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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

eMDR utilizes the Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events (MDRs). The low volume reporting option using FDA eSubmitter provides users an effortless way to generate the HL7 ICSR files – the software is programmed so once entry of the MDR information is completed, an ICSR compliant xml file is generated.

For the high volume reporting option, users can extract data from their adverse event databases and generate MDRs as XML files, formatted to the HL7 ICSR Release 1 specification. This was designed so once the initial effort and systems are set up, users can generate electronic MDRs to submit either as a batch or individually.

Health Level Seven: Standards Development Organization

HL7 is a not-for-profit volunteer organization. Its members all assist in standards development and include providers, vendors, payers, consultants, government groups, pharmaceutical groups, and others who have an interest in the development and advancement of clinical and administrative standards for healthcare. HL7 is one of several Standards Development Organizations (SDOs) accredited by the American National Standards Institute (ANSI) that operate in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as clinical data, pharmacy, medical devices, imaging, or insurance (claims processing) transactions. HL7’s domain is clinical and administrative data.

Like all ANSI-accredited SDOs, HL7 adheres to a strict and well-defined set of operating procedures that ensure consensus, openness, and balance of interest. A frequent misconception about HL7 is that it develops software. In reality, HL7 develops specifications—the most widely used being a messaging standard that enables disparate healthcare applications to exchange key sets of clinical and administrative data.

HL7’s mission is to provide messaging standards for the exchange, management, and integration of data that supports clinical patient care and the management, delivery, and evaluation of healthcare services. Specifically, the organization works to create flexible, cost-effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems.

ICSR: Individual Case Safety Report

The HL7 ICSR message Release 1 (Normative Edition 2005) supports the exchange of data and other safety reporting requirements between various public health and patient safety organizations—specifically, reporting of adverse events or product problems associated with the use of drugs, therapeutic biologics, vaccines, and devices. Currently, work is under way to expand the scope of the message to support other types of products such as food, dietary supplements, cosmetics, or veterinary products and services.

The ICSR message is specifically designed to support individual case safety reports and does not support population-based case reporting for disease surveillance or outbreak events. The message can support international safety reporting between public health organizations.

This implementation guide refers to portions of the ICSR Release 1 message that capture the information needed to report a device adverse event.

ICSR and eMDR

The parts of the ICSR implemented via eMDR map to the device reporting requirement sections of the current MedWatch Form 3500A. The CDRH files include a “schema” or “file format” to utilize for submission of MDR data as an ICSR message. Reporters can use the specified format to submit MDR data.

Technical specifications for implementation of ICSR for the eMDR project are provided in a package of files. To download the files, please go to Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files.

VOCABULARY

One of the key features of HL7 version 3 is the use of a standard vocabulary as part of the message. Members of the CDRH ICSR team worked with terminology experts from the National Cancer Institute Enterprise Vocabulary Service (NCI EVS) to identify the majority of vocabulary terms for MDRs. These terms will be stored in the NCI Thesaurus—an open-content vocabulary built for interpretation and access by both people and computers. Concepts such as event type have an alphanumeric code that corresponds to Death, Serious Injury, and Malfunction. The receiving system then accesses the vocabulary service information—in this case the NCI EVS—to translate it from the code to the appropriate event type. The package of files provided above contain the vocabulary information needed for the project.