On October 17 – 19, 2017 the global GS1 Healthcare community came together for their fall conference in Chicago, IL. The conference was packed with practical information for implementing GS1 Standards across every spectrum of the Healthcare industry. To cover the entire event, I’ve asked Karen Fleshman, Co-founder, COO of the Haskins Advisory Group, to cover the medical device sessions while I cover the pharma sessions. Let’s hear from Karen first.
THE MEDICAL DEVICE SESSIONS
Overall, the sessions I attended were filled with updates, implementation best practices, lessons learned, and the challenges faced by global Healthcare providers, manufacturers, distributors, and regulatory agencies, as they meticulously work to comply with the requirements for implementing the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI).
As a GS1 Solution Partner providing consulting services that help medical device manufacturers with UDI compliance, my purpose for attending the conference was to acquire the latest information on UDI implementations across the globe, but I got so much more.
There were so many great sessions and the overall event was very well organized. To keep me focused, I’m only going to cover the major highlights from a UDI perspective and a site visit I attended:
Compliance Date Extension
The compliance date for Class I and non-classified devices has been extended to September 2020. Data Quality is imperative in the success of any system. The FDA’s analysis of the data in the Global Unique Device Identification Database (GUDID) has revealed data quality issues, such as inconsistencies with pre-market submission information and GUDID entries. The extension will be used to address technology and policy issues as well as provide product labelers with more implementation time.
According to Terrie L. Reed, FDA Senior Advisor for UDI Adoption, “Sufficient confidence in the accuracy and completeness of the data is critical to ensure UDI integration into REAL WORLD DATA—from manufacturing through supply chain to patients’ Electronic Health Records (EHRs) and claims”.
EUDAMED and New GS1 Key
The Public Policy—Medical Devices session, normally a closed session but was opened to the public at this event, was facilitated by Géraldine Lissalde-Bonnet, GS1 Global Office and Jackie Elkin, Medtronic. The session provided an update on the European UDI initiative known as the European Databank on Medical Devices (EUDAMED). EUDAMED is well on its way to developing the regulatory requirements for the EU’s UDI program.
One of the main difference between the US and the EU requirements is the introduction of a new GS1 Key called the Basic-UDI-DI (BUDI-DI). The BUDI-DI is used as the primary identifier of the device model, assigned at the device unit of use. It is the main key for records in the EUDAMED UDI Database and is referenced in relevant certificates and EU declarations of conformity. The BUDI-ID is not applied to the device; it is not part of the trade item supply chain. Its aim is to support market surveillance activities and clinical investigations. For more information, see www.gs1.org/sites/default/files/docs/gsmp/cta_basic_udi_di_final.pdf.
I look forward to hearing more as the initiative progresses.
For any medical device manufacturer trying to figure out where to get started, I suggest starting with the Day 2, UDI – AIDC Implementation Experiences session moderated by Jackie Elkin, Medtronic.
The panelists from Abbott, B. Braun, and Teleflex shared their practical experiences in implementing UDI.
- The Abbott presentation, presented by John Terwilliger, outlined the step by step process for implementing UDI. The steps can be translated into a baseline project methodology to, at the minimum, start the conversation on the impact of the UDI.
- Georg Keller from B. Braun’s presentation provided excellent examples on how to create various barcode types and direct mark devices using laser technologies.
- Finally, Teleflex’s Mark Hoyle covered the Master Data aspects of the UDI implementation. Mark walked through how Teleflex uses the 1WorldSync/LANSA GDSN solutions to design a program that addresses their worldwide regulatory needs.
The combination of these presentations can be the foundation of designing any UDI program.
On to Bogota…
José Luis Sabogal and Juan Camilo Rincon, Centro Médico Imbanaco provided insight into the implementation and use of DataMatrix in the pharmacy and how the standards are used to dispense and replenish medication.
Rafael Florez, GS1 Columbia delighted the audience with a presentation designed to showcase the next conference in Bogota, Columbia. So, brush up on your high school Spanish and I hope to see you there!
Site Visit – Zebra Experience Centre
Zebra Technology, Lincolnshire, IL, builds tracking technology and solutions that generate actionable information and insight, giving companies unprecedented visibility into their businesses by giving physical things a digital voice. www.zebra.com.
The tour group was greeted with enthusiasm as we were lead into their elegant, relaxing, and upscale office space. Senior Vice President of Sales, Joachim Heel, proceeded to present the company’s vision called Enterprise Asset Intelligence (EAI). EAI is the process they use to ensure real time visibility into people, processes, and things.
EAI consists of three components:
- SENSE – Zebra helps companies connect devices, to software and to mobile workers, enabling companies to know much more about what’s going on in their enterprise.
- ANALYZE – Provides easy access to an unprecedented amount of data that allows companies to plan effective short and long-term strategies. Zebra helps to deliver real-time insights into the critical data being captured by the sensors in connected devices.
- ACT – Large and growing fleet of mobile devices enables management and workers at all levels to act on these visibility-driven insights in real time, anytime and everywhere.
Have you noticed, there appears to be more “too-many-players-on-the-field” penalties in the NFL this year? Well, we have Zebra to thank for that. Joachim informed us that each NFL player now has a tracking sensor in his shoulder pad! See www.zebra.com/us/en/nfl.html for more about that.
