We Won the Battle – But What About the War? The Next (BIG) Challenge for a Globally Harmonized UDI System

by Jay Crowley

As I mentioned in my last post, we were focused not only on developing a US UDI System, but maybe more importantly on a globally harmonized approach to UDI. There were a number of reasons for this; the first, and hopefully obvious one, is that a global UDI would allow all to have visibility across the global supply chain and be better able to share data among regulators about the safe and effective use of devices and, for example, be able to identify problems more quickly or address recalls across borders. Moreover, the device industry often labels and packages a single product for many (most/all) markets. And – unlike the pharma industry – we did not want (nor did we think we could afford) to have “national” or regional labels/packages (which would be required if there was national/regional device identifiers). Therefore, a “global” UDI – one that could be put on the labels and packages of devices and used anywhere in the world that UDI was required – was a paramount concern during the development of UDI.

Among the many activities undertaken to support this, including many bilateral discussions between FDA and other regulators, was the development of first the Global Harmonization Task Force (GHTF) and then the International Medical Device Regulators Forum (IMDRF) UDI guidance documents (see here and here). The goal of these documents, as stated in the Introduction, is to “… [provide] a framework for those regulatory authorities that intend to develop their UDI Systems that achieves a globally harmonized approach to the UDI.” To a VERY large extent, the US FDA UDI System regulation, as well as the recently published EU MDR/IVDR UDI System requirements, follow the guiding principles in these documents. Other regulators (e.g., Canada, Taiwan, Saudi Arabia) who have indicated a desire to develop their own UDI requirements have also indicated their willingness to follow these guidance documents.

So, from an identifier and label/package perspective, we can see that the goal of these guidance documents has largely been realized. With some (mostly) minor differences, we should be able to assign device identifiers to labels/packages and use that to meet global device identification requirements. The rules for assignment, changes, and construct are also largely aligned. What is NOT aligned, however, is the data that each country/regulator will want associated with each device identifier. Each country/regulator regulates devices differently and has different purposes for UDI, and therefore has specific (and different) national data needs. This means the new (and exponentially more complicated) challenge for the device industry is understating how to develop and maintain the ever-increasing (and different) data set associated with a single product distributed in multiple markets. More on master data management and UDI databases next time…

About the Author

Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.

The Evolving Global UDI Landscape

by Jay Crowley

It is hard to imagine that, what I started in 2002 as an idea to better identify the specific medical devices potentially involved in adverse events, has – over the past nearly 15 years – become the globally recognized and accepted concept of Unique Device Identification – or UDI. The term and concept did not exist before this point. There were of course other concerns to address – the better identification of devices subject to a recall, availability of devices for public health emergency response, supporting anti-counterfeiting efforts, and the need to identify devices specifically in the emerging Medical Device Epidemiologic Network (MDEpiNet). But the beginning was focused on knowing specifically which device was potentially involved in an event – and having quality information about the manufacturer and the brand name – and other important information – such as how the device was on the market (e.g., its 510k or PMA number). It is hard to imagine now that we didn’t have this already.

And now looking back – it is amazing what the past 15 years has brought us. A bit more than a decade was spent working with the vast number of stakeholders to understand how UDI (and GUDID) could work and what could be its benefits – and developing what is now the UDI regulation and its associated Global UDI Database (GUDID). And though we all thought that we understood a lot – in reality, that was just the beginning. Since the publication of the final rule on September 24, 2013 – we have, sometimes painfully, continued to learn and evolve our understanding of both UDI and how it could or should work for the VERY broad (and diverse) array of medical products regulated as devices (including combination products and HCT/Ps) – and, more maybe interestingly, to address the myriad of issues that, while not directly related to UDI, sometimes significantly affect how UDI can or should be implemented.

We also realized very early on that the ultimate objective was not a US based UDI system (as we have for example with pharmaceutical products with the NDC) – but rather a GLOBAL system that allowed us to have visibility across the global supply chain and be able to easily share data about the safe and effective use of devices globally. And now we are starting to realize that vision – we have the EU MDR/IVDR and its UDI requirements – as well as many other countries and regulators looking to leverage UDI to address a host of other safety, cost, and access issues. In subsequent posts we will address both the specific (e.g., labeler, accessories, kits) and the broad (master data management, GUDID, global regulatory convergence/harmonization). We look forward to the conversation and welcome any feedback or thoughts about topics.

