Q. What is UDI?
A. The FDA UDI Rule establishes a system to standardize and adequately identify medical devices through distribution, use and the supply chain, including hospitals and patients. The unique device identifier is a unique set of alphanumeric codes consisting of both a Device Identifier (company and product code) and a Production Identifier (specific manufacturing information). The UDI labeling must be readable to both machines (e.g. barcode, radio-frequency identification) and humans (text). Manufacturers must also populate a publically accessible database, the Global Unique Device Identification Database (GUDID), with generic product information. The GUDID does not contain manufacturing information, such as serial numbers, for specific medical devices. The FDA UDI Rule applies to all medical devices sold in the US.
Q. Is a UDI truly a "unique" identifier?
A. No. There are some products that do not have serial numbers, for example, masks, tubes and filter packs. These products will have a lot number listed in the UDI – all items produced within that same lot, will have the same UDI.
Q. Is ResMed required to comply with FDA requirements for the UDI Rule?
A. Yes. There is a staggered timeframe for implementation:
- September 2015: All ResMed life-supporting and life-sustaining medical devices will contain UDI labeling (Astral™, Stellar™, ResScan™)
- September 2016: The majority of ResMed medical devices will contain UDI labeling
- September 2018: All ResMed medical devices will contain UDI labeling
Q. How is this new UDI being used?
A. The UDI will stay with the product from the time of manufacture and has the potential to be added to patients’ Electronic Health Records (EHRs).
Q. When will product be shipped to customers?
A. ResMed introduced UDI on its first products starting in May 2015, and will roll across our entire product lines by the end of September 2018. Customers will see the UDI on ResMed’s life-support devices from July 2015.
Q. Where can I find the UDI labeling on my ResMed medical device?
A. UDI compliant labeling must appear on the primary packaging of a medical device. This includes carton or bag labels at the time of manufacture.
UDI compliant labeling must also appear on the medical devices themselves if they require reprocessing or sterilization between uses. This may be an applied label or directly marked on the medical device (e.g. laser etched).
Q. What is the layout/format for this barcode?
A. For the machine readable component of the UDI, ResMed uses the GS1 DataMatrix 2D barcode. The data contained within the GS1 DataMatrix image is encoded to the full GS1 encoding system, using Application Identifiers (AIs) to separate the individual parameters.
For the Human Readable Interpretation (HRI) component of the UDI, this will appear adjacent to the 2D barcode with each parameter prefixed by its AI in parentheses "(...)".
To learn more about the barcode, see "How will ResMed implement UDI".
Q. Will the information contained within the UDI always appear in the same order?
A. Yes. The UDI label will contain 1–5 fields of data depending on the product. The fields that contain information will always be in the same order as shown below. This is a requirement of the GS1 standards for UDI.
- Global Trade Identification Number (GTIN). The GTIN is a mandatory field, which describes ResMed as the labeler and includes the product code.
- Date of Manufacture
- Use By Date
- Lot/Batch Number
- Serial Number
Q. What will the new product labels look like?
A. Sample of a device label with UDI
Sample of a package label with UDI
Q. Do I have to use the new UDI barcode?
A. No. All ResMed labels will continue to have the same information and barcodes prior to the implementation of UDI labeling. The UDI labeling (2D barcode and/or the Human Readable Interpretation) is additional information. This means you can continue to use the individual linear (1D) barcode as you always have.
Q. What’s the difference between the two types of barcodes?
Q. Why do we have this new barcode, and how can I use it?
A. It is a new FDA regulation that all medical devices for sale in the US be labeled with a UDI. You can save time by scanning our new 2D barcode, where most of the information you need for your records is stored in one place. Most barcode scanners will automatically decode GS1 compliant barcodes. Find out more information about the GS1 Standards.
Q. Can I use my current scanner for the new 2D barcode?
A. 2D barcodes require a 2D imager. The data stored in a 2D barcode runs both horizontally and vertically, so only an imager (2D barcode scanner) can properly decode the information. A 1D barcode scanner will not be able to read a 2D barcode; however, a 2D barcode scanner can read a 1D barcode.
Q. How do I program my scanner for this new barcode?
A. Please ensure you have a 2D barcode scanner. This scanner contains an imager that is necessary for scanning 2D barcodes. Most barcode scanners will automatically decode GS1 compliant barcodes. If you are uncertain if your barcode scanner is GS1 capable, please contact your barcode scanner supplier.
Q. Can I scan this from a packing slip?
A. Unfortunately, not at this time.
Q. Why do only some of my products have this new barcode?
A. ResMed has introduced the UDI barcode as a rolling change across all its product lines. By September 2018, all ResMed medical devices and accessories for sale in the US will contain this new labeling. It is possible that customers may receive mixed shipments during this transition period.
Q. Where is the UDI stored?
A. Manufacturing information that forms part of the UDI will not be stored in the GUDID. It is intended that the UDI will be stored by each party in the supply chain.
Q. What is the GUDID?
A. The GUDID is a database administered by the FDA as part of the UDI system. The database, which serves as a reference catalog of information about medical devices with a UDI, will be publicly accessible to allow all stakeholders (provider systems, payers, clinicians, patients, industry, the FDA and others) to search, download and use generic information about the medical device. Find out more information about the GUDID.
Q. Why are some ResMed products not listed in the GUDID?
A. The product you have may not yet need to be UDI compliant.
Q. May I have a list of my products that have UDI labeling?
A. We can provide you the breakpoints for each product range. Please consult your customer service representative for more information.