The FDA’S plan to track devices /
UDI system aims to help FDA identify problem products more quickly
Hospitals and health systems will have varying abilities to use the government’s new system of marking medical devices with unique identifiers, though the effectiveness of the effort to improve safety and efficiency relies on providers’ voluntary participation.
The Food and Drug Administration issued a long-awaited proposed rule this month on unique device identifiers, recommending a risk-based approach that would require highrisk medical devices to begin implementing UDI standards a year after the final rule is published. The implementation period is expected to take seven years.
While some manufacturers have established standard identification systems for their products, the FDA’s UDI system will be the first consistent standards system for medical devices.
It’s expected to improve recalls and adverse-event reporting, as well as reduce medical errors and establish consistent standards for entering information about devices into electronic health records and clinical information systems. Lawmakers passed legislation in 2007 mandating the development of the UDI system. The release of the proposed rule was delayed for years until the user-fee legislation that was passed in June required the FDA to issue the proposed rule before the end of 2012.
Many hospitals and organizations representing patients and providers have advocated for the FDA to move forward with the implementation of the UDI system despite the expected costs for implementation and training.
“We built it and now people have to make changes to their systems and processes so they can take advantage of it,” said Jay Crowley, senior adviser for patient safety at the FDA’S Center for Devices and Radiological Health. “We’re hoping they will, for a host of reasons.”
Improved patient safety and business efficiencies are two reasons why some providers are eager to implement the UDI system. One report estimated that UDIS could save the healthcare industry billions of dollars.
Mercy Health System in St. Louis expects to invest in other scanning and record-keeping technology to implement the UDI system, said Gene Kirtser, president and CEO of Resource Optimization & Innovation, Mercy’s group purchasing organization.
About a year and a half ago, Mercy began putting new scanning technology on its nursing floors. When nurses scan a medical product’s bar code, they can record the patient’s use of a product, send a notice to refill the product, transfer the data to an electronic health record and bill the patient.
However, up to 40% of the products on Mercy hospitals’ nursing floors do not have a bar code or use a bar code that doesn’t register with the scanning technology. Manually entering the bar code is time-consuming, inefficient, frustrating and unnecessary, Kirtser said.
“The patient-safety benefits and business-efficiency benefits will significantly outweigh any kind of incremental costs that we incur,” he added.
There are no estimates for what providers can expect to pay to implement the types of technology needed to fully use the UDI system, but the FDA and groups representing providers say they believe the advantages of the system offset any costs.
The hospitals and health systems that are advanced users of EHRS and other coding systems will likely be early adopters of the UDI system.
According to a comment letter filed in 2009 by SSM Health Care, the upfront expense would be made up in the time the hospital would save in a recall that would require identification of products.
“The benefits come about from electronic data capture and the movement and exchange of that information and then the visibility that (information) provides,” Crowley said. “The real benefits accrue for those hospitals or health--
care systems that have moved or are moving into having integrated electronic systems.”
During the past several years, the FDA has worked with numerous trade groups and government agencies to encourage provider participation in the UDI system. In particular, the FDA has worked closely with the Office of the National Coordinator to position the UDI system as tied to meaningful- use requirements and certain quality measures, Crowley said.
“The electronic health record is a big, big, big piece of this,” he said. “Those healthcare systems that have the infrastructure in place will be able to much more quickly take advantage of and accrue the benefits of a standardized identification system.”
However, the FDA does not have the authority to require providers to use the system, which was an issue that the Government Accountability Office raised in a 2011 report about device recalls.
“FDA’s senior adviser stated that larger hospitals might be more eager to adopt the technology necessary to track devices using the UDI once it is implemented, but acknowledged that benefits for the recall process are greatly dependent on hospitals’ implementation of the UDI, which could take up to 10 years for many hospitals, especially smaller ones,” the GAO wrote.
The device industry has also expressed concern about providers’ role in the UDI system.
In a statement responding to the July 3 proposed rule, Janet Trunzo, senior executive vice president of technology and regulatory affairs at The Advanced Medical Technology Association, said the benefits of standard identification are dependent on “device users consistently and effectively utilizing the UDI system for recalls tracking, adverse-event reporting and within electronic health records.”
About half of manufacturers were using standards identifications systems created by GS1 and HIBCC in 2009, according to AdvaMed. Both systems meet the FDA’s proposed requirements.
Kirtser and Siobhan O’Bara, vice president for healthcare for GS1 US, an information standards organization, noted that the hospitals that don’t acquire the technology needed to draw data from the UDI database that FDA has developed can also manually retrieve the data as necessary. O’Bara noted, though, that it’s clear the providers that are early adopters of health technology will also be the early adopters of standards identification systems. “Some of these larger, more well-integrated (delivery networks) will be the ones that are the first adopters, and then, hopefully, it will continue to percolate through the entire healthcare system,” Crowley said.
The FDA is working to get a handle on the scope of danger presented by all-metal artificial hips, such as this one removed from a patient at Massachusetts General Hospital in Boston.