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| The health care industry has always known there’s been a need for unique device identification, but not until recent events has the urgency to act been so great. In October 2006, Premier surveyed its members to better understand how the industry tracks and records medical device recalls—and the results were telling. More than 80 percent of health care professionals believe that an industrywide UDI for medical devices would enhance patient safety. Other studies prove that billions of dollars could be saved. |
Early in 2007, pet owners were shocked to learn of a threat to their dogs and cats. To make matters worse, the danger didn’t come from a tick or a flea or even a virus. It came from their food.
A rat poison called aminopterin had found its way into some pet food brands. It caused more than 100 animals to die of kidney failure. And it spurred a recall of more than 60 million pet food packages. But, in some ways, the pet owners were lucky. Like virtually every consumer product, pet food is sold with a bar-coded identifier. Each package is numbered by the manufacturer and given a unique product code (UPC) by a standards monitoring organization, so that when a disaster occurs, products are readily identifiable. This enables retailers to quickly pull them from the shelves. And consumers can trace the product by brand name, UPC,product descriptions, container sizes or any combination of identifiers.
But if a similar crisis had struck ventilators, defibrillators or IV pumps, health care patients might have fared worse than the pets. That’s because, experts say, the health care world is facing a crisis in medical device identification.
From gloves, tongue depressors and orthopedic implants to MRI machines, medical devices are not subject to a uniform identification system. Advocates say a unique device identification (UDI) system could save lives by facilitating recalls and monitoring product failure. And, they say, it could save billions of dollars by streamlining the health care supply chain.
A Premier Safety Institute survey of nearly 1,000 health care professionals showed that more than 80 percent of respondents believe an industrywide UDI for medical devices would enhance patient safety. (See www.premierinc.com/safety to view the survey results.)
An Arizona State University study concluded that more efficient device identification would save $16 billion.
“The efficiency gains [of UDI] could be enormous in reducing the costs of products and of the supply chain,” says Joseph Pleasant, CIO of Premier Inc., Charlotte, N.C. “And the patient safety aspects are astronomical. There’s just no excuse for not putting this in place.”
Medical devices often have numbers imprinted on them. But those numbers can be different depending on the hospitals, manufacturers and distributors.
In fact, each player in the supply chain may use a different identifier for the same product. A manufacturer might assign an ID number to an infusion pump, for example. But the distributor may attach a different number to the pump’s pallet. And the hospital might create its own pump identifier. Indeed, in the current system, a manufacturer may give the pump an ID number that the hospital has already assigned to anything from a hip implant to a toothbrush.
“The risk of failure in the health care supply chain is quite significant,” says Joe Dudas, director of accounting and supply chain informatics for the Mayo Clinic in Rochester, Minn. “The whole purpose of the supply chain is to get the right product at the right price to the right place at the right time. Lacking a standard identifier for a product creates a lot of overhead, cost and risk.”
In its simplest form, UDI would consist of a coded number attached to medical devices. The number would be registered with a standards organization such as GS1 or HIBCC. Encoded in the number could be information such as the manufacturer, make and model, unique attributes (e.g., whether it contains latex), serial numbers and expiration dates.
This number would be recorded in a database. Hospitals and other health care facilities would subscribe to the database. Using some form of technology—most likely bar coding—health care officials would scan a product’s number into their electronic records.
In the event of a recall or product failure, a facility could easily match its records against the database to determine which product was affected and exactly where it is within the hospital.
What will it take?
But, while most health care organizations and manufacturers support some form of UDI, the enormity of creating a medical device identifier, not to mention disagreements over everything from who will pay for it to where to place an identifier on the product, has led to a decade of debate.
“It’s so big and so hard to wrap your arms around [UDI] that it hasn’t managed to congeal on its own,” says Jay Crowley, senior advisor for patient safety with the FDA. “There are so many disparate groups with a stake in this and they all speak different languages. They haven’t found a way to work with one another that would allow [UDI] to happen naturally. There are a lot of very frustrated people, the FDA included, who can’t understand why it hasn’t happened.”
But all that debating may have finally spurred action. Some form of UDI may be on the verge of implementation. The FDA has spent the last year exploring ways to make UDI a reality. The agency has met with manufacturers and distributors as well as virtually every prominent health care group.
The Department of Defense has conducted pilot programs with manufacturers such as BD (Becton, Dickinson and Company) and Sage. Premier has been a member of the pilot since its inception, and Amerinet recently joined the project as well. There also has been intense interest from international manufacturers, which has “accelerated” the drive toward UDI, Crowley says.
