Theresa's profileHealth and Wellness News...BlogListsNetwork Tools Help

Blog


    November 01

    FDA's Device Adverse Events Database... Who Cares?

     
    Device group inefficiently uses adverse-event reports

    A new study from the HHS inspector general's office has found that while overall reporting of medical device adverse events increased significantly between 2003 and 2007, the Food and Drug Administration's Center for Devices and Radiological Health, or CDRH, has done an inadequate job of using those reports to detect and address product safety concerns.“We found that CDRH has not documented follow-up on adverse events, nor does it consistently read adverse-event reports for the first time in a timely manner,” wrote HHS spokesman Don White in an e-mail sent to reporters. “In addition, CDRH rarely acts when manufacturers and user facilities submit reports late.”

    Comments

    Please wait...
    Sorry, the comment you entered is too long. Please shorten it.
    You didn't enter anything. Please try again.
    Sorry, we can't add your comment right now. Please try again later.
    To add a comment, you need permission from your parent. Ask for permission
    Your parent has turned off comments.
    Sorry, we can't delete your comment right now. Please try again later.
    You've exceeded the maximum number of comments that can be left in one day. Please try again in 24 hours.
    Your account has had the ability to leave comments disabled because our systems indicate that you may be spamming other users. If you believe that your account has been disabled in error please contact Windows Live support.
    Complete the security check below to finish leaving your comment.
    The characters you type in the security check must match the characters in the picture or audio.

    To add a comment, sign in with your Windows Live ID (if you use Hotmail, Messenger, or Xbox LIVE, you have a Windows Live ID). Sign in


    Don't have a Windows Live ID? Sign up

    Trackbacks

    The trackback URL for this entry is:
    http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!1371.trak
    Weblogs that reference this entry
    • None