The following is an excerpt of Xerafy Healthcare whitepaper entitled “RFID for Medical Device and Surgical Instrument Tracking” originally published on Medical Design Briefs on September 1,
Ensuring patient safety and quality of care has become an increasingly technology-reliant process for most healthcare providers. With 4,000 reported “retained surgery items” cases per year in the United States alone, hospitals have turned to automatic identification technology such as RFID to track medical devices and surgical instruments. Leading hospitals like the Mayo Clinic’s Saint Mary’s Hospital in Minnesota and Rush University Medical Center in Chicago have deployed RFID to track equipment, surgical instruments, and staff members.
An operating room in China during an onsite institution survey. (Credit: Xerafy)
Hospital central sterile departments often have difficulty managing compliance with IFUs; RFID can help automate inventory and compliance processes.
In a recent article published entitled “Insufficient for Understanding: Are IFUs Failing Us or Are We Failing Them?” , writer Hank Balch outlines the gaps in understanding between front-line central sterile service department (CSSD) employees and the instructions for use (IFUs) provided for medical devices and surgical instruments that explain how to clean, sterilize and maintain each item. Following is an expert from the article, originally published by NewSplash/Ultra Clean Systems:
New “smart factories” will require a high degree of digitization and real-time data. RFID, sensors and other industrial internet of things (IIoT) technologies will enable this new level of visibility.
As interest in creating “smart factories” increases, manufacturers are turning to the industrial internet of things (IIoT) to improve factory efficiency and prevent machine failures. This will require a high level of automation and increased visibility enabled by RFID, sensors, and other technology. The ability to “see” the entire production process and adjust or control it remotely is a key part of Industry 4.0 – a concept for the future of manufacturing that includes interoperability, information transparency, decentralized decision making, and connectivity.
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
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.