The US medical device regulating authority, the FDA, terminated the Alternative Summary Reporting Program, used for reporting for over 10 years. Medical device manufacturers exempted from reporting were informed that they would also be required to submit reports.
Differences Between the Reporting Systems
According to the previously existing Alternative Summary Reporting System, medical device manufacturers could file quarterly summary reports informing the regulating authority on all events occurred during the reporting period. Information provided was not publicly available due to its form, which was the main reason of concern related to this reporting system. In fact, this system created an environment where there was no public access to the information on incidents with medical devices present at the market. At the same time, due to the importance of this information to the public health and safety of the patients, it should be available not only for the regulating authority, but for healthcare specialists and patients too.
To deal with imperfections of the reporting system existing previously, the FDA is going to extend the use of Manufacturer and User Facility Device Experience database (MAUDE). Since 2017 medical device manufacturers have to file the summary report on number of the incidents, but the information provided was relatively limited. According to the new requirements, medical device manufacturers would have to file a separate report on each incident related to their medical device production to the MAUDE database, which is publicly available. This would make incident reporting information available for all interested parties and increase transparency.
At the same time, special exemptions based on the type of medical device and the appropriate risk level would exist within the new reporting system. For such cases the regulating authority would apply the Voluntary Malfunction Summary Reporting Program. According to this program, medical device manufacturers producing low risk medical devices that are exempted from obligatory incident reporting, could file summarized reports for specified periods instead of reporting on specific events. The approach is aimed to simplify the reporting procedures for medical devices bearing relatively low potential risk to public health and safety of patients, allowing the regulating authority to focus on high risk regulatory issues. The information provided in the course of Voluntary Malfunction Summary Reporting Program would not be publicly available, just as it was with Alternative Summary Reporting System.
Summary of Changes
In accordance with recent regulatory changes, the Alternative Summary Reporting System no longer exists. Instead, two reporting procedures would be applied:
1. Filing information on each certain event to the MAUDE database to provide public access to the information on serious incidents
2. Voluntary Malfunction Summary Reporting Program providing that medical device manufacturers would file summarized reports directly to the regulating authority
It was also announced that the next step would be the implementation of National Evaluation System for health Technology to improve the access to the information on safety. This system would require the use of unique identification codes (UDI), so it will require more time to be implemented.
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