Xerafy Healthcare Whitepaper Featured on Medical Design Briefs

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.
X_OR in China__Kunming_IMG_20171221_143128 (2)

An operating room in China during an onsite institution survey. (Credit: Xerafy)

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Instructions for Use: The Sterilization Challenge

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:

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IIoT Technology Will be the Heart of the Smart Factory

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.


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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