Success of Hospital Pilot to Document Implants is First Step Leading to Data Analytics Used to Combat Dangers Stated in Netflix Documentary "The Bleeding Edge"

WHEELING, West Virginia, November 9, 2018 /PRNewswire/ --

GS1 Ireland led an international coalition which successfully employed a sterile field scanner during surgery. The "TRACTUS" scanner by Matrix IT Medical Tracking Systems effectively collected detailed medical device information from extremely small codes known as data matrix codes on hospital-sterilized implants at Wheeling Hospital in West Virginia, USA. For the first time, full medical device traceability was proven on these implants, allowing for future device analytics.

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Patient injury and death motivated governments worldwide to pass laws requiring medical devices be traced through their life cycles. Known as Unique Device Identification (UDI), a substantial barrier to compliance is the inability to fully identify hospital-sterilized devices.

"Many implants and surgical instruments are removed from their packaging, placed into trays and sterilized in the hospital," said Alan Gormley, Industry Engagement and Solutions Manager at GS1 Ireland. "The surgeon typically uses only what is needed, and the rest are returned to be re-sterilized for another surgery. Once placed into trays all detailed information from the package label can be permanently lost," he said.

TRACEABILITY IS A MUST

Mike Schiller, Senior Director of Supply Chain for the Association for Healthcare Resource & Materials Management-a professional membership group of the American Hospital Association-has been working to solve challenges associated with UDI documentation.  Schiller said, "for these devices, fast, accurate and complete traceability is a must, but has been a significant challenge for hospitals."  

Further complications include the inability to identify how many times these devices were used on patients and/or re-sterilized so that they may be safety checked. Many of these devices may have been sterilized or used hundreds of times.

BEST PRACTICE GUIDELINES

The aim of the coalition of top worldwide healthcare stakeholders known as 'Blueberry Castle' (BBC), is to analyze the speed and accuracy of numerous documentation methods for surgical implants.  From this data, a "best practices" guide for manufacturers and hospitals is being created.