Even members of Congress have gotten into the act. In May, 26 House members, led by Reps. Mike Doyle (D–Pa.) and Pete Sessions (R–Texas), announced their support for requiring UDI. The lawmakers asked the FDA to expedite their work on the issue.
UDI still has obstacles to scale, including to determine what products would get identifiers, cost factors and concerns about whether hospitals would use such a system. But experts believe that some version of UDI will become a reality sooner rather than later.
“I think we are closer than we have ever been thanks to those who have been involved to date,” Mayo’s Dudas says. “It feels like we are in the red zone. But we have the hardest part left—punching it into the end zone. We have a lot of hard work in front of us.”
The UDI answer
While medical devices don’t have an identifying system, pharmaceutical products have long required drug tracking. In 1972, Congress mandated drug identifiers through a unique, three-segment number called the national drug code (NDC). In 2004, the FDA required manufacturers to encode the NDC number in a bar code on packages of drugs and biological products. The bar code enabled health care professionals to track and monitor medications by scanning equipment into their electronic systems.
But the bar code rule didn’t apply to medical devices. FDA officials say the devices weren’t included in the pharmaceutical discussions because no unique numbering system like the NDC existed for medical products. At the time, creating a system for devices was seen as such a monumental task that it would have ground pharmaceutical standards to a halt. But today, most health care experts believe that it’s time to pick up the mantle of UDIs again. The benefits of UDI are extensive, advocates say, from both a patient safety and a health care efficiency standpoint. Perhaps the biggest benefit of UDI is to facilitate recalls in case of product failure. More than 600 medical device recalls are issued each year. And, in the last four years, there have been more than 60 Class 1 recalls, which are the most serious events involving dangerous and defective products that could cause health problems or even death.
But unlike the pet food example, hospitals often use manual systems to track products and implants.
“Depending on how they have labeled those products, if there’s a recall, [hospitals] have to go to their manual record and see if they received any notification and, if they have, find where it is located,” Pleasant says. “And if they implanted [this device], for example, they have to go through medical records to see who had that surgery and try to trace the device back to a particular patient.”
UDIs would also help hospital officials track and replace obsolete products. They could improve efficiency by cutting down on reordering efforts.
“You may have a situation where a physician has ordered a particular device and, because of the way that it is sourced, they end up getting the wrong device,” Pleasant says. “That could either delay surgery or it could cause something less than optimum to be implanted or used on that patient.”
From a materials management standpoint, UDI offers the opportunity to grease the supply chain, resulting in a more efficient process. A good numbering system would allow the materials manager to better keep track of inventory. It could reduce “repeat” work, like relabeling products or multiple billing and ordering when the wrong products are received.
“The more process steps and translations that we have involved in getting that product to the right place at the right time, the more points of failure we have,” Dudas says.
Not so fast
But if the benefits of UDI are so obvious, why doesn’t it already exist? For one thing, not every member of the supply chain is convinced that that the pluses of an identifying system outweigh the costs.
Washington, D.C.-based AdvaMed, an association that represents manufacturers, has questioned the lack of comprehensive studies detailing patient safety benefits. Given the sheer diversity of medical products, even advocates agree that not all products carry the same risks.
Numbering some products won’t necessarily have a significant patient safety impact. Experts say that manufacturers and health care officials are still a long way from determining which products need to be numbered.
“I don’t think we have a common understanding of the problem,” Dudas says. “The supply chain itself is quite complex. We don’t have a common understanding of what products and processes are in scope.”
Manufacturers note that they already provide identifiers for their products, usually as serial or lot numbers. Many acknowledge the potential benefits and efficiencies of UDI. But creating a system is a huge and costly project, they say. Before starting, many manufacturers say a common standard must be agreed upon.
“We want one standard, not just an arbitrary number. Ideally, we’d like to see them use one of the existing standards so we don’t have to relabel everything,” says Dennis Black, director of e-business for BD.
Likewise, manufacturers have questioned details about whether existing product numbers would be used as identifiers and where the identifier might be placed on a product. Many claim it would be too costly to label each product—they’d prefer placing a label on cases or boxes.
Manufacturers are also concerned about how much information a UDI code should contain. “We don’t want to see manufacturers overburdened with product data requests that customers couldn’t use anyway,” Black says. Instead, he says most manufacturers would support a phased implementation. “This would have to be a long-term process. We want to implement data in different phases to ensure it’s attainable and not too burdensome,” he says.
