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Biologically Derived Product

Data Element

Information from the submission form

Biologically Derived Product
This resource is defined by HL7 FHIR as "a material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.” See HL7 FHIR R4 specification for additional details (http://hl7.org/fhir/biologicallyderivedproduct.html).

The major components of the BiologicallyDerivedProduct data class are comprised of the following components below:
1. Product information
2. Storage information

Comment

ICCBBA support for Biologically Derived Product Class

As identified by FDA/CBER, medical products of human origin are a group of therapeutic products that have unique characteristics due to their human origin.  In particular, the fact that each product is derived from a human donor, and that many different product types can be derived from a single donation event, creates special traceability requirements to support tracking between donor and recipient, and cross-referencing of all products derived from a donor.  Existing traceability systems for synthetic medicines and medical devices do not provide optimal identifiers to support these requirements.  Currently traceability information for these products is captured in hospital blood bank systems, other clinical systems, or product manufacturer systems but is not held in a structured manner in the EHR.  For this reason, ICCBBA strongly supports the creation of a new Class for Biologically Derived product in the USCDI.

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