A medical device labeled with "Medtronic Adapta ADDRO1, DDR, Deidentified Serial number, and USA." The specimen is for gross examination only.
Please note that it is important to get a photograph of a readable brand name and serial number for identification of medical devices or surgical hardware.
All foreign material removed from humans, whether of medical origin or not, is generally sent to pathology for documentation (except for temporary medical devices such as intravenous catheters). Some of these specimens will be of legal significance (e.g., silicone implants or bullets), and others will be subject to legislation that requires the tracing of certain medical devices.
The Safe Medical Devices Act (SMDA) went into effect in August 1993. This act requires that certain medical devices used after this date must be tracked by the manufacturer as well as by physicians and hospitals. Current information about implants can be found on the
U.S. Food & Drug Administration website.The types of devices tracked include those with the following features:
- If the device is likely to have serious adverse health consequences should it fail.
- If the device is intended to be implanted in the human body for more than one year.
- If the device is intended to be life-sustaining or life-supporting.
