Tackling What’s Next in Med Device Labeling
by Laura Johnson, on July 14, 2017
As companies continue to catch their breath after last year’s deadline to comply with the FDA’s UDI requirements, the focus now turns to international compliance and adoption at the provider level. Those were two of the main themes at the recent Q1 Productions' 7th Semi-Annual Medical Device Labeling Summit in San Jose, CA. And judging by the sessions and interactions with attendees, there is still a good deal of work to be done.
Lost in Translation – The language barrier alone presents a distinct challenge for English-speaking companies working with distributors and partners in Europe and Asia Pacific. Each region has its own regulatory body and the rules established for labeling are not always clear cut. We’ve seen many times how the direct translation from Chinese to English (and vice versa), for example, can be confusing, if not almost comical.
Compounding the issue are the cultural differences between countries. At the event, we heard instances where safety messaging was not properly conveyed in the manner that end-users would understand, which could lead to misuse, resulting in significant risk and liability. It’s important that companies take time to really study the unique requirements of each country and take the necessary steps, organization-wide, to adjust their UDI programs accordingly. This could mean reaching out to partners and customers in these regions and including them in the label design and review process. Yes, it can be a painful endeavor, but it’s better than facing the consequences of product being held up, returned or rerouted because it didn’t meet requirements.
Downstream of Consciousness – Another topic that was touched on in a few sessions was the role of the provider in UDI labeling. Serving as that critical point in the supply chain where patients receive or are treated with devices, hospitals are often the last mile in the journey, expected to scan barcodes and keep record of UDI data. Surprisingly, there were instances cited where nurses and staff in some hospitals are not tracking UDI in their surgical suites. In some ways, it’s understandable as the burden of FDA compliance has really been put on manufacturers of the devices. But how effective is the system if providers and end-users are not complying themselves?
More than one presenter advised that the key to end-to-end compliance with UDI is for manufacturers, distributors and providers to open up communications and work to understand each party’s role in the medical device ecosystem. One presenter recommended for manufacturers to take the time and visit hospitals and clinics to see firsthand how medical device packages and labels are used in these environments.
Strength in Collaboration – Overall, the Q1 Productions event was informative, timely and valuable. There were numerous opportunities for attendees to share ideas, lessons learned and other experiences in their journey to UDI compliance, including the leveraging of GS1 labeling and standards. What’s especially comforting to many is the feeling that they're not alone—and that there are some smart, innovative organizations and solution providers available to help companies overcome challenges along the way.
For additional insight into how you can develop a more sustainable UDI process tailored to your organization, we invite you to check out a recent webinar with GS1 US’s VP of Healthcare Greg Bylo, “Make UDI Labeling a Program, Not a Project.” And if you have further questions or concerns regarding Medical Device Labeling, please contact Loftware anytime at your convenience.