Article re-posted with permission from Parker Hannifin Life Sciences Division.
Original content can be found on Parker’s Website.
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.
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.
So, what are the unique advantages of built-in RFID tags for medical devices?