By assessing device traceability, the
study aims to curb potential human errors as
well as death and injuries related to
the devices

International consortium kicks off multicountry study on device traceability

July 03, 2018
by John R. Fischer, Senior Reporter
An international consortium of government representatives and nonprofit and corporate leaders kicked off a multicountry study last month at Wickenburg Community Hospital in Arizona for improving traceability of medical devices.

Dubbed “Blueberry Castle”, the study will compare current manual methods for documenting operating room implants and documentation through scanning to assess the risk of human error. A range of technologies, including TRACTUS by Matrix IT Medical Tracking Systems Inc., will be evaluated as part of the effort, which goes hand in hand with the Unique Identification Initiative (UDI) to reduce medical device-related injuries and deaths.

“Medical device implant documentation is an incredibly manual process, oftentimes requiring a nurse to spend valuable time writing down identification numbers and then entering them into the patient’s medical record at a later date,” Dr. Brandon Donnelly, CTO of Matrix IT Medical Tracking Systems Inc., told HCB News. “Further, product stickers or packaging might have multiple bar codes, leading to confusion on which one to scan, including when paper bar codes have faded or been easily damaged.”

The idea of converting manual recording methods to automated bar code scanning is becoming widely popular for the prevention of human error as hospitals continue to digitize medical health records.

Direct part mark scanning is one of these automated approaches that cuts average documentation time for a nurse from six minutes to ten seconds while using live decoding to alert clinicians if a product or implant is expired or subject to recall. Government mandate of direct part marking also requires large manufacturers to make more information easily accessible.

Equipped for UDI with a machine learning, advanced data analytics platform powered by Google, TRACTUS captures sterile, direct part-marked implants and instruments, 1D and 2D bar codes on packaging and RFID, decoding in real time, and alerting nurses to recalls or out-of-date items.

It also ensures automatic transfers of data to the EMR, billing and decrements from the hospital’s inventory system, and will be assessed against various solutions, including Medtronic’s clip-on 2D scanner tag system, which risks getting lost and has even had cases of clips being implanted in patients. Human-readable, laser-marked characters on implants that are difficult to read due to their small font size require human-enabled decoding and lack the 50+ characters of a UDI.

Other evaluations include Johnson and Johnson’s suggestion of a bar code reference sheet for nurses to scan; stickers that come with implant trays but often lack a full UDI and are prone to fading or getting lost; and sterile packaged items which are more expensive, may not be used in a case, and lose their UDI once opened.
“The study looks at all current and suggested ways of UDI compliance and aims to come up with a blend of suggestions for those in the U.S. and EU to comply with the upcoming UDI mandates in a safe and comprehensive way for maximum adoption,” said Donnelly. “We want a reasonable way that doesn't suggest any blockades or hurdles to those in the industry, including manufacturers, hospitals and public sector.”

The study is made up of 40 hospitals and 7 countries who seek to aid in collecting and providing international medical device data to programs such as the FDA’s National Evaluation System for Health Technology and the European Union’s Medical Device Regulation initiative, in order to ensure improved patient outcomes and reduce healthcare costs.

Top UDI stakeholders overseeing the assessment include GS1 Ireland, American Hospital Association's AHRMM, Association of Peri-operative Registered Nurses (AORN), and various U.S. and European government agencies.