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No salte el excedente de los procedimientos que el dispositivo médico nuevo se preocupa, el FDA dice

por Brendon Nafziger, DOTmed News Associate Editor | December 29, 2011
How worried should you be about getting sick from an inadequately sanitized, reusable medical device, such as an endoscope? Not very, according to a new consumer update from the Food and Drug Administration.

Posted Wednesday, the alert said disease transmission from the devices was "extremely rare" and the risk wasn't large enough for patients to "cancel or delay your plans."

The reassurances come as the FDA launched a consumer-focused website on the issue, part of the agency's broader program to tackle problems surrounding reprocessed medical devices.

In late April, the FDA published draft guidance that advises manufacturers on how to make reprocessing instructions easier to follow. And in June, the FDA held a workshop on the subject with providers, device makers and patient advocates.

Still, even if the risks are low, they're certainly not non-existent. In its study on endoscopes, the FDA found about 80 cases of inadequate reprocessing over a three-year period, which were linked to 28 infections. Of course, that should be put in perspective: endoscopes are used in nearly 10 million medical procedures a year.

The FDA does suggest patients get involved, though. One attendee at the June meeting, Dr. Frank Nemec, a gastroenterologist from Las Vegas, recommended patients ask their doctors what steps the health facility had taken to prevent contamination from reused devices, according to the recent update.

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