UDI Deadline Here Many Still Not Ready

• Karen Conway, Vice President, Healthcare Value

The deadline for Class II medical devices passed last month, and with Class III devices, all implantables regardless of class, and now Class II devices covered by the UDI regulation, more than 50 percent of devices sold in the United States should be labelled with unique device identifiers (UDI). However, a considerable number of manufacturers are still struggling to fully comply with the rule or create a sustainable process for ongoing compliance. Some may not have even begun the process. The final UDI ruling was published in September of 2013. With three years to prepare and several deadlines already passed, what is standing in the way of manufacturers? It turns out there is more than one reason many manufacturers haven’t completed their initial submissions to the FDA’s Global UDI Database (GUDID).  

UDI Readiness - Technology Will Only Take You So Far

• Karen Conway, Vice President, Healthcare Value

An overarching theme behind creating a sustainable UDI strategy lies in taking a holistic approach. Manufacturers that develop a sustainable master data management strategy that meets current compliance requirements and customer needs, but also takes into account future requirements, will see the most return on investment from an operational efficiency and cost perspective.

Developing a Sustainable UDI Strategy

• Denise Odenkirk, Vice President, Supplier Sales

We’ve seen that as manufacturers embark on the UDI process it is quickly realized that UDI is not once and done. Many manufacturers begin with a tactical approach, only to realize that taking a broader perspective will serve better. Define your strategy with the end state in mind.

Achieving Success for UDI Rule

• Karen Conway, Vice President, Healthcare Value

Do you think your data is ready to submit to the Global UDI Database (GUDID)? What will you do if your submission fails? Do you know how you will archive communications with the U.S. FDA?

UDI - Build for Today and Tomorrow

• Karen Conway, Vice President, Healthcare Value

The long term benefits of UDI implementation will be felt as adoption and integration into health care delivery increases. The FDA’s goals for UDI include improved patient safety, modernization of medical device post-market surveillance and the facilitation of medical device innovation.

A First Glance at UDI Regulation in Europe

• Karen Conway, Vice President, Healthcare Value

Last week, my colleague in the UK, Ed Palferman, got a first glance at the text of the proposed Unique Device Identification (UDI) regulation for the European Union (EU). The language regarding UDIs for medical devices is contained in a larger document known as the Medical Device and In Vitro Diagnostics Regulation (MDR) document. The regulation is expected to be formally adopted by the end of the year, with compliance for the sections related to medical devices in 2020 and for in vitro diagnostic sectors two years later.   

EU UDI - Laws and Sausages

I’m waiting in the lounge at the Eurostar Terminal, heading home after two days at the MedTech Summit in Brussels, reflecting on all that I heard on the draft European Medical Device and In Vitro Diagnostics Regulation (MDR). The MDR is designed to bring greater scrutiny, traceability and transparency to medical devices and in-vitro diagnostic equipment used in Europe. It includes unique device identification language similar to what is currently being enacted in the United States. My colleague, Karen Conway, will provide a compare and contrast analysis of the two regulations later in another post in the Healthcare Hub. 

Better Data Management for a Sustainable UDI Strategy

• Karen Conway, Vice President, Healthcare Value

The third deadline for the FDA UDI rule is fast approaching. With Class II medical devices making up the largest group of classified devices, there is likely to be a big surge in activity regarding data submission to the Global UDI Database (GUDID). But, before this step even begins, manufacturers should begin with a comprehensive approach to product master data management.

GDSN MR3 Update Met Through GHX Health ConneXion℠

The GDSN Major Release 3 updates GDSN to better meet today’s regulatory and digital requirements. Developments such as the FDA’s Unique Device Identification (UDI) rule and the European EU1169 mandate make it necessary for changes in GDSN. With the release roll out in May 2016, questions have been raised about how this impacts GHX and our clients. The news is good! You are covered as a Health ConneXion℠ subscriber – and this release is good for the healthcare community too.

Now is the Time to Prove the Value of GS1 Standards in Healthcare

• Scott Kelley, Vice President of North American Sales and Marketing

For many years, the North American healthcare industry has explored the potential advantages of standardizing product and location data using GS1 standards. The general consensus is that data standardization and synchronization can improve clinical and operational performance, but with the exception of a few brave leaders like members of the Healthcare Transformation Group and Franciscan Missionaries of Our Lady Health System in the U.S., very few organizations have carried out standards implementation to a point where they have been able to document both results and the pathway to achieve them.

UDI: Lessons Learned on the Journey to Compliance

Two years ago, the U.S. Food and Drug Administration (FDA) issued its Unique Device Identification (UDI) final regulations. That’s the rule that requires manufacturers to assign and label their products with UDI-compliant codes and, significantly, to publish data attributes about those products to the Global Unique Device Identification Database (GUDID). The goal: to improve patient safety. The how: by reducing the incidents of injury and death that can result from the misidentification of medical devices. The when: to be fully implemented by September 2018. The reality: the journey is a winding road!