UDI Medical Device Tracking Goes Global

A recent compliance push for UDI in the U.S., EU, Australia/New Zealand, and China will lead to greater use of surgical instrument tracking in hospitals.

The U.S. FDA is now several years into its unique device identifier (UDI) program for medical device tracking. As we approach the Sept. 24, 2018, deadline for class II device UDI marking, a number of other countries are rolling out their own similar programs.

The goal of these programs is to improve safety, increase efficiency, and provide unambiguous accountability when it comes to control and tracking of medical devices and surgical instruments. RFID has rapidly emerged as a viable solution for tracking reusable devices like surgical instruments across these initiatives.


EU: The European Union has matched the FDA regulations for its own UDI programs via the EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Medical Device Regulation 2017/746. Compliance deadlines for different classes of medical devices in the EU will be rolled out through 2027. Continue reading

Artificial Intelligence at Center of New British Health Initiative

The UK has launched a project to leverage artificial intelligence to help improve medical diagnoses and outcomes; data from RFID systems could help enable these types of solutions.

Earlier this year, British Prime Minister Theresa May announced the AI (artificial intelligence) and Data Grand Challenge, an initiative targeted as using AI to improve the prevention, diagnosis and treatment of chronic diseases like cancer, diabetes, heart disease, and dementia by 2030.

The healthcare project is one of four Grand Challenges that are part of the UK’s new Industrial Strategy, and could have a significant impact on public health. According to Cancer Research UK investing in an early diagnosis research platform with AI data could result in over 56,000 more people annually having cancers diagnosed at an early rather than late stage within 15 years. That in turn could result in 22,000 fewer deaths within five years of diagnosis compared to the current mortality rate.


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IoT and AI for Healthcare Will Drive Savings

The use of AI and Internet of Things (IoT) technology in healthcare will drive operational cost savings as well as improve regulatory compliance.

The use of artificial intelligence (AI) in the healthcare industry will rely heavily on data gleaned from a number of different systems. A major emerging source of important data will be what Accenture calls the Internet of Health Things (IoHT) – a network of connected medical devices and assets that will provide more visibility into patient status and outcomes.

By introducing more connectivity, remote monitoring and information gathering, Accenture says the IoHT can “encourage better use of healthcare resources, more informed decisions, a reduction in inefficiencies or waste and the empowerment of health consumers.”

In Article_SPD in BrazilSPD Department is facing the challenge of meeting Unique Device Identification (UDI) tracking requirements (Source: Xerafy)

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A Call to Action on Patient Safety

The World Health Organization has called for global action to improve patient safety. Technologies like AI and RFID can help automate processes and reduce patient risk.

Hospitals can be dangerous place for patients. Even if they are successfully treated for the ailment that led to their admission, there are risks of secondary infections, injury, and the possibility of retained surgical items (or instruments left inside a patient’s body after a procedure).

Surgeons performing surgery in operating Theater. Continue reading