Preparing Your Organization for New FDA Requirements and eMDR

December 1, 2014

By Sparta Editorial


In February 2014, the FDA finalized its Electronic Medical Device Reporting Rule that calls for manufacturers and importers to use a very specific electronic format for event reporting to the FDA. This rule will go into effect on August 14, 2015, with two options – using eSubmitter (for low volume) or HL7 (batch or individual XML). One of the biggest challenges that manufacturers face in preparation is to gather the right data into a data management system before the rule is implemented. Until now, many manufacturers were able to just upload files manually to a database on a product by product basis. This new, more stringent rule calls for a more exact form of record keeping that looks to a specific style of formatting alongside documented checks and balances. This is to ensure that when a quality issue has been detected by a server, it is reported in a timely manner.

Different Facilities, a Common Problem

What complicates the issue is that many large companies are data-challenged. Data from a manufacturer may be in one location, while its supplier may have data sitting in another facility. Although these data sets may relate to a common product or common quality issue, they exist in different silos, formats and databases. Bringing it into a common set, even in larger companies, will prove to be a challenge.

It’s not just large manufacturers and suppliers that are isolated in terms of data. Mid-size companies that grew as a result of M&A activities acquisitions may still have data management systems in place that were used prior to acquisition. Rather than consolidate those separate databases together in a unified hub, each enterprise still has its own data set. The new eMDR rule will drive these companies to combine data together into one quality system to report accurately.

Reports must be submitted through the FDA’s Electronic Submissions Gateway (ESG). This is where an EQMS such as TrackWise can help bring separate data sets together for accurate, timely reporting that helps to keep an organization compliant with FDA medical device regulations, as well as prepared in the event of an audit.

TrackWise makes use of a submissions manager that interfaces with FDA compliance software and an eMDR record that gathers the required data from different sources into a single file. By allowing configuration of mandatory fields, this process becomes a seamless part of the workflow by, understanding if a submission has errors and provides the steps needed to correct those errors incrementally prior to allowing submission.  Therefore when the company is ready to submit the report, errors have already been checked.

Errors are inevitable. Without a workflow and system of checks and balances in place, a required piece of data can be missed or not submitted properly. When the ESG gateway sends back an acknowledgement that your report has been received, but certain fields were missing, many companies may not know what the next steps are. An EQMS can help to eliminate errors before they happen, or correct those errors and easily allow you to resubmit in a timely manner. Moreover, an EQMS can keep track of FDA changes and conformance policies through a data mapping component of the submission tool on the developer’s side.

How EQMS Works with eMDR

EQMS eliminates the need for manual checks into reporting and “babysitting” on the part of the Regulatory Affairs team within an organization. When there are thousands of reports to submit, the manual process of combing through submissions for errors can be both time-consuming and resource intensive.  It is important to make sure that submissions are not only completed correctly, but that they are done effectively.

EQMS can help to check content for errors and move it into the CDRH medical device registration and inspections database to check if valid information is present. If there is a failure or lapse in the information, an error code is generated and notifications are submitted to the proper personnel to correct the information and keep the process / cycle moving smoothly. When the final report is submitted, an acknowledgement is generated. That acknowledgement (ack3) is the last step of confirmation that the process has been completed and no further input is required.

In the case of an adverse event, depending upon its severity, manufacturers have between 5 and 30 days to report the event to the FDA. However, some events with no immediate dire consequences may merit voluntary reporting instead. In these instances, the FDA encourages manufacturers to evaluate the issue to see if it is reportable, based on information and findings.

Until recently, this has been a common issue for many companies and medical device manufacturers. An EQMS can help to determine whether a voluntary report is warranted, as well as the severity of an event. Moreover, it can also help with gathering the information to submit in a timely manner when timing is crucial.

Decision trees, when used as part of the workflow and based on the answers provided, help organizations to determine the type of adverse event,  as well as the deadline to submit a report. Decision trees encourage consistency of process, help separate subjectivity and objectivity and have the ability to take action  in that anyone within the organization can jump in and help to resolve the issue.

More and more businesses are looking to the risk-based analysis model of dealing with known adverse events and potential adverse events. The decision tree helps you to determine the course of action, but it’s also possible to look at trends to stay proactive in terms of business and product safety. What makes this model so attractive to many companies is that it promotes a stable, repeatable and consistent process.

In terms of reporting adverse events to the FDA, gathering the information to submit in a timely manner comes down to workflow. Once the intake of a complaint has been submitted, the company moves to the triage phase before consulting the decision tree and answering the questions that surround the event.

At present, the FDA is not prescriptive on voluntary submissions. Instead, the regulatory body has left it to each individual company to determine their course of action based on internal processes, SOPs, and what a company wants to or does not want to report. However, whether a company chooses to submit a voluntary report, it’s always to their benefit to be able to address any internal issues before they become an adverse event leading to patient safety, product reliability and intended use issues.

Learn more about what medical device manufacturers need to do to become more compliant with the eMDR mandate. Download our whitepaper, eMDR: Issues Facing Device Manufacturers as FDA Moves Closer to Mandating Electronic Reporting.

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