According to the new EU medical devices regulation, all medical devices must carry a “unique device identifier” – a unique alphanumeric code, before being placed on the market. Similarly, on the other side of the Atlantic, the U.S FDA’s Unique Device Identification (UDI) requirements have been enforced. Likewise since October 2020, the health authority in China has required implementation of a UDI system for a range of medical devices sold and used in the country.

By allowing to track what device was used on which patients, a unique device identifier ensures that medical devices are not only safe for use, but are in the right place at the right time. In the current COVID-19 pandemic, this can reduce the risk of cross-contamination between patients.

Increasing transparency on what takes place during medical procedures is also highly efficient in reducing unnecessary clinical practice variation. In the event of a product recall, it may greatly limit the scope of the recall.

While complying with these new international rules is certainly costly, the use of an accurate tracing and tracking system is also highly beneficial for the healthcare industry.

At hospitals, one of the obvious advantages is an optimized inventory management based on the actual usage of medical material, thus limiting waste. According to Glen Hodgson, head of healthcare at GS1 UK, one of the leading UDI issuing agencies, the use of GS1 barcodes by the Derby Teaching Hospital NHS Foundation Trust in 2016/17 helped save £1.2 million. It also reduced valuable time previously spent ordering stock.

While the challenges are numerous, meeting UDI requirements will increase the need for smart instrumentation and connected medical devices. Not surprisingly, the Internet of Medical things market is booming.