Surgery May Leave More Than A Scar
The FDA has recently issued a public heath notification alerting healthcare practitioners of the dangers associated with unretrieved device fragments (UDFs) unintentionally left behind after surgery. The UDF is a fragment of a medical device, for example, a screw, wire, or broken needle.
According to the FDA, over 1,000 adverse event reports have been received by the Centers for Devices and Radiological Health (CDRH) concerning UDFs, which have included fragments from over 200 different medical devices or instruments. Since 2003, over 72 deaths and 4,675 injuries caused by UDFs have been reported to the CDRH database responsible for tracking adverse events.
Doctors are often hesitant to tell patients about UDFs because the UDF may not be cause for concern or the removal of the UDF may not be worth the medical risk. However, patients who are unaware of a UDF often become confused and concerned when that UDF causes problems later in life. The patient may suffer from "local tissue reaction, infection, perforation and obstruction of blood vessels, and death" if the UDF is not revealed and removed if possible.
The FDA recommends clinicians to:
- "Use medical devices in accordance with their labeled indications and the manufacturer’s instructions for use, especially during insertion and removal.
- 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.
- Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.
- If the device is damaged, retain it to assist with the manufacturer’s analysis of the event.
- Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs. leaving the fragment in the patient.
- 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;
- 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."
For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.