Products & Services
Logically, the use of data standards would make transactions so much easier to track and trace, as well as facilitate detailed analysis of product movement and process progression. Yet while the end game may be obvious, the journey to reach it apparently is fraught with obstacles, largely of a healthcare organization’s own making.
Snap judgments aside, Healthcare Purchasing News has surveyed its readers annually about their adoption and implementation of supply data standards, specifically the Unique Device Identification (UDI) system. During the last three years, the survey results illustrated some heartening news: A growing number of facilities ever-so- slowly is adopting and implementing UDI, while the number of facilities not using the UDI for a variety of reasons is trending downward.
In short, all of the educational sessions, editorial features and case studies during the last two decades at last may be solidifying opinions, generating traction and directing implementation.
Since its inception in 1977 HPN has covered and explored supply data standards from a variety of angles, including challenges and opportunities, features and benefits, costs and savings, spanning such efforts as the Common Category Database, the UPN initiative and the UDI initiative.
Early on, skeptics and cynics demanded case studies with virtually irrefutable proof that adoption and implementation would be painless and generate such a wealth of rewards that the supply data standard champion would be granted such heroic status to qualify for the parking space closest to the front door for the duration of his or her career at the facility, bumping the CEO to the next spot.
Well, hyperbole and unrealistic expectations and fantasy aside, some facilities have been making headway with supply data standards, scoffing at the naysayers and reaping realistic rewards for their organizations. And not just those daring and willing souls who go on the speakers circuit year-after-year, dutifully sharing their stories before audiences that feel they’ve heard it all before – and from the same names.
But how much have providers and suppliers progressed in the area of implementing supply data standards?
Sidebars below:
For some relayed success stories, see “Spotlighting the standards savvy,” and for some subjective measurements by supply data standards experts, see “Assessing standards momentum.”
Balancing the scales
Despite all of the content publicized and shared about the features and benefits of implementing supply data standards using the UDI, these efforts apparently have not convinced everyone enough to make adoption and implementation a higher priority or even a necessity.
“Every area of the hospital benefits from data standards, especially as reimbursement is based more on the value delivered to patients, than on the volume of services performed,” said Karen Conway, Vice President, Healthcare Value, GHX, and a leading advocate for supply data standards. “Standardized supply data supports the ability to understand the relationship between the costs to deliver care and the outcomes achieved.”
Such understanding directs providers to adjust and hone their priorities.
“The priority for most hospitals and health systems has been to focus on the higher-risk, and usually higher-cost, items, such as implantables,” Conway continued. “The U.S. FDA also prioritized risk in its phased implementation of the UDI regulation, starting with Class III and implantable devices.”
These efforts enable providers to garner a plethora of additional data, too, with deep-reaching effects.
“Standardized product data supports post market surveillance to understand how products are performing in routine clinical practice,” Conway indicated. “This can enable more effective and faster response in light of adverse events, but it also helps understand which products work best on which kinds of patients. For this reason, many organizations have prioritized capture of standardized product data at the point of care.
“Ideally, hospitals and healthcare systems will identify products the same way, regardless of the function, system or purpose,” she noted. “For example, by using standards in transactions, hospitals can understand what products they purchased, which also supports recall management. Further, use of standards for both product and organization/location identification can improve contract price alignment and cost accounting.”
“The use of industry standards benefits numerous aspects of a healthcare organization’s processes and product usage,” O’Bara said. “It enables consistency and interoperability for data exchange between trading partners throughout the entire supply chain – from manufacturers all the way to the point of care. It also helps various departments within an organization to share information consistently so that an individual product is identified the same way throughout the healthcare provider’s operations. As a result of a standards implementation, every department and company across the healthcare ecosystem is able to talk about each product in a common language they all understand.”
O’Bara cites three common and familiar benefits to reinforce supply data standards’ inherent value.
