FAQs - Medical Devices


  1. What types of medical devices do ISBT 128 UDIs apply to?
  2. Why use ISBT 128 over the other standards approved for UDI?
  3. How do I choose between ISBT 128 and GS1?
  4. What is the regulatory importance for the ISBT 128 Donation Identification Number (DIN) in labeling HCT/P medical devices as the distinct identification code?
  5. What is the importance of using the standardized ISBT 128 product description code when labeling HCT/P medical devices?
  6. In regards to UDI, will ISBT 128 requirements affect the proprietary image of my product’s outer packaging? 
  7. I want to assign ISBT 128 UDIs to my HCT/P medical devices. How do I get started? Where do I begin?
  8. How do I create a device identifier (DI) using ISBT 128?

 

 

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1. What types of medical devices do ISBT 128 UDIs apply to?

ISBT 128 UDIs apply to human cells, tissues, and cellular and tissue-based products (HCT/P) that are regulated as medical devices (e.g. an implantable suture with a human tendon component).

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2. Why use ISBT 128 over the other standards approved for UDI?

ISBT 128 has been specifically designed to meet the special traceability needs of medical products of human origin to provide the donor to patient link of each product. In particular, it incorporates the identification of the donor within the standard to ensure this identification is globally unique and is presented in a standard format. 

The globally unique ISBT 128 Donation Identification Number (DIN) satisfies the FDA requirements for a distinct identification code as a production identifier for HCT/P.

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3. How do I choose between ISBT 128 and GS1?

ISBT 128 focuses on coding and labeling HCT/P that are regulated as medical devices, whereas, GS1 applies to general medical devices. In a joint document by GS1 and ICCBBA, it is recommended by both GS1 and ICCBBA to use ISBT 128 for coding and labeling HCT/P.

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4. What is the regulatory importance for the ISBT 128 Donation Identification Number (DIN) in labeling HCT/P medical devices as the distinct identification code?

Outside of the US, the distinct identification code is generally referred to as a donation number or donor number and corresponds to the donation identification number in ISBT 128. This number is an essential identifier in product recall and investigation of serious adverse reaction events and has to be reported to regulatory bodies in many countries as part of adverse event reporting. Some examples include:

  • In the European Union it is a required item to be reported by the tissue establishment to the competent authority.
  • In Australia, their Therapeutic Goods Administration (TGA) requires the donation number to be provided in the event of a tissue recall.
  • Health Canada recall policy and associated legislation may regard the donation number as an essential data item in the report to Health Canada.

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5. What is the importance of using the standardized ISBT 128 product description code when labeling HCT/P medical devices?

The standardized product description code (i.e. the last 5 characters of the device identifier) is very important to ISBT 128.

  • It is essential to providing uniqueness to each transplanted device. The Donation Identification Number (DIN) is common to all products from the same donor, so the product description code is essential for differentiating products from the same recovery event (e.g., differentiates bone, skin, corneas, etc., from the same deceased donor).
  • It supports biovigilance. Since all suppliers use the same product code for what are essentially the same products, it allows organizations like the Center for Disease Control (CDC) to pool data across the US and across the world. The product codes correspond to descriptions with sufficient granularity to allow biovigilance studies to zero in on characteristics that might be associated with problems.
  • It supports product management at the hospital. By having different suppliers use the same code for similar products, hospitals can create tables that allow appropriate substitution. If they want to differentiate similar products from different suppliers, they can still do it by using the facility-defined element of the device identifier.

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6. In regards to UDI, will ISBT 128 requirements affect the proprietary image of my product’s outer packaging?

ISBT 128 only requires a portion of the package label to be standardized, carrying the ISBT 128 bar code and essential eye-readable information.

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7. I want to assign ISBT 128 UDIs to my HCT/P medical devices. How do I get started? Where do I begin?

Your facility must first be registered with ICCBBA to use ISBT 128 and be assigned a unique Facility Identification Number (FIN) from ICCBBA. This FIN is incorporated into the elements that make up the UDI. Please refer to Coding and Labeling of Medical Devices Using ISBT 128 (ST-011) for additional guidance in the coding and labeling of medical devices containing an HCT/P. You can register your facility with ICCBBA here.

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8. How do I create a device identifier (DI) using ISBT 128?

The device identifier for the UDI is made up of the ISBT 128 Processor Product Identification Code (PPIC) Data Structure 034. See Section 2 in Coding and Labeling of Medical Devices Using ISBT 128 (ST-011) for more information regarding Data Structure 034.

The PPIC data structure consists of the following elements:

  • The Facility Identification Number (assigned by ICCBBA when the facility registers to use ISBT 128)
  • A facility-defined product code
    • This element is optional. A default value of “000000” (zeroes) is used if the facility chooses not to define their own product code.

Additional Information

The following document clarifies some misconceptions regarding the use of ISBT 128 for tissue and tissue-based products.

10 Myths about ISBT 128 - PDF