The emdr Requirement. Best Practices for Enhancing Collaboration with the FDA

Transcription

1 The emdr Requirement Best Practices for Enhancing Collaboration with the FDA

2 Executive Summary The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries encompassed within the food and drug arena are produced safely and effectively. The FDA receives more than 400,000 reports on adverse events each year. In order to give each of these events the individual attention necessary to mitigate risk, the FDA must be properly informed by an organization of all reportable adverse events and in an industry that produces devices that directly affect human lives, proper collaboration with the FDA is crucial. As market demand increases the need for quick product cycles and the distribution of regulated products, the ability to react quickly to an adverse event must be considered. This trend has led to an initiative within the FDA to increase the ability to collaborate and communicate more quickly with reporting organizations. This is where the electronic Medical Device Reporting (emdr) initiative comes in. The FDA originally provided medical device reporting through the use of MedWatch forms 3500 and 3500A. The emdr initiative began as a manual process and has recently evolved into a fully automated Web-based process, which enables companies to submit both voluntary and mandatory reports in one central location through the FDA s Electronic Submissions Gateway. This was put into place because the FDA believed one point-of-entry would better enable organizations to submit information. 1 This paper will give an overview of the FDA s emdr program as well as the benefits and best practices of using the FDA s Gateway. The Evolution of emdr The FDA recognized a need for a centralized system with the ability to submit both voluntary and mandatory reporting forms due to the large amount of forms they receive that must be manually processed. The current paper processes proved to be time-consuming and difficult to reconcile data inconsistency. In addition, the FDA is resource-strained in updating these manual forms to keep pace with the changing post-market safety standards. 2 In order to effectively meet the needs of the consumers in regulated industries and to ensure product safety, it has become necessary to have a system in place that can seamlessly submit information to the FDA without the use of paper-based methods. In response to this need, the emdr program evolved, which follows the High Level 7 Individual Case Safety Report (HL7 ICSR) 3 standard for receiving adverse events. emdr integrates the 3500 and 3500A forms into the FDA s Adverse Event Reporting (FAERS) database, allowing the FDA to more efficiently analyze and identify safety reports. 2 emdr automates the process of submitting medical device reports (MDR s) by providing electronic submission through the FDA s Gateway. Let s take a look into the emdr process and its evolution. Once a product hits the shelves, an organization begins receiving feedback, some of which will be complaints complaints from consumers, from institutions using their devices, even complaints directly from the patients themselves. They will then need to determine which events warrant mandatory FDA notification. These will be items that pose critical risk to the patient or consumer. To ensure the timely submittal of reports, the FDA currently offers two options for reporting on their website. The first, for voluntary reporting or for events that do not carry significant consequence, is called the MedWatch 3500 and allows for the submission of individual reports through the FDA Gateway s Web interface. The second, for mandatory reporting of adverse events which carry significant consequences, is called the Med- Watch 3500A and is also available on the FDA website, however, it cannot be submitted online like the FDA s earlier processes, it can only be faxed or mailed to the FDA. On average, the communication time from a fax submittal to the FDA and an FDA acknowledgement is 5 to 7 days.

