With a final rule from FDA for UDI expected this year, device makers have accelerated development of a UDI system. As a first step, “labelers” need to adopt a system for issuing UDIs from an issuing agency accredited by FDA. Support continues to grow in the supply chain for the GS1 System of Standards, embraced by early innovators pushing for a global standard for device identification and tracking.
In an interview with PMPN, Siobhan O’Bara, senior vice president, industry engagement, GS1 US discusses issues raised by manufacturers in comments on the proposed rule, and the advantages of using GS1’s system.
[Editor’s note: Siobhan O’Bara will join Jay Crowley, senior advisor patient safety, FDA, and panelists from Medtronic, GHX, and Premier speaking on Creating a Roadmap For UDI Compliance
at the upcoming MD&M West trade show and conference, Feb. 11-14 in Anaheim, CA.]
Q. How far along is the medical device community in preparing for UDI?
Many organizations across the U.S. healthcare supply chain have been championing a UDI system to the benefit of patients, healthcare providers, and manufacturers here in the U.S. and around the world. Once the rules about UDI are known and understood in the final ruling, more meaningful actions to fully implement UDI will take place across the industry. A UDI system leveraged by all constituents in the supply chain will enable the flow of accurate information as the product moves through the supply chain. The ultimate goal of UDI is improved patient safety. GS1 members feel a key component of improving safety is the speed and accuracy of product recalls and adverse event reporting, as UDI ensures that all trading partners are speaking the same electronic language with respect to what information is shared about products.
Q. What first steps should manufacturers be taking?
Now that we know a final rule is imminent, to implement UDI capabilities, a manufacturer should, in short order:
--Select their system of standards (i.e. the GS1 System of Standards).
--Understand their item master framework and the master data management protocol in their organization. The UDI item attributes – a critical and required component of the proposed rule-- may or may not match the item master details in the manufacturer’s current system. Obtaining the complete and accurate listing of item attributes for existing products is not a small undertaking. Once the attributes are assembled, the ongoing process of master data management keeps that data accurate and complete.
--A key part of the item master and packaging assessment will be for a manufacturer to review and decide which level of packaging an item will need to have a UDI. The guidelines for these decisions are outlined in the [proposed rule]. In simplest form, the UDI will need to go beyond the physical or logistical package and most inner packs of products will also need to be marked. (i.e. case, box, each) The manufacturer will need to make decisions about how far down the packaging levels will labeling occur to be compliant to the UDI final rule. There is no single answer to this question – it will vary by products, packaging, item device classes (Class III, II or I) and is perhaps one of the largest hurdles for starting the UDI journey.
Once the manufacturer determines what needs a UDI, they next need to assess existing business and manufacturing processes. With the UDI attributes, will any processes, packaging or system (both commercial and manufacturing) need to be changed? Answers here may drive additional internal projects such as systems changes, modifications, and 21 CFR Part 11 validation retesting.
--To start on all the above, manufacturers should engage in industry education opportunities and take advantage of the information already being shared to leverage best practices from early implementers.
Q. How influential has the Healthcare Transformation Group been in promoting GS1 standards?
As five of the top healthcare providers in the country (Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic, and Mercy), HTG has worked to incorporate the GS1 standards with the 20 major suppliers to all hospitals. Their effort and use of a single set of global data standards has complemented the parallel work by government to create a UDI system and database. Anytime large, influential, and technologically leading providers get together to drive change in healthcare, good things happen.
Q. What bar code formats will manufacturers use?
The draft UDI regulation appropriately does not suggest which barcodes manufacturers must use; it will focus on regulating the standards of how a barcode is structured and built. Manufacturers are likely to select GS1 barcodes including GS1-128, GS1 DataMatrix, and GS1 DataBar. These barcode structures enable enough information to be stored that would likely comply with the final UDI rules for primary and secondary product attribute information. Healthcare retail products would likely continue to use the UPC.
Q. The proposed rule says FDA is phasing out the NCRIC and NDC system for devices. GSI has asked that FDA not withdraw the NCRIC labeler codes as these are codes already registered with GS1 as the company prefix. What is the issue here?
Manufacturer members of GS1 Healthcare US have told us that this is an important and serious issue. Many manufacturers were originally assigned FDA NHRIC labeler codes decades ago. These numbers were registered with HIBCC and GS1. As the standards movement evolved, they turned into GTINs and GLNs and other commonly used standards, and manufacturers that use NHRIC have the NHRIC prefixes embedded into GTINs on equipment that will be in hospitals for years. We are against phasing out these numbers where they might be re-used or recycled. Also, if FDA pulls these numbers back, all manufacturers using these numbers would need to start over with their GTIN enumeration, GLN assignment, GDSN efforts, etc. We have no problem phasing out the term "NHRIC." We are proposing that manufacturers continue to use these old NHRIC numbers embedded into GTINs for UDI, but stop referring to them as “NDC” or “HRI” or “NHRIC” numbers.
