Or will they?

The FDA has been touting its Unique Device Identification (UDI) system for several years.

Interestingly enough, the UDI safely was tucked into the U.S. House of Representatives’ healthcare reform bill on page 1,510: "Unique Device Identification System. — The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this Act."

Even more interestingly, a UDI reference didn’t make it into the U.S. Senate healthcare reform bill.

Meanwhile, GS1 Healthcare US has been promoting its system of data standards for several years, and the Health Industry Business Communications Council (HIBCC) has been stumping for product data standards for about two decades.

The X factor remains how far the FDA will push the device data standards issue in healthcare. The federal agency already has gone on record outlining the need for device data standards and encouraging industry adoption and implementation. But it has stopped short of recommending the industry rally around a single standard or acceptable multiple standards and adamantly refuses to endorse a brand or company offering standards.

Industry reactions are mixed as to what the FDA ultimately will decide.

Mary Beth Lang

"The FDA has gone on record that with their charter and the climate of what the agency can and cannot regulate, they do not have the desire or authority to mandate a single standard," said Mary Beth Lang, Amerinet Inc.’s senior vice president for business intelligence and president of Amerinet’s Diagnostix unit. "They can simply state the requirements and end-goals of having standards, and allow the marketplace to develop and deliver any number of multiple standards that meet the FDA requirements." 

Yet others think FDA officials have a clear preference without revealing it on the record.

"The FDA simply wants the same thing most of the providers want – transparency, efficiency and safety," said Joseph Dudas, director of accounting and supply chain informatics, Mayo Clinic. "The FDA believes a single standard, GS1, makes the most sense. However, they prefer that the industry endorse and implement because they do not feel it’s their role to legislate it."

The FDA’s primary goal is traceability of supplies, according to Steve Paskvalich, director, technical services, MedAssets Inc. "That being said, I believe the FDA’s preference is for the adoption of a single standard across all providers and suppliers," he continued. "Providers use multiple suppliers and having to manage and interpret multiple standards for these items is not efficient and creates a potential patient safety risk. In addition, suppliers merge and acquire other product lines, which would lead to cross-references unless a unified standard is in place."

But Alex Zimmerman, director, supply chain information management, Resource Optimization & Innovation, a division of Sisters of Mercy Health System, argues the FDA’s penchant for globalization and industry uniformity speaks volumes.

Joseph Dudas

"We believe the FDA is encouraging providers and suppliers to adopt a set of standards that is both industry-wide and global," Zimmerman noted. "The industry has witnessed FDA involvement in many global data standards initiatives around the globe sending a message that their intention is to work with other nations towards global acceptance."

But some contend the tension right now cloaks a bigger picture.

"There is already industry consensus about the need for data standards as trading partners clearly recognize that patient safety and trading efficiency through data standards are in everyone’s best interest," said Dennis Orthman, senior director, Strategic Marketplace Initiative. "But our industry is currently focused on both surviving today’s economic turmoil while simultaneously preparing for the potential impacts of healthcare reform.

"The real question here is not whether there is a mandate, but rather how do we garner the resources necessary to adopt standards?" Orthman continued. "Only then can the benefits seen by other industries finally be realized in healthcare.

SMI members continue to work diligently and voluntarily toward adoption of GS1 standards, with half of the SMI member community recently reporting that they are already progressing toward GLN adoption. We are optimistic that similar progress toward adoption of the GTIN will be experienced. As the healthcare supply chain industry contributes to our national efforts to bend the cost curve, the speed of data standards adoption is what is important."

Indeed, the focus shouldn’t necessarily be on whether one or more standards will be supported and whose standards – those administered by GS1 Healthcare US or HIBCC, according to MJ Wylie, director, global data standardization, GHX.

MJ Wylie

"We believe the far more important questions are how to get healthcare organizations to adopt accredited ‘industry’ standards, which would include but are not limited to the GS1 or HIBCC standards, for product and location identification, as opposed to using their own proprietary identifiers," Wylie insisted, "and how to make it possible for healthcare organizations and trading partners to actually use those industry standards in their business processes."

But how would the lack of a single standard, regardless of administrator, affect the process that is moving forward?

"I think it makes the process less efficient and requires us to have to maintain multiple databases and multiple places to go to for multiple pieces of information," said Joe Pleasant Jr., FHIMSS, senior vice president and CIO, Premier Inc. "But it’s better than what we have today and shows we’re moving in the right direction. Hopefully, the marketplace will look to what it needs. It’s a lot like electrical outlets. We all have them and use them around the world but they’re different in the U.S. than in Europe. Each has its own. It’s not as efficient as having one. As we start to look at global companies and standards we’ll start to ferret out which companies and standards truly are global."