- Inventory management – Scanning unique device identifiers enables the provider to improve accuracy and realize efficiencies in its inventory management. Errors are reduced by eliminating manual data entry and an item’s current availability, location, and use is easily tracked by pulling up the electronic record according to the device’s GTIN. And if a product is recalled, it can be quickly located for efficient inventory cleansing.
- Patient records – Scanning standardized device identifiers at the point of care makes it possible for healthcare providers to maintain the data in a patient’s Electronic Health Record (EHR). This information can be invaluable in the event of an adverse reaction or product recall.
- Point-of-care medical device scanning – Scanning unique device identifiers (UDIs) at the point of care enables operational efficiencies, improved record-keeping, time savings and better patient care.
Patient care and procedural settings both can reap benefits from UDI adoption and consumption, particularly in the areas of implantable medical device data and the transactional aspects of the overall supply chain, according to Denise Maxwell-Downing, R.N., CNOR, Vice President, Clinical Quality and Patient Safety, SteriTrack, a Matrix IT company.
The lack of medical devices sporting a standardized method to identify a device across the product lifecycle made post-market surveillance, adverse event/recalls and comparative effectiveness difficult to achieve, Maxwell-Downing observed.
“This not only impacts patient safety, but also the healthcare organization’s ability to manage supply chain work flow processes efficiently and accurately,” she said. “The UDI for implantable medical devices is an essential piece of data enabling patient safety [that] allows for accurate one-to-one comparison of device performance and provides guidance for strategic procurement decisions.” Further, she added that UDI captured at the point-of-use provides accurate medical data that will improve outcomes across patient populations and will support the development of standardized practices and products.
Maxwell-Downing encourages healthcare leaders and professionals to learn from other industries how leveraging technology to automate the transactional supply chain generates considerable value.
“The operating room can be a siloed area of the healthcare organization that has no end-to-end automated process that supports the logistical coordination of activities and medical devices needed to prepare for and perform a patient procedure,” she said, referencing a GHX report from October 2012 on the state of the implantable device supply chain that posited the lack of visibility and control over medical devices costs the healthcare industry an estimated $5 billion per year due to inefficient, disconnected manual processes, as well as lost, expired and wasted product.
Maxwell-Downing acknowledges, however, that “even the most technologically sophisticated healthcare organizations manually capture much of their clinical supply documentation at the point-of-care, a practice that introduces the known potential for human-error when entering product information used during patient care.”
UDI adoption benefits include the reduction of obsolescent inventory, improved recall management, ensuring product pedigree and safeguarding the healthcare supply chain from counterfeit product, the common denominator across all these variables being patient safety, she added.
As Cory Turner, CMRP, Industry Strategy Director, Healthcare Supply Chain, Infor, travels around the country meeting with healthcare leaders from a variety of organizations he hears very similar messages.
“‘I need to track my OR and Cath Lab supplies in a more meaningful way,’” Turner recalled as the common refrain. “These items are typically more expensive and possess more of a direct patient impact. Being able to know every step a product takes is a key to success.
“As a former supply chain director for one of the largest IDNs in the southeast, our goal was to have complete visibility throughout the product life cycle, from the manufacturer all the way throughout the logistics process and eventually to the patient,” Turner continued. Having total visibility throughout was and continues to be on the minds of leadership and not just the supply chain leaders. OR and Cath Lab supplies affect the cost, quality and outcomes directly. They are most expensive items that must be the best quality in order to ensure the highest patient outcomes. This is the priority of all healthcare organizations…or it should be.”
Turner previously served at Greenville (SC) Health System, which earned “Supply Chain Department of the Year” status from HPN in 2013.
Making the economic case
Justifying any financial, operational and processional investment in supply data standards implementation requires hard- and soft-dollar savings estimates – essentially data.
Matrix IT’s Maxwell-Downing defines each category and cites a University of Tennessee Medical Center UDI Capture Work Group Case Study, published by the Association for Healthcare Resource and Materials Management in 2017 (http://www.ahrmm.org/resources/learning-udi-community/pdfs/repository/utmc-luc-case-study-2017.pdf), to buttress the logic.
