Looking Holistically At Unique Device ID

While some proposed elements of the unique device identification (UDI) rule—compliance timelines included—are unlikely to change, FDA is reviewing industry feedback on issues from  convenience kits to direct part marking (DPM),  Jay Crowley, senior advisor, patient safety, FDA, said at the Medical Design & Manufacturing West conference in Anaheim in February.
“The implementation time frame was a balance we struck. I don’t think it is going to change much in the final rule,” Crowley said.
Crowley addressed the issue of labeling of existing inventory, which companies argued would create significant costs. “Does existing inventory have to be relabeled?  The short answer is no. We will come up with a process similar to that used with the (2005) bar code rule,” Crowley said.
Noting industry push back on the date format and DPM on implants, Crowley said the agency will work toward reasonable approaches to those issues. The proposed rule calls for DPM on three categories: implantables, on devices that will be resterilized in multiple uses, and on software.
“We received a lot of comments on the DPM exemption process. We recognize this is a new space for many manufacturers. We laid out an open-loop process. Many want to see a more closed-loop process, with prospective exemptions. There were many good issues raised and we are working through these now,” Crowley said.
Jackie Elkin, global process owner-SPI, Medtronic,  said that “we are struggling with DPM on implants.
“We have products that are too small, or where the material is not amenable, or it impacts the safety or efficacy of the product. This gets into the realm of testing where you have to get the product reapproved—which gets expensive. We think a better solution is to capture the UDI at the time of implantation,” Elkin said.
Crowley said the expectation is that convenience kits will be uniquely IDed, though  “we have to lock down the wording. There is a lot of work going on at IMDRF (on the issue).  IMDRF the successor to GHTF, will publish guidance on issues raised by the proposed UDI rule at the end of calendar year, he said.
The UDI rule requires that “labelers”—those responsible for the product—use a UDI in human readable and AIDC format on the label, with separate UDIs required for higher levels of packaging. While industry has applauded the agency’s technology-neutral position on the coding, companies will need to ensure that coding is scannable both internally and at supply partners .
“We are hoping that people will make intelligent decisions on the type of bar codes to use (and) expect to see convergence in this space,” Crowley said.
With the globally unique device identification data base, FDA will collect “what we consider as basic identifying information.” The data will be made publically available with the exception of the listing number. A draft users’ guide on the d-base will be published next month (March), Crowley said.
Presenters stressed that UDI is not just an issue for the packaging department but rather requires a view throughout the enterprise and the global supply chain. In preparing to meet the requirements of UDI, medical device manufacturers should keep the business benefits of a standards-based system in view.
Master data management will be a significant hurdle as firms source data from many different systems internally and externally that may not be connected or in the format FDA wants.
QSR-based processes and systems for capturing data, with change control for CFR 21 Part II compliance, will be needed, as firms push data out to different needs and applications.
“We see many public health benefits, particularly in the post-market space. (In addition), you have to look holistically at the way you think about UDI. It is important for everyone to understand the larger benefits,” Crowley said.
Companies have an opportunity to maximize business value, as labeling becomes the foundation for understanding how product is being used across the chain.
 “We have worked in silos previously. Now we can help the providers develop and standardize on their own systems and processes,” said Elkin, who described Medtronic’s development of “standard product identifiers,” and use of GS1 standards to automate and verify supply chain product movement.
“End-to-end integration (with consistent, synchronized data) is just plain good business practice. You leave a lot of money on the table if you are just labeling and submitting to (FDA’s data-base). It’s like buying a smart phone, paying the monthly dues, and just using it as a phone,” Elkin said.
Supply chain parties have heretofore focused on “maximizing silos,” said Joe Pleasant, CIO, Premier.
As health systems’ drive to outcomes-focused practice, they need consistent data from integrated systems pulling information from inside the hospital and from outside sources such as doctors and pharmacies.
“In order to really understand what is going on with the patient, all parties in the chain need to be speaking the same language,” Pleasant said.
Pleasant noted that use of GS1 standards continues to grow among the GPO’s partners, with 50% of product bearing a GLN (global location number), 35% a GTIN (UDI).
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