they are serious about patient safety and maintaining federal labeling law compliance will have a better chance at effectively promoting and selling their quality and reliable products. Having a system in place that allows the entire supply chain to adapt instantly to new changes in labeling requirements will keep organizations operating strongly and boosting profits for years to come.
At Stranco, we offer a wide selection of thermal transfer labels for manufacturers seeking durable and reliable solutions to maintain regulatory compliance. Contact one of our skilled customer service representatives today to discuss various label materials, sizes and applications to find the right product to fit your needs.