Unique Device Identification Essential In Health Records

Back to NAM Blog

Unique Device Identification Essential In Health Records

Unique Device Identification Essential In Health Records

Medical device manufacturers are all too familiar with unique device identification and the looming compliance deadlines implemented by the FDA.  While it's been a confusing and complicated process for many in the medical device industry, there are other areas where UDIs are a must - in insurance claims and electronic health records, or EHRs.  Why?

A UDI corresponding to the product's model type and manufacturer must be assigned to every medical device as mandated by Congress.  Essentially, the FDA was required to create the UDI system by Congress, which is to be used throughout the healthcare system.  This includes insurance claims and EHRs.

When unique device identifiers are used in EHRs doctors can more easily recognize precisely what device is implanted in a patient - essential in case of an adverse event. Patient safety is improved dramatically, as pinpointing which devices may or may not be MRI-compatible or expired is now a simple matter for healthcare providers.

Why should unique device identifiers be included in insurance claims?  One, insurance claims include specific details about patient procedures, so adding UDIs for medical devices will make the process of gathering data more efficient for providers.  Two, providers will be able to more easily demonstrate the value of specific devices when UDIs are included in claims.  Physicians will also be able to determine which medical devices provide patients with care that is cost-effective.

Ultimately by including UDIs in EHRs the benefits are numerous as patient safety is supported, coordination between multiple clinicians is enhanced, and all hospital systems including billing and the supply chain will have product information available to them.

While UDIs are not currently required in insurance claims, many experts agree that Congress should require CMS (Centers for Medicare & Medicaid Services) to include a field in the next claims form update to document the unique device identifiers of implanted devices.  In doing so, patients would have an extra level of protection from unsafe products, and researchers, clinicians and regulators would be able to access the data essential to enhancing quality for millions of patients who have medical devices implanted for various health reasons.

At Markem-Imaje we provide coding and marking solutions to help ensure medical device manufacturers comply with UDI regulations.  From laser, thermal inkjet, and continuous inkjet to thermal transfer and print & apply, we offer the right technology for all of your UDI printing specifications.  

January 10, 2014
Markem-Imaje Announces Acquisition of CSAT

Markem-Imaje Announces Acquisition of CSAT
Back to top