SOFTWARE >>
Getting a Grip on
Electronic MDRs
Technologies available today are enabling medtech engineers to
plan for the electronic regulatory reporting future.
Peter Hyman
At the 2007 annual meeting of the Regulatory Affairs Professionals Society (RAPS), the former head
of FDA’s postmarket management transformation
group, Don St. Pierre, updated attendees about the agency’s
status with regard to electronic medical device reporting
(eMDR). Encouraging device manufacturers to begin using
electronic reporting systems, St. Pierre quipped, “You can
do it now, or you can wait for it to be done to you.”
CDRH is actively working to complete a rules document
that will outline dates and requirements for medical device
manufacturers to go fully electronic with their adverse-event reports. In short, the time to understand and implement eMDR has arrived.
FDA’s Transition
A major force driving FDA to adopt electronic reporting is the sheer volume of reports received by the agency,
making electronic reporting a must in order to protect the
public welfare.
By 2000, FDA was receiving 100,000 paper reports per
year. Over the next six years, the volume of reports that the
agency received more than doubled to 220,000. In some
months, FDA has received more than 20,000 MedWatch
form 3500A device reports, each of which must be manually rekeyed into an online database. This method of transferring paper 3500A device reports is both costly and prone
to error. For the report sender, manual entry and transmission of paper 3500A forms is also expensive and prone to
error—especially when report updates are required.
As volume has increased, more reports have been delayed, filed late, or not filed at all. As a result, it became increasingly clear that in order for the agency to meet its legal
obligation to track adverse events pertaining to medical
devices, the entire MDR process needed to be overhauled.
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An overview of the eMDR process.
In January 2006, FDA convened a working group—the
Postmarket Transformation Leadership Team (PTLT)—to
address these issues. The team’s mandate was to conduct
a top-to-bottom review of CDRH and to make organizational and other recommendations that would improve the
device center’s processes, data analysis, and compliance.
The top recommendation in the PTLT summary report
was to institute electronic reporting and to make electronic
reporting of adverse-event data mandatory.1
From Med Watch to eMDR
Making electronic reporting a reality also creates new
challenges. To automate a process, standards and rules
must be written, agreed to, and applied (see Table I). The
