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" - Seite 3

The second option is for manufacturers to laser mark the UDI directly onto each implant via very small data matrix codes. Each device is placed into trays that are sterilized before surgery and positioned into the operating room sterile field.  The scrub technician removes the correct device from the tray, and scans the laser marked data matrix code via sterile field scanner before handing it off to the surgeon.  Staff noted that it's the first time they have been able to fully document hospital sterilized implants before being handed off to the surgeon and requires no extra staff.

A FIRST IN THE U.S.

Wheeling Hospital in West Virginia has become the first U.S. hospital to use the sterile field scanner for UDI documentation during surgery.

David B. Cohen, M.D., the neurosurgeon who carried out the first surgery employing the scanner, reported his satisfaction with the new medical device documentation system, saying, "Scanning the UDI was easy and efficient as it did not delay the surgical process."  

David Rapp, Chief Information Officer at Wheeling Hospital, stated, "Wheeling Hospital is a technologically advanced hospital.  As Chief Information Officer (CIO), I wanted Wheeling to be first to utilize this new technology. My hope was that it would integrate seamlessly in the operating theater.  Change can be difficult and it's important that a new technology doesn't interfere with surgery. I'm delighted to say that in our first clinical use, the feedback I've had from the clinical staff was overwhelmingly positive."

HOW STERILE FIELD SCANNING WORKS

During surgery, sterile draped wireless scanners paired with intelligent software are employed to maximize the efficiency and accuracy of clinical care documentation at the point of care. The system captures, and documents hospital sterilized medical device information, while a handheld scanner is used to scan sterile packaged devices.

Until now methods to document medical devices used in the operating theater have been subject to human error and lacking in adequate traceability of devices in the event of a recall.

With a scan just before implantation TRACTUS collects all implant and surgical supply data. This information is transmitted to the software interface where each device is matched with the patient's surgical site and recorded in the patient's health record where they will have immediate access to their medical device information.  TRACTUS cross checks government databases to ensure that recalled devices are identified before surgery.  This is the last chance to verify that no active recall exists on a device before it's implanted.