The tour proceeded to the Product Showcase area where each product line leader provided demonstrations, insight, and answered questions on their areas of expertise. I went to the RFID section and saw a demonstration on how RFID technology is used to track specimens in-route to the lab. It was fascinating!
It was an amazing conference and I just covered a small portion of it; there was so much more. I didn’t cover the Networking events or the trade show exhibitors. I didn’t cover the new connections formed at the lunch tables and during the 1.5-hour bus ride in rush hour traffic from Zebra. The conversation was captivating as we discussed technology processes from “back in the day”!
What a conference… Did I say I enjoyed it?
THE PHARMA SESSIONS
Thanks Karen! Well done. I had my hands full (actually, my head-full) with just the pharma sessions so your reporting is very helpful. I also attended two site visits: the Macy’s store on Michigan Avenue, to see their use of RFID, and the McKesson pharma distribution center in Aurora.
Dr. Connie T. Jung, RPh, PhD, Senior Advisor for Policy, Office of Drug Security, Integrity, and Response (ODSIR), Center for Drug Evaluation and Research, Office of Compliance, U.S. Food and Drug Administration discussed the US FDA Drug Supply Chain Security Act (DSCSA). For those of us who follow the DSCSA developments closely, there was nothing new in her presentation.
A very interesting session was presented by Ta-Jen (TJ) Chen, Project Management Officer, FDA/CDER/ Office of Strategic Programs, U.S. Food and Drug Administration on Identification of Medicinal Products (IDMP). IDMP is a set of five International Organization for Standardization (ISO) standards that are designed to work together to uniquely and unambiguously identify medical products, including standard ways of identifying things like dosage forms and units of measure for strengths. The National Drug Code (NDC), GS1 GTIN and SGTIN fit into distinct layers of IDMP. I hope the reason the FDA is building expertise in IDMP is to come up with the modern replacement for the NDC, but I’m not holding my breath (see “NDC Nearing Its End, Afflicted by ‘Identifier Failure’” and “How To Properly Define GTINs For Your NDCs”).
Industry traceability veteran and leader, Mike Rose, Vice President, Supply Chain Visibility, Johnson & Johnson, U.S., spoke about the European Union (EU) Falsified Medicines Directive (FMD). Mike is a leader within the supply chain groups of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and his presentation demonstrated a solid understanding of the current state of the regulation and industry preparations for meeting it.
For me, the best presentation of the day came from Ms. Bianca Zimon Giacomini Ribeiro, Deputy Chief Adviser for International Affairs, National Agency of Sanitary Surveillance (Anvisa). Ms. Zimon spoke about Pharmaceutical traceability in Brazil. She provided a brief history of traceability regulations in Brazil (see also “Brazil Gets Rational With Their New Pharma Traceability Law”, and “Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot”). It’s always nice to see such a clearly designed timeline (ANVISA 1) and sample barcode (ANVISA 2) from a regulatory agency.
As I have observed in the past, Brazil has shown an incredible willingness to learn from their mistakes and those of others—to the point of terminating their whole traceability regulation and starting over…at the legislation level! They are on a very rational path now and I, for one, applaud them for what they have done. I’m looking for greatness in their future.
A very good presentation that I wasn’t expecting came from Tjalling van der Schors, Pharm.D., Hospital Pharmacist, President NVZA, Director of Pharmacy, WestfriesGasthuis, Netherlands. This is what I love about the Global GS1 Healthcare Conferences, learning about unexpectedly great ideas. Tjalling’s presentation was called “Achieving single unit pharmaceutical traceability”. He is a hospital pharmacist, and his goal is to stop medication errors through Bar Code Medication Administration (BCMA). I’m so wrapped up in the use of serialization through barcodes on medication for meeting national pharma serialization regulation, I rarely think about the problems of a hospital pharmacist or other health professionals. It turns out that the supply chain regulations bring standardized, machine-readable product identification so close to where it could have made a huge difference in solving the serious problem we have with medication errors, but not quite far enough.
Tjalling showed us some of the text of the FMD where it talks about safety—as in “safety features” on drug packages. But standardized barcodes on secondary packaging isn’t enough to bring needed safety benefits directly to patients. What is needed is standardized barcoding of every single unit of use. Only then will pharmacists be able to count on the accuracy of barcodes for solving persistent medication errors that patient safety professionals have been talking about for decades (see “To Err Is Human”). If feels like we are close, but we need to move the ball forward a little farther.
Macy’s RFID Tour
I attended the early-morning tour of Macy’s Michigan Avenue store to see their store floor RFID processes in action. They’ve been increasing the number of products that have RFID tags on them for quite a few years now because they have been able to demonstrate benefits that translate directly into increased sales and profitability. I was told that RFID is not the enabler of Macy’s omnichannel program, which is what I had assumed, but it makes it a lot more efficient. Very interesting.
McKesson’s Pharma DC Tour
This tour was particularly interesting to me because I used to work for a competitor of McKesson. Being very familiar with pharma distribution and no stranger to a modern pharma DC, I was able to mentally compare their technology and processes to those of my former employer. Of course, the hosts were well aware of my employment history. All I can say is the McKesson DC is state-of-the-art. For me, the tour exposed some of the many challenges that serialization will pose for wholesale distributors in the future. It was clear that the local DC management team and the corporate team are well aware of those challenges and are on their way toward addressing them.
I look forward to the next Global GS1 Healthcare Conference here in North America. Thanks to Karen for helping me out with this essay.