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Which AIDC technology should a UDI system choose?
Which AIDC technology should a UDI system choose?
来源: | Arthuor: XTIOT Barcode Scanner | Time: 2022-12-02 | 186 Reading | 分享到:

In its core recommendation, the IMDRF states that the UDI regulations "do not limit the approach to AIDC," and therefore, the FDA did not specify AIDC techniques in the final rule.

 

Retaining manufacturers' freedom to choose technology enables faster adoption of the global UDI system and makes future use of upcoming new technologies available to medical device manufacturers and regulators.

 

1D barcode

 

1D barcodes are ubiquitous, simple to make and easy to read. Most healthcare facilities have scanners that can read 1D barcode symbologies. Some common 1D medical device barcodes:

 

Code 39 can encode fewer characters than most barcodes in use today. However, the world's largest purchaser of medical equipment is the U.S. Department of Defense, and DoD specifies Code 39 marking for many applications in its supply chain.

 

Code 128 can encode any 128 ASCII characters, which is more efficient than Code 39, so more information can be stored in a relatively small space. ICCBBA 128 is a specialization of Code 128 for labeling blood - FDA classifies medical devices according to human tissue.

 

The DataBar family of barcodes is owned by GS1, one of the issuers of UDI. It includes barcodes commonly used in the healthcare sector, formatted using less space for use on smaller projects.

 

2D barcode

 

2D barcodes use a series of square dots arranged in a grid pattern to encode any form of alphanumeric information and include robust error correction capabilities. QR codes were previously considered an “exotic” technology because there were very few scanners. Now that mobile devices and 2D code reading apps are readily available, 2D has become more practical and is expected to become the standard for marking medical devices. Symbologies include Data Matrix, QR Code, Aztec Code, and PDF 417. Increasing the second axis substantially increases the amount of data contained in the code, while color also provides a third axis of information.

 

RFID tag

 

RFID tags can be read as long as they are within a certain distance of the scanner, unlike bar codes, which require a straight line of sight. The marker can be sewn onto fabric devices, contained in cartons, or even embedded in implantable devices.

 

Devices equipped with read-write RFID tags can provide dynamic data exchange between the device and the user. Reading and writing RFID also has the potential to connect medical devices to the Internet of Things (IoT).


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