The European Parliament recently voted to adopt its own version of the unique device identification regulation. The deadline for compliance toward these regulations is already in motion, and similar to U.S. FDA UDI regulations, the dates for compliance will be rolled out over several years for different classes of products – three years for medical devices, five years for in vitro diagnostics (IVDs).
We held the April GHX Global Data Standards User Group Meeting on-site at the 2017 Healthcare Supply Chain Summit in National Harbor, MD on April 26, 2017. As always we had a tremendous turnout with individuals from throughout the healthcare supply chain continuum - providers, suppliers, GPOs, distributors — engaging in constructive dialogue on how to drive greater data standardization within our industry.
Pressure continues to mount for the healthcare industry as it works to manage costs and deliver measurable improvements in the value of care delivered. The growing wealth of healthcare data, especially for medical device manufacturers, is key to relieving some of these pressures.
Both sides of the healthcare supply chain – providers and suppliers – derive value from the data they collect and report. At GHX, we believe that as the healthcare supply chain continues to mature, a fundamental shift in the critical role data plays in delivering quality patient care is also taking hold.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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!
The resounding message I heard from the Advamed MedTech Conference in Chicago is that the MedTech industry needs to prepare for a transformative shift in how business is done in healthcare as we transition from a healthcare system that was traditionally focused on volume to a leaner, optimized healthcare system that focuses on value. Throughout the conference, the message was reinforced as industry leaders from manufacturers, distributors, payers and providers emphasized the need to transform the practice of medicine in America to focus on value.
So, the first deadline for the U.S. FDA Unique Device Identification (UDI) rule is here, but to me, it's not as much about today, as it is about tomorrow, and the next day, and the next day, and so forth. That is not in any way a comment to diminish the significant effort undertaken by manufacturers whose Class III products need to be in compliance with the UDI rule today, but rather about the number of products that still need to comply with the rule and, even more importantly, how hospitals, healthcare systems and others will use the unique identifiers. For many their work is just beginning and has some surprising similarities to what providers must also do to prepare.
Today, we are just one month away from the first official US FDA UDI deadline: September, 24, 2014. That's when manufacturers of Class III devices must be in compliance with the US FDA rule. Over the years, GHX has been providing assistance to manufacturers to prepare for and now comply with the rule, not to mention making recommendations to hospitals and healthcare systems that ultimately must use the unique identifiers to achieve the vision of UDI. Below, I have posted a link to many of those blog posts, videos and articles. You can also find more at www.ghx.com/udi.
It’s opening day for the 2014 GHX Healthcare Supply Chain Summit, but hundreds of providers, suppliers, government officials, standards bodies and supporting business partners have already been actively engaged in Philadelphia sharing insights on topics ranging from applying supply chain best practices from other industries to healthcare, developing more relevant metrics to measure supply chain performance in a value-based system, and how to achieve value, not just cost and regulatory burden, from the adoption of unique device identification (UDI).
I arrived yesterday in Orlando for the HIMSS14 Annual Conference and Exhibition, and I am more optimistic than ever that there is growing recognition for the role the supply chain can play in improving meaningful use of electronic health records. It started last month, when I was at the Office of the National Coordinator for Health IT (ONC) and met the new national coordinator, Karen DeSalvo, MD. I was part of a delegation from AHRMM (the supply chain organization for the American Hospital Association) there to discuss how we can help increase adoption and use of unique device identifiers (UDIs) in healthcare delivery organizations. While only a few days on the job, Dr. DeSalvo seemed genuinely interested in the possibilities.