Era of medical-device tracking finally arrives

Medical-device manufacturers say it makes no sense to mark their products with unique identification numbers since hospitals and other healthcare providers are not required to use the system.

But that's no longer true, at least for some devices. The Food and Drug Administration last month began requiring that reports on adverse events that led to a patient death and involved high-risk medical devices (such as implants whose malfunction could be life-threatening) must include the unique device identifier, or UDI, if the safety failure occurs at specified facilities such as hospitals, ambulatory surgery centers or nursing homes. Those medical facilities are required by law to report cases of patient deaths related to a device to the FDA and now are required to report the UDI, as well. Manufacturers also must notify the FDA.

“This is the one piece where they impact providers,” said Karen Conway, executive director of industry relations for GHX, a trading exchange that seeks to reduce costs for medical and surgical suppliers and hospitals.

About 50,000 serious adverse events related to medical devices are reported to the FDA each year, including about 3,000 deaths.

Improved reporting and tracking of adverse events has long been one of the goals of moving to a universal UDI system. Supporters say marking most medical devices and their labels with an electronically readable UDI will help reduce medical errors, improve product registries and make recalls much more effective.

Patient-safety advocates have been pressuring hospitals to move more rapidly toward implementation. Having providers use the system is “the whole point of having the UDI,” said Diana Zuckerman, president of the National Center for Health Research, a Washington-based advocacy group. “If something goes wrong, you can't have to recall every single heart valve, just the ones that are causing a specific problem.”

When devices don't have or hospitals don't use UDIs, it can be difficult and time-consuming to track down patients who received faulty implants when they are recalled. Hospitals also can't keep track electronically of device usage and inventory within their walls, a requirement for any modern inventory control system.

Yet not all hospitals are using the UDI system, which now requires marking package labels with a unique identifier code on Class III, or high-risk, devices and will require direct labeling on the device next September. The rest of the device world will roll out UDI labels over the next seven years.

Manufacturers, who've resisted rapid implementation of UDIs, question the value of a system providers have not been required to use until now. Without provider participation, the system won't be successful, they say. A spokeswoman for the FDA said the agency does not have an estimate of the number of providers that were voluntarily using the system prior to the new requirement.

If providers don't use the UDI system but manufacturers are required to mark their devices, the UDI requirements will add “costs and regulatory burden to the healthcare system,” Conway said. “We will all pay the price.”

Yet some providers and purchasing organizations are pushing for a broader set of requirements for providers beyond including the UDI in submission reports for patient deaths that are related to the use of a device. They want to see the inclusion of a UDI requirement in HHS' Stage 3 meaningful-use criteria, which are expected to be proposed next year. They would also like to see the UDI tied to claims data. HHS' Office of the National Coordinator for Health Information Technology, which has worked with the FDA on the issue, this year proposed that electronic health-record companies update their systems to record device identifiers for implantable devices.

At the Healthcare Supply Chain Association's annual expo last week in Washington, a number of sessions focused on the implementation of the UDI system. A representative for one manufacturer questioned the costs and burden of implementing the system for low-risk devices. Another said it seems most hospitals had materials management information systems that couldn't handle UDI tracking. A third manufacturer executive noted a public UDI database would be a tool to better market products to hospitals that may be using a competitor's technology.

But the underlying issue that led many manufacturers to resist rapid implementation of the UDI is the potential use of the data by analysts at hospitals and elsewhere to determine which supplies and technology perform best. “Without UDI, we don't have the data to really do that—to understand what are the best products for the patients,” Conway said.

Follow Jaimy Lee on Twitter: @MHjlee