In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices.
The agency said it now includes new adverse-event summaries, the number of events, and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database (MAUDE).
The FDA also recently added a data field called “patient problem code,” an outcome code assigned to an adverse event. This has been available in drug reports but the device division redacted them from public view in the past, according to patient safety advocate Madris Tomes.
By the end of 2020, MAUDE data for previously submitted adverse-event reports will be updated to include this information in these newly-available data fields, the agency said today. The FDA expects submitters to use these new data fields by February 28, 2021, in place of entering the information in narrative sections of its Form 3500A, a voluntary reporting document.
These fields will help identify adverse-event reports that are related to exemptions the FDA has granted to manufacturers, allowing them to report similar events grouped together in “alternative summary reports” rather than individually. Investigations into the practice of allowing such summary reports to document multiple adverse events related to the same device — and keep them from the public — have raised public outcry.
It remains unclear whether the patient problem codes for 5.8 million alternative summary reports submitted from 1997 through 2019 will be made available as well, according to Tomes, CEO of Device Events and a former FDA public health analyst.
“This is critical information as the summary reports do not contain a narrative,” she said in an email to MassDevice. “Without patient problem codes, there is virtually no way to determine what happened in those 5.8 million adverse events.”
The agency also said it updated the MAUDE database to supplement previously submitted adverse-event reports related to registry exemptions with more detailed information on individual events.
“The addition of these data in comma-separated values (CSV) format in public MAUDE, along with additional resources to understand and make use of this information, will allow the public to more easily analyze these events,” the agency said on its website. “The FDA is also actively working to improve usability of the MAUDE database in the next few years as part of a broader effort to modernize CDRH’s information technology systems, furthering our efforts to increase transparency in medical device reporting as part of the Digital Transformation Initiative.”
Tomes praised the agency for adding transparency to its adverse-event reporting data, but said more could be done.
“Variances and exemptions to MDR reporting have been granted to certain firms, and there has never been a public forum to view which devices and companies were granted these exemptions,” she said. “Making them available in MAUDE is helpful only if there is some way for the user to know what they are looking for. In addition, some companies have been granted exemptions but the data was not included in the FDA’s data release. There is no way to know they exist without detailed analysis of (adverse event reports).”
The FDA has granted exemptions in the past for the DaVinci surgical robot, surgical mesh and the Medtronic Infuse bone graft without releasing data for them, Tomes noted. “This indicates there are additional types of exemptions that have not been well-defined to the public,” she said.
Device manufacturers, importers and users can still request an exemption or variance from any or all of the agency’s statutory medical device reporting requirements. If it grants the exemption or variance, the FDA will permit deviations from certain aspects of its reporting requirements. The agency may also impose specific reporting conditions beyond those listed in its regulations, including:
- Specific devices covered by the exemption, variance or alternative form of adverse-event reporting.
- Contents of the subsequent reports.
- Timeframes or mechanism for submitting these reports, or other reporting aspects.
The FDA may also revoke or modify an exemption, variance, or alternative to protect public health.The agency concluded that it will make public, through MAUDE, “releasable” adverse-event information submitted as part of a reporting exemption, variance, or alternative. It did not define “releasable.”