Scanner tracks sterilised instruments during surgery

Researchers have pilot tested testing a field scanner that can track the use of sterile instruments and medical devices during in-hospital surgical procedures.

A pilot study led by coding standards group GS1 used Matrix IT Medical Tracking Systems’ Tractus scanner to read unique device identification (UDI) codes – which as of September 24 are required on some Class I and all Class II and III medical devices in the US as part of a phase-in process that is due to complete in 2020.

A similar system is also being rolled out in Europe whilst other markets are also following a similar path with the aim of improving the traceability of medical devices. However, it’s not easy to trace devices used in surgeries as they are often removed from packaging and placed on trays, to either be used or re-sterilised and saved for future procedures.

The pilot – conducted at Wheeling Hospital in West Virginia – is thought to be the first to use a sterile field scanner to document the UDIs of devices used during surgery. The system captured and documented hospital-sterilised medical device information, while a handheld scanner was used to scan sterile packaged devices. In some cases, 2D datamatrix codes were etched directly onto metal instruments.

Using this approach, it was possible to provide full traceability for medical devices used during procedures, for example linking an implant to the patient’s surgical site and health records, and cross-check the device’s UDI against a federal database to ensure it hasn’t been subject to a recall or carry a fake code.

Until now methods to document medical devices used in the operating theatre have been subject to human error and lacking in adequate traceability of devices in the event of a recall, according to GS1. The new approach represents the first time theatre staff have been able to fully document hospital-sterilised implants before being handed off to the surgeon and requires no extra manpower.

“For the first time, full medical device traceability was proven on these implants,” said the company. “The healthcare industry will be able to use the data to help combat counterfeits and analyse performance trends of devices and surgical procedures, ensuring the appropriate implant for each patient is selected.”

It adds: “By tracking every medical device manufacturers, hospitals and payers will save significant healthcare dollars while improving patient safety and providing better care.”