Others have questioned who would maintain the UDI database. Most parties agree that manufacturers should own the database. But device makers worry that the cost of implementing the system would only be worthwhile if hospitals used UDI. “It has to be used over all levels of the supply chain. Otherwise you’d get no benefit,” Black says. Even advocates agree that it’s a legitimate concern. “Hospitals have been slow in implementing” systems like UDI, Pleasant concedes.
Dudas admits that installing the system in a physician-led organization might be a hard sell. Materials managers often face a choice: “I can implement this next technology in the supply chain or I can buy this new, high-tech medical device that can save lives,” he says.
Moving forward
Experts say the momentum for UDI is increasing. The FDA has looked to the NDC example for lessons on how to best implement it. Unlike the pharmaceutical example, a UDI for medical devices must be internationally based, Crowley says. Recent meetings with European and Asian manufacturers have stressed that internationally distributed products must have a code that meets global standards. Also, he says, a medical device UDI needs to have more robust numbers than the NDC codes. The pharmaceutical code can contain duplicates or outdated numbers. “We really have to keep an eye on the technical issues of making sure the information is good and accurate and kept up to date,” Crowley says.
So when will UDI appear in U.S. health care facilities? One source speculates the announcement of a plan may come before the end of the year. The FDA says it hopes to have a system in place within the next three years.
Still Crowley notes that initially the system may look less comprehensive and include fewer devices than some advocates would like. But he adds that all signs point to the inevitability of UDI. “The writing is on the wall,” he says. “Now it’s up to everyone to read it.”
John DiConsiglio is a freelance writer based in Arlington, Va.
What synchronization can do for health care
Clearly there is a strong movement in the health care industry to improve patient safety and increase hospital efficiencies. Chief among these goals is to reduce the alarming number of medical errors as well as better control health care costs. Supplies represent the second largest expense to U.S. hospitals after labor expenses, an estimated $200 billion annually. Streamlining the supply chain will result in billions of dollars saved, and suppliers and health care providers are recognizing that supply chain efficiency and improving patient safety are linked.
The absence of a unique device identifier (UDI) causes patient safety issues. Unlike virtually every other product in commerce, medical supplies and devices cannot be identified in a systematic and consistent manner. Without a UDI, it is difficult to track the recipient of a faulty product (e.g., recalls of implantable devices) or to accurately and consistently track adverse events related to a specific product.
Recalled peanut butter contaminated with Salmonella can be quickly and efficiently removed from shelves, but we can’t reliably identify potentially life-threatening recalled or defective medical devices. Most experts also agree that one of the primary reasons for increased supply costs and the inefficiency of the health care supply chain is the lack of a UDI.
Inconsistent product identification
The absence of a UDI also results in “dirty” or inaccurate product item masters that create mismatches in accounts payable, wasted clinician time searching for correct products, and inaccurate pricing, rebates, returns and credits.
Nearly 6,000 hospitals in the United States are buying from more than 22,000 manufacturers and distributors.
The health care supply chain wastes 24 percent to 30 percent of supply administration time on data cleaning and corrections at a cost of billions of dollars, according to a 2003 Medical Product Data Utility (PDU) Feasibility Study conducted by the Coalition for Healthcare eStandards (CHeS) and the Health Care eBusiness Collaborative (HCEC).
A better way
Other multibillion dollar industries, including grocery and retail, run their supply chains more effectively. What is their secret? Data synchronization is a tool that brings consistency of product information to every part of the supply chain. It is a two-step process.
First, manufacturer data on products (UDI) is submitted to a PDU where it is synchronized, audited, verified and distributed to members of the supply chain. The PDU registers, validates, disseminates and synchronizes product data throughout the supply chain. A health care PDU would enable all participants to synchronize and maintain accurate item files in near-real time from the manufacturers through the supply chain to the end user.
PDU flow lagging in health care
Despite the work of other industries, which engage in data synchronization through a PDU, the health care industry, one of the largest in the United States, has yet to adopt this logical, cost-effective and proven process. As determined in a 2006 Premier Safety Institute survey, (see sample of survey results, page 30), more than 80 percent of respondents stated that a national UDI system would enhance patient safety.
However, every participant in the health care supply chain needs to support the effort to have a UDI, the initial and key component in the overall synchronization of medical supply and device data.
Congress has already agreed this is an important issue and is working on a bill that will require the FDA to create a UDI system for medical devices. The time for action is now.
Joseph Pleasant is the CIO for Premier Inc., Charlotte, N.C.
This article first appeared in the September 2007 issue of Materials Management in Health Care.
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