Medical Device Regulation (MDR) datasets are the lifeblood of post market surveillance. Regulating medical devices with the help of accurate and complete data is paramount to improve device quality, reduce risk for patients, and ensure that we are meeting the standards set by governing bodies. Examples of governing bodies include the Food and Drug Administration in the United States, MedEffect Canada in Canada, The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and more.
While the vast majority of the information in these datasets originates with medical device manufacturers and distributors, the regulatory bodies above provide oversight into device approval and issue device recalls. Post-market adverse event reports, meanwhile, are collected from both mandated and voluntary reporters.
Mandated reporters are groups like manufacturers, device distributors, hospitals, outpatient diagnostic or treatment facilities, nursing homes, and ambulatory surgical facilities. Voluntary reports are made by health professionals, patients, or consumers of the medical devices.
This diverse group of reporters is both a blessing and a curse: on one hand, you have more sources of information, but on the other there is a lack of standardization, which leads to reporting bloat and data sprawl that make it that much harder to extract insightful information.
A Deep Dive into the MAUDE Dataset
Let’s dive deeper into a specific dataset from just one database. We can look at the MAUDE dataset from the FDA, the MAUDE dataset stands for the Manufacturer and User Facility Device Experience Dataset. This dataset is a collection of reports sent to the FDA that are created when something goes wrong with a medical device. They are reports around events that happened during use that lead to an unexpected outcome, or that strays from the Instructions for Use (IFU). These events can be adverse events or not, and if they are adverse events they can lead to patient injury or death.
The MAUDE dataset is used for post market surveillance by the regulatory or quality control teams of manufacturers. They use reports in the MAUDE dataset to make corrections or post market changes to the medical devices they manufacture. Those changes can be to the device itself, the software, or the instruction set around the device.
Who is Using These Datasets?
These datasets are used by all medical device companies because they are required to interface with to get approval in the markets that they regulate.
Medical Device companies are required to write reports to the Regulatory Agencies about the devices they are bringing to the market so they can be registered and categorized with the governing agencies and surveillance can be done on them.
Additionally after the devices come to market the human factors engineers of the medical device companies use the datasets to support post market surveillance and to fix issues that are found in the adverse events reports created by others.
What are the Challenges of Working with the MAUDE Database?
The core issues that are associated with the MAUDE database fall into 3 categories: data accessibility, data relevancy, and data usability.
The MAUDE database requires a lot of specialized information to access and be able to pull important information from it. Understanding things like the codes for products, how to use the advanced search, device classes and more. The online database search is clunky and feels like a library system from the 90s, making this rich dataset inaccessible to many people who haven’t already used it. Which limits its accessibility and adoption by other teams that may find the data useful to them.
In terms of relevancy, it is hard currently with the systems available to those using the database to easily find highly relevant information. You are able to narrow down the scope to, for instance, 10,000 reports, but then from there you have to go through and read the reports to understand if that report has any meaningful information or if that meaningful information is relevant to you which takes time when you could be doing more important work, such as making device changes or writing usability studies.
As far as usability issues, there are no high level ways to view that data in the online search, and it limits you to only look at 500 records, which may be fine for a product that doesn’t have a lot of reports but for something that has 1000s of reports a month that can be a drop in the bucket in terms of the reports you have to look through. You can access the information in its raw format but that requires additional technical skills and time to get that up and running to be usable to you or your organization.
Forging a New Path to Regulating Medical Devices with Hakkōda
By making this data more accessible, usable, and relevant to your organization and end users, we can enable you to make faster decisions when it comes to combating problems related to medical devices—ultimately saving lives and keeping people from being injured.
The issues of data accessibility, relevance, and usability can significantly impact the ability of medical device manufacturers, regulatory bodies, and healthcare professionals to make informed decisions. As an extension, compliance-related processes become unnecessarily complex, and throttle speed to market times for device manufacturers and distributors. Streamlining these aspects not only improves the quality of post-market surveillance but also has the potential to prevent adverse events and ultimately safeguard patient health.
Interested in shortening time to market by making device regulation data more accessible and relevant for your organization? Be on the lookout for future blogs from the Hakkoda healthcare and life sciences team, where we will explore strategic interventions in the device regulation space. You can also explore ways of streamlining operations by talking to one of our healthcare data experts today.
The post A Smarter Approach to Regulating Medical Devices: Addressing Data Accessibility, Usability, and Relevance to Improve Patient Outcomes appeared first on Hakkoda.