February 2008

Status Report:
eMDR (electronic medical device reporting) and the FDA

The FDA’s bold electronic Medical Device Reporting (eMDR) project is off to a solid start and should begin to really take off in early 2008, says FDA project leader Indira Konduri with the Center for Devices and Radiological Health (CDRH).

Collection of adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements of the Food Drug and Cosmetics Act (FD&C Act) (21 USC 360i), and comes primarily from manufacturers, user facilities, importers and voluntary reporters. In 2005, CDRH received over 200,000 reports, which included approximately 90,000 initial and several thousand supplemental, follow-up and summary medical device adverse event reports. Currently these reports are entered manually by data entry contractors.

The process is slow at both ends. Device companies are frustrated with the bottle-neck, and the budget-strapped FDA is frustrated because handling the process electronically would help ease its manpower shortage at a time when it is under fire for food and other recall issues from a more aggressive Democrat-led U.S. Congress.

Mandate Coming?
While the agency won’t say that it is going to mandate eMDR anytime soon, experts outside the agency say it’s only a matter of time – especially with larger device manufacturers. And at least one FDA advisory committee has called for mandatory eMDR adoption (see below under Background).

“eMDR makes life easier for the FDA and improves efficiency for everyone, so I think the agency will mandate it within two years,” an attorney who works closely with FDA officials told us in October 2007.

The FDA’s stated goal for the eMDR project is to develop the capability to allow for electronic data entry and processing of medical device adverse event reports.

Beginning in early 2008 Konduri said she expects a “spike” in interest for both low and high volume submitters. She’s basing that in part on the fact that the agency is getting more and more inquiry calls from device makers since Summer 07.

Device firms are seeing the advantages for them in leveraging eMDR, but their understanding and appreciation of those advantages is coming along more slowly than some experts expected.

As a leading device industry attorney told us in October 2007, “The device industry is always viewed as more cutting edge versus the drug industry when it comes to technology, but they’ve been kind of slow to see the advantages of eMDR,” he said.

Part of that sluggish pace, the device attorney suggested, could come from the fact that the device industry is generally comprised of smaller companies than the drug industry.

eMDR will utilize the FDA Gateway, an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The Gateway will authenticate and validate electronic submissions and route it to CDRH. Please visit http://www.fda.gov/esg/ to register as a trading partner. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the website.

eMDR is still a pilot project, and can only accommodate a limited number of participants via each mode of receipt, the FDA said.

Background
In November 2006 the FDA announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.

"Many of today's medical devices are smaller and more complex than ever, offering new medical opportunities that have benefited literally millions of people," said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA. "But this technical sophistication sometimes means that the margin for error with device manufacturing shrinks and so we need to be working even harder, after devices and engineering changes are approved, to monitor for potential safety problems."

In 2005, CDRH completed a comprehensive assessment of the tools used to monitor the safety of medical devices after the agency approves them for marketing. In January 2006, the agency formed a Postmarket Transformation Leadership Team to develop an action plan focusing on four main areas: enhancing the center's culture of collaboration; developing world class data systems; enhancing risk/benefit communication efforts; and collaborating on improved enforcement strategies and outcomes.

"The agency is committed to improving its medical device safety program and ensuring that medical devices and radiation-emitting products remain safe and effective once they are in the hands of health professionals and the public," said Daniel Schultz, M.D., Director, CDRH. "Postmarket systems that enable constant learning and feedback not only help support best medical practices to ensure safe use of devices with maximum effectiveness but they also spur continued innovation. This plan is a major step in that direction."

Advisory Team Touts eMDR
The November 2006 Postmarket Transformation Leadership Team report outlines actions to transform the postmarket program. These efforts will increase the agency's ability to identify, analyze, and act on the risks that may be posed by the thousands of devices used by health professionals and consumers every day.

In addition to calling for mandating eMDR usage, the action items include the following:

• creating a cross-cutting organizational structure within CDRH to better integrate premarket, postmarket and enforcement efforts;
• developing internal performance measurements to track the center's handling of postmarket issues, such as recalls;
• pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime;
• proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system);
• increasing the use of Medical Product Safety Device Network (MedSun) programs—a network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide "real time" data on signals and safety problems;
• enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news; and
• increasing the coordination among the agency's compliance and enforcement programs.

Conclusion
Whether or not the FDA formally mandates eMDR, it is clear that the benefits of it are there. For device companies it can speed their products to market, and help keep those products safe and effective.