Unretrieved device fragments

AORN Journal, May, 2008 by Sheila Mitchell

QUESTION: Recently during a procedure, an instrument broke off in a patient and a metal fragment was lost in the patient. The surgeon was not able to retrieve the fragment and decided to leave it in rather than further traumatize tissue and unnecessarily lengthen the surgical time. What are the consequences for leaving the fragment in the patient? Are there rules requiting disclosure of the information to the patient? Are there regulatory reporting requirements for when a portion of an instrument breaks off in a patient during a procedure?

ANSWER: The US Food and Drug Administration (FDA) requires health care organizations to report deaths and serious injuries associated with the use of medical devices. In January 2008, the FDA advised health care professionals of serious adverse events associated with unretrieved device fragments (UDFs). The FDA defines a UDF as a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Consequences of concern for the patient are that during magnetic resonance imaging (MRI) procedures, magnetic fields may cause metallic fragments to migrate, and radio-frequency fields may cause them to heat, resulting in internal tissue damage or bums. (1)

The FDA Center for Devices and Radiological Health receives nearly 1,000 adverse event reports each year related to UDFs. (1)

   The adverse events reported included local
   tissue reaction, infection, perforation and obstruction
   of blood vessels, and death. Contributing
   factors may include biocompatibility
   of the device materials, location of the
   fragment, potential migration of the fragment,
   and patient anatomy. (1)

The FDA recommendations for preventing and reporting UDFs include the following:

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 [UDFs], including the following information:

a. the material composition of the fragment (if known);

b. the size of the fragment (if known);

c. the location of the fragment;

d. the potential mechanisms for injury, (eg, migration, infection);

e. 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.

If you suspect that a reportable adverse event was related to an unretrieved device fragment, you should follow the reporting procedure established by your facility. (1)

The full FDA alert on UDFs can be accessed at http://www.fda.gov/cdrh/safety/011508-udf.html.> Accrediting organizations also may have reporting requirements for UDFs. Health care organizations accredited by the Joint Commission are required to establish a policy that defines reportable sentinel events. Adverse events resulting in death or return to surgery to remove the foreign object are considered sentinel events. Hospitals are encouraged, but not required, to report any sentinel event to the Joint Commission. (2)

Recognizing and reporting sentinel events allows an organization to:

* have a positive impact in improving patient care, treatment, and services and preventing sentinel events;

* focus attention on understanding the causes that underlie the event and on changing the organization's systems and processes to reduce the probability of such an event in the future; and

* increase general knowledge about sentinel events, their causes, and strategies for prevention. (2)

Inspecting surgical instruments for proper working order after decontamination is an effective strategy for identifying potential damage to instruments that may result in fragmentation during use. (3)

Health care professionals are encouraged to maintain public confidence by communicating with patients regarding their treatment and outcomes. Organizations are held accountable for informing patients of their rights when they enter into the health care system. In the case of UDFs, the organization should have a system established for informing the patient about the outcomes of care and treatment so that the patient can participate in current and future health care decisions. (4)

REFERENCES

(1.) FDA public health notification: unretrieved device fragments. US Food and Drug Administration. Center for Devices and Radiological Health. http://www .fda.gov/cdrh/safety/011508-udf.html. Accessed March 9, 2008.

(2.) Sentinel events policy and procedures. The Joint Commission. http://www.jointcommission.org /NR/rdonlyres/F84F9DC6-A5DA-490F-A91F-A9 FCE26347C4/0/SE_chapter_july07.pdf. Accessed March 9, 2008.