Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Data Element

Information from the submission form

Biologically Derived Product
Description
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.

Support for the assignment of unique identifiers on BDP

Symmetric Health Solutions response to Comment:  We support the assignment of unique identifiers on biologically derived products and recognize ISBT-128 as a potential standard for these products.   However, there are no regulatory requirements requiring manufacturers of biologics to follow a particular identification standard and no requirements to store data associated with that identifier in a publicly accessible database.  Given our experience with manufacturer variance in identifying these medical products in healthcare settings, we believe that public policy changes to require a defined product identification format are necessary before the standard format would benefit from inclusion in USCDI.

FDA CBER Biologically Derived Product Unique Identifiers

Thank you for your comment. This was referenced in FDA’s April 15, 2021 comment on the main page (https://www.healthit.gov/isa/uscdi-data/biologically-derived-product). We agree that the submission could be further modified to clarify that inclusion of Biologically Derived Product in USCDI would not require the use of a particular identification standard if it is not currently being exchanged by an organization. The current submission references code systems/identifiers (i.e., ISBT-128, RxNorm, and NDC) that are widely used and support a majority of use cases.

Support for “Biologically Derived Product” Data Element

AABB is an international, not-for-profit association representing institutions and individuals involved in transfusion medicine and cellular therapies. The association is committed to “improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide.” AABB works toward this vision by developing and delivering standards, accreditation, and educational programs that focus on optimizing patient and donor care and safety. AABB individual membership includes physicians, nurses, scientists, researchers, administrators, medical technologists, and other health care providers. AABB supports the addition of a Biologically Derived Product data element to the United States Core Data for Interoperability (USCDI) and believes that using the ISBT-128 standard will enhance the nation’s understanding of blood availability and utilization, advance hemovigilance capabilities and improve health outcomes.   A Biologically Derived Product data element would enable providers to uniformly capture the utilization of individual blood components as well as adverse events for hemovigilance. As noted in the FDA’s use case description, the absence of interoperability in this area was particularly problematic during the rollout of COVID-19 convalescent plasma (CCP) and limited the ability of regulators and researchers to perform safety and effectiveness surveillance. The data could be used to assess whether the current supply of specific blood components is adequate to satisfy patient needs and to monitor safety and effectiveness. Additionally, a Biologically Derived Product data element has the potential to inform policies and guide clinical practices early in the course of treatment (e.g., capturing blood group genotyping in chronically transfused patients or patients initiating novel monoclonal therapies known to cause complication in transfusion workups). It would also serve as a tool to help identify non-infectious complications, such as transfusion-associated circulatory overload (TACO), the transfusion-related acute lung injury (TRALI), and transfusion of an incompatible unit of blood. Importantly, interoperability in this area would facilitate the ability of providers to have access to a patient’s transfusion history, regardless of where a previous transfusion occurred. This can help prevent incompatible transfusions, support red blood cell antigen matching, and ultimately improve health outcomes for chronically transfused individuals, such as patients with sickle cell disease. AABB believes that adding a Biologically Derived Product data element to the USCDI is key to strengthening the nation’s blood system, advancing patient safety, and improving health outcomes.

FDA CBER Response to AABB

Thank you for your comment. AABB's use cases reinforce the need for inclusion of the Biologically Derived Product classification and data elements in the USCDI.  

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