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Monday, August 7, 2017

Update on "8." and MAUDE Patient Outcomes

I have previously posted about the FDA's adverse events database for medical devices (known as MAUDE). In past years, the MAUDE database had captured patient outcome information (whether the patient died, was hospitalized, suffered some form of disability, etc.).

The database no longer reports patient outcomes (it stopped doing so in late 2015). Instead, the database field that should contain outcome data contains the cryptic entry of "8." (the number 8 with a period). I recently contacted the FDA, asking why MAUDE no longer provided patient outcome data. I received the following responses (thus far). I've edited out identifying information (and superfluous text).

This is from an email dated 28 July 2017. It's moderately encouraging. In particular, it's encouraging to know that the patient outcome information  is _still_ captured, and it will probably be added back to the database once they determine what the error is.

I will post updates as they develop.

 Dear Dr. Danese,
Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) xxxxxxx@fda.hhs.gov e-mail account. As far as I am aware, patient outcome information is still collected on so adverse event reporting forms. So, at this time I am not clear on why this information is not included in the data sets for 2015 and beyond. I am in the process of researching the issue and contacting the medical device reporting staff. I apologize for the delay but hope to have an answer for you next week. .... Sincerely, xxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx Division of Industry and Consumer Education Office of Communication and Education Center for Devices and Radiological Health U.S. Food and Drug Administration
I then received a follow-up email on 4 August (Friday)
Dear Dr. Danese, 
Thank you for your patience while I looked into your inquiry. I have spoken with a member of the Information Analysis Branch and it seems some of the patient outcome information may have been inadvertently excluded from the downloadable zip files. xxxxxx has kindly agreed to look into this issue to figure out what happened and how the problem may be corrected. Please feel free to contact xxxx directly. xxxxx name is xxxxxxxxxxxxxx and xxxxx email address is xxxxxxxx@fda.hhs.gov. I hope you have a pleasant weekend. Sincerely, 
xxxxxxxxxxxxxxxxxxxxxxxxxxx 
xxxxxxxxxxxxxxxxxxxxxxxxxx
Division of Industry and Consumer Education Office of Communication and Education Center for Devices and Radiological Health U.S. Food and Drug Administration
And then this email from the Information Analysis Branch (dated 7 August)
Paul, I was notified of the issue by xxxxxx on Friday, and we are currently investigating. We will get back to you when we know more. Thank you. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Information Analysis Branch Division of Post Market Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological HealthUS Food & Drug Administration