Medical Devices Fragments Left Behind After Surgery
February 21st, 2008 joshua
The Food and Drug Administration recently sent a letter to physicians warning of unretrieved device fragments.
Earlier this month we reported on this blog about the nearly 1,000 incidents a year when a medical device, or at least part of one, is left inside a patient’s body. Patients are often not aware of this medical gaffe, but the complications from it could be severe.
Reactions to this accident include tissue reaction, infection, perforation, obstruction of blood vessels and death. To try and mitigate these incidents, the FDA is encouraging doctors to follow guidelines.
1. Use medical devices in accordance with their labeled indications and the manufacturer’s instructions for use, especially during insertion and removal.
2. Inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.
3. Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.
4. If the device is damaged, retain it to assist with the manufacturer’s analysis of the event.
5. Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs. leaving the fragment in the patient.
6. Advise the patient of the nature and safety of unretrieved device fragments including the following information: The material composition of the fragment (if known); the size of the fragment (if known); the location of the fragment; the potential mechanisms for injury, e.g., migration, infection; and procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments. This may help to reduce the possibility of a serious injury from the fragment.