3 Using emdr, this process of reporting takes 6 to 12 minutes, significantly reducing the wait time in between submission and FDA acknowledgement. The FDA s emdr initiative also has the Rational Questionnaire built in, which is a data collection tool that helps the user determine the data that needs to be included for each individual report. Implementing emdr: Build or Buy? emdr is a method of reporting that provides an electronic Gateway from an organization s internal Quality and Compliance Management System to the FDA s database. To be effective, the emdr form is best integrated directly into an organization s Quality and Compliance Management Software System. Like any software solution, emdr requires a certain degree of integration to effectively implement into an organization s existing Quality and Compliance Management solution. The dilemma that an organization might be faced with when deciding on a solution is, Do we build the solution, or do we buy? This decision is usually dependant on whether their currently implemented Quality and Compliance Management System is the most cost effective and convenient option for the organization. Both are sound options but both have their benefits and pitfalls. The key is for an organization to select the option best suited for their business needs. Building a software solution around emdr often requires significant development resources. For example, a custom-developed emdr solution that integrates with existing business systems can cost upwards of $200K to $350K to implement. These developed systems are often hardcoded and offer little flexibility. So, if business processes change 6 to12 months down the line, an organization must put forth more development resources to adapt to the change. While this option offers a true custom solution, the development overhead can often outweigh the benefit. emdr Submissions Are on the Rise If an organization chooses to buy their emdr integration solution, there are providers in the market that offer Quality and Compliance Management solutions that have the emdr integration package built into the application, and, through use of configurations, allows adjustments to be made to the business rules, forms, and workflow to meet individual business needs. The benefit behind this out-of-the box solution is that organizations are able to focus their resources on the usage of the tool, rather than on its development. This allows many organizations to have the same flexibility offered in a custom solution, but without the development time and resources that usually make up a majority of the cost. An organization should look for solutions that are robust enough to accomplish the Quality and Compliance processes needed for their unique business needs, with the regulatory reporting package built-in. The system should also be configurable, so that changes made to the business processes can be done seamlessly and without programming or development. Benefits to Using emdr Collaboration: The entire concept behind the emdr electronic submission tool is to enhance the collaboration between an organization and the FDA. The FDA s goal is to not only provide an environment for easy and seamless submission of adverse events, but to also speed up the time in which the FDA is able to respond to events. emdr also enhances the communication process with the FDA and eliminates or reduces crossover s. Those using emdr will benefit from an immediate receipt and acknowledgement within 6 to12 minutes as opposed to days or longer with the manual reporting process. Cost Reduction: Use of emdr can also result in cost savings. It eliminates the need for the administrative overhead incurred from traditional communication. Through the use of batch event reporting, and immediate interaction with the FDA, companies can literally upload multiple adverse events in a single click to the FDA, saving time and resources in the process. Record Retention: One of the major challenges with the traditional emdr forms is that they are recorded on paper. These manual processes unfortunately require a lot of paperwork and usually end up in a filing cabinet or file server and can take a long time to even locate. With the emdr submission, old records can be retrieved at the click of a button, as everything is automated and centrally stored in a data repository. emdr ensures that all necessary documentation is available at the click of a button and automatically links the acknowledgement to the original submission,

4 eliminating any confusion as to which receipts/acknowledgements belong with which submissions. This provides complete transparency and accuracy of correlating data and results in an efficient and reliable process. Responsiveness: emdr enables the ability for involved parties to flag submission errors quickly, as opposed to the more manual and time-consuming correspondences to and from the FDA. This allows for the efficient and real-time response to all events from the FDA. Furthermore, emdr provides a collaborative environment between the organization and FDA to proactively review and correct errors and respond to questions. In the case of major adverse events, time is a critical factor in responding to the market, and emdr allows for significantly reduced response time from the FDA. Single Environment for all Adverse Events: Technology is all about the consolidation of systems and providing a comprehensive, enterprise method for storing data. Much like any business systems integration, emdr is designed to provide a holistic environment for all regulatory submissions. emdr also acts as a single point-of-entry for processing all electronic submissions in a highly secure environment. This is beneficial because complaints at the organization can be directly linked to a MedWatch form, and integrated with the FDA s Gateway. Within a single environment, organizations can store not only their internal compliance data, but also store any FDA responses to the original event. Complaints or adverse event data can also be linked to product lines in external systems such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), and Laboratory Information Management System (LIMS), providing multiple points of data throughout the business. A Best-Practice Approach for Implementing emdr Like any software implementation, there are always challenges to ensure the software is designed to meet specific business needs. emdr is no exception, but with careful consideration, steps can be taken to ensure that implementation of emdr is smooth, seamless, and completely meets business needs. The following are best practices to take into consideration before implementing an electronic reporting system. Identify the submission tool that best meets organizational needs: There are currently two options available for an organization to submit MDRs electronically through emdr or the Center for Devices and Radiological Health e submitter (CeSub), which was offered by the FDA to encourage the use of electronic medical device reporting. CeSub is best suited for smaller organizations who do not send out reports in batch and whose submissions do not exceed 50 each month, whereas emdr requires integration with an existing Compliance Management system and is designed for batch submissions, or submissions that exceed 50 per month. An organization should weigh the costs versus the benefits of implementing either CeSub or utilizing the Electronic Gateway to determine which tool is best suited for their needs. Select technology that will integrate with the FDA: If an organization s needs include integrating emdr with their existing Compliance Management system, the most effective solution is to implement a tool that incorporates emdr, integrated with an automated Quality and Compliance Management application (QMS). Below are just a few of the QMS functions that can be integrated with emdr, enhancing the overall effectiveness of the system. Complaint Handling: Through the use of a QMS Complaint Handling module, complaints are filtered through the QMS and then integrated with emdr, ensuring a well-rounded process. Complaint Handling applications manage the investigation and resolution of customer complaints or adverse events in compliance to FDA guidelines. A system that can record all complaints made by customers/patients and archive these records is ideal and also necessary the FDA mandates that any record of an adverse event must be kept a minimum of 2 years. Decision Trees: When recording an adverse event, organizations must determine whether the event is reportable to the FDA. MDRs often include Decision Trees that aid in the decision making process. QMS solutions that integrate Decision Tree technology into their Complaint system are able to automate and streamline the Decision Tree process, and can automatically trigger an emdr form based on the responses to the MDR Decision Tree. Quantitative Risk Assessment: Another benefit that is offered by leading QMS solutions is the concept of Quantitative Risk Assessment. When determining whether an adverse event is reportable to the FDA, it is important to weigh the potential risks associated with the event. Quantitative Risk Assessment tools aid in the decision-making process in determining the overall impact of the event, and whether the event is reportable. CAPA: Another QMS function that can be integrated with emdr is Corrective and Preventive Action (CAPA). The CAPA

