WASHINGTON — The deadline for medical device manufacturers to comply with new U.S. Food and Drug Administration identification rules is coming, but there's still a lot up in the air.
FDA's Unique Device Identification (UDI) system is a two-pronged approach, requiring both a bar code for machine scanning and text that can be read by the good old Mark One human eyeball on most medical devices. It's an effort to better manage materials and improve the quality and safety of medical devices coming to and already on the market.
Unfortunately for manufacturers, coming into compliance with the new regulation involves much more than simply slapping on a new label, and time is of the essence. FDA issued the final UDI rule in late September 2013 and the first compliance deadline, for Class III medical devices and their labels and packaging, is Sept. 24. One year after that, devices described in the FDA Safety and Innovation Act as “implantable, life-saving, and life sustaining,” which are mostly class II devices, have until September 2015. The remaining Class II devices have until 2016 and by 2018, all non-exempt class I devices must also be UDI compliant, according to FDA timelines.
There is a little bit of leeway available if a manufacturer isn't able to make FDA's UDI deadline, but not much and it comes with a deadline of its own, the agency says.
“A labeler may submit a request for a one-year extension of the compliance dates for a class III medical device or a device licensed under the Public Health Service Act,” said FDA spokesperson Jennifer Rodriguez. “Such a request must be submitted no later than June 23, 2014. Requests for such extensions can be submitted to the FDA UDI Help Desk at www.fda.gov/udi.”
A lengthy process
If the compliance schedule wasn't complicated enough, the process itself is not exactly simple. First, one of the three accredited issuing agencies — GS1 in Lawrenceville, N.J.; Health Industry Business Communications Council (HIBCC) in Phoenix or ICCBBA in San Bernardino, Calif. — must produce device identification codes. Next, the medical device manufacturers' working groups must identify a database to store device and product data and assign unique codes to all the applicable items. From there, the manufacturer is responsible for labeling both the device and its packaging with the machine and human-readable alphanumeric codes, including direct part marking, when applicable.
“The proposed UDI rule would have required an implantable device required to bear a UDI on its label to also bear a permanent marking providing the UDI. This provision has been removed in the final rule; an implantable device will not be required to be directly marked with a UDI,” Rodriguez said. “The proposed rule also would have required a device required to bear a UDI on its label to also bear a permanent marking providing the UDI if the device is intended for more than one use and must be sterilized before each use. The final rule changes this provision to apply to devices that are ‘reprocessed' before each use; this broadens the scope of the provision.” For most products, the DPM deadline is two years after its initial compliance date, she said.
And it's not a one-time thing. Creating sustainable in-house UDI assignment processes now is important because if a company develops a new device, significantly enhances old one or acquire new products through mergers and acquisition, FDA says they will all need a UDI.
For some companies, especially those with many versions of one device or even thousands of different devices, adapting to the new government regulations could be daunting.
But help is available. FDA has put together a comprehensive Web site to provide guidance on the GIUDI and UDI rules and a list of resources (www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/).
Live seminars and webinars are also popping up around the country as the countdown to the first deadline continues, many featuring as a speaker Jay Crowley, vice president of the Unique Device Identification Practice at USDM Life Sciences, a global regulatory consulting firm. Before joining USDM, Crowley helped write the UDI rule while serving as a Senior Advisor for Patient Safety at FDA.
Once a number is developed and assigned, all the UDI information must be submitted to FDA's Global UDI Database (GUDID) prior to manufacturing, the agency said. According to the regulations, Class I medical devices' UDIs must include the expiration date and/or manufacturing date. UDIs for Class II devices must include lot and batch numbers. Class III device UDIs will need to include batch/lot numbers or a serial number in the UDI. While lower-risk Class I devices can include more information than is necessary, high-risk Class III devices cannot include less than is required, according to FDA.
More than just a number
It's creating a global database that is really at the heart of the new UDI regulation, said Gregory Daniel, managing director for evidence development and innovation, at the Brookings Institution's Engelberg Center for Health Care Reform in Washington.
Currently, most medical device manufacturers are using their own processes and proprietary identifiers to monitor products, Daniel said. But that means the systems used to track a product through the manufacturing chain of subcontractors, manufacturers, assembly, distribution, and then on to health care providers and eventually to the patient can be very disconnected.
“The way medical devices are used in healthcare are very different from the way drugs are used,” Daniel said. “It is so much more challenging for providers and manufacturers to identify the actual patient who has the implant. Drugs have their standard system but on the device side you don't, so you don't have way of linking device and patient.”
Recall management, device tracking, evidence generation on effectiveness and safety of devices becomes difficult to impossible, he said, causing problems for patients, providers and even device OEMs and designers. Brookings research shows the new UDI system will mean:
Faster and easier product recalls.
• Improved traceability.
• More effective counterfeit detection and abatement.
• Increased accuracy in electronic transactions and information sharing.
• Reduced supply chain costs.
• Increased access to product.
“Manufactures have the first step of the responsibility,” Daniel said. “The FDA rule, it's great that it goes so far. But it really only requires anything of manufacturers. The real value is in making sure that we're using UDIs in the right way, to make sure that we're using all the benefits.”
The responsibility to implement and use the UDI system doesn't end with the OEMs but unfortunately, the regulation does. FDA does not have jurisdiction over the other stakeholder groups such as healthcare providers, insurance companies and healthcare IT systems, Daniel said, “the user side.” UDIs and the GUDID will not realize their full potential — for patients or the medical device industry — until the healthcare information technology side of the industry gets up to speed, scanning, logging and storing device-use information.
“It is going to be a heavy undertaking for the medical device industry to develop and implement the UDIs,” Daniel said. “The rule is a way to make sure that the manufacturers do this. But it is going to take the healthcare system as a whole to implement this successfully rather than just one sector.
“Manufacturers are focused on doing their part, but I have to say they have also been very supportive of making sure that the rest of the healthcare system is also equipped to implement UDIs. Support from manufacturers in helping identify how UDIs can be effectively and effectively implemented into the rest of the healthcare system will be an important step because the value of UDI won't be realized unless it's implemented beyond the manufacturer control.”