Hard-dollar savings represent those dollars than can be seen in a budget and an organization can quantify, she indicated. Some examples of hard-dollar savings realized by healthcare organizations from UDI adoption and implementation include:
- One-time inventory reduction of $2.5 million
- One-time IT infrastructure investment of $1.2 million plus $150,000 annual maintenance that nets a positive $24 million in savings in first six years
- Labor savings of 200 minutes per case for EHR to quality data registry submission
- Process efficiency savings derived from not pulling products that won’t be used for surgical or invasive procedures that can increase the cost of a $1.50 sponge up to $8 based on all the handling and labor.
- Soft-dollar savings represent those dollars that are more difficult to impossible to quantify, she noted. “Even though these savings are more difficult to quantify doesn’t mean they aren’t as important as the hard-dollar savings,” she said. Soft-dollar savings examples associated with UDI adoption and implementation include:
- Strong teamwork, commitment to patient safety
- Existing infrastructure, roles and processes are in place and easy to build on
- High-functioning team [generating] quick delivery with minimal meeting time and no project leadership or executive escalation required
- Access to clean, normalized data in a clear, readable format required by different stakeholders because those in supply chain need different data attributes than those in clinical areas
- Labor savings via efficient recall processes such that instead of taking months or hours to determine who was affected the time can be reduced to 30 minutes
Sense and sensibility
Certainly, supply data standards experts can make equitable cases for UDI adoption and implementation across a variety of product or process areas, but how reasonable the expectations are for universal acceptance attracts healthy debate.
Mike Schiller, CMRP, Vice President, Healthcare Engagement, SteriTrack, a Matrix IT company, scoffs at even the hint of an excuse but acknowledges the lumbering hurdles to behavioral change.
“An unreasonable expectation, no,” Schiller told HPN. “Comprehensive adoption in every area, however, is where the real challenge lies, and no one does silos better than healthcare. There are several challenges that must be addressed and overcome across all the major stakeholder groups, including health IT, providers, manufacturers and distributors, before comprehensive adoption becomes a reality.
“AHRMM’s Learning UDI Community (LUC), and its numerous work groups, is a tremendous step in the right direction,” continued Schiller, who previously served as AHRMM’s Senior Director, Supply Chain, and prior to that had led supply chain departments at several children’s hospitals. “The LUC brings together these various stakeholder groups along with regulatory and issuing agencies to address the difficulties associated with UDI adoption as they seek to collectively develop standardized approaches and recommended practices to solving these challenges.
“As a result of the LUC and the steady beating of the UDI drum by industry speakers and educational initiatives, UDI awareness and knowledge has grown. However, total awareness has not been achieved as indicated by a recent survey we took at the 2019 Association of periOperative Registered Nurses (AORN) Annual Conference and Expo [in Nashville] where 38 percent of the [registered nurses] surveyed were unaware of the ‘FDA’s UDI Regulation,’” he added.
Maxwell-Downing, who previously served as Nurse Informaticist, Perioperative Services, at AORN for nearly 12 years, offers some contextual background to any awareness issues among registered nurses, indicating that AORN has provided formal UDI educational sessions for several years.
“When UDI education was presented the first year the attendees had a bewildered look with no hands raised when asked if they have heard of UDI,” Maxwell-Downing recalled. “It has been wonderful to see how the deer-in-the-headlights look has changed to a more collaborative discussion about the benefits and challenges of adopting and implementing UDI. Many still rank themselves as a UDI beginner, but 50 percent of the audience has heard of UDI now. To me, we are getting the UDI word out there to the front-line leaders and users, which will help move the bar.”
Schiller acknowledges that that the trend toward adoption continues to grow, but not as smoothly as it could or should. He hints at regulatory issues as one culprit.