5 function generates a corrective action request that routes through review, root cause, corrective action taken, and verification stages, ensuring proper actions when dealing with a defective product. This software should also have the ability to process multiple complaint reports in a single batch and submit them to the FDA, providing an effective mechanism for submitting a large number of complaints, and tracking the status of all events in the system. Select a tool that has the ability to record and review data: In the event of an FDA audit, the auditor will need to see the submission history in legible report format, not in raw data. Choose a tool with the ability to convert documents into a viewable format such as PDF. PDF can also be used in the event of system malfunction, and can be sent directly to the FDA if needed. Test the System: Before sending out actual adverse event reports, the FDA requires that a test run be conducted through the FDA Gateway by setting up a test account. This is necessary to ensure that the system, whether built or bought, is running seamlessly. The Future of emdr Many Life Sciences organizations continue to use manual reporting processes and have not implemented emdr, but more and more organizations are now recognizing a need for it. Although many Life Science professionals now see the value, they are not yet implementing it because it is currently not required; however, the FDA is planning a deadline for mandatory implementation in the near future. Once emdr has been made mandatory, the FDA will benefit from the timesaving, increased collaboration, and electronic retrieval of emdr data. Similarly, organizations will benefit from emdr in providing a Web-based, central point-of entry, resulting in significantly lower wait time between submissions and less chance of the human error factor that often accompanies manual processes. While not currently mandatory, the FDA has advised that acting now in the transition to emdr will enable organizations to benefit from FDA assistance in the implementation. Once more organizations begin to transition closer to the mandatory deadline, the FDA will have fewer resources to assist all participants. Conclusion This paper described how the FDA has taken the next step in increasing efficiency of electronic regulatory reporting through the implementation of the Electronic Submissions Gateway. This paper also discussed the benefits of implementing emdr, including Collaboration, Record Retention, and Responsiveness. It described the best practices of implementing a MedWatch Plus system, such as deciding which tool meets individual business needs, choosing a tool that will integrate with the FDA s Gateway and existing business practices, as well as a tool that can record and review data. emdr is proving to be a seamless solution for submitting reports directly through the FDA s portal and is able to increase efficiency and reliability in the process through automation. Organizations within the Life Sciences industry now have the ability to take advantage of the convenience of online reporting by integrating their Quality and Compliance Management Systems to the FDA s Gateway and reaping the benefits of real-time collaboration. About EtQ Founded on March 4, 1992 by former lead auditors of Underwriters Laboratories, EtQ has always had a unique knowledge of compliance processes related to GMP, Quality, Safety, and Environmental Health and Safety (EHS) Management. EtQ continues to be the leading FDA Compliance, Quality, Safety and EHS solution provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ encompasses a wide variety of industries, providing solutions for FDA Compliance, Quality, EHS, Aviation Safety, and Food Safety Management. EtQ uses best in class integrated modules and enterprise application integration to manage and measure these compliance processes and execute organizational change. EtQ s solution, Reliance, is an enterprise suite of modules designed to foster operational excellence in businesses with modules and utilities such as emdr, evalidator, Complaint Handling, Risk Management, CAPA, Document Control, Employee Training, Supplier Rating, FMEA, Audits, and many more. EtQ has been providing software solutions to a variety of markets for over 20 years. For more information, please visit Resources 1. Adverse Event Reporting News. 4 Dec Vol. V, No /11/ Federal Register. Vol. 73, No Thursday, October 23, Notices pdf. 2/13/ Individual Case Safety Report: 2/17/09.

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