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Medical Devices and Foreign Material


All foreign material removed from within human tissue is generally sent for pathologic evaluation and documentation. These can include objects introduced due to trauma (e.g., bullets or shrapnel) or for medical treatment (e.g., implanted ventricular assist devices). Medical devices temporarily introduced for medical treatment, such as intravenous catheters, are generally not examined. Some of these specimens have legal significance (e.g., bullets) and others may be subject to legislation that requires the tracing of certain medical devices.

The Safe Medical Devices Act of 1990

The Federal Safe Medical Devices Act of 1990 (PL 101–629) went into effect in August 1993. This act requires manufacturers of medical devices, health care personnel who use or install them, and hospitals to keep records of patients and the history of specific medical device (“tracking”). This allows manufacturers to remove devices from the market and/or notify patients should problems arise. The subsequent Food and Drug Administration Modernization Act (FDAMA) in 1997 eliminated automatic mandatory tracking for certain devices.

The types of devices tracked include those with the following features:

  • If the device failed, it would be reasonably likely to have serious adverse health consequences.

  • The device is intended to be implanted in the human body for more than 1 year.

  • The device is intended to be life sustaining or life supporting.

A patient with a tracked device is allowed to refuse to release personal information for the purpose of tracking.

Pathologists play an important role in recognizing medical device associated complications. Reports of problems with medical devices can be made on forms available at the MedWatch home page at www.fda.gov/medwatch (accessed January 28, 2022). The medical device should be saved.

Current Devices Subject to Tracking Under the Safe Medical Devices Act

Permanently implantable devices:

  • Vascular graft prostheses (see Chapter 13 “Cardiovascular Specimens”)

  • Vascular bypass (assist) devices (see Chapter 13 “Cardiovascular Specimens”)

    Implantable pacemaker pulse generator

  • Cardiovascular permanent pacemaker electrode

  • Annuloplasty ring

  • Replacement heart valve (see Chapter 13 “Cardiovascular Specimens”)

  • Automatic implantable cardioverter/defibrillator (see Chapter 13 “Cardiovascular Specimens”)

  • Tracheal prosthesis

  • Implanted cerebellar stimulator

  • Implanted diaphragmatic/phrenic nerve stimulator

  • Implantable infusion devices

Life-sustaining or life-supporting devices:

  • Breathing frequency monitors (apnea monitors)

  • Continuous ventilator

  • CD-defibrillator and paddles

FDA-designated devices:

  • Silicone inflatable breast prosthesis (see Chapter 12 “Breast”)

  • Silicone gel-filled breast prosthesis (see Chapter 12 “Breast”)

  • Silicone gel-filled testicular prosthesis

  • Silicone gel-filled chin prosthesis

  • Silicone gel-filled angel chik reflux valve

  • Electromechanical infusion pumps

Breast implants are rarely associated with breast implant associated anaplastic large cell lymphoma (BIA-ALCL). All diagnoses of BIA-ALCL should be reported to the BIA-ALCL PROFILE registry, a collaborative effort of the Food and Drug Association (FDA), the American Society of Plastic Surgeons, and the Plastic Surgery Foundation ( https://www.thepsf.org/research/registries/profile ) (accessed January 28, 2022) as well as to the FDA (Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm (accessed January 28, 2022). Additional information on these specimens is available in Chapter 12 “Breast”.

Additional information about cardiac devices is available in the Chapter 13 “Cardiovascular Specimens”.

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