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U.S. Department of Health and Human Services

Medical Devices

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Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files

CDRH staff has created a packet of files to assist in implementation of the HL7-ICSR message.

The following provides a description of each of these files. Certain individual files are available outside of the packet, and are linked to from their file name.

File NameContents
ReadMeFirst Release.xls

There are two sheets in this file. The mm.dd.yyyy in the file name indicates the date of the most recent update.

ReadMeFirst Sheet – Provides an overview of all the files in the package

ChangeLog Sheet – Documents all changes made to the files in the package with the exception of the HL7Medwatch.xls file, which has its own changeLog sheet for ease of use

HL7Medwatch.xls

3500A_HL7 Sheet – Lists each MedWatch element, current instructions, HL7 pointers, and field lengths

Vocabulary Sheet – Lists all the vocabulary items required by the ICSR message

x_path Sheet – Used to find the particular nodes in the XML document that are used in the 3500A form

ICSRDiagrams.xlsICSR diagrams for CDRH implementation
voc.xsdSchema file used for vocabulary validation. Note that this file is also available on –
Con.xsdUnpopulated ICSR schema for implementation; consolidated XML schema file to which the HL7 message will be validated; includes InfrastructureRoot.xsd.
mappingInstance.xml

Example MDR instance using our xml schema. Your MDR submission should look similar to this. This file is a sample HL7 message validated against the Con061019.xsd schema file.

When creating your own messages, the data may change from one message to the next, but the structure and meta data should stay the same.

3500AforMappingInstance.pdfThe 3500a representation of the CDRH ICSR mapping instance file (see mappinginstance.xml).
sample_attachment.pdfThis file provides the sample document used as an attachment to the mappingInstance.xml.
datatypes.xsd, datatypes-base.xsdCommon files used to support datatype structures; schema file that defines the representation of HL7 V3 data types in XML; includes Datatypes-base.xsd. Note that there are some sections of these files that are not used by the ICSR and are commented out.
infrastructureRoot.xsdFor future use only; this schema file includes datatypes.xsd and voc.xsd and is also used to validate the HL7 message.
narrativeBlock.xsdFor future use only; this schema is for use with HL7 Clinical Document Architecture (CDA) standard for electronic forms.
nciuserguideicsr.docFor future use only; provides a user guide on how to access the vocabulary used in the ICSR, including definitions and components and how to download those terms into an application.
Ack3Schema.xsdSchema document for Acknowledgment 3 in xml format
ICSRImplTechSpecv1_1Release.docTechnical specifications to be used to implement a high volume submitting solution.