Unretrieved Surgical Medical Device Notice from FDA

Sandy Grinnell

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This week the FDA issued a Public Health Notification to the healthcare community which to a lay person would seem to be pretty obvious. The Notice begins:

Dear Healthcare Practitioner:

This is to advise you of serious adverse events associated with unretrieved device fragments (UDFs) and provide recommendations to mitigate these events. A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties.

The notice goes on to describe the types of reactions a patient may have if a UDF is left inside. They include infections, perforations, blood vessel obstruction, even possible migration of the UDF during an MRI (that's a sacry thought!). Then there is a list of recommendations on how to prevent such occurences.

Don't get me wrong - I appreciate the FDA's concern with regard to these devices being left in unknowing patients. However, I would expect any physician, surgeon, or healthcare practitioner should already know the hazards of leaving any type of medical device inside the body and wouldn't need to hear it in a Public Health notice from the FDA.