“It is clear that there’s a building sense of frustration and confusion among healthcare providers,” he told HPN. “Which device class or classes need to be captured, barriers to interoperability across health IT platforms, competing priorities, as well as finite resources and bandwidth are all contributing factors. The reality is that as of today there is no specific, accreditation or regulatory requirements, for healthcare providers to capture the UDI aside from ‘Adverse Event Reporting’ and the FDA stating that implementing a UDI system will ‘adequately identify medical devices through their distribution and use.’
“For UDI adoption to accelerate across the healthcare field, organizations will need to strategically plan for and incorporate this into their short- and long-term clinical, operational and capital planning processes,” he insisted.
Schiller recognizes that the UDI system only has been in place for five years. The FDA UDI Rule was written into law in Sept. 24, 2013, and the first class of medical devices – Class III and Implantable Life Sustaining/Life Supporting devices – that needed to comply with the FDA’s UDI labeling requirements was implemented in September 2014, he added.
Priority-setting remains the key issue.
“I agree, it is a priority, but also a competing priority with other organizational initiatives,” he noted. “Infrastructure changes that need to be made to accommodate the UDI capture at the supply chain and clinical level require financial, technical and human resources to complete. These changes can take multiple years to complete along with the change management and culture change that needs to occur within the various departments across the healthcare organization.”
One competing priority involves EHR interoperability with UDI, according to GS1’s O’Bara.
“Healthcare providers are highly motivated to continuously improve their business processes and efficiencies as well as quality of care,” she said. “Because data standards offer system-wide opportunities for improvement, we expect to see widespread adoption to develop in time throughout providers’ operations. Standards are a critical piece of the electronic accuracy, interoperability and efficiency needed for better healthcare.
“Providers have been at the forefront of the transition to Electronic Health Records (EHRs) as part of a mandate within the American Recovery and Reinvestment Act enacted in 2009,” O’Bara continued. “An important part of the EHR regulation provides criteria for doctors and other caregivers to be certified for ‘meaningful use.’ The Meaningful Use Stage 3 requirements make it a requirement to capture UDI on implantable devices, beginning in 2018.
O’Bara offers up several GS1 documents as resources to help providers implement system-wide standards, including the GS1 US Implementation Guidance for Point-of-Care Scanning for Surgical Implants and “Examining UDI Capture & Orthopedic Implants” white paper. She further encourages providers to reach out to service and technology suppliers for “practical methods for information management and data capture [as] canning equipment and data infrastructure are key components to a provider’s implementation readiness.”
Infor’s Turner recognizes implementation as a daunting task that requires a solid internal framework, but starting small may be most advantageous.
“It is highly reasonable for healthcare providers to eventually adopt these best practices into all areas,” he said, “however, eventually is the key word. Being able to implement this has not been a small task for even the largest and most advanced IDNs in the country. Organizations must have a strong Supply Chain and IT infrastructure in place to be successful. This is needed due to large ties backward into the suppliers/manufacturers as well as forward into the clinical world, and these parties don’t always play well with each other. This is a huge factor in why the adoption of UDI, GTIN and other data standards has been such a slow-moving process. If we can ever get to a point in time where at least the OR and Cath Lab supplies are better managed and tracked, I feel that we can start making even bigger strides on cost control on our supply spend within our healthcare organizations.”
GHX’s Conway dismisses any question or talk of reasonableness as two areas must be on board simultaneously.
“As reimbursement shifts to a value-based model, it’s become a clinical and business imperative,” she said. “We have to understand all of the resources, including services and products, used to care for patients, the outcomes achieved and the associated costs. It’s a fundamental component to understanding the relationship between what delivers quality care, including reducing hospital acquired conditions, readmissions and waste, and the costs. The good news is, when we deliver better care and reduce errors, we lower total costs. But we cannot make improvements if we do not first understand what is currently involved in care delivery.”
Conway points to increased regulatory expectations and the data requirements to support advanced analytics within hospitals as requiring these changes.