About the Author

Jay Crowley is the Vice President of the UDI Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.

Can Data be Synchronized Between Child and Parent Record at Any Point During the Workflow Process?

TrackWise offers the option to “Copy to Child” when configuring data fields types for business process workflows, this configuration provides the flexibility to copy down data fields values from parent record into child upon creation of child record, therefore limiting users to synchronize from child to parent only. To obtain two-way synchronization functionality, TWS can be developed to synchronize child with parent records or vice versa at any point during the workflow process by pressing a button and providing users discrepancies between parent and child (useful in the case of eMDR and complaints).

USDM Life Sciences leverages an experienced delivery team, proven methodologies, and best practices validation documentation to provide our life science customers a rapid, cost-effective approach to implementing, configuring, validating, integrating and supporting your QMS.

Global UDI Database: What if a Medical Device is Discontinued?

At some point in the future when a product is no longer distributed, the medical device company will need to put a commercial distribution end date into the Global UDI Database (GUDID).  The product’s data will still reside in the database, but a flag will be set to let people know this product is no longer in distribution.  The product may still be in the supply chain and people may still own it, but medical device companies are required to add a date of when the product is no longer being distributed.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation

strategy for the changes that need to be made. USDM's assessment methodology is

extensive and includes the labels and packaging, the management of identification

changes to each product, the changes to PLM, ERP, EPCIS and packaging systems,

changes to printing, vision inspection and warehouse/inventory management systems

and interfaces to the GUDID.

What is The Difference Between Complex Systems and Convenience Kits?

A convenience kit is one or more devices put together for the convenience of the user.  An example of a convenience kit would be a suture removal kit.  The FDA has published draft guidance that further clarifies the definition of convenience kit to limit it to those situations where everything is kept together.  A configurable system is multiple devices that come together to create multiple pieces of a system that come together to create a finished product.  A configurable system, has one or more available components or subsystems that a user can choose. The components come together at the point of installation to create the finished device.  The convenience kit has a group of already finished devices that come together to create yet a different finished device, a configurable system is a finished device, so there are various ways to assign UDI to configurable systems, understanding both the intent and the letter of the UDI rule.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

How does the Medical Device Single Audit Program Fit With ISO 13485? Is This Just an Emerging Program?

This emerged back in 2012 with IMDRF.  The FDA adopted it in 2014 and it can be found on their website.  It states that for the Medical Device Single Audit Program they are willing to accept audit reports as a suitable supplement for routine agency inspection.  The full implementation of this vision is still evolving.  It seems to be more focused on ISO 13485 2016 standard and some of the new case for quality might be out prioritizing this MDSAP.  If you consider the FDA’s compliance and inspection strategy they have always had a scalable approach.  In the past, it has been based more on a firm’s historical EIR experience and they would use that to determine the frequency of inspections.  This would determine whether an abbreviated inspection or full inspection would be given, and how often they would come out.  The latest case for quality initiative is a part of their evolving vision.  It does not seem as though this has reached its full implementation state at this point.  On the FDA’s website there are some testimonials about how this has helped companies to decrease the number of audits that they have done and harmonize between ISO 13485 and this MDSAP.  The participants, aside from the US, Australia, Brazil, Canada, and Japan, the world health organization and EU are observers right now.  That might be attributing to the delay. However, based on what's on the FDA website, looks like it got some momentum and that they're looking at this program to roll out in 2017 or 18.

USDM Life Sciences leverages an experienced delivery team, proven methodologies, and best practices validation documentation to provide our life science customers a rapid, cost-effective approach to implementing, configuring, validating, integrating and supporting your QMS.

How Would a Cloud Application be Verified for a Company by USDM Life Sciences?

The USDM Life Sciences cloud hardware is qualified and our software will be on the cloud as a service. The software has been implemented with the different modules which relate specifically to the work that our clients will be doing. USDM Life Sciences will specifically go about using our validation accelerator packs that we have for each of these specific packages.  USDM Life Sciences will define a master validation plan. USDM Life Sciences will work with the clients to define their requirements beyond what has been configured as the baseline and we'll basically validate that as part of the installation qualification and operational and performance qualification.

USDM Life Sciences leverages an experienced delivery team, proven methodologies, and best practices validation documentation to provide our life science customers a rapid, cost-effective approach to implementing, configuring, validating, integrating and supporting your QMS.