March 31, 2020

Enhancing healthcare quality with RFID innovations for the sterile goods cycle

Surgical instruments are a challenge for today’s RFID technology: made of stainless steel, they are delicate, and are sterilized at extreme temperatures (up to 121°C/250°F). Tiny, super-high frequency tags (SHF, 5.8 GHz) are needed to create a digital copy of the sterile goods cycle.

Funded by the European Union's Regional Development Fund and the state of Nordrhein-Westfalen, Germany, the project is being carried out by a consortium including Smartrac, ID4us, IT4process, and several university hospitals and scientific bodies. The project’s unpretentious name is DAST (Digitales Abbild des Sterilgutkreislaufs mittels Transpondertechnik), which means "Digital copy of the sterile goods cycle using transponder technology.”

"The innovation is all about making the transponder so small and readable even under difficult conditions," — Professor Dr. Nils Pohl of consortium member Ruhr-Universität Bochum (RUB).

Dealing with a surprisingly urgent problem
A fancy name is unnecessary, as the reasoning for starting DAST is quite obvious. Sterile goods such as surgical instruments are used daily in hospitals and are constantly in a cycle of use, cleaning, sterilization, testing and distribution throughout the facility. Complete sets of instruments for medical surgery are assembled and transported in sieves. Studies have revealed that high error rates of up to 30 percent occur, so that improvisation is required during the operation, for example by removing items from other sets, which then of course are incomplete.

Surgical instruments

The DAST consortium wants to provide a technical solution that allows the sterile goods cycle to be tracked in real time, so that it is always certain where each instrument is located – a requirement profile that typically calls for RFID-based solutions. In addition, accidentally leaving instruments inside patients' bodies should also be rendered impossible.

Extremely demanding conditions
In the case of DAST, the devil lies in the details. At first glance, the need for a bulk reading capability – reliably capturing the data of all items in a sieve in one go – shouldn’t pose a challenge for existing UHF technology. However, there’s a problem. For reasons of hygiene, the transponders must be encapsulated in tiny glass or ceramic tubes measuring only 1.4 X 8mm, and then integrated into the stainless-steel bodies of the instruments. "The innovation is all about making the transponder so small and readable even under difficult conditions," says Professor Dr. Nils Pohl of consortium member Ruhr-Universität Bochum (RUB). "For both aspects, it is essential to use a high frequency of 5.8 gigahertz, which allows significantly smaller antennas than previous state-of-the-art transponder tags at 13.56 or 866 megahertz.”

Innovative technologies needed
However, tags with these dimensions based on purpose-built SHF ICs are not commercially available yet. This prompted Smartrac and the RUB to initiate such a product  development, with RUB taking care of the IC, and Smartrac taking care of the antenna and hard-tag design. “We are still in an early stage, but we defined the parameters for an innovative Maxdura® Ceramic tag that uses an in-development SHF IC and has a significantly smaller form factor than our existing UHF hard tags,” said Frederic Meyer, Associate Director Project Management, Research & Development at Smartrac. “In close cooperation with the RUB and its IC development team, we are very optimistic that we will produce prototypes well within the planned duration of the DAST project, which has almost three years to run.”

Tracking of sterile goods: A promising market
A speedy commercialization of the SHF technology used in the DAST project makes sense in two respects –medical quality assurance as well as market exploitation. In the European Union alone, there are some 12,000 hospitals, each of which uses on average 40,000 surgical instruments that could and should be tracked.

DAST at a glance

DAST aims to create a digital lifecycle file for each sterile item, and to automatically maintain it during the cycle. Each item will be monitored and tracked in real time by hospital staff. Users will be able to see, for example, where the sterile goods are located; whether, when and for what purpose they were used; and if they were sterilized and handled in accordance with protocol. For the first time, DAST will allow the fulfillment of requirements defined in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (aka "Medical Device Regulation"), without the need for separating the sterile goods or trays at the reading points.

In addition to Smartrac and the RUB, the companies ID4us, IT4process, the University Hospitals of Cologne and Essen, the Helios University Hospital Wuppertal, and the Fraunhofer Institute for Microelectronic Circuits and Systems complete the consortium. The additional advisory board consists of Professor Stockmanns from the Krefeld University of Applied Sciences, Aesculap, Instruclean, the German Society for Sterile Supply, the German Society for Hospital Hygiene, the Scientific Society for Hospital Technology and the Association for Operating Room Management.


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