Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
We’ve already covered the impact of recent eMDR regulation updates on the industry (the overall benefits for patients and the health care community as a whole) in a previous post. Now let’s take a closer look at why medical device manufacturers may not want to delay their transition to electronic medical device reporting. August of 2015 may seem far away to some, but manufacturers should get moving now to realize these benefits of eMDR sooner:
1. Meet deadlines and reduce risk of FDA fines.
When submitting electronic Medical Device Reports, there are no delays associated with mailing or overnighting MedWatch reports. This process happens more quickly, with a receipt typically sent within a few hours to let you know the file has been received (acknowledgement 1). In fact, all three acknowledgements should be received within a short window (typically within 24 hours). If a med device manufacturer were to submit on day three for a 5-day MedWatch report, they would still have time to resubmit their report if the content is rejected as invalid on the third acknowledgement. Further, the time savings can be reallocated to respond more quickly to any FDA requests for information that was not included in the initial MedWatch report. This adds up to a reduced risk of missing any reporting deadlines, even if a follow-up action is required from one of your eMDRs.
2. Cut costs associated with managing paper MedWatch forms.
eMDR submissions eliminate the high costs of physically sending files to the FDA. This eradicates expenses associated with creating and shipping reports and gives you speedy access to your acknowledgement files. Therefore, med device manufacturers will no longer need to maintain the resources to anticipate and manage paper acknowledgements for their required follow-up action(s).
3. Mistake-proof adverse event reporting.
Manufacturers need to pass their adverse event data to the FDA’s CDRH quickly and efficiently to remain in compliance. By handling the process electronically, CDRH systems can automatically validate the format and completeness of the eMDR XML file. Without the electronic process, potential errors take longer to discover, which factors into the timeline of your regulatory reporting deadlines. Your goal should always be to have everything correct the first time, and an electronic process helps meet this goal by reducing the risk of human errors, such as mis-keying data or entering data in the wrong data field of the MedWatch form.
A Streamlined eMDR Process with Complaint Management
For manufacturers, leveraging automation and the benefits of a sophisticated complaint management system helps to further validate the reported adverse event details before they reach the FDA. A complaint management solution can cross-reference CDRH codes to mistake-proof the eMDR file content beforehand. With such a solution in place, a medical device manufacturer can have its adverse event data (content) validated, automatically create the eMDR file in the correct FDA-compliant format, and pass it over to CDRH where the file (format) will be validated once it successfully loads into the database.
The Future of eMDR
August of 2015 may still be a year away, but the reality is that more than 70% of adverse events are already being reported electronically. This significant progress toward 100% electronic Medical Device Report submissions is likely due to the benefits of eliminating the costs and delays of paper processes, and the need for organizations to streamline their processes to meet regulations and focus on other critical business areas. The future brings a more cohesive system for the FDA, unifying formats and reporting data among various FDA centers, including CDER, CBER, and CDRH. With quicker access to adverse event data, the FDA can better achieve its goals to track and identify events in order to improve patient safety. Additionally, the FDA is working toward retiring its MAUDE (Manufacturer and User Facility Device Experience) database for MedWatch reports in favor of a system that better meets the needs of its multiple centers.
Please stay tuned to the Pilgrim blog for more on eMDR, complaint management, and other related topics.
IQVIA Quality Compliance
Learn how IQVIA can help you advance your quality maturity by supporting your people, processes and technology.