Even though the FDA has begun to determine data elements to attach to medical devices for identification and the necessary data fields, by and large, have worked with either GS1 or HIBCC formats, Pleasant said he "would be surprised if the FDA required only one [standard]. They will show both as acceptable.

"My understanding is that they’ve been given some regulatory authority by legislation that will require certain data be recorded and submitted on medical devices for approval, certification and clearance [for] 510ks, PMAs and recalls," he added.

The legislated UDI and UDI tracking system creates the environment for data standards to be identified, according to Lang, but the legislation still allows "some freedom and choice of systems" to meet the standards.

Dennis Orthman

"Although I do not want to guess what FDA will do," admitted Keith Lohkamp, product strategist – supply chain management, Lawson Software, "I do believe that, assuming FDA wants to execute on its strategy for Unique Device Identifier, FDA should at a minimum lay out a set of acceptable ways to provide UDI information that will include at least one established standard."

FDA will ultimately require a single set of data standards, Paskvalich concurred. "This already has been successfully implemented in the pharmaceutical industry and proven to be particularly beneficial when products are recalled," he said. "Because of the significant cost to suppliers as well as providers in switching to a single standard, it will not be implemented in the absence of a mandate. Until the FDA intervenes, people will procrastinate."

Zimmerman agreed, noting further that the FDA will have mandated industry adoption of a set of data standards, including a unique device identifier by 2012. "We frequently cross paths with FDA representatives at industry conferences and have heard them allude to this type of action many times," he added.

But Dudas doesn’t buy it. "They are likely not going to mandate a single standard," he said. "They do not see it as their role.

"But the FDA should endorse and require GS1 standards for UDI," Dudas continued. "While it might not be their typical role it would be in best interest of our country’s healthcare system. Many of the largest providers have asked that the FDA step up and legislate that the GS1 standards be used."

 Pleasant conceded that the FDA likely will favor the two available options offered by GS1 and HIBCC. "I don’t know that they can be any more specific than that," he said. "They will stop short of anything more than that. They’ve been very clear on that."

Alex Zimmerman

The FDA merely wants to nudge the industry into action and taking responsibility, Zimmerman observed. "It appears the FDA is attempting to simply regulate adoption of standards without specifying a specific standards body in hopes that the industry will select one on its own," he said. "This methodology will work as long as a preponderance of industry participants leans towards a specific standard. However, a mandate of a specific set of standards would hasten the adoption process. We believe the FDA does not specifically endorse one standard over the other because it would infringe on the free market-driven selection process, which will lead to stronger practices."

A government mandate certainly has its risks, according to Lohkamp. "Although selecting a single standard would simplify requirements and expectations, a mandate for only one standard could slow down implementation of a unique device identifier, either because suppliers – or standards groups – resist the change or because the transition is time consuming," Lohkamp said. "Ultimately, an FDA requirement for UDI that includes the use of a standard will provide a catalyst that will help the market begin to settle on a single standard as providers lay out their expectations of their suppliers." As an example, he cited a growing number of providers and group purchasing organizations issuing their own mandate to adopt GS1 standards even without a federal mandate, which is a trend he thinks will continue.

Steve Paskvalich

Without clearly established and identified boundaries, however, the absence of a single standard mandate may subvert any efficiencies that could be gained.

"Allowing a provider or supplier to choose or create its own standard will not fully support optimizing the supply chain," Paskvalich said. "It may solve issues with traceability and recall, but unless there’s a single unified standard, data sharing and communication between trading partners cannot be optimized."

Clearly, the industry wants to avoid proprietary standards as a choice, absent a federal mandate for a universal standard.

"Most healthcare organizations recognize that moving to industry accredited standards, as opposed to proprietary standards, can help improve administrative and operational efficiencies as well as patient safety," Wylie said.  "Government mandates can help move the industry in this direction, but they are not the only driver. In recent years, GHX has seen a significant increase in organizations expressing interest and taking meaningful steps toward standards adoption. Certainly the pending UDI regulation has sparked interest, but the sunrise dates for the use of GS1 standards for product and location identification, the GTIN and GLN respectively, have also played an important role, as have educational efforts by organizations such as AHRMM and SMI."  

But Zimmerman charges that without a government mandate it will be very difficult for the industry to adopt a single set of standards. "Already we have competing standards and much of the momentum directed towards adoption of a single standard has been a direct result of perceived FDA action," he noted.

