FDA Proposes Mandatory Electronic Safety Reporting

NEWS TRENDS

In a move that industry has expected for some time, FDA announced in late August a proposal to require all postmarket safety data for medical devices to be submitted electronically.

Part of a larger shift that reflects the agency's quest for more efficient reporting, FDA issued a similar proposed rule that applies to drug and biologic product adverse-event reports.
“Both proposed rules will improve the agency's ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, PhD, director of CDRH's postmarket surveillance division. “Information obtained from these reports may be critical to future action that improves patient safety.”
In a Federal Register notice dated August 21, 2009, FDA cited the following benefits for transitioning to electronic-only submissions:
•Reduce industry's time and costs associated with transcribing data from internal data management systems to paper and mailing the paper reports to the agency.• Eliminate the agency's transcription errors, time, and costs associated with receiving paper reports and transcribing data to electronic format for review and analysis.• Expedite the agency's access to safety information in a format that would support more efficient and comprehensive data analyses and reviews.•Enhance the agency's ability to rapidly communicate information about suspected problems to the medical device industry, healthcare providers, consumers, and other government agencies.
The notice also says that setting up new electronic systems is expected to cost the industry $58 million–$80 million. The systems will cost another $8.5 million per year to maintain. However, FDA says the rule would save industry $3.2 million annually and save the agency about $1.25 million per year in data entry costs.
Medical device manufacturers have two options for submitting electronic medical device reports (eMDRs). For small manufacturers with a limited number of reports, FDA recommends eSub. The program runs on free software available from the agency's Web site. FDA says that manufacturers with high volumes of reports may prefer to use a batch submission protocol, which is based on a well-known informatics standard.
Last year CDRH received 588,161 adverse-event reports, and most were on paper. Manufacturers have been able to submit eMDRs for more than two years, but the method has been slow to catch on. One possible reason is that electronic submissions simply aren't required. Another reason is the general uncertainty surrounding a move from traditional paper-based systems.
“A lot of medical device companies are more legacy in their approach toward technology,” says Mike Jovanis, vice president of product management at Sparta Systems (Holmdel, NJ), a company that offers enterprise quality management software. “They aren't using EDI [electronic data interchange] to submit data over the Internet. These are new concepts that are a departure from their comfortable paper world.”
But the paper forms appear inefficient for both companies and FDA. For example, some manufacturers submit MDRs via paper forms shipped to FDA. Or they produce the forms electronically and then print and mail them.
“Once [manufacturers] send them to FDA, FDA has a room full of people that manually keys those [forms] back into a software system,” Jovanis says. “The whole process from one end to the other is very manual, resource intensive, and error-prone.”
The proposed rule for medical devices does not apply to voluntarily submitted reports. Also, manufacturers need to obtain an electronic certificate to use the FDA Electronic Submissions Gateway.
For information on how to prepare and send eMDRs, visit www.fda.gov/forindustry/fdaesubmitter/ucm107903.htm.
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