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FDA warns about device fragments

Device Regulation Alert: Safety, Compliance and Reimbursement News, January 21, 2008

On January 15, the FDA issued a Public Health Notification warning providers that pieces of medical devices may break off and remain in a patient after a procedure. The FDA defined such pieces as "unretrieved device fragments (UDFs)" that break apart from a medical device and are left behind in the patient.

The notification indicates the FDA has received "nearly 1,000 adverse event reports" relating to UDFs involving over 200 different devices. The FDA said the types of adverse events include:

• Infection
• Tissue reaction
• Damage to blood vessels
• Death

The FDA advised providers to take the following steps to avoid or deal with adverse events relating to UDFs:

• Use devices according to manufacturers' instructions
• Check devices for damage before and after procedures
• Keep damaged devices to help in any review following an adverse event
• When UDFs do break off, explain to the affected patient the risks of removing or leaving the UDF and describe the type of UDF and how to avoid further injury relating to the UDF
• Report any adverse events relating to UDFs even when reporting isn't mandatory

Click here to review the notification on the FDA's Web site.

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