“Both suppliers and providers are being expected to answer new questions by customers, patients, insurers and regulatory bodies, etc., all of which require more standardized and structured data,” she continued. “To complete the cost-quality equation, there are a myriad of questions we must answer. What procedures were done on which types of patients? Who was involved in the delivery of care? What supplies were used? What is the relationship between the price paid for products, the amount charged, and the reimbursement for the procedure in which those products were used? Standardized data is the key to accurately answering these questions.”
Spotlighting the standards savvy
When it comes to adopting and implementing supply data standards, a number of providers and suppliers have made significant headway, improving their track-and-trace progress voluntarily and with regulatory encouragement. Here are a few worth noting as recognized by supply data standards advocates who saluted them with Healthcare Purchasing News.
Karen Conway, Vice President, Healthcare Value, GHX
GHX works with a significant number of U.S.- based providers and we are seeing a familiar theme among the more forward-thinking organizations: a push to understand the role of products in meeting the objectives of value-based care. Data standardization is fundamental to the success of these initiatives. Here are a few examples.
Stanford Health Care has created tighter integration between its supply chain and clinical systems, which allows supply chain professionals and physicians to collaborate on standardization and cost reduction initiatives for implantable devices. Key to this integration was Stanford Health Care building its master data in accordance with global data standards, including the GS1 Global Trade Item Numbers (GTIN). Stanford supply chain leaders engaged clinicians to understand their priorities for standardized product data. The integration between the clinical and supply chain systems, along with data standardization and analytics, has enabled physicians and supply chain to collaborate on value-based purchasing decisions.
Standardization has also enabled supply chain leaders at Duke Health to provide data to physicians to support care redesign. The integration of unique device identifiers (UDIs) into various systems and processes allows Duke Health to identify variation in cost and quality down to the individual physician level. By integrating its EHR and ERP systems, Duke Health is able to accurately document in both systems every supply or implant used. The supply chain data is then integrated with quality and financial data to give Duke Health a more accurate picture of the total cost and quality of care, and identify opportunities for improvement.
Franciscan Missionaries of Our Lady Health System (FMOLHS) is using standardized and enriched supply chain data to understand the cost of providing patient care and how variation affects both cost and quality. FMOLHS’ electronic health record (EHR) system is fed precise, known and accurate product data in real time from a virtual item master so that detailed information on the supplies used in an episode of care are captured in the patient record. Data enrichment includes Global Trade Items Numbers (GTINs), which supports bar-code scanning. This provides clinicians an efficient and accurate method of capturing supply data at the point of care and supports complete documentation flowing through internal systems. With this information, FMOLHS can conduct cost analysis, assess the impact of clinical variation on patient outcomes, achieve more accurate billing/reimbursement, and better manage recalls and adverse event reporting.
According to research completed by the AHRMM Learning UDI Community, bar-code scanning can be challenging for many organizations. To overcome these challenges, FMOLHS invested significant time and resources in capturing complete supply item data throughout the hospital that was then made available in the EHR at the point of care. This effort resulted in a dramatic increase in automated documentation and accuracy of data capture.
Siobhan O’Bara, Senior Vice President, Industry Engagement & Services, GS1 US
At GS1 US, we work with many healthcare providers to help them incorporate data standards in their operations for improved efficiencies, inventory management, record-keeping and quality of care.
The benefits are demonstrated in a case study just completed with the Veterans Affairs (VA) Medical Center, Miami, FL (https://www.gs1us.org/industries/healthcare/standards-in-use/provider/va?utm_source=article&utm_medium=pr&utm_campaign=hc-hpn-va). The medical center once spent countless hours each week manually entering product codes for hundreds of medical implants and other products into various systems – for items that were received, placed into inventory, and ultimately used in patient procedures and care. To stay on top of correct product names and expiration dates, to prevent inadvertent human error, and to positively impact patient safety, the hospital introduced GS1 bar-code scanning to its inventory management processes.
