New White Paper

The Device Visibility Gap

Why UDI Has Not Delivered on Surgical Device Safety - and What Hospitals and ASCs Must Do Now

Every implant, scope, and surgical device in your OR already carries a unique identifier. A decade after the mandate, that part worked. What didn’t: almost no hospital or ASC can tell you, in the moment it matters, whether the device in front of them is the one that was recalled, the one that’s expired, or the one tied to a growing pattern of adverse events.

The identifier exists. The evidence behind it doesn’t follow it anywhere clinically useful. That’s the gap this paper names – and the one CMS is about to stop letting hospitals ignore.

“The EHR field stores an identifier. It does not store whether the device was fit for use, recalled, expired, or implanted in the patient.”

Why manufacturer compliance with UDI is effectively complete – and why that has had almost no effect on what happens in the OR.
The one data field most hospitals still aren’t capturing, and why CMS is about to tie it to a payment program starting in CY2027.
The five specific points in the surgical supply chain where device evidence breaks down – and which one is most likely happening in your facility right now.

CMS Has Already Set the Clock

Starting with the CY2027 reporting period, hospitals must attest they can capture and store complete UDI – device identifier and production identifier together – tied to a federal payment program. Most organizations capturing UDI today are only capturing half of it. The paper explains exactly what changes, who’s exposed, and how far out of position the typical hospital or ASC already is.

No spam. One paper, straight to your inbox – unsubscribe anytime.

448 North Cedar Bluff, Suite 270, Knoxville, TN 37923, US