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eMDR process included mapping each of the fields on the 3500A device report form to a data field. Moreover, a standard for storing the mapped fields had to be developed.

To accomplish this task, FDA turned to the Health Level 7 organization (HL7; Ann Arbor, MI). HL7 is a not-for-profit group composed of volunteers from industry, government, consultants, and others who have an interest in advancing clinical and administrative standards for healthcare. HL7 does not produce any software, hardware, or policy—it develops specifications. And, in the case of eMDR, these included a messaging standard for the transmission and acknowledgment of individual case safety reports (ICSRs).

Electronic ICSRs are data structures that support the exchange of adverse-event data pertaining to drugs, devices, vaccines, and therapeutic biologics. The structures are versatile, in that different types of adverse events can be transmitted. However, each type of ICSR is governed by very strict rules that control what data can be transmitted, how the data must be ordered and organized, and what type of file format must be used for transmission. The file format used for eMDR is extensible markup language (XML), and the governing documents for XML files are schema files called document type definitions.²

HL7’s scope of influence was the format of eMDR transmission, not the mode or method of transmission. In

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late 2006, FDA opened the electronic submissions gateway (ESG; www.fda.gov/esg), a centralized conduit for receiving and routing all e-reports being sent to the agency or any of its centers or offices. ³ It is the report sender’s responsibility to properly configure the electronic data interchange (EDI) software that it will use to send eMDRs.

In August 2007, with the format for eMDR set and the gateway for receiving reports established, FDA began accepting eMDR reports. To encourage use of eMDRs, FDA published free CDRH electronic submissions software, CeSub, which is designed for low-volume reporters. CeSub enables reporters to input single reports and transmit them to CDRH immediately without the need for EDI software.

eMDR Use and Acceptance

According to FDA statistics, only one company is currently making use of the ESG, and only seven are using the

CeSub low-volume submissions tool. The lone high-volume submitter came online in March 2008, accounting for a significant increase in the number of eMDRs received by the agency each month (see Table II).

There are several reasons why device manufacturers have so far failed to make greater use of FDA’s new eMDR capabilities. First—and probably most important—is the simple fact that use of the system is not yet required. In 2007, there was speculation that FDA would begin requiring eMDR submissions sometime during 2008. But this timetable has since been pushed back, and now it is unknown when the agency will mandate eMDR submissions.

A second reason that industry has been slow to move toward eMDR submissions has to do with the complexity and uncertainty involved in shifting from traditional paper-based systems. Designing software applications that can create eMDR-approved outputs necessitates a foundation in electronic reporting knowledge and a level of comfort with the requisite technologies.

A third reason involves the not-so-small matter of acknowledgments (ACKs) and negative acknowledgments (NAKs), which are cornerstones of all electronic reporting systems. In an automated environment, ACKs and NAKs are essential for proper execution of data transfers, retries, process flow, and error handling. Many systems provide acknowledgments in the form of XML files with specific formats and known element definitions.

For proper functioning, the eMDR system also depends on having a process for handling acknowledgments. It is essential for the sender to know that its transmission has been received and that the transmitted data have been validated. To accomplish this, the current eMDR platform incorporates three levels of acknowledgment, as follows:

• The ESG sends an XML-formatted ACK or NAK that indicates whether the transmission was valid.

• The ESG sends an XML-formatted ACK or NAK to inform the sender that its data have been forwarded to CDRH.

• CDRH sends an HTML document indicating whether the sender’s reports were valid.

It is the format of the third acknowledgment that has slowed software vendors and users from being able to fully transition to eMDR. Instead of a structured XML file, this acknowledgment is an HTML-formatted document (i.e., a Web page) that lists each report submitted by the sender,