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 healthcare systems that have moved or are moving into having integrated electronic systems.”