Let’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: https://youtu.be/VaPZPVYI_cg. 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.