"A mandate would certainly put a stake – and timeline – in the ground that the industry could shoot for, but I don’t believe this is essential to moving forward with standards," Lohkamp countered. "Even without a government mandate, providers, suppliers, GPOs and solution providers are moving forward with standards adoption. Providers recognize the potential savings and efficiencies from standards and will continue to push their suppliers to adopt. Suppliers, particularly global manufacturers, are already driven by both mandates from other countries as well as a desire to simplify product packaging. Solution providers like Lawson understand the value of standards to improve outcomes and ROI from software and thus are responding to the needs of their customers."

While Lang concedes that the lack of FDA mandate likely "will cause confusion and delays to a process that is currently poised to move toward full implementation in the next three years, it’s not a deal-killer.

"Because the current state of technology allows for code-readers that can accommodate different types of codes, the idea of having multiple standard sets will not be much of an issue with regard to reading different codes on the actual product labels," she noted. "However, in terms of data synchronization and gaining access to full product attributes that can be updated in real time, using more than one system becomes problematic and expensive." 

Joe Pleasant Jr

Without FDA direction and parenting will the industry reasonably be able to meet the succession of standards adoption dates for GS1 products during the next few years?

Pleasant remains positive and optimistic. "I think there’s a good segment of the industry that will meet these dates," he said. "We’re just going out and doing an assessment of our manufacturers and seeing their progress. We’re also going back to our hospitals who have supported us and committed to doing it.

"[We anticipate] manufacturers will commit but the question is whether hospitals will commit," Pleasant continued. "I do believe it’s going to happen. Large organizations are doing a great job moving this thing down the road and forward. They are serious and adamant about meeting the deadline. Others, however, may not be centrally organized, something that allows them to have one voice. GPOs will have to continue being steadfast about this. That’s what will drive deadlines. Not FDA."

Pleasant predicted that hundreds of Premier hospitals will be ready and if other GPOs contribute as much, perhaps 1,000 or more could be on board, leading to half the industry within the next few years. "When early movers put things in place and start demonstrating achievements others follow pretty quickly," he added. "People move a lot quicker when they see what others are doing and accomplishing in terms of benefits."

Lohkamp indicated that Lawson sees many of its customers marching toward the GS1 Sunrise dates, regardless of any FDA mandate, and expects them to meet the industry-developed deadlines, which have become an important catalyst to action.

Keith Lohkamp

But he offset that upbeat observation with some realism. "Standards adoption will be a journey that providers in particular will take at different times," he said. "Therefore, 100 percent adoption in all facets of supply chain processes across all providers and suppliers cannot be expected by the upcoming deadlines. Instead, we could evaluate the industry sunrise dates on three criteria:

1. Have they helped motivate a significant portion of the industry to action?

2. Do we have critical mass in terms of acceptance, understanding, use of the standards and availability of data to ensure that the standards will stick?

3. Have the early adopters learned enough and provided the right solutions and guidance to point the followers in the right direction on their journeys?

GHX spies progress, too, but no miracles.

"GHX has already worked with a number of its provider and supplier members to help them meet the industry imposed sunrise dates for the use of GLNs and GTINs," Wylie noted. "That said, it is highly unlikely that the entire industry will be able to utilize the designated standards in all transactions with all trading partners by the sunrise dates. Even suppliers and providers that are completely ready for the sunrise dates in their own organizations will have trading partners that are in varying stages of readiness. But despite these challenges, we do not believe that the sunrise dates will need to be postponed.

"One of the roles GHX can play is to help organizations cross reference their data to industry standard information," she continued. "For example, if a supplier or provider is unable to receive or send transactions with the designated standards, we can provide translation services between industry standard and proprietary data. However, we do not believe this should be used as an excuse for organizations to delay reasonable efforts to work toward adoption and implementation of industry standards."  

Paskvalich acknowledged the challenges the industry has experienced so far and the potential problems stemming from indecision.

"The standards initiative has struggled to create critical mass, and any uncertainty in proposed regulations/mandates will not help," he said. "Now more than ever, suppliers, providers and solution providers are extremely thoughtful about how they invest resources. The big issue is that it is expensive for the manufacturers and to some point, the providers, to switch standards. Without clear direction, the majority of the players will not fully implement by these deadlines."

Dudas agreed. "It is likely that there will be confusion in the industry and some that will claim that it does not really matter – or the FDA would have legislated," he observed. "This will set us back some, but it is also likely that significant progress will be made in 2010 through 2012. Too many of us know the value and are committed. Will we be at critical mass? Hard to say. A lot will need to happen this year to get there and we need to continue to press for progress as this is a very important step towards maturity for our industry."

Contended Lang: "With the economic downturn and continued decrease in reimbursements, we can’t afford to delay the adoption of standards. In addition to the supply chain efficiencies, data standards will contribute to patient safety as products can be scanned at the point of care and then documented in the electronic health record."