In June 2019, the FDA formally ended the Alternative Summary Reporting (ASR) Program and revoked all such exemptions, now making all reports received under ASR exemptions from 1999 to 2019 available. The extensive database of ASR incident reports regarding medical device malfunctions was previously hidden from public review.
Th FDA announced the end of the ARS program in June 2019, stating “ASR reports were not made publicly available because they were not submitted in a format compatible with the public database.” The previously hidden ARS reports are now available for public view.
The FDA stated in announcing termination of the ARS program:
“The Alternative Summary Reporting (ASR) Program was in effect from 1997 through June 2019. By law, manufacturers may request exemptions, variances or alternatives to reporting requirements under 21 CFR 803.19. Under this provision, the FDA has allowed alternative summary reports (ASRs) for specific well-known and well-characterized events associated with specific devices.
It is important to note that data in ASRs are subject to the same limitations as MDR data in MAUDE; they are based on the same threshold for reporting and differ in format. This passive reporting system relies on information provided by users of the devices and other sources, and therefore some information about certain events may be missing, inaccurate, or unverified. Manufacturers are responsible for following up to obtain missing information, but it is not always possible to track down details of an event. Therefore, some fields in both MAUDE and ASR reports may be blank. Like all MDR data in MAUDE, MDR data in ASR reports cannot be used to determine rates of adverse events due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. In addition, the number of events may fluctuate over time for a variety of reasons that do not reflect a change in the actual rate of the events, such as changes in technology that impact rate of use in clinical practice, changes in a firm’s reporting processes, and following a public communication or media reports about a technology. Moreover, the presence of an event or multiple events does not necessarily mean there is a problem with a device. Often additional investigation and data collection are necessary to make that determination.
ASR exemptions excluded events where the device may have caused or contributed to a patient death from being submitted in ASRs, except for sudden death associated with cardiac arrest for certain surgical heart valves when the device had been implanted for at least five years and the event did not necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.
When an ineligible event was reported through an ASR, the FDA’s standard practice has been to contact the manufacturer to obtain additional information regarding the event. If the event was labeled in error, the manufacturer was asked to submit a supplemental ASR to correct it. If an event was ineligible for reporting as an ASR, the FDA’s standard practice was to require the manufacturer to submit an individual report in MAUDE for the event. In some cases, the FDA revoked ASR exemptions following continued reporting of ineligible events in ASRs.
In some cases, manufacturers also submitted supplemental ASRs providing additional information, such as following an investigation into an event. The supplemental ASRs may include only new information; fields where information did not change from the original ASR may be blank. Both original and supplemental ASRs are posted on our website. Supplemental reports are identified, and caution should be taken so as not to count the same events twice when they appear in both a supplemental and original report.
ASR reports were not made publicly available because they were not submitted in a format compatible with the public database. The FDA recognized the public interest in this information and modified the conditions of the ASR Program in 2017 to require submission of a companion report on the official mandatory reporting form. The companion report included the total number of events being summarized in the quarterly report through the ASR Program and is available publicly in the MAUDE database. When both an ASR and companion report were submitted, the same events were captured in both systems. Therefore, adding events from ASR and companion reports will result in some double counting.
The … files contain ASR data by reporting year, comprising over six million records in total over the last 20-plus years. Each file is large and contains all ASRs received for that year.” (emphasis added)
If you or a loved one suffered harm due to a medical device or implant in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
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