Counterfeit goods circulating through the supply chain are always a cause for concern. But, if any products that are consumed or put into a human body are found to be phony, they are never taken lightly. Bootleg medicines and meat with counterfeit labeling can cause widespread illness and compromise the integrity of the supply chain.
Implantable medical devices in the supply chain haven't always received the attention they deserve from authorities. Though, if they're made with imitation components, they could either not work properly, causing more issues for patients, or pose a threat to patients' health.
In order to more efficiently combat the distribution of these devices, four U.S. Senators have urged the Food and Drug Administration to use a better method of tracking them. The proposed legislation, "Ensuring Safe Medical Devices for Patients Act," calls for a system of unique device identifiers for implantable devices to go into effect by the end of 2012.
"Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them," bill co-sponsor Senator Herb Kohl (D-Wisconsin) said in a statement.
"Innovative technology has provided valuable, life-saving medical devices that have prolonged life and reduced suffering, but the drive toward getting new technologies to market shouldn’t be done at the risk of patient safety. This legislation will help achieve that needed and delicate balance between safety and innovation."
Senator Jeff Merkley (R-Oregon), also a co-sponsor of the bipartisan proposal, explained in a statement that when patients need a hip replacement or cardiac stent, shouldn't need to be concerned that the device is defective. With the identifier system, patients and doctors can quickly identify and locate substance devices and make the appropriate adjustments.
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