Tuesday, March 20, 2012

Public wants strong medical device oversight

Poll: Public wants strong medical device oversight:

" . . . 71 percent of the poll respondents said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

Ninety-four percent of poll respondents indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.

Similarly, 95 percent of respondents said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law."

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