Q.What issues are devices that are serialized facing?
In most cases, uniquely identifying products in the supply chain down to the unit level aids in the collection of data about product movement, and allows manufacturers, distributors, providers and regulatory agencies to have more accurate information regarding the device. Better information leads to improved patient safety by ensuring that products at the point of care are the ones that are supposed to be there. Serialization enables the identification of the specific device for a focused recall, as well verifying that products remain current on versions and expiry dates. The hurdle for serialization will be the link between the serialized unit and the UDI records supporting it. There is no change, under UDI, for which devices require serialization. However, by having a UDI system in place, manufacturers will have a new way to tie the serialized items together with attributes of the products in a repository that providers and patients can easily access.
Q. How will manufacturers and providers use the GS1 Global Data Synchronization Network (GDSN)?
GDSN is a single, synchronized source of accurate product information that manufacturers, providers, and anyone else in the supply chain will be able to leverage for up-to-date information they need about a medical product or device. The GDSN serves as a data source for the UDI as well, so that when there is an update to a product, such as a new model introduction, an enhancement, or a recall, the manufacturer would only need to provide one feed to the GDSN versus having to update all of their customers and the FDA individually and in multiple electronic formats. Having this single source of information makes it easier for manufacturers to manage data about their products out in the marketplace, and makes it easier for providers to keep their item (master files) clean and updated as well. When there is an update to the GDSN, that information is pushed out to all subscribers simultaneously. FDA would be a subscriber, as would providers and GPOs. Having access to real-time data increases the opportunity for that data to be used, which of course improves patient safety. The industry would leverage one source of true product data, allowing accurate information to be shared in a more timely manner.
Q. Will hospitals have to invest in new scanning technology before they can realize benefits from UDI?
Not necessarily. Hospitals will be able to leverage the patient safety and efficiency benefits of using consistent, accurate product information and having clean records in the hospital’s item master, regardless of their ability to scan devices at the dock or at the bedside. Obviously, hospitals that do invest in scanning technologies are able to access the enhanced benefits that automation provides, including accuracy of information about product movement, input of data into medical records of patients that use the device, and push/pull of GDSN information.
Q. Industry has commented extensively on the scope and definitions of product attributes that will be reported to the GUDID (Global Unique Device Identification Database). Does GS1 favor any modifications to the proposed rules for the GUDID?
The most recent published GUDID attributes are in our standards and are supported by GDSN. We anticipate any future attributes would also be supported. When the final rule is published, we expect that GS1 Standards will align with what is required in the regulation.
Q. GS1 has called for exempting convenience kits from requiring a separate device identifier (DI)? What is the argument for exempting kits?
The GS1 workgroups composed of both providers and manufacturers favored exempting kits from requiring a separate DI. The reason for this exemption request is straightforward. Convenience kits by definition are an assembly of items that are otherwise sold independently as finished goods. That is a key element – since the items are sold independent of their inclusion in a kit – they will already be marked with a UDI (GTIN). The attributes and UDI information on these kit components will be marked on the package contained in the kit as well as be available in the UDID. By adding another UDI (GTIN) to the convenience kit itself, GS1 US and our members believe this additional UDI will cause confusion and add cost. Thus far, there has not been a compelling case presented that this additional marking would provide any additional patient safety benefit.
Q. Will the changes that FDA has defined for when a new DI is require conflict with GS1’s rules in this area?
GS1 standards will align with FDA requirements. When FDA comes out with its guidelines on the occurrences and attributes that would trigger the need for a new UDI, if we are not aligned, we will work to align our rules and guidelines to FDA’s.
Q. Why are companies favoring the GS1 system for meeting the UDI requirement?
The GS1 System of standards offers a global system used by more than two million member companies worldwide. Additionally, our members report that with a completely numeric UDI (GTIN) the identification of the item is easier for their staff and the patient. While many supply chain participants will read and transact UDIs via technology, some constituents will rely on manual, person-dependent, processing. All-numeric versus an alpha/numeric UDI is deemed preferable and decreases the error rate when entered by a person (vs. machine.)
The industry also likes having an integrated system for accurate identification and communication of information for locations, products, and other identifying information. In addition, many healthcare manufacturers also produce for other industries, such as retail and grocery, and those industries are already using GS1.
While GS1 would like to be the standard of choice for healthcare, the goal for us is patient safety. We believe that patient safety is improved when using a single set of consistent, accurate and global standards.
Q. What support services does GS1 provide for helping companies prepare?
We see our services as threefold:
--To help educate the industry and serve as a resource to share what other members have learned in using standards. This education and resourcing comes in the form of the publication of guidelines, case studies, lessons learned, and best practices.
--To help implementation become a reality for our members. The use of standards and compliance to UDI will no longer be voluntary. So we at GS1 need to support implementation with implementation roadmaps, readiness programs and other services as needed to ensure success of the UDI.
--To innovate in the use of standards so that the mission and vision of UDI – improved patient safety – becomes a reality.