Now as medical devices and implants are received, the Miami VA Medical Center scans the bar codes to automatically capture product information. The data is then stored in the hospital’s Medical Device Management System (MDMS) called UDITracker, provided by Champion Healthcare Technologies, a GS1 US Solution Partner. This has enabled them to improve operational efficiency by easily and accurately keeping track of implants and other medical devices. Champion helped the hospital cleanse its database of imprecise product names and non-unique manufacturer catalog numbers, and use standardized, unique device identifiers (GS1 Global Trade Item Numbers (GTINs)) instead so all product information is aligned and can easily be found.
As a result, the hospital has improved productivity and inventory management. For instance, in one week the hospital performs approximately 100 eye surgeries. For each surgery, a single manual entry of a device code takes 70 seconds; scanning the same device takes just 20 seconds. The time savings adds up to more than one hour of data entry time savings in any given week.
With inventory tightly and accurately controlled, product expirations can also be reduced, reducing waste and saving the medical center money. The UDITracker program enables a search by expiration date, quickly displaying the products with the closest expiration. The VA Medical Center estimates a $5,000 to $10,000 savings each month by using inventory that might otherwise have expired.
Most important, patient safety has improved since scanning barcodes helps to eliminate human error from manual data entry. And since capturing unique device identification information saves tracking time, it could conceivably save lives in the event of a recall.
Denise Maxwell-Downing, R.N., CNOR, Vice President, Clinical Quality and Patient Safety, Matrix IT
Project Blueberry Castle took the 2015 Strategic Marketplace Initiatives (SMI) Unique Device Identifier (UDI) Simulation Lab Project into the real-world setting of the Operating Room. Our objectives were simple:
Given the clinical and financial importance of UDI, a coalition was formed to observe and report on the results of a unifying Universal AIDC platform to collect implant, instrument, and supplies in the operating room and;
Analyze the effectiveness of current data capture methodologies against new medical device sterile field scanning technology in the operating room and provide a guide for manufacturers and hospitals to follow.
EHR documentation times (real-time versus post-op), accuracy (human error potential), and full UDI data capture capabilities were observed.
Benefits: Blueberry Castle learnings showed from the point of surgeon request to documentation into the EHR, based on current practices versus sterile field scanning, that times ranged from 30 minutes for UDI tags to 13 seconds for sterile field scanning of direct marked surgical implants. This allowed the nurse to complete their documentation prior to the completion of implantation and created an extremely efficient surgeon request to hand-off process. The least preferred method was the reference/count sheet.
From an accuracy standpoint, sterile field scanning of direct marked surgical implants and UDI tags (if scanned in the sterile field and not handed off to the circulator to scan outside the sterile field) were the most efficient and accurate method for capturing the UDI data and generated the least human decision points. Sterile packaging and reference/counts sheets involved the most human decision points.
Points to Consider: The impact of the quality of the direct mark on the surgical implant was observed. In comparing implants with suboptimal laser marks to appropriately marked implants an increase in scanning time was noted.
While minimal training did prove out the ability for a user to quickly pick-up the documentation, it also demonstrated the need to provide more comprehensive training regarding trouble-shooting suboptimal implants.
Some surgeons were apprehensive about how this data is going to be used. How will it impact their practice? Feedback and sensitivity to surgeon concerns, which include capture of performance data related to quality and cost indicators must be considered.
Additional goals to consider are supply chain focused and include identifying potential decreased cost, increased efficiency, inventory reduction and transactional error elimination.
Assessing standards momentum
Convincing healthcare providers to adopt and implement standards either voluntarily or through some regulatory pressure may feel like completing a three point turn of a sea-faring oil tanker ship wedged in the Erie Canal, but supply data standards advocates remain optimistic regardless of how fast and furious the progress. Even if pokey and placid.
Healthcare Purchasing News asked these experts to rank the UDI preparation efforts of providers and suppliers on a scale of 1 to 5 with 1 being the least prepared and 5 being the most prepared. Here’s how they scored the groups and their reasoning. Not surprisingly, suppliers edged out providers by a sliver.
