Lifting the Curtain on Alternate Summary Reports
FDA is ending the ASR program and data is now available. It’s time to take a look.
Under the Alternate Summary Reporting (ASR) program, FDA allowed medical device manufacturers to report certain “well-known and well-characterized” device related events in an alternate summary format instead of the individual medical device reports (MDR) otherwise required by regulations. The idea was to make it easier and more efficient to report low-risk, routine events in a summary format on a quarterly, semi-annual or annual basis depending on the type of exemption granted by the FDA.
The ASR program began in 1997, revised in 2017 and recently terminated amid intense media scrutiny of these reports “hidden” out of the public view. MDRs filed with the FDA are open to the public and searchable under the MAUDE database, but the ASR data files were excluded because of a different, incompatible format.
The good news is that all of the ASR data files going back to 1999 are now available on FDA’s website). It is a large data set with over a million individual reports of device related injuries and malfunctions. We have started looking into this data and plan to provide insights that will help all of us better understand this information.
As a starting point, the interactive chart below shows an overview of the initial reports filed in 2018. The bar graph on the top panel shows total ASRs classified as either a serious injury (I) or malfunction (M) by product codes. As an example, the highest number of reports were filed for product code DZE, which corresponds to a dental implant. In this chart, you can select a specific product code by clicking on the corresponding bar in the top panel to see specific details related to that product code in the bottom two panels. As an example, when you click on the bar for DZE, you can see the split between injuries and malfunctions in the bottom left panel and distribution by manufacturer in the bottom right panel. Click anywhere in the white space of the top panel to revert back to all product codes.
*Note: You may have to refresh your browser to see the interactive chart below.
Top product code DZE (dental implants) account for 75% of the total reports, nearly all of them for serious injuries. Other top product codes are FTR (silicone breast implant), OYC and LZG (insulin pumps) and OZO (automated insulin dosing). In all, the top 5 product codes account over 90% of the total reports.
Nearly 90% of the reports are related to serious injuries and only about 10% account for malfunctions. In the entire 2018 data file, there is only one case of a malfunction where a death was reported. This corresponded to a Paradigm brand insulin dosing pump (Product code – OZO). Note that such events, where a patient death may be associated with a device malfunction, were supposed to be excluded from ASR eligible events. It seems that manufacturers did not strictly adhere to this exclusion. In such cases, FDA’s “standard practice” was to follow up with the manufacturer to seek additional information, and to require a corrected supplemental report if the original event was reported in error. If the original report was correct, then the expectation was to require the more traditional individual MDR. It is not clear if this follow up and correction always occurred, and it will be interesting to see the frequency of such ineligible reporting in prior year’s ASRs.
There were serious concerns about public access and transparency of millions of ASRs reported through two decades of this program since this information was not included in the MAUDE database. In particular, safety concerns around breast implants and surgical staplers widely reported in the media led to additional FDA inquiry and actions related to these devices.
An important question to ask is whether manufacturers included this data in their post-market safety surveillance process to evaluate if there were any changes to the risk profile of their devices and if additional actions should have been taken. This is a key requirement of ISO 14971, the international standard for medical device risk management, but not always effectively practiced in the industry.
The ASR data files have a lot of good information and we will be looking into it further. In the meantime, let us know if you have specific questions that we should consider in our analysis. Please share in your comments below.