Article re-posted with permission from Parker Hannifin Life Sciences Division.

Original content can be found on Parker’s Website.

RFID Tags and Medical Devices

Preventable Medical Errors Prompts U.S. FDA's UDI Rule

The influential 1999 report To Err is Human (National Academy of Sciences, Institute of Medicine) reported that preventable medical errors caused at least 44,000 and perhaps as many as 98,000 deaths each year, with total costs of between $17 and $29 billon. One response to that and other reports was the U.S. Food and Drug Administration’s Medication Barcode Rule of 2004, which built on the existing National Drug Code (NDC) — a universal product identifier for drugs. In turn, the FDA Amendment Act of 2007 directed the FDA to create a Unique Device Identifier (UDI) system for most medical devices distributed in the United States.

Automatic Identification and Data Capture Technologies for Medical Devices and Instruments

The FDA UDI Final Rule states: “ Automatic identification and data capture (AIDC) technology means any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.” AIDC (aka auto-ID) for medical devices may employ — at least in theory — any automatic data capture technology, including bar codes, radio frequency identification (RFID), magnetic stripe cards, optical character recognition (OCR), smart cards, etc. But from a practical design and user application point-of-view, most medical device designers are looking to either RFID tags or bar code technology.

Barcode Labels vs. RFID Tags

• RFID systems can have their reading distances “tuned” over a broad range through tag selection, tag antenna size and configuration, choice of tag reader/reader power, and Parker Chomerics RF shielding technologies.
• Barcode readers must have direct line of sight; RFID readers do not.
• Barcodes require either a specific orientation to their reader or a larger reader that is omnidirectional; RFID tags can be read in virtually any orientation.
• Barcode readers read one label at a time; RFID readers can read hundreds or thousands of tags at once.
• RFID tags can contain much more information than is practical on a most barcodes.
• RFID tags can be written-to (and/or locked and encrypted) at their point of use. For example, the number of autoclave cycles a device has endured could be recorded on both its tag and a database: data collection and its use become real-time.

So, what are the unique advantages of built-in RFID tags for medical devices?