For consumers, having quality goods means also having safe goods. A mislabeled product can lead to serious risks just as poor quality can lead to widespread contamination. So how can users ensure safety and quality adheres to rules and regulations?
This can be done by integrating tools that facilitate engagement throughout the process. With electronic Medical Device Reporting (eMDR) built into a Quality and Compliance Management system, reporting becomes seamless.
The U.S. Food and Drug Administration (FDA) mandated eMDR in 2015 to identify critical issues of data quality and integrity associated with reporting serious injuries related to all classes of medical devices. This was one of the FDA’s leading technology wins in its focus on quality innovation. The FDA offered two electronic Medwatch reporting options for medical device companies: the eSubmitter online direct entry Web form, and the automated eMDR interface connecting complaint handling systems to the FDA Medwatch database.
Organizations will benefit from a central entry point of reportable events, lower wait times between submissions, and less chance of human error. Selecting technology that integrates seamlessly with the FDA enhances the system’s overall effectiveness.
Let’s get down to business.
The purpose: MDR regulation provides a mechanism that allows the FDA and requires all device manufacturers to identify and monitor adverse events from issues such as serious injuries to death and certain malfunctions involving medical devices, utilizing risk management tools.
The goal: detect, report, and correct problems in a timely manner, using harmonized codes that improve reporting and analysis such as Medwatch Method Code, Result Code, Conclusion Code, Patient Code, and Device Code.
The requirements: Manufacturers, including foreign manufacturers, of legally marketed medical devices in the United States must:
- Submit reports of MDR reportable events involving all classes of medical devices (I, II, III).
- Develop, maintain, and implement written procedures to identify and evaluate all medical device events.
- Establish and maintain complete files for all complaints concerning medical device events.
- Establish a formally designed unit responsible for receiving, reviewing, and evaluating all product complaints.
Therefore, tools have been developed allowing users to seamlessly and efficiently submit eMDRs to the FDA gateway. Medical device manufacturers can then electronically automate the quality process for a medical device while following quality and FDA compliance standards.
With software, eMDR users can automatically submit reports directly to the FDA’s system. They are also provided with functionality that ensures fewer submission errors by tying the submission process directly into complaint handling software and corrective action software workflows. Here are the benefits:
Collaboration: The concept behind eMDR submission tools is to enhance collaboration between an organization, the FDA, and patients. The FDA’s goal is to provide both an environment for easy and seamless submission of adverse events, and speed up the FDA response to those events. eMDR also enhances the communication process with the FDA and eliminates “crossover emails” by using an immediate receipt and series of acknowledgements that verify data quality and integrity and confirms complete record acceptance in six to 12 minutes. This could take days (or longer) with a manual reporting process.
Cost Reduction: eMDR can also result in cost savings. Automation reduces the need for administrative overhead and traditional communication; it helps to speed up the process and fosters effective event reporting, resulting in immediate interaction with the FDA. Companies can directly upload adverse events—either singular or multiple—with a single click to the FDA.
Record Retention: A major challenge of eMDR forms—they are recorded on paper. Manual processes require a lot of paperwork and usually end up in a filing cabinet or file server, which can take a long time to locate. With eMDR submission, old records can be retrieved with one click, as everything is automated and centrally stored in a data repository. eMDR ensures all necessary documentation is readily available and links acknowledgement to the original submission. This eliminates any confusion over matching receipts, acknowledgements, or events to each submission. The complete transparency and accuracy of correlating data results in an efficient and reliable process. All file attachments and updates are also captured in the same record.
Faster Report Submission: eMDR enables parties to flag submission errors quickly, as opposed to manual and time-consuming correspondences with the FDA. This allows for efficient and real-time responses. Furthermore, eMDR provides a collaborative environment between the organization and FDA to proactively review and correct errors and respond to questions. eMDR allows for significantly reduced response time from the FDA, which is important when dealing with major adverse events where response time is critical.
Faster Data Retrieval: A key advantage of eMDR software within an integrated solution is all related files are centralized in one easily accessible and searchable location. This saves time on sifting through old hard drives, server files, and email chains. Instead, users can quickly pull up documentation. They are can access any data related to the original report, follow-ups/updates, the specific product batch/lot identification information, corrective action requests, change management history, and customer complaint records.
Single Environment for All Adverse Events: eMDR is designed to provide a holistic environment for all regulatory submissions. It acts as a single point of entry to process all electronic submissions in a highly secure environment. This is beneficial because complaints at the organization can be linked directly to the Medwatch form and integrated within the FDA’s gateway.
Within a single environment, organizations can store both internal compliance data and any FDA responses to the original event. This links complaints or adverse events to product lines in external systems such as Customer Relationship Management, Manufacturing Execution System, and Laboratory Information Management Systems, and provides multiple points of data throughout the business.
The FDA eMDR team added a dedicated field to the eMDR process to support the mandated Unique Device Identification regulations for all classes of medical devices to continue improving transparency, harmonization of processes, and to support product traceability. The FDA is in transition to replace the current assigned codes with CI Concept Codes that will assist in the event codes various organizations are adopting as device problem terminology. The CI code is alphanumeric, with the format C##### that uniquely identifies each term in the NCI Thesaurus. Each Patient, Device, and Component term is also assigned an NCI concept code.
eMDR enables companies to benefit from a central point of entry, significantly lower wait time between submissions, and lessens the chance for human error normally accompanying manual processes.
Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com.