Patient Safety and Breast Implants Recall

This presentation looks at the issue of medical device recalls and UDI tracking solutions at the point of care.
The 2019 Allergan textured breast implant recall highlighted the inadequacy of hospital and vendor medical device tracking. When a patient safety recall was issued following the discovery of potentially fatal flaws in the Biocell breast implants, all parties struggled to locate the full list of patients who were affected.
This crisis lead to the development of Unique Device Identification - known as UDI.
UDI tracking is now an FDA requirement that needs to be adhered to in order for hospitals to respond effectively to product recalls and operate compliantly.
Despite the new regulations being in place, many healthcare organizations still struggle to achieve 100% tracking of medical device and implant usage.
The weakest point in the workflow is undoubtedly in the surgery setting.
In this presentation, IDENTI Medical highlights the 2019s breast implant crisis and looks at the resulting shift in the landscape, in a bid to prevent the same situation from happening again.
IDENTI Medical have developed a first-of-its-kind soloution - Snap&Go.
identimedical.com/snap-and-go/
Snap&Go is an image capture tool that makes 100% data capture in surgery a quick and simple act for nurses, resulting in full UDI capture.
00:00 The connection between Patient Safety and Data Integrity
00:05 Breast Implant Recall and the FDA's UDI tracking system
00:10 What is UDI? Unique Device Identification
00:15 Challenges of point of care UDI capture of implantable devices
00:20 The clinical and practical challenges of introducing UDI capture workflows
00:25 IT system and barcode challenges in capturing UDI data
00:30 Why hospitals find it hard to get full UDU capture
00:35 IDENTI Medical's Snap&Go - image capture technology for full UDI tracking
00:40 Snap&Go - image recognition, global database, cloud platform
00:45 How Snap&Go works - item identification, automatic charting, lowers litigation risks
00:50 Benefits of Snap&Go for nurses, patients, supply chain and revenue
00:55 Find out more about Snap&Go to achieve 100% item capture at the POC
IDENTI Medical creates groundbreaking tools for surgery spaces.
Our use of patented technology and healthcare know-how results in smart, user friendly solutions.
Contact us for a demo. identimedical.com/contact-us/