RFID technology application in medical and healthcare circles is nothing new. It could almost be perceived as ubiquitous. But, if one only considers RFID capability as a data carrier, comparable to a bar code, the technology’s growing dynamism is overlooked. With expanded features, greater computing power, lowered costs, and rich data streams, medical and healthcare RFID is innovative, disruptive, and transformative to processes and, potentially, to entire business models.
The thing is, medical applications using RFID have a few — ok, a lot — more performance and regulatory hoops to jump through to achieve compliance in the complex environments in which they operate, particularly when used as, or in conjunction with, medical devices. Just how heavy is that regulatory burden? Amended product safety requirements for medical electrical equipment, updated in 2015, fall under IEC 60601, and include new and updated standards for:
- Risk management
- Essential performance
- Marking and Labeling
- Electrical hazards
- Temperature testing
- Programmable electrical medical systems (PEMS)
IEC 60601 is a widely accepted benchmark indicating regulatory compliance of medical electrical equipment and, in terms of global commercialization, many companies view compliance with IEC 60601 as a requirement to enter most markets. In spite of these updated standards, RFID is the leading technology being used by medical device manufacturers to enable smart devices to deliver higher quality patient care. Common RFID applications include:
- Delivery and tracking the right device for a particular patient
- Verification of proper sterilization
- Compliance control for equipment maintenance and calibration
- Billing, to link medical device use to a patient
- Inventory management
- Reduction in staff time spent tracking items and devices
Operationally, RFID offers low electromagnetic interference (EMI) properties, low cost, small size, low power, and battery-less technology capabilities. Additionally, Advances in RFID tag technology offer expanded memory capacity, enabling additional data to be stored on each tag, which helps to prevent counterfeiting and ensures product reliability. Data such as lot number, manufacturing date, expiration date, etc. can be written to the tag during the manufacturing process, while new information —such as shipping date, date of sterilization, or treatment history — can be added throughout the product supply chain and lifecycle.
Moreover, a distinctive anti-collision scheme allows RFID tags to be individually identified, enabling accurate reading and identification of tags even in large batches, or inside packed boxes. Of course, reliable identification is crucial when dealing with logistics and tracking systems for medical devices and instruments. This importance is magnified when tracking biological samples in transit, or when verifying that a reusable piece of equipment has been sterilized. To that end, RFID tags are able to withstand harsh sterilization conditions, making them ideal for verification of sterilization, safeguarding against accidental cross-contamination with secure data that cannot be revised by unauthorized personnel.