Real Benefits of UDI in the Operating Room and Beyond

benefits of udiLet’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We believe in its overall benefit for patient health and safety, and also as a means of facilitating business and reducing cost and errors.

The AIM North America Healthcare Committee recently presented a webinar to investigate the functionality of a system which makes extensive use of the UDI as a means of identifying medical devices in the operating room and associating those devices with patients’ medical health records. Through the use of in-line scanning technology during production, each device is entered into the chain of custody process where it is controlled throughout the supply chain from production to patient implantation. Part of this control includes anti-counterfeiting through confirmation of the pedigree at multiple checkpoints. Combatting counterfeit product is one of the benefits of UDI as counterfeit medical devices have wreaked havoc in the lives of patients, caregivers and others in the medical device community. Although the challenge in UDI is that multiple agencies and multiple barcodes can be used, there are differentiators that can allow a scanning device to be pointed at any barcode and in turn determine the agency and barcode type.

NOTE: The presentation below does contain some product marketing from the company which created the software however, it is a good demonstration of what a central device database can provide to the entire medical device industry. Capabilities include the ability to:

  • Identify which items are used and generate an invoice, thereby eliminating manual data entry
  • Compare costs, revisions, waste, and recalls, by manufacturer device, hospital and/or surgeon through real-time analytics
  • Identify and measure outcomes by physician, hospital and/or implants
  • Cross-reference devices, allowing stakeholders to alert patients when a recall occurs.
  • Deliver access to member information by recalled device
  • Provide member access to master implant database
  • Identify prior implantations by member/surgeon/payer
  • Eliminate overbilling by ensuring accurate device utilization by case
  • Identify actual device implants as opposed to paying for wasted or defective implants
  • Know exactly where each implant has been placed, targeting devices that need to be replaced because of a recall
  • Identify the responsible party when a revision or replacement is required

With AIM focused on AIDC matters, about 30 minutes into the presentation, focus shifts to the AIDC implications and the use of bar codes and issuing agencies and complexities that go along with it. You can view the presentation at this location: This is not an endorsement of the company or product, just a means of whetting the appetite for all of the possibilities that UDI provides.

UDI Implementations In Full Swing With Innovatum

UDI Implementations

So far this summer is off to a sizzling start with Innovatum managing seven global labeling UDI implementation projects concurrently. Four of these projects had their go live take place in the month of June 2015 alone! In conjunction with successfully submitting significant amounts of product UDI attribute information to the FDA Production Global UDI Database (GUDID) via Innovatum’s ROBAR Master Data Manager (ROBAR MDM) and ROBAR Communication Manager (ROBAR COM) products, Innovatum’s customers are taking advantage of Innovatum’s intensive experience with UDI implementation management. An extension of this for two major Medical Device Manufacturers is that they are now relying upon Innovatum’s expertise as a validation services provider to manage their complete validation processes.

Innovatum customers are fully exploiting the efficiencies of using ROBAR MDM and ROBAR Labeling along with ROBAR COM to deliver a system that uses one database to coalesce regulatory device and device production data throughout the enterprise and use the very same data for multiple purposes. The ROBAR product family does this while tightly managing security permissions and data access to various business departments. It makes the same data available for product labeling, can convert the data into Health Level 7 Structured Product Label (HL7 SPL) for regulatory data upload to the GUDID, and can supply product attribute data via a Global Data Synchronization Network (GDSN) certified data pool, a combination of data pools and other trading partners including “GUDID like variants” that will be required by other regulatory bodies.

According to Innovatum’s President Ardi Batmanghelidj, “Word is getting out. We have the only complete UDI management offering in the industry which includes a Master Data Management database that is the single source of truth or can get to the single source of truth. New fields can be added as requirements advance without a need for programming changes or validation. All of this data is easily tied to our industry leading medical device labeling system and/or our integrated regulatory data submissions and communication system though a few simple configuration changes. This greatly improves efficiency and reduces complexity by eliminating any requirements for duplicate approvals on the same data since one set of data is approved and then used for several purposes.” Innovatum has also announced its plans to integrate eIFU management starting in 2016 which further exploits the efficient use of this data. One of the overarching goals of Innovatum’s product set design is to minimize the involvement of IT resources required for implementation and on-going management.

The ROBAR Labeling, ROBAR MDM and ROBAR COM products maintain full audibility and are fully validatable in Medical Device Manufacturers environments with 21 CFR Part 11, 820, 830 and others. ROBAR Labeling is available separately or it can be used in conjunction with ROBAR MDM and ROBAR COM.