Unretrieved Device Fragments Linked to 1000 Injuries Every Year, FDA WarnsJan 15, 2008 | Parker Waichman LLP
Unretrieved Device Fragments are causing serious injuries to patients, the Food & Drug Administration (FDA) reported today. According to the FDA public health advisory, an Unretrieved Device Fragment is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to Unretrieved Device Fragments. According to the FDA, these have included more than 200 different medical devices and numerous medical specialties.
The issue of Unretrieved Device Fragment injuries is separate from the problem of injuries caused by surgical instruments left in patients’ bodies. Every year about 1,500 people in the United States leave the hospital after surgery with surgical objects still inside them. Surgical objects can include everything from tweezers to clamps and sponges.
Very often, patients are unaware that an Unretrieved Device Fragment might be responsible for problems. However, Unretrieved Device Fragments can cause some very serious injuries. According to the FDA, Unretrieved Device Fragments have caused local tissue reaction, infection, perforation and obstruction of blood vessels, and even death. Contributing factors to such injuries include biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy. During MRI procedures, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns.
To avoid problems with Unretrieved Device Fragments, the FDA has warned healthcare practitioners 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; and procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments.
The FDA said that following these recommendations could reduce the possibility of a serious injury from an Unretrieved Device Fragment.