Provider perspective
Cory Turner, CMRP, Industry Strategy Director, Healthcare Supply Chain, Infor
3 – Providers are definitely moving in the right direction. Unfortunately there are many more speedbumps for the process within the hospital setting. Getting all the key stakeholders involved and to buy in to the project is often enough to drive the project into the ground. Usually over time and countless meetings regarding lower costs and improved outcomes, the project begins to take traction.
Siobhan O’Bara, Senior Vice President, Industry Engagement & Services, GS1 US
3 – The U.S. FDA established the Unique Device Identification rule to “adequately identify medical devices through their distribution and use.” When fully implemented by the 2020 deadline, the label on most medical devices will include a unique device identifier in both human- and machine-readable forms, ultimately readable by the caregiving community. Providers’ readiness depends upon the cleansing and updating of their databases to accommodate standardized data, as well as procurement of scanners, training, and other process improvements. This applies also to pharmaceutical products, per the 2013 U.S. Drug Supply Chain Security Act (DSCSA).
Serialized product identifiers that are required by DSCSA make tracking medications more accurate and efficient. They also have the potential to help providers and distributors save money by facilitating verification of saleable returns, and to improve patient safety by enabling quick, accurate purging of inventory in the event of a product recall.
Mike Schiller, CMRP, Vice President, Healthcare Engagement, Matrix IT
While there are those progressive organizations that would register higher, it is our opinion that providers, in general, register a 2 on the preparedness scale. Those progressive organizations have realized significant benefits associated with the UDI and continue to aggressively pursue adoption and we see them extending that influence on their trading partners. The current healthcare environment encourages UDI adoption through voluntary programs. Education occurs through several modalities including case studies, webinars, and conference learning lab sessions. In light of these voluntary measures, we can expect the pace of adoption to be measured and gradual.
UDI adoption and implementation is a priority among many priorities’ healthcare organizations have. Mandating a UDI system with legislation or with a program that isn’t subsidized, such as Meaningful Use (now called “Promoting Interoperability”), could create extreme hardships for some healthcare organizations that are currently adapting to alternative payment models that are a component of today’s value-based care environment.
Supplier perspective
Cory Turner, CMRP, Industry Strategy Director, Healthcare Supply Chain, Infor
4 – Within the supplier communities, companies are well ahead of baking this information into the manufacturing process. These organizations are able to ebb and flow with more fluidity when making these types of transitions.
Siobhan O’Bara, Senior Vice President, Industry Engagement & Services, GS1 US
3 – Suppliers of both medical devices and pharmaceutical products are already implementing data standards as required by the FDA. Compliance deadlines have now passed for UDI labeling of all Class II and Class III medical devices; manufacturers are currently working to meet the September 2020 deadline for labeling Class I and unclassified devices. In addition, DSCSA requires pharmaceutical products packaged after November 27, 2018, to be marked with a National Drug Code (NDC), serial number, lot number and expiration date. (When using GS1 Standards, the NDC is represented by a GS1 Global Trade Item Number or GTIN.) The DSCSA also specifies that packages (“lowest saleable units”) must be marked with a two-dimensional (2-D) bar code (e.g., GS1 DataMatrix barcode), and homogeneous cases with either a 2D barcode or linear bar code (e.g., GS1 DataMatrix barcode or GS1-128 barcode, respectively).
Now that suppliers are marking their products with the required identifiers, healthcare providers have the opportunity to incorporate the same standards within their data systems, completing the loop and bringing the full benefits of data standards to fruition.
Mike Schiller, CMRP, Vice President, Healthcare Engagement, Matrix IT
It is our opinion that manufacturers, in general, register a 4 on the preparedness scale, scoring highly on UDI labeling for Class III, Class II and Life-Saving/Life-Supporting medical devices. There remain several hurdles that hinder mainstream adoption including multiple UDI device identifiers (UDI-Dis), multiple barcodes on product packaging, comingled product that remains in the healthcare supply chain (UDI- and non-UDI-labeled inventory), nonsterile implants and GUDID data quality reconciliation efforts.
