FDA regulations require companies to immediately notify the agency when a company receives complaints of device malfunctions, serious injuries, or deaths associated with its medical devices. These adverse events are reported on what's called the Medwatch form, or 3500a. Quality-management software such as Trackwise from Sparta Systems Inc., Holmdel, N.J., (www.sparta-systems.com) lets device manufacturers manage complaints and investigations, assess potential adverse events for safety and risk problems, while complying with FDA requirements. “Essentially, users take data that is probably in an Excel spreadsheet, import it into the 3500a form, print it, and send it to the FDA,” says Mike Jovanis, vice president of product management at Sparta. “Then someone at the FDA gets the paper form and keys it back into an electronic database. It's not the most efficient system.”

An electronic medical-device reporting (eMDR) project from the FDA provides for electronic data submission and processing of adverse event reports. The eMDR program accepts electronic reports two ways, one for low volume and on for high-volume users. The CDRH eSubmitter (CeSub), a free downloadable application, allows filling in and submitting reports one at a time. The Health Level 7 individual case safety report (ICSR) process defines a file format (schema) that permits electronic filing either individually or as a batch for high-volumes. The FDA says when the system is mandatory and used by manufacturers, it will reduce data entry costs by over 50%.

eMDR uses a electronic-submission gateway (ESG) as an agency-wide entry point for all electronic submissions. The process through the ESG (www.fda.gov/esg/) includes the receipt, acknowledgement of receipt to the sender, routing, and notification to a receiving FDA center or office of the delivery of an electronic submission.

The FDA does not yet require medical-device companies to submit eMDRs. “But there are rumors it will be mandated,” says Jovanis. And if they do mandate the approach, they typically give the industry a considerable lead time to implement it.

From the user's perspective, there is little reporting difference. “When you're filling out the form, you don't notice whether the report will be printed or submitted electronically. Additional work comes from mapping that form into the eMDR output,” says Jovanis. “I think the challenge is embracing a new way of doing things. Whenever you have something new and different, there will be skeptics.”

So far, adoption of the electronic system has been limited. “It's not that there's a great deal of difficulty in implementing the processes, but most device manufacturers need a compelling force to adopt something new,” says Jovanis. “Unless someone is telling them to do it, only leading edge companies will take initiative to implement it on their own.”

That being said, Jovanis has noticed a recent increase in inquiries, such as proposals for implementation. “For customers who have shown an interest we build systems into their software so they can easily migrate from the paper 3500a to its electronic version,” he says. There are similarities in the fields on the forms in both versions, so as a device company develops its next generation complaint system, it would be a seamless process to switch from paper to electronic forms. “We make sure anyone purchasing new software is aware of the option. We always encourage the most current and efficient way of reporting,” he says.

There's obviously some upfront effort and cost into putting eMDR into practice. But the whole process will be more efficient. “So if you look at the total cost of ownership, there's savings over time, despite an initial investment,” Jovanis adds. “I hope manufacturers realize this is a better way of reporting, both from the user perspective and on the FDA's side.”

To follow updates on eMDR regulations, visit www.fda.gov/cdrh/emdr/.