Maturing models are coming online as leading manufacturers strategically partner with leading healthcare organizations. These models raise the bar, providing a roadmap for the mainstream healthcare industry to adopt and build upon. This iterative learning is a foundational element.
What will it take for these two groups to improve their performance? Continued collaboration and communication between all major stakeholder communities is critical. Hurdles have been identified that span each of these communities. Interoperability between ERPs and EHRs needs to improve as does the ability to store the UDI-DI for every packaging level and not just the unit of purchase or use. As more organizations come online with their adoption efforts our understanding increases, and in turn our ability to uncover and overcome these and other adoption hurdles advances. Finally, just as EHR adoption across the healthcare field was subsidized, a similar program should be considered and undertaken to subsidize the purchase and implementation of scanning technology within the healthcare setting. This will allow the healthcare industry, to maximize the benefits associated with AIDC technology and build upon the bar code and clinical technology infrastructure that so many have invested significant time and resources implementing.
The reality is that the manufacturers have already implemented the FDA UDI requirements and have complied with the labeling requirements based on the device class and implementation date. Where the challenges begin is how the manufacturers provide UDI-compliant device labels to the providers for clinicians to use and capture UDI data at the point-of-use. The examples are: Multiple bar codes on packages; hospital sterilized implants, where UDI compliant labels are lost when placed into a provider sterilized tray; or provider bar-code technology that only reads linear bar codes, and suppliers only provide the UDI in a 2-D barcode. The suppliers are hesitant to provide alternative UDI strategies until they know which UDI strategy the providers will use, and the providers are waiting for the suppliers to provide them with a cohesive strategy to capture the UDI data. Bringing together all the key stakeholders to work through these issues is what is needed. To date, great work and much progress have been seen from these efforts across the stakeholders and the AHRMM LUC workgroups.
Karen Conway, Vice President, Healthcare Value, GHX
It’s difficult to generalize and rate all providers and all suppliers as a group for their level of preparedness. As we’ve seen, there’s great variance in terms of the progress organizations have made with standards in different aspects of their clinical and business operations. There are a few visionary organizations on both the provider and supplier sides that are solid 4s in terms of their efforts in multiple areas. Others are 4s in some areas, such as point-of-use capture, but not in transactions and vice versa. Some are just getting started or still seeking support to make the necessary investments in technology and process change.
Because of the FDA’s UDI rule, many suppliers have made progress in terms of product identification, although some have only done what is required by the regulation. Others have used the regulation to form a business case for incorporating standards in multiple systems and processes. In other words, they recognize the value beyond compliance. These organizations, for example, are using standards in transactions and inventory management to improve how they do business with customers and reduce stockouts. In fact, since the advent of the UDI rule, we have seen suppliers using GTINs in purchase order confirmations and invoices, even when the provider did not include the standard identifiers in the original purchase order.
When it comes to standards for organization and location identification (e.g., Global Location Numbers or GLNs), a significant amount of work remains. Today, providers aren’t mandated to assign GLNs or other standard location identifiers to their ship-to locations, and providers must make the first move to enumerate, just as manufacturers had to take the lead for product identification. Taking that first step is worth it in the long run, because then providers will no longer have to manage different numbers assigned by different suppliers for the same location. Use of both GTINs and GLNs can also help ensure providers are paying the correct contract price and increase price alignment, which remains a significant industry challenge. Unfortunately, even though GHX can enable standards in transactions, the number of organizations using GLNs in purchasing and especially contracting transactions remains very low.
Rick Dana Barlow | Senior Editor
Rick Dana Barlow is Senior Editor for Healthcare Purchasing News, an Endeavor Business Media publication. He